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Objective: To evaluate the cost-effectiveness and budget impact of using standard care (no advanced treatment, NAT) compared with an advanced treatment (AT), dehydrated human amnion/chorion membrane (DHACM), when following parameters for use (FPFU) in treating lower extremity diabetic ulcers (LEDUs). Method: We analysed a retrospective cohort of Medicare patients (2015–2019) to generate four propensity-matched cohorts of LEDU episodes. Outcomes for DHACM and NAT, such as amputations, and healthcare utilisation were tracked from claims codes, analysed and used to build a hybrid economic model, combining a one-year decision tree and a four-year Markov model. The budget impact was evaluated in the difference in per member per month spending following completion of the decision tree. Likewise, the cost-effectiveness was analysed before and after the Markov model at a willingness to pay (WTP) threshold of $100,000 per quality adjusted life year (QALY). The analysis was conducted from the healthcare sector perspective. Results: There were 10,900,127 patients with a diagnosis of diabetes, of whom 1,213,614 had an LEDU. Propensity-matched Group 1 was generated from the 19,910 episodes that received AT. Only 9.2% of episodes were FPFU and DHACM was identified as the most widely used AT product among Medicare episodes. Propensity-matched Group 4 was limited by the 590 episodes that used DHACM FPFU. Episodes treated with DHACM FPFU had statistically fewer amputations and healthcare utilisation. In year one, DHACM FPFU provided an additional 0.013 QALYs, while saving $3,670 per patient. At a WTP of $100,000 per QALY, the five-year net monetary benefit was $5003. Conclusion: The findings of this study showed that DHACM FPFU reduced costs and improved clinical benefits compared with NAT for LEDU Medicare patients. DHACM FPFU provided better clinical outcomes than NAT by reducing major amputations, ED visits, inpatient admissions and readmissions. These clinical gains were achieved at a lower cost, in years 1–5, and were likely to be cost-effective at any WTP threshold. Adoption of best practices identified in this retrospective analysis is expected to generate clinically significant decreases in amputations and hospital utilisation while saving money. [ABSTRACT FROM AUTHOR]

To explore the effect of acellular dermal matrix therapy on neuropathy and foot function in patients with diabetic foot syndrome and lower extremity arteriosclerosis occlusion. The 80 patients with diabetic foot syndrome and arteriosclerosis occlusion of the lower extremities who were admitted to our hospital from May 2017 to May 2020 were divided into two groups, observation group and control group. Patients in the control group were given conventional intervention combined with intracavitary treatment of lower extremity arteries, while the observation group was given acellular dermal matrix treatment on the basis of the control group. The differences of TCSs score, nerve conduction velocity, foot function, treatment effect, wound infection rate, treatment cost and complication rate between the two groups before and after treatment were analyzed. After treatment, TCSS score and foot function score of observation group were lower than control group, and nerve conduction velocity was faster than control group, the difference was statistically significant (P<0.05). The total effective rate, the incidence of wound infection and the incidence of complications in the observation group were 100.00%, 2.50% and 2.50%, respectively, while those in the control group were 80.00%, 17.50% and 55.00%, respectively. The hospitalization cost in the control group was higher than that in the observation group, with statistical significance (P<0.05). Acellular dermal matrix therapy has a definite relieving effect on neuropathy in patients with diabetic foot syndrome combined with lower extremity arteriosclerosis occlusion, especially on the function of the foot, and it is worthy of widespread clinical use. [ABSTRACT FROM AUTHOR]

Objectives: This study compared two surgical techniques using acellular dermal matrix (ADM) for the treatment of multiple gingival recessions. Material and methods: Twenty patients, with bilateral RT1 gingival recessions, were selected. One side received a modified extended coronally advanced flap (MECAF), and the contralateral side a supra-periosteal flap (TUN). The evaluated parameters were probing depth (PD), relative clinical attachment level, gingival index, gingival recession height (GR), width of keratinized tissue, keratinized tissue thickness, and gingival recession area at baseline and 6 months postoperative. Pain was evaluated weekly, using a visual analog scale (VAS) during first month postoperative. Results: Both groups were effective in reducing GR (ΔGR: MECAF 2.28 mm; TUN 1.93 mm), without significant differences. The % of root coverage was numerically superior favoring MECAF (MECAF 61.24%; TUN 56.07%), without significant differences between groups. VAS scale failed to provide differences between groups. Conclusions: Both treatment were effective in root coverage and might be valuable for the treatment of multiple gingival recessions. The use of vertical releasing incisions and a flap design including the papillae did not hamper root coverage. Clinical relevance: This study compared two techniques for use of ADM in large multiple gingival recessions. Within its limitations, both treatments successfully achieved root coverage and were able to reduce gingival recession. It is expected a partial root coverage when using these techniques in large gingival recessions. The study failed to provide significant differences between groups. The use of modified extended coronally advanced flap may be advisable for the treatment of multiple gingival recessions, specially involving large defects when using ADM, to avoid early matrix exposure. [ABSTRACT FROM AUTHOR]

Background: Both mesenchymal stromal cells (MSCs) and acellular dermal matrices (ADMs) represent fascinating therapeutic tools in the wound healing scenario. Strategies aimed at combining these two treatment modalities are currently under investigation. Moreover, scarcity of quantitative, nondestructive techniques for quality assessment of engineered tissues poses great limitations in regenerative medicine and collagen autofluorescence‐based imaging techniques are acquiring great importance in this setting. Objective: Our goals were to assess the in vitro interactions between ADSCs and ADMs and to analyze extracellular‐matrix production. Methods: Adipose‐derived MSCs (ADSC) were plated on 8‐mm punch biopsies of a commercially available ADM (Integra®). Conventional histology with hematoxylin‐eosin staining, environmental scanning electron microscopy, and confocal‐laser scanning microscopy were used to obtain imaging of ADSC‐seeded ADMs. Collagen production by ADSCs was quantified by mean fluorescence intensity (MFI), expressed in terms of positive pixels/field, obtained through ImageJ software processing of three‐dimensional projections from confocal scanning images. Control conditions included: fibroblast‐seeded ADM, ADSC‐ and fibroblast‐induced scaffolds, and Integra® alone. Results: ADSCs were efficiently seeded on Integra® and were perfectly incorporated in the pores of the scaffold. Collagen production was revealed to be significantly higher when ADSCs were seeded on ADM rather than in all other control conditions. Collagen autofluorescence was efficiently used as a surrogate marker of ECM production. Conclusions: Combined therapies based on MSCs and collagenic ADMs are promising therapeutic options for chronic wounds. Not only ADSCs can be efficiently seeded on ADMs, but ADMs also seem to potentiate their regenerative properties, as highlightable from fluorescence confocal imaging. [ABSTRACT FROM AUTHOR]

Approximately 60% of implant-based breast reconstructions (IBBR) are performed with an acellular dermal matrix (ADM), for which, reliable, good quality long-term outcome data is limited. In a retrospective multicentre cohort study, we aimed to determine long-term aesthetic and quality of life outcomes of IBBR with ADM (Strattice™) compared to a submuscular technique. Capsular contracture (Baker III/IV capsule) was determined by clinical examination by an independent researcher. Quality of life was assessed using BREAST-Q and aesthetic outcome by photographic assessment from a breast surgeon, breast care nurse and lay person, blinded to reconstruction type. We recruited 117 (51 bilateral) patients with ADM reconstructions, median follow-up 62 months (range 29–113) and 49 patients (16 bilateral) with submuscular reconstructions, median follow-up 76 months (range 38–111). 17 (10.1%) ADM reconstructions were Baker 3/4 compared to six (9.2%) submuscular (p = 0.85). Of the Baker 1/2 reconstructions six (3.6%) ADM and eight (13.6%) submuscular had previously undergone revision surgery to correct capsular contracture (p = 0.01). Combining both findings gave an estimated rate of capsular contracture of 13.6% in the ADM group and 21.2% in the submuscular (p = 0.14). A higher mean score for satisfaction with breasts was demonstrated when comparing ADM to submuscular (62 and 55, respectively; p = 0.01) but no significant difference in other BREAST-Q domains. The mean 'general satisfaction' score was higher in the ADM group for all three photograph assessors. This study provides evidence of improved aesthetic outcome and reduction in capsular contracture with ADM reconstruction when compared to submuscular, consistent over long-term follow-up. [ABSTRACT FROM AUTHOR]

