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Introduction: Nonsurgical rhinoplasty or rhinomodelation is a sought-after procedure in aesthetic practice. The current product of choice remains hyaluronic acid (HA) because of its ease of use and reversibility. However, it does carry some risks. Polycaprolactone (PCL) fillers hold a lot of promise in aesthetic practice. It has an established safety profile and a longer duration of action. Because of its unique properties, it may hold the key to the future of nonsurgical rhinomodelation., Methods: Twelve patients were enrolled in the study. Ten out of these were not willing to ask for surgery and had no breathing problems. Two were post-surgical rhinoplasty complications who did not want another surgery. 0.2 mL of PCL filler was injected at each site according to the need (radix, spine, and or tip). The Global Aesthetic Improvement Scale (GAIS; 3 = very much improved, 2 = considerably improved, 1 = improved, 0 = no change, and -1 = worse) was used along with a patient satisfaction scale (highly satisfied, satisfied, dissatisfied) were used. The sum of the GAIS ratings was quantified as total improvement (TMI). The patients were followed up for 12 months before and 12 months after procedures were taken and documented., Results: The GAIS score was 98% for the study and all patients were highly satisfied with their treatment right after procedure and 12 months later., Conclusion: PCL fillers may be the way forward for long-term sustained results in nonsurgical rhinomodelation. Expert injection techniques and knowing the side effects and handling them is mandatory., (© 2025 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Microfocused ultrasound (MFU) and (MRF) are non-invasive modalities widely used for skin rejuvenation and are often combined with injectables, including neuromodulators and soft tissue fillers. However, large-scale, long-term safety data on such combination therapies are lacking. To address this gap, we conducted a retrospective chart review at two private practice dermatology clinics in South Korea from June 2005 to December 2023. A total of 1,040 patients were included, comprising 515 (49.5%) and 525 (50.5%) patients undergoing MFU and MRF, respectively. Regarding combination therapy, the patients received neuromodulators (76.9%) or dermal filler injections using hyaluronic acid (HA) (17.3%) or poly-L-lactic acid (PLLA) (5.8%) in conjunction with MFU/MRF. Documented adverse events included one case of paradoxical bulging and three cases of eyelid ptosis among those treated with MFU/MRF and neuromodulators (overall incidence: 0.1% and 0.4%, respectively), two cases of surface irregularity among those treated with MFU/MRF and HA fillers (overall incidence: 1.1%