Background: The effectiveness of different acellular dermal matrices (ADM) used for implant-based reconstruction immediately following mastectomy is an important clinical question. A prospective randomized clinical trial was performed to evaluate the superiority of DermACELL over Alloderm-RTU in reducing drain duration. Methods: Patients undergoing mastectomy with subpectoral immediate and permanent implant-based breast reconstruction were randomized to Alloderm-RTU or DermACELL. The primary outcome was seroma formation, measured by the duration of postoperative drain placement. Secondary outcomes included: post drain removal seroma aspiration, infection, redbreast syndrome, wound dehiscence, loss of the implant, and unplanned return to the operating room. Results: 62 patients were randomized for 81 mastectomies (41 Alloderm-RTU, 40 DermACELL). Baseline characteristics were similar. There was no statistically significant difference in mean drain duration (p = 0.16), with a trend towards longer duration in the Alloderm-RTU group (1.6 days; 95%CI, 0.7 to 3.9). The overall rate of minor and major complications were statistically similar between the two groups; although patients with Alloderm-RTU had 3 times as many infections requiring antibiotics (7.9% vs. 2.5%) with a risk difference of 5.4 (95%CI −4.5 to 15.2), and twice as many unplanned returns to the operating room (15.8% vs. 7.5%) with a risk difference of 8.3 (95% CI −5.9 to 22.5) as DermACELL. Conclusion: This is the first prospective randomized clinical trial comparing the two most commonly used human-derived ADMs. There was no statistically significant difference in drain duration, minor, or major complications between DermACELL over Alloderm-RTU in immediate subpectoral permanent implant-based breast reconstruction post-mastectomy.

Background Polyurethane implants have been used on and off in breast reconstruction since 1991 while prepectoral breast reconstruction has gained popularity in recent times. In this study, we present our outcomes from the use of acellular dermal matrix (ADM) complete wrap with polyurethane implants in prepectoral breast reconstruction. Methods This is a retrospective review of prospectively maintained database from 41 patients receiving complete ADM wrap with prepectoral polyurethane implants over a 3-year period. Selection criteria were adapted from a previous study (4135 Trust Clinical Audit Database) evaluating prepectoral reconstruction with Braxon matrices. Patient demographics, operative data, surgical complications, and outcomes were collected and analyzed. Results A total of 52 implant reconstructions were performed in 41 patients with a mean follow-up of 14.3 months (range, 6–36 months). The overall reported complication rates including early (less than 6 weeks) and late complications. Early complications included two patients (4.9%) with wound dehiscence. One of which had an implant loss that was salvageable. Another patient (2%) developed red-breast syndrome and two women (4.9%) developed with seroma treated conservatively. Late complications included one patient (2%) with grade II capsular contraction, 12 patients with grade I-II rippling and two patients (4.9%) with grade III rippling. Conclusions We present our experience of prepectoral polyurethane implant using complete ADM wrap. This is one of the few papers to report on the outcome of the prepectoral use of polyurethane in immediate implant-based breast reconstruction. Our early observational series show satisfactory outcome and long-term results are warranted by a large multicenter study.

Extracellular matrix (ECM) material with good biological activity is essential to simulate cell growth microenvironment, induce cell infiltration and angiogenesis, and promote the repair of large area acute skin wound. In this study, tilapia skin acellular dermal matrix (TADM) was prepared to simulate ECM microenvironment, which can promote substantial area acute wound healing in rats. The main component of TADM is type I collagen, which has good physical and chemical properties, biological activity and cell adhesion. TADM is a form of biomaterial with low immunogenicity, low risk of prion infection and lower economic cost than other related materials such as mammalian collagen biomaterials. Our results show that TADM can guide cell infiltration, angiogenesis, regulate the expression and secretion of inflammatory and skin repair correlated factors to promote tissue healing.

BackgroundPatients with chronic injuries of the proximal hamstring can develop significant impairment because of weakness of the hamstring muscles, sciatic nerve compression from scar formation, or myositis ossificans.PurposeTo describe the surgical outcomes of patients with chronic injury of the proximal hamstrings who were treated with hamstring repair and sciatic neurolysis supplemented with nerve wrapping with acellular dermal matrix.Study designRetrospective case series; Level of evidence, 4.MethodsFifteen consecutive patients with a diagnosis of chronic complete proximal hamstring rupture or chronic ischial tuberosity apophyseal avulsion fracture (mean age, 39.67 years; range, 14-69 years) were treated with proximal hamstring repair and sciatic neurolysis supplemented with nerve wrapping with acellular dermal matrix. Nine patients had preoperative sciatica, and 6 did not. Retrospective chart review recorded clinical outcomes measured by the degree of pain relief, the rate of return to activities, and associated postoperative complications.ResultsAll 15 patients were followed in the postoperative period for an average of 16.6 months. Postoperatively, there were 4 cases of transient sciatic nerve neurapraxia. Four patients (26%) required postoperative betamethasone sodium phosphate (Celestone Soluspan) injectable suspension USP 6 mg/mL. Among the 9 patients with preoperative sciatica, 6 (66%) had a good or excellent outcome and were able to return to their respective activities/sports; 3 (33%) had persistent chronic pain. One of these had persistent sciatic neuropathy that required 2 surgical reexplorations and scar excision after development of recurrent extraneural scar formation. Among the 6 without preoperative sciatica, 100% had a good or excellent outcomes and 83% returned to their respective activities/sports. Better outcomes were observed in younger patients, as the 3 cases of persistent chronic sciatic pain were in patients older than 45 years.ConclusionThis study suggests that when used as an adjunct to sciatic neurolysis, nerve wrapping with acellular dermal matrix can be a safe and effective method of treating younger patients with and preventing the development of sciatic neuropathic pain after chronic injury of the proximal hamstrings.

Immediate direct-to-implant breast reconstruction with acellular dermal matrix (ADM) is the method of choice for many plastic surgeons and patients, but the use of ADM remains a controversial subject in the literature. This study aimed to investigate complications, reconstructive failure and possible risk factors in direct-to-implant breast reconstruction with ADM (primarily Strattice™). We retrospectively examined all patients undergoing immediate direct-to-implant breast reconstruction with ADM, during a five-year period (2014–2019) at a university clinic. Study outcomes were all complications and explantations. Complications were stratified within and after 6 months postoperatively and subcategorized by type of intervention. Explantations were subcategorized into loss of implant or salvage with immediate insertion of a tissue expander, the same or a new implant. We included 154 patients and 232 breasts. Complications within 6 months per patient included hematoma (4%), seroma (8%), infection (9%), necrosis, wound dehiscence and delayed wound healing (19%). The total complication rate per patient was 34%. Explantation occurred in 20 patients (13%) of which 9 (6% of all) had implant loss. Preoperative radiotherapy was a significant predictor of explantation (adjusted OR 4.9, 95% confidence interval (CI), 1.0–23.5; p = 0.045), and smoking was also associated with risk of explantation, although only borderline significant (adjusted OR 4.0, 95% CI, 1.0–15.8; p = 0.050). This study demonstrates acceptable rates of re-operations and implant loss compared to other studies but highlights the importance of proper patient selection with regards to risk factors to minimize complications. • Patient selection is important in direct-to-implant breast reconstruction with ADM. • Preoperative radiotherapy is a significant predictor of explantation. • Cases of late complications were seen up to 3 years postoperatively. • Median number of re-operations were low during median 3.1 years follow-up. [ABSTRACT FROM AUTHOR]

Aims: Postoperative tendon adhesions contribute to functional disability and reconstructive failure. In this study, we present the long-term outcomes of a prospective study in which acellular dermal matrix (ADM) was used to prevent postoperative adhesion after tendon injury. Methods: The study was conducted between March 2014 and February 2017. Patients, aged 19–65 years, with an acute single flexor tendon injury in zones 1 or 2, distal to the palmar digital crease were candidates for the study. Patients were allocated to either an ADM treatment group or a control group without ADM treatment. Results: A total of 37 patients were enrolled in the study: 21 patients in the ADM group and 16 patients in the control group. At six months after surgery, the range of motion in the proximal interphalangeal joint was 81.0±5.1 degrees in the ADM group and 75.8±6.9 degrees in the control group. The range of motion in the distal interphalangeal joint was 79.9±7.1 in the ADM group and 71.2±5.7 degrees in the control group, with significant difference (p=0.03 and p<0.05, respectively). In addition, the total active motion was higher in the ADM group than in the control group. The patients' scores on the Patient Satisfaction Questionnaire were also significantly different, with higher satisfaction scores in the ADM group (p=0.02). The minimal follow-up period was six months. Conclusion: The use of ADM after tendon repair has the potential to significantly improve the outcome of tendon surgery in terms of range of motion. Declaration of interest: None of the authors has any financial interest in the products, devices, or drugs mentioned in this article. [ABSTRACT FROM AUTHOR]

Reconstructive options in nonmelanomatous skin tumors of the head and neck region are limited in the frail, elderly patient group, where split skin thickness or full thickness grafts may not be a viable option. This study examines the use decellularized cadaveric dermis (DCELL), an acellular dermis product produced in the United Kingdom for the reconstruction of these skin defects. This was a single-center, prospective study of patients undergoing single stage wide local excision of nonmelanomatous skin cancer and reconstruction with decellularized dermis. Our inclusion criteria included any patient that required a curative excision but had risk factors where conventional local flap or free tissue transfer could have a potential adverse outcome. Thirty-seven wounds were treated with DCELL in 31 patients. Mean age was 81.6 years (range 61–94 years) and at the time of operation, 25 patients (80.7%) were ASA 3 or above. The scalp was the most common anatomical area operated on ( n  = 28, 75.7%). The overall proportion of wounds with complete closure was 89.2% (33 out of 37 wounds), with a failure rate of 10.8% (four complete graft failures). Device-related complications included one episode of crusting over the graft which resolved with topical antibiotics, and a hypertrophic scar over the wound edges. Cosmesis was satisfactory in all cases. DCELL demonstrated a very good take rate with equally satisfactory cosmetic outcomes in patients where standard reconstructive approaches may have adverse outcomes. Further research is needed to better define its role in the management of these skin cancers. [ABSTRACT FROM AUTHOR]

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Introduction: Large and ptotic breasts always represented a great reconstructive challenge for plastic surgeons. In order to deal with these patients, we started performing Wise-pattern skin-reducing mastectomies (SRM) followed by direct-to-implant breast reconstructions (DTI-BR) in the prepectoral space where the implants were covered with the autologous adipo-dermal flap and a human acellular dermal matrix called MODA. Materials and Method: We retrospectively reviewed all patients that underwent Wise-pattern SRM followed by MODA-assisted, prepectoral, DTI-BR between January 2017 and November 2019 at our Institution. Inclusion criteria were large ptotic breast and pinch test >2cm, while exclusion criteria were smoking >10 cigarettes/day, history of prior radiotherapy, patients supposedly requiring breast implants bigger than 550cc or post-mastectomy radiotherapy. Patients' data were collected through their electronic medical records. Both short- and long-term outcomes were reported. Results: Seventeen patients underwent Wise-pattern SRM followed by MODA-assisted, prepectoral, DTI-BR for a total of twenty-one breast reconstruction and fourteen matching procedures. Mean follow-up was 13.4 months (SD= ±3.67). No major complication was reported. Three (14.3%) reconstructed breasts had minor complications: 2 (9.5%) minimal (<1cm2) wound dehiscence and 1 (4.8%) de-epithelization of the skin at the T junction that were treated conservatively. Drainages gave mean output of 410.59 ml (SD= ±214.83) and were kept in place on average for 8.59 days (SD= ±3.45). Conclusion: Few are the reports in the literature regarding DTI-BR following SRM and even fewer are those where BR was performed in the prepectoral space. Our work demonstrated the safety of prepectoral DTI-BR following SRM in selected patients in accordance with the "conservative reconstruction" principles. Furthermore, we confirmed the reliability of MODA in accordance with previously published works. Level of Evidence IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266. [ABSTRACT FROM AUTHOR]

SUMMARY: The selection of ideal posttraumatic augmentation rhinoplasty materials and technical strategies has always been a pressing challenge. Owing to the complexity of the traumatic nasal anatomical structure, such procedures are more complicated than ordinary cosmetic rhinoplasty. The choice of reconstruction material should emphasize its inherent characteristics, such as biocompatibility, anti-infective ability, strength, and plasticity. With the development of rhinoplasty, the choice of material is less limited and composite materials have become mainstream. This review outlines current composite materials and techniques in posttraumatic augmentation rhinoplasty.

Background: According to the American Association of Periodontology, subepithelial connective tissue graft (SCTG) is one the most reliable surgical technique available for the treatment of gingival recession (GR) with Miller's Class I defect. However, due to its various disadvantages, alternate grafts such as acellular dermal matrix (ADM) grafts have been introduced for recession coverage. The present study compares the clinical outcome of these two grafts in treating Miller's Class I GR. Materials and Methods: All the 15 patients participated in the study who had totally 30 bilateral Miller's Class I GR were divided randomly into SCTG group and ADM group each containing 15 defects. In the SCTG group, coronally advanced flap (CAF) with SCTG was performed, and in ADM group, CAF with ADM was done. Clinical parameters were measured on the day of surgery (baseline) and after 6 months. Data collected were statistically analyzed using paired and unpaired t-tests. Results: The analysis of the data collected at the baseline and 6 months later showed that there were no statistically significant differences in the recorded clinical parameters such as probing pocket depth, clinical attachment loss, and GR depth. ADM group showed a better color match than the SCTG group, while SCTG group achieved more keratinized tissue width than ADM group. Conclusion: From the outcome of the current study, we can conclude that ADM is an efficient substitute for SCTG for treating Miller's Class I GR. However, additional studies with greater number of samples and lengthier follow-up periods are necessary to validate the present inference.

Acute compartment syndrome (ACS) of the lower extremity is a surgical emergency, often secondary to severe crush injury, and requires immediate fascial release. In treatment of ACS, the underlying fascia is left unrepaired and the subsequent fascial defect does not generally cause negative consequences. Here, we present a 24-year-old man who developed symptomatic muscle herniation 3-years after undergoing fascial release secondary to ACS of the anterior thigh. Given the size of the defect, reconstruction was performed using Acellular Dermal Matrix (ADM). The patient did well, with no complications 6 months postoperatively. Symptomatic muscle herniation following fasciotomy can be treated with hernia reduction and fascial repair. When primary closure is not possible, Acelluar Dermal Matrix (ADM) is an option for successful fascial reconstruction.

Objective: To investigate the physicochemical properties, osteogenic properties, and osteogenic ability in rabbit model of femoral condylar defect of acellular dermal matrix (ADM)/dicalcium phosphate (DCP) composite scaffold., Methods: ADM/DCP composite scaffolds were prepared by microfibril technique, and the acellular effect of ADM/DCP composite scaffolds was detected by DNA residue, fat content, and α-1，3-galactosyle (α-Gal) epitopes; the microstructure of scaffolds was characterized by field emission scanning electron microscopy and mercury porosimetry; X-ray diffraction was used to analyze the change of crystal form of scaffold; the solubility of scaffolds was used to detect the pH value and calcium ion content of the solution; the mineralization experiment in vitro was used to observe the surface mineralization. Twelve healthy male New Zealand white rabbits were selected to prepare the femoral condylar defect models, and the left and right defects were implanted with ADM/DCP composite scaffold (experimental group) and skeletal gold ® artificial bone repair material (control group), respectively. Gross observation was performed at 6 and 12 weeks after operation; Micro-CT was used to detect and quantitatively analyze the related indicators [bone volume (BV), bone volume/tissue volume (BV/TV), bone surface/bone volume (BS/BV), trabecular thickness (Tb.Th), trabecular number (Tb.N), trabecular separation (Tb.Sp), bone mineral density (BMD)], and HE staining and Masson staining were performed to observe the repair of bone defects and the maturation of bone matrix., Results: Gross observation showed that the ADM/DCP composite scaffold was a white spongy solid. Compared with ADM, ADM/DCP composite scaffolds showed a significant decrease in DNA residue, fat content, and α-Gal antigen content ( P <0.05). Field emission scanning electron microscopy showed that the ADM/DCP composite scaffold had a porous structure, and DCP particles were attached to the porcine dermal fibers. The porosity of the ADM/DCP composite scaffold was 76.32%±1.63% measured by mercury porosimetry. X-ray diffraction analysis showed that the crystalline phase of DCP in the ADM/DCP composite scaffolds remained intact. Mineralization results in vitro showed that the hydroxyapatite layer of ADM/DCP composite scaffolds was basically mature. The repair experiment of rabbit femoral condyle defect showed that the incision healed completely after operation without callus or osteophyte. Micro-CT showed that bone healing was complete and a large amount of new bone tissue was generated in the defect site of the two groups, and there was no difference in density between the defect site and the surrounding bone tissue, and the osteogenic properties of the two groups were equivalent. There was no significant difference in BV, BV/TV, BS/BV, Tb.Th, Tb.N, and BMD between the two groups ( P >0.05), except that the Tb.Sp in the experimental group was significantly higher than that in the control group ( P <0.05). At 6 and 12 weeks after operation, HE staining and Masson staining showed that the new bone and autogenous bone fused well in both groups, and the bone tissue tended to be mature., Conclusion: The ADM/DCP composite scaffold has good biocompatibility and osteogenic ability similar to the artificial bone material in repairing rabbit femoral condylar defects. It is a new scaffold material with potential in the field of bone repair.

Cerebrospinal fluid (CSF) leak is a crucial complication after endoscopic skull base surgery. Therefore, multilayer reconstruction with grafts is as essential as a reconstruction with pedicled flaps. Although widely used, the multilayer technique with autologous fascia lata has drawbacks, such as additional wound and donor site complications. We compared acellular dermal graft and banked homologous fascia lata graft (alternative grafts) with autologous fascia lata graft for high-flow CSF leak repair. We retrospectively enrolled 193 subjects who underwent endoscopic skull base reconstruction with multilayer fascial grafts and nasoseptal flap for high-flow CSF leaks from November 2014 to February 2020 at a single institution. Acellular dermal matrix (ADM), banked homologous fascia lata, and autologous fascia lata were used in 48 (24.9%), 102 (52.8%), and 43 (22.3%) patients, respectively. Postoperative CSF leaks occurred in 23 (11.9%) patients and meningitis in 8 (4.1%). There was no significant difference in postoperative CSF leak (p = 0.36) and meningitis (p = 0.17) across the graft groups. Additionally, we could not find out contributing risk factors for postoperative CSF leak and meningitis. ADM and banked homologous fascia lata are non-inferior to autologous fascia lata for endoscopic skull base reconstruction in water-tight reconstruction or safety without additional donor site morbidities.

Reconstructive surgery often confronts large tissue defects. This creates a need to look for materials that are immunogenic but offer the possibility of tissue filling. ADM—acellular dermal matrix—is a biological collagen matrix without immunogenicity, which is more commonly used in surgical treatment. Reconstructive surgery is still searching for various biocompatible materials that can be widely used in surgery. The available materials have their advantages and disadvantages. This paper is a literature review on the use of human acellular dermal matrix (ADM) in reconstructive surgery (surgical oncology, plastic and reconstructive surgery, and gynecologic reconstructive surgery). ADM appears to be a material of increasing use in various fields of surgery, and thus, further research in this area is required.

Background Single-stage direct-to-implant (DTI) breast reconstruction after mastectomy has gained popularity over the last decade, thanks to the wide use of biological matrices and synthetic meshes. Despite their high cost, there is no evidence of superior outcome from the biological matrices compared to the synthetic meshes. In this study, we aimed to evaluate our experience with TIGR, a synthetic, long-term absorbable mesh, in mastectomy and immediate breast reconstruction (MIBR) with a focus on patient-reported outcomes (PROMs). Methods This was a single-trust prospective quality improvement study conducted between 2017 and 2019. The main objectives were complication rates including infection, implant loss, and other surgical complications in patients undergoing TIGR mesh-assisted MIBR in the prepectoral plane for either cancer or risk reduction. PROMs were measured using the validated European Organisation for Research and Treatment of Cancer (EORTC) breast questionnaire module. Clinical evaluations were conducted at one week, three weeks, and 12 months postoperatively. All patients provided written consent, and the audit was registered with the Quality Improvement Department of the organization. Results One hundred and twelve meshes were used in 93 patients with a mean age of 49 (24-75) years and a body mass index (BMI) of 23.4 (19.1-29.6). During the follow-up period, complications occurred in 26 patients (28%), including infection in four (4.3%), complete skin flap necrosis in one (1%), partial flap necrosis in three (3.2%), and implant loss in four (4.3%) patients. PROM data from 41 individuals indicated a moderate overall quality of life (82.7%), with high functional domain scores with relatively lower emotional functioning scores. Symptom domains generally scored poorly except for body image and sexual functioning. Conclusion Mastectomy and immediate prepectoral breast reconstruction using TIGR mesh is safe with low major complication rates. It is associated with high functional and quality of life scores but low scores in symptom domains which could be multifactorial. However, limitations due to study type and follow-up duration suggest caution in generalizing findings., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Razdan et al.)

Aims: This randomized trial assessed for the first time the efficacy of coronally advanced flap (CAF) followed by micro-needling (MN) in contrast to CAF with acellular dermal matrix (ADM) on gingival thickness (GT, primary outcome), keratinized tissue width (KTW), clinical attachment level (CAL), probing depth (PD), recession depth (RD), recession width (RW), recession reduction (Rec-Red), complete root coverage (CRC) and percentage of root coverage (all secondary outcomes) in management of RT1 gingival recession in patients with thin gingival phenotype., Methods: A total of 24 patients (n = 24) with a thin gingival phenotype and single RT1 gingival recession in the aesthetic zone were randomly allocated to test- (CAF + MN; n = 12) or control group (CAF + ADM; n = 12). All clinical parameters were evaluated at baseline, 3 and 6 months., Results: Both groups independently demonstrated significant gain in GT, RW, RD, CAL, PD, Rec-Red, CRC and percentage of root coverage, with reduced PI and BOP (p < .05) at 3 and 6 months, without intergroup differences (p > .05). At 6 months, KTW gain was significantly higher in CAF + MN (5.08 ± 0.9 mm) than in CAF + ADM-group (4.25 ± 1.06 mm; p < .05). Stepwise linear regression model with GT as dependent variable showed that base-line GT was the only statistically significant predictor for GT with a direct correlation between base-line GT and GT after 6 months., Conclusion: CAF followed by MN could represent a promising graft-less approach for increasing gingival thickness, comparable to CAF with ADM, with superior keratinized tissue width improvement, in the treatment of RT1 recession defects in patients with thin gingival phenotype., (© 2024 The Authors. Journal of Periodontal Research published by John Wiley & Sons Ltd.)

Tissue expansion is an integral procedure of the vast majority of breast reconstruction and has a significant impact on the final clinical outcomes. Therefore, technological advances leading to a fewer number of unfavorable outcomes and a decrease in complication rates are imperative. In this study, using a porcine model, we investigated an effect of acellular dermal matrix (ADM) used as a tissue expander cover on the dermal changes induced by mechanical forces during tissue expansion. After 14 days of expansion, skin samples were collected from one animal, while the second animal underwent radiation, and tissue was collected 8 weeks later. Tissue expanded without the use of ADM and unexpanded skin served as the controls. Collected skin biopsies were used for histological and immunohistochemical evaluation, and for gene expression analysis. We revealed that the biological cover incorporation into host tissue is facilitated by macrophages without inducing a broad inflammatory response. The utilization of ADM mitigated disruption in the dermal structure, excessive collagen deposition, and capsule formation in non-irradiated expanded skin. The protective effect was not fully maintained in irradiated skin. These results demonstrate that tissue expansion might be improved by using the tissue expander cover.

Background: This study aims to compare the rate of nipple necrosis between the submuscular (SM) versus the prepectoral (PP) implant placement after immediate breast reconstruction (IBR)., Methods: An institutional review board-approved database was reviewed of patients who underwent nipple sparing mastectomy (NSM) with IBR at our institution between 2016 and 2019. Patients who had SM versus PP IBR were compared. Incidence of nipple necrosis was evaluated between the two groups., Results: A total of 525 NSM with IBR were performed in 320 patients with SM reconstruction in 61% (n ​= ​322) and PP in 39% (n ​= ​203) of the mastectomies. Overall, 43 nipples experienced some form of necrosis with 1% of mastectomies experiencing nipple loss. There was no difference between SM group and PP group at the rate of nipple necrosis (9 ​% vs 7 %, P ​= ​0.71)., Conclusion: In patients undergoing NSM with IBR, the rate of nipple necrosis, nipple loss or complications did not differ between groups whether the implant was placed SM or PP, supporting the safety of this newer procedure., Competing Interests: Declaration of competing interest ElSherif, MD, Bernard, MD, Djohan, MD, Atallah, MD, Tu, MS, Valente, DO have no conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To investigate the effect of acellular dermal matrix in preventing laryngeal stenosis in glottic carcinoma patients. Methods: Fifty-five patients with glottic carcinoma（T2, T3） from February 2018 to December 2022 were divided into experimental group（28 cases） and control group（27 cases） according to their wishes. Acellular dermal matrix was placed in the operation cavity in the experimental group after laryngofission, while control group 12 cases were sutured by pulling the upper and lower edges, 15 cases were repaired with sternohyoid muscle fascia flap. Results: In the experimental group, 1 case had laryngeal stenosis caused by laryngeal mucosa swelling after operation, and extubated successfully after symptomatic treatment. In the control group, 7 cases had laryngeal stenosis after operation, of which 3 cases were caused by granulation tissue hyperplasia in laryngeal cavity, and extubated after symptomatic treatment. 2 cases extubated after operation suffered from progressive dyspnea during radiotherapy, and underwent tracheotomy again, extubation successful after treatment. 2 cases caused by laryngeal mucosa swelling, after symptomatic treatment, one case was successfully extubated, and one case had long-term intubation. The laryngeal stenosis rate of the experimental group was 3.6%（1/28） , which was lower than control group 25.9%（7/27）, and the therapeutic effect of the experimental group was significantly better than control group （ χ²= 5.526, P =0.019）. Conclusion: Implanting acellular dermal matrix in the operation cavity of glottic carcinoma can reduce the occurrence of laryngeal stenosis and have satisfactory preventive effect on laryngeal stenosis., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.)

Abstract Acellular dermal matrices are biological materials of porcine, bovine, or human origin used as scaffold for reconstructive purpose in plastic surgery; these materials are well-tolerated and safely integrated in host tissues without causing resorption, contracture, and encapsulation thanks to their low antigenicity. Recently, human acellular dermal matrix has been used as a filler in breast-conserving surgery to improve aesthetic results. Adequate knowledge of biomaterials properties, appropriate skill, and careful compliance with some specific recommendations are mandatory in order to optimize outcomes and obtain a work of success.

Background: To evaluate the usefulness of surveillance-abbreviated magnetic resonance imaging (AB-MRI) for the detection of ipsilateral local tumor recurrence (LTR) in patients who underwent oncoplastic breast-conserving surgery (BCS) with acellular dermal matrix (ADM) by comparing its diagnostic performance with that of mammography (MG) and ultrasonography (US). Methods: The postoperative MG, US, and AB-MRI findings of the ipsilateral breast and pathological results of 324 patients who underwent oncoplastic BCS using ADM were reviewed. The cancer detection rate (CDR), sensitivity, specificity, positive predictive value (PPV) for biopsy, accuracy, and area under the curve (AUC) for each imaging modality were calculated. Results: A total of 8 ipsilateral LTRs were diagnosed, and most cancers (87.5%) were stage 0 or 1 (median size of invasive cancer, 1.44 cm; range, 0.7–2 cm). The CDRs of MG, US, MG + US, and AB-MRI were 0.009, 0.012, 0.015, and 0.025 per woman, respectively. Three cancers were detectable on only AB-MRI, and the additional CDR of AB-MRI was 0.010. The sensitivity and specificity of MG, US, MG + US, and AB-MRI were 37.5%, 50%, 62.5%, and 100% and 99.7%, 98.4%, 98.1%, and 97.8%, respectively. The PPVs for biopsy were 75%, 44.4%, 45.5%, and 53.3%, respectively. The AUC was significantly higher for AB-MRI (0.989) than for MG alone (0.686, P = 0.0009), US alone (0.742, P = 0.009), and MG + US (0.803, P = 0.04). A total of 66.7% of cancers visible on only AB-MRI were located at the deep posterior portion of the excision cavity, which might have been missed with MG or MG + US due to masking by the ADM filler. Conclusion: AB-MRI can improve the detection of ipsilateral LTR despite postoperative changes caused by ADM fillers compared to conventional MG and US. Patients who undergo BCS with ADM can be candidates for AB-MRI surveillance considering improved cancer detection and high sensitivity. [ABSTRACT FROM AUTHOR]

Acellular dermal matrix (ADM) allografts are commonly used in the surgical treatment of complex and irreparable rotator cuff tears. Multiple studies report that superior capsule reconstruction (SCR) using ADM has resulted in short-term clinical success as assessed via radiographic and patient-reported outcomes. However, limited information is available regarding the biologic fate of these grafts in human subjects. This case series describes histologic results from 8 patients who had reoperations, during which the previously implanted ADMs were removed. These explanted ADMs were subjected to histologic analysis with the hypothesis that they would have evidence of recellularization, revascularization, and active remodeling. Eight patients, 38-82 years old, underwent reoperation 6-38 months after undergoing SCR. ADM explants were voluntarily shipped to the manufacturer for histologic analysis. Each graft's structure and composition were qualitatively evaluated by 1 or more of the following histologic stains: hematoxylin and eosin, safranin O, and Russell-Movat pentachrome. Pan-muscle actin staining also assessed the level of neovascularization, potential myoblast or myocyte infiltration, and muscle tissue development in the graft, and was analyzed to determine the proportion of graft that had been recellularized in situ. Grafts showed varying levels of gross and microscopic incorporation with the host. An uneven, but high, overall degree of recellularization, revascularization, and active remodeling was observed. The degree of remodeling correlated with implant duration. These results are consistent with successful biologic reconstruction of the superior shoulder capsule. The present histologic analysis suggests that ADMs used in SCR undergo active recellularization, revascularization, and remodeling as early as 6 months after implantation, and that graft recellularization positively correlates with duration of implantation. These results represent a significant advancement in our knowledge regarding biologic incorporation of ADMs used in SCR. [ABSTRACT FROM AUTHOR]

Treatment of full-thickness skin defects still presents a significant challenge in clinical practice. Three-dimensional (3D) bioprinting technique offers a promising approach for fabricating skin substitutes. However, it is necessary to identify bioinks that have both sufficient mechanical properties and desirable biocompatibilities. In this study, we successfully fabricated acellular dermal matrix (ADM) and gelatin methacrylamide (GelMA) bioinks. The results demonstrated that ADM preserved the main extracellular matrix (ECM) components of the skin and GelMA had tunable mechanical properties. Both bioinks with shear-thinning properties were suitable for 3D bioprinting and GelMA bioink exhibited high printability. Additionally, the results revealed that 20% GelMA with sufficient mechanical properties was suitable to engineer epidermis, 1.5% ADM and 10% GelMA displayed relatively good cytocompatibilities. Here, we proposed a new 3D structure to simulate natural full-thickness skin, which included 20% GelMA with HaCaTs as an epidermal layer, 1.5% ADM with fibroblasts as the dermis, and 10% GelMA mesh with human umbilical vein endothelial cells (HUVECs) as the vascular network and framework. We demonstrated that this 3D bioprinting functional skin model (FSM) could not only promote cell viability and proliferation, but also support epidermis reconstruction in vitro. When transplanted in vivo , the FSM could maintain cell viability for at least 1 week. Furthermore, the FSM promoted wound healing and re-epithelization, stimulated dermal ECM secretion and angiogenesis, and improved wound healing quality. The FSM may provide viable functional skin substitutes for future clinical applications. We propose a new 3D structure to simulate natural full-thickness skin, which included 20% GelMA with HaCaTs as an epidermal layer, 1.5% ADM with fibroblasts as the dermis, and 10% GelMA mesh with HUVECs as the vascular network. It could not only maintain a moist microenvironment and barrier function, but also recreate the natural skin microenvironment to promote cell viability and proliferation. This may provide viable functional skin substitutes for future clinical applications. [Display omitted] [ABSTRACT FROM AUTHOR]

It has been reported that the use of the acellular dermal matrix (ADM) in expander-based breast reconstruction is related to an increase in seroma-related complications. The aim of this study is to compare the actual drainage volume, time to drain removal, and seroma formation rate in patients with prepectoral expander placement with anterior coverage of a fenestrated ADM to those patients with partial subpectoral expander placement with inferior coverage of a fenestrated ADM. This is a single-surgeon retrospective review of patients who underwent prepectoral expander-based breast reconstruction following non-nipple-sparing mastectomy. Patient demographics, operative data, and complications were analyzed and multivariate linear regression analyses were conducted to evaluate the significance of factors that influences total volume of fluid formation. A total of 89 breasts from 87 patients were included in the study. Twenty-seven breasts had prepectoral expander reconstruction and 62 breasts had partial subpectoral expander reconstruction. Mean total volumes of fluid formation (total drainage volume + additional aspirated volume) were not significantly different (p = 0.190) in the two groups. In the subpectoral group only, high body mass index (BMI) was correlated with the total volume of fluid formation among the independent factors. (p = 0.017) Although total drainage volume was not significantly different between prepectoral and subpectoral groups, prepectoral positioning of the expander can be a protective factor against seroma formation in high BMI patients. Further definitive studies with larger patient numbers are warranted to corroborate these data and draw definitive conclusions. [ABSTRACT FROM AUTHOR]

Background/Aim: Acellular dermal matrices (ADMs) have become popular in implant-based breast reconstruction. The aim of this study was to compare three commonly used ADM products in vivo in an animal model. Materials and Methods: The nucleic acid content (residual double-stranded DNA) and the levels of the remaining growth factors after decellularization were measured for each ADM. Cytocompatibility with ADMs was documented using NIH 3T3 mouse fibroblast cells. In vivo, the implanted ADMs were histologically evaluated at 1, 2, 3, and 6 months (n=5) using male 8-week-old Sprague-Dawley rats. Results: Fibroblasts grew in the SureDerm HD and DermACELL with no cytotoxicity. In a rat model, SureDerm HD and DermACELL incorporated more readily into the surrounding host tissue, as measured by rapid cell influx and collagen deposition, and showed more delayed tissue remodeling with decreased matrix metalloproteinases levels compared to AlloDerm. Conclusion: SureDerm HD and DermACELL can be used as biological materials for breast reconstruction. [ABSTRACT FROM AUTHOR]

Aim: This research compares postoperative complication rates with Strattice™, SERAGYN® BR, and TiLOOP® Bra interposition devices for subpectoral implant placement after skin or nipple sparing mastectomy. Patients and Methods: 188 breast reconstructions in 157 patients after primary (n=96), secondary (n=71), or prophylactic (n=21) surgery were analyzed regarding major and minor complications. Results: With acellular dermal matrix (ADM) Strattice™, 27.5% major and 27.5% minor complications occurred. Implant loss rates were 27.3% in primary and 30.8% in secondary reconstructions. With SERAGYN® BR, 11.1% major and 13,0% minor complications occurred. Implant losses (6.1%) occurred exclusively in primary reconstructions. With TiLOOP® Bra, 14.9% major and 9.6% minor complications occurred. Implant loss rates were 7.7% in primary and 7.1% in secondary reconstructions. Conclusion: ADM was associated with high complication rates in primary and secondary reconstructions. Low complication rates were seen with mesh interposition devices in primary, secondary, and prophylactic reconstructions. [ABSTRACT FROM AUTHOR]

BACKGROUND: A large number of animal and clinical experiments have confirmed that local transplantation of adipose-derived stromal vascular fraction can promote articular cartilage repair. OBJECTIVE: To explore the feasibility of constructing tissue-engineered cartilage with acellular dermal matrix/biomineralized collagen integrated bone cartilage scaffold combined with autologous adipose-derived stromal vascular fraction. METHODS: The groin fat pads of both sides of the female rabbit were taken out under sterile conditions, and the stromal vascular fraction was obtained by enzyme digestion. Flow cytometry was used to detect the surface specific protein and observe the ability of adipogenic, osteogenic and chondrogenic differentiation. Adipose-derived stromal vascular fraction (experimental group), adipose-derived mesenchymal stem cells containing transforming growth factor-β3 (cartilage induction group) and adipose-derived mesenchymal stem cells containing 10% fetal bovine serum (control group) were co-cultured on acellular dermal matrix/biomineralized collagen scaffold. CCK8 assay was used to detect cell proliferation. The number of cells was observed under fluorescence microscope. Real time-quantitative PCR detection was used to detect cartilage related gene expression. The content of glycosaminoglycan in extracellular matrix was determined by dimethylmethylene blue colorimetry. RESULTS AND CONCLUSION: (1) The results of flow cytometry showed that the adipose-derived stromal vascular fraction had high expression of CD44, CD105 and CD90, and low expression of CD14, CD19 and CD45. Adipose-derived stromal vascular fraction had the ability to differentiate into adipocytes, osteoblasts and chondrocytes. (2) CCK8 assay showed that with the extension of culture time, the number of three kinds of cells on the acellular dermal matrix/ biomineralized collagen scaffold increased, and the number of cells in the experimental group was higher than that in the other two groups (P < 0.05). Under the fluorescence microscope, the number of cells in the experimental group was more than that in the other two groups at 7 days after culture. (3) Real timequantitative PCR results showed that at 21 days after culture, the mRNA expression levels of Sox9, proteoglycan and type II collagen in the experimental group were higher than those in the other two groups (P < 0.05). (4) Dimethylmethylene blue colorimetry results demonstrated that at 7, 14, and 21 days, the content of glycosaminoglycan in the experimental group was higher than that in the other two groups (P < 0.05). (5) The results showed that adipose-derived stromal vascular fraction combined with acellular dermal matrix / biomineralized collagen scaffold could effectively support cartilage formation in vitro. [ABSTRACT FROM AUTHOR]

Objective/Hypothesis: To define the best surgical technique able to reduce Frey syndrome (FS) incidence after parotidectomy. Study Design: Systematic review and network meta‐analysis. Methods: An arm‐based network analysis was conducted using a Bayesian hierarchical model. The primary and secondary outcomes were the incidence of subjective (clinical) and objective (positive starch‐iodine test result) FS, respectively. Results: A total of 3830 patients with a median age of 50.35 years (n = 2323; IQR 44.25–54.18) were included for six interventions [temporoparietal fascia (TPFF), free fat graft (FFG), acellular dermal matrix (ADM), sternocleidomastoid muscle (SCM) flap, and superficial musculoaponeurotic system (SMAS) flap]. If compared to no treatment, the greatest reduction of subjective (clinical) FS incidence was measured for the TPFF (OR: 0.07, CI: 0.004–0.57), the ADM (OR: 0.09, CI: 0.02–0.35), and the FFG (OR: 0.11, CI: 0.03–0.42) techniques. However, a significant difference was measured also for the SCM flap (OR: 0.38, CI: 0.18–0.73) and for the SMAS flap (OR: 0.42, CI: 0.19–0.97). All treatments showed a significant reduction of the objective FS incidence if compared to no treatment (FFG, OR: 0.06, CI: 0.002–0.62; TPFF, OR: 0.07, CI: 0.01–0.33; ADM, OR: 0.11, CI: 0.03–0.44; SMAS, OR: 0.36, CI: 0.17–0.71; SCM, OR: 0.40, CI: 0.19–0.74). Conclusions: TPFF, ADM, and FFG seem to be the best treatment strategies to prevent FS after parotidectomy. Further randomized controlled trials comparing these techniques should be conducted to define specific indications. Laryngoscope, 131:1761–1768, 2021 [ABSTRACT FROM AUTHOR]

Background: Human-derived acellular dermal matrix (ADM) has been widely used as an effective alternative to autologous grafts in tympanoplasty. However, evidence of ADM as an alternative to autologous grafts in the repair of tympanic membrane (TM) perforation still lacks adequate empirical evidence. Objectives: To determine the clinical safety and efficacy of human-derived ADM as TM graft material for tympanoplasty. Data sources: The PubMed, EMBASE, Cochrane Library, EBSCO, Ovid, Scopus, and Web of Science databases and reference lists of the retrieved articles were searched, with no language restriction. Selection criteria: All randomized controlled trials and retrospective cohort studies that compared the use of human-derived ADM and autologous grafts in tympanoplasty for TM perforation were included. Data collection and analysis: Two review authors independently assessed risk of bias in the included studies and extracted data. The pooled results for continuous data were reported as a mean difference (MD) and 95% confidence intervals (CI). For dichotomous data, odds risk (OR) with 95% CI was used. ChI2 statistic and Galbraith plots were used to assess the heterogeneity. Publication bias was assessed with a funnel plot and Egger's test. Main results: Five retrospective cohort studies and four randomized controlled studies with a total of 610 participants were included in the meta-analysis. No significant differences in graft success (OR: 0.71 [0.39, 1.29], p = 0.26), air-bone gap (ABG) reduction (MD: − 0.59 [− 3.81, 1.19], p = 0.51), or complications (OR: 1.23 [0.07, 20.64], p = 0.89) were found between the ADM group and autologous graft group. The use of ADM significantly shortened tympanoplasty surgery time (MD: − 16.14 [− 21.22, − 11.07], p < 0.00001) and reduced postoperative pain (MD: − 2.57 [− 3.57, − 1.58], p < 0.00001) compared with the autologous graft group. Conclusion: Human-derived ADM might be an effective alternative to autologous grafts for tympanoplasty. However, some of the studies that were included in the present meta-analysis had rather low methodological quality, and more adequately designed clinical trials should be performed in the future. [ABSTRACT FROM AUTHOR]

Wound closure after post‐traumatic injuries and/or localized at peculiar body sites (head‐and‐neck, oral cavity, legs) are particularly challenging and can often be delayed due to local and systemic factors. In case of deep wounds and/or hard‐to‐heal wounds, grafting of dermal acellular matrices (ADM) is often needed. Though a great variety of synthetic and semisynthetic dermal and skin equivalents are available, viable human dermis, is still considered the most physiological alternative to replace the loss of autologous dermis, by acting as a physiological scaffold that add structural support to soft tissues. To date, human ADMs (hADMs) have been employed in the reconstruction of skin defects affecting almost all body sites, ranging from visceral sites to the skin and subcutaneous tissues. This review aims to investigate the use of hADM at different body sites and their peculiar advantages. A literature search was using the search terms "acellular dermal matrices", "dermal regeneration", "advances wound healing", "human acellular dermal matrices surgery". A total of 50 out of 150 papers was included. Based on the current body if evidence, hADMs appear to bring several advantages, such as: protection of deep structures (eg, tendons, bones, cartilage and nerves); stimulation of a functional new dermis (rather than a scar); reduction of wound closure time; control of pain and exudate. Finally, hADMs may represent the best treatment option for hard‐to‐heal wound not only in terms of efficacy and patient satisfaction bout also in terms of sanitary costs, especially across Europe, where hADMs cannot be commercialized as medical devices. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effect of a bone substitute material combined with fibroblast growth factor‐2 (FGF‐2) loaded barrier membrane on the preservation of alveolar ridge after tooth extraction. Material and methods: Four dogs were included. Six extraction sockets of each animal received the 3 treatments and were randomly divided into three groups. Group A: negative control; Group B: bovine xenografts + membrane; and Group C: bovine xenografts + FGF‐2‐loaded membrane. CBCT and histological analysis were performed to evaluate changes in the width and height of alveolar ridges and extraction socket bone healing 8 weeks post‐extraction. Results: CBCT showed that the alveolar bone in Group A was significantly thinner than that in Group B and Group C at 1 and 3 mm apically from the alveolar crest. The alveolar width at 1 mm in Group C (60.99 ± 15.36%) was significantly thicker than that in Group B (39.75 ± 30.18%). Histomorphmetrical measurements showed that the buccal alveolar width at 1 mm was significantly thicker in Groups B and C than in Group A. Additionally, buccal bone height and lingual bone width at 1 mm in Group C (87.06 ± 10.34%, 89.09 ± 10.56%) were significantly greater than in Group A (53.48 ± 23.94%, 82.72 ± 12.59%). Conclusion: The present findings indicate that application of bovine bone combined with barrier membrane with or without FGF‐2 over tooth sockets can effectively reduce ridge absorption, especially in terms of ridge width and FGF‐2 modified membrane seems to improve the outcomes obtained with membrane alone. [ABSTRACT FROM AUTHOR]

Background: With the increased use of acellular dermal matrices (ADMs) in implant-based breast reconstructions (IBBRs), the evaluation of patient-reported outcomes becomes more important. Methods: Patients who underwent an immediate human ADM-assisted, submuscular IBBR were included in this noninterventional, multicenter, prospective cohort study. Patients with primary reconstruction (cohort A) and patients with a revision surgery after capsular fibrosis (cohort B) were followed up for 12 months after surgery. Quality of life (EORTC BR-23) and patient and surgeon satisfaction scores (1 ["very satisfied"] to 6 ["not satisfied"]) with the outcome and the aesthetic result evaluated by 2 independent, external experts were assessed. Results: Eighty-four patients were enrolled in the study. The mean patient satisfaction score was 2.1 ± 0.8, with higher satisfaction in cohort B (p = 0.041). The score did not change significantly during the follow-up (p = 0.479). The mean satisfaction score of the surgeons was 2.0 ± 0.7; it was also higher in cohort B (p = 0.016) and showed no changes over time (p = 0.473). The mean aesthetic result was 2.2 ± 0.7. 92.9% of the patients completed at least 1 quality of life questionnaire. Body image and sexual functioning increased during follow-up. One year after surgery, the mean scores were 77.2 ± 22.5 and 44.7 ± 27.3, respectively. Conclusion: The level of satisfaction among patients and surgeons and the score of the aesthetic result were constantly high among patients after ADM-assisted IBBR. Higher satisfaction scores could be observed after revision surgery caused by capsular fibrosis (cohort B) compared to primary reconstruction (cohort A). Quality of life increased during the first year after surgery. [ABSTRACT FROM AUTHOR]

Objective: To evaluate large propensity-matched cohorts to assess outcomes in patients receiving advanced treatment (AT) with skin substitutes for lower extremity diabetic ulcers (LEDUs) versus no AT (NAT) for the management of LEDUs. Method: The Medicare Limited Dataset (1 October 2015 through 2 October 2018) were used to retrospectively analyse people receiving care for a LEDU treated with AT or NAT (propensitymatched Group 1). Analysis included major and minor amputations, emergency department (ED) visits and hospital readmissions. In addition, AT following parameters for use (FPFU) was compared with AT not FPFU (propensity-matched Group 2). A paired t-test was used for comparisons of the two groups. For comparisons of three groups, the Kruskal-Wallis test was used. A Bonferroni correction was performed when multiple comparisons were calculated. Results: There were 9,738,760 patients with a diagnosis of diabetes, of whom 909,813 had a LEDU. In propensity-matched Group 1 (12,676 episodes per cohort), AT patients had statistically fewer minor amputations (p=0.0367), major amputations (p<0.0001), ED visits (p<0.0001), and readmissions (p<0.0001) compared with NAT patients. In propensity-matched Group 2 (1131 episodes per cohort), AT FPFU patients had fewer minor amputations (p=0.002) than those in the AT not FPFU group. Conclusion: AT for the management of LEDUs was associated with significant reductions in major and minor amputation, ED use, and hospital readmission compared with LEDUs managed with NAT. Clinics should implement AT in accordance with the highlighted parameters for use to improve outcomes and reduce costs. Declaration of interest: WHT and JD are employees of MIMEDX Group, Inc. TLT serves as a consultant to MIMEDX Group, Inc. WHT, JLD and TLT have stock in MIMEDX Group, Inc. DGA, TJC, PMG, JHH, MRK, JML and JAN served on MIMEDX Group, Inc. advisory Board. PMG, MRK and JAN served on a speakers bureau. Analysis of the Medicare database was funded by MIMEDX Group, Inc. [ABSTRACT FROM AUTHOR]

Background: Pilonidal sinus disease (PSD) is a chronic inflammatory disease affecting the soft tissue of the sacrococcygeal region and remains a challenging disease for clinicians to treat. The optimal treatment for PSD remains controversial and recent reports describe several different surgical approaches offering different benefits. Approximately 40% of initial incision and drainage cases require subsequent surgery. Due to high recurrence rates and postoperative complications, a more complex revision surgery involving a flap reconstruction may be required. We hypothesised that the combination of an extracellular matrix (ECM) graft with tissue flap reconstruction may decrease the postoperative complications and recurrence rates for PSD. Method: We report a retrospective case series using a surgical flap reconstruction with concomitant implantation of an ovine forestomach ECM graft under a fasciocutaneous flap with an off-midline closure for recurrent PSD, where previously surgical intervention had failed due to wound dehiscence and/or recurrent disease. Results: The case series included six patients. After three weeks, all patients except one were fully healed, and the sixth was fully healed by week 4; all wounds remained fully healed at 12 weeks. All patients achieved good cosmesis and were able to return to normal function without any residual symptoms. Conclusion: This pilot case series explored augmenting a flap reconstruction for complex PSD with advanced ECM graft materials, demonstrating that it may improve outcomes and minimise typical complications seen in flap closure, such as inflammation, infection, haematoma/seroma and hypoperfusion. Although the study had a limited number of participants, long-term outcomes were promising and suggest that further studies are warranted. Declaration of interest: AEC has received educational travel grants from Aroa Biosurgery Limited. SGD and BAB are employees of Aroa Biosurgery Ltd. The authors have no other conflicts of interest. [ABSTRACT FROM AUTHOR]

Aim: The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine acellular dermal matrix (FBADM) plus standard of care (SOC) for treating hard-to-heal diabetic foot ulcers (DFUs). Method: A prospective, multi-centre, randomised controlled trial was carried out. The study included a 2-week run-in period, a 12-week treatment phase and a 4-week follow-up phase. The primary endpoint was complete wound closure at 12 weeks. Results: Twenty-one US sites enrolled and randomised 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients, with 103 in the FBADM group and 104 in the SOC group. Of these participants, 161 completed the study per protocol (mPP population), with 79 receiving FBADM, and 82 without. At the first analysis point, patients treated with FBADM were found to be significantly more likely to achieve complete wound closure compared with SOC alone (mITT: 45.6% versus 27.9%; p=0.008; mPP: 59.5% versus 35.6%; p=0.002). The difference in outcome yielded an odds ratio of 2.2 (95% confidence interval (CI): 1.2, 3.9; p=0.008). Median time to closure within 12 weeks was 43 days for the FBADM group compared to 57 days for the SOC group (p=0.36). The median number of applications of FBADM to achieve closure was one. Adverse events were similar between groups and no product-related serious adverse events occurred. Conclusions: These results indicate that in many cases a single application of FBADM in conjunction with SOC offers a safe, faster and more effective treatment of DFUs than SOC alone. Declaration of interest: This study has been fully sponsored by Integra LifeSciences Inc., manufacturer of PriMatrix®, a fetal bovine acellular dermal matrix. JCL is a paid consultant of Integra LifeSciences. RS, DV and LAL receive consultancy fees from Integra. The authors have no other conflicts of interest to declare. [ABSTRACT FROM AUTHOR]

Background: Venous leg ulcers (VLUs) are hard-to-heal, recurrent and challenging to treat. Advanced wound care matrices (AWCMs) have been developed to supplement conventional therapies. These costly AWCMs warrant careful comparison as healthcare expenditures are subjected to increasing scrutiny. Aim: This study was designed to compare AWCMs in their ability to heal VLUs and their cost efficacy through a systematic review of randomised controlled trials (RCTs). Method: An organised search of Medline, Cochrane Library, Central and CINAHL databases identified RCTs that compared AWCMs to standard compression therapy in the healing of VLUs. Bias was assessed using the Effective Public Health Practice Project (EPHPP) Quality Assessment Tool for Quantitative Studies. Eight studies analysing bilayered skin substitute (BSS) (Apligraf), dehydrated human amnion/chorion membrane (dHACM) (Epifix), human fibroblast-derived dermal substitute (HFDDS) (Dermagraft), extracellular wound matrix (ECM) (Oasis), advanced matrix (AM) (Talymed) and matrix wound dressing (MWD) (Promogran) met the inclusion criteria. Results: Four studies reported significant improvement over standard therapy: BSS, dHACM, ECM and AM. Incremental cost per additional successful treatment was determined for each trial, ranging from $2593 (MWD) to $210,800 (HFDDS). Conclusion: Our consolidated analysis of eight major RCTs of AWCMs in the treatment of VLUs revealed a great variation in clinical and cost efficacy among these products. The included trials were inconsistent in methodology, and these limitations should be noted, but, in the absence of RCTs to compare these products, our systematic review may serve as a guide for practitioners who seek to optimise wound healing while considering cost efficacy. Declaration of interest: This research did not receive any specific grant from funding agencies in the public, commercial or not-forprofit sectors. CAL is a member of the National Speakers Bureau for Organogenesis. The authors have no other conflicts of interest. [ABSTRACT FROM AUTHOR]

Various implant wrapping methods with acellular dermal matrix (ADM) have been introduced, but most focus on random trimming and suturing aimed to maximize implant coverage. Here we present our clinical experience using a “tear-drop appearance” wrapping method to achieve natural contours through upper pole volume replacement. We retrospectively reviewed the data of 56 consecutive cases of prepectoral prosthetic-based breast reconstruction (PPBR) using this wrapping method following nipple-sparing mastectomy between March 2020 and June 2021. The “tear-drop appearance” wrapping design creates an anatomical tear-drop–shaped pocket to encourage lower pole fullness and create a natural contour through upper pole volume replacement by ADM. Patients’ baseline characteristics, operative data, and complications were analyzed. Aesthetic outcomes were measured using the BREAST-Q and Aesthetic Item Scale (AIS). A successful reconstruction was achieved without major complications and using a single ADM sheet. Four types and three sizes of ADMs were used. The mean resected breast tissue weight was 274.3 g, while the mean implant volume was 230.0 cc. The average BREAST-Q and AIS scores were 4.6 ± 0.8 and 4.5 ± 0.7, respectively. Owing to its simplicity, reproducibility, and effectivity, this method is an excellent implant coverage option that achieves a natural contour in PPBR.

Hidradenitis suppurativa is a chronic disease that significantly reduces patients’ quality of life. Patients are chronically treated with systemic therapies, which are often ineffective. Surgical treatment for severe cases of hidradenitis suppurativa is one option for affected patients. Surgical treatment has its limitations, and wound closure may be particularly problematic. This requires the use of reconstructive techniques. The methods of choice for wound closure are split-thickness skin grafts or local flaps reconstructions. However, each method has its limitations. This is a presentation of a new reconstructive surgical method in hidradenitis suppurativa surgery: the use of a co-graft of Acellular dermal matrix and split thickness skin graft as a novel method in wound closure after wide excisions, based on two cases. The results of this method are very promising: we achieved very fast wound closure with good aesthetic results regarding scar formation. In this paper, we used several examinations: laser speckle analysis, cutometer tests, and health-related quality of life (QoL) questionnaire to check the clinical impact of this method. Our initial results are very encouraging. ADM with STSG as a co-graft could be widely used in reconstructive surgery. This is a preliminary study, which should be continued in further, extended research.

The aim of our study is to draw attention to the multitude of applications of acellular dermal matrix (ADM) in the surgical treatment of urogynaecological disorders, such as reduction in the reproductive organs, and in reconstructive gynaecology. Despite the existence of numerous operational methods and materials, the effectiveness of transvaginal operation is still insufficient. Native tissue operations are often not durable enough, while operations with synthetic materials have numerous side effects, such as infections, hematomas, vaginal erosion, or dyspareunia. Hence, the search continues for a different material with a better efficacy and safety profile than those previously mentioned. It seems that ADM can meet these requirements and be a useful material for urogynaecological surgery. Key words related to the usage of ADM in gynaecological reconstructive surgery were used to search relevant databases (NCBI MedLine, Clinical Key, Clinicaltrials.gov). This manuscript is based on 43 literature sources, 28 (65.11%) of which were released after 2016. Older sources are cited for the purpose of presenting basic science, or other important issues related to the manuscript. ADM seems to be an ideal material for urogynaecological and reconstructive surgery. It has high durability, and thus high effectiveness. Moreover, it does not have the side effects typical for synthetic materials. There are no reports of material rejection, erosion or dyspareunia directly related to the presence of the mesh. Due to the difficulties in obtaining ADM and the need to perform additional tests, this material is not common in routine clinical practice. Therefore, the number of cases and the size of the research groups are insufficient to clearly define the potential of mesh from biological tissue. However, the results are so promising that it is worth considering a wider introduction to the use of this material. Our hope is that increasing clinicians’ awareness of this topic will lead to more studies comparing methods using native tissues or synthetic materials and those using ADM.

The accidental injury or surgery on soft and hard palatal tissue has an adverse impact on normal maxillary morphology. To design a single-factor experiment that excludes other interfering factors on maxillary growth, a young rat model was established to simulate the various degrees of palatal trauma. Eight maxillary parameters were measured to evaluate the impact of palatal trauma on maxillary growth. Furthermore, the acellular dermal matrix (ADM) was applied to cure the palatal trauma and alleviate the adverse impact of bone denudation on the maxillary growth. Micro-CT scanning and histology analyses were used. One-way ANOVA with least significant difference (LSD) post-test was used to evaluate the statistical significance. The palatal trauma mainly disturbed the transverse development of the maxilla. ADM promotes mucosa healing, but there is still an inhibitory effect on maxillofacial growth.

The use of acellular dermal matrix (ADM) implants has enhanced breast reconstruction. ADM is a biotechnologically designed human tissue of bovine or porcine origin in which tissue processing removes cellular antigens. In this case report, we describe the use of ADM in one-stage prepectoral breast reconstruction. Skin-reduction breast reconstruction with a prepectoral implant was performed. We created a combined dermal pocket using the inferior dermal flap, sutured with a patch of acellular dermal matrix to continue its extension until the upper pole, to cover the implant. This technique offers single-stage immediate reconstruction, with a decreased requirement for ADM and increased use of vascularized tissue and implant support. Additionally, in the pre-pectoral space, decreased pain postoperatively and less anatomic disruption is offered.

Objective: To present the application of two different soft tissue grafts around dental implants during stage-two surgery. Furthermore, the ultrastructure of these materials is shown and discussed using scanning electron microscopy (SEM). Summary: Although soft tissue autografts may be currently regarded as the gold standard, harvesting of these grafts might lead to higher morbidity, longer chair time, and intra-/postoperative complications at the donor site. New developments in collagen scaffolds have provided an alternative to successfully replace autologous grafts in clinical practice. The SEM pictures clearly show the different composition of a bilayer scaffold (collagen matrix, CM) and a porcine acellular dermal matrix (ADM). These distinctive properties lead to different possible indications. Within the presented cases, ADM was used to augment the ridge contour and was placed into a buccal pouch to achieve complete coverage and an uneventful closed healing. On the other side, CM was left exposed to the oral cavity to successfully gain keratinized mucosa around and between two dental implants. [ABSTRACT FROM AUTHOR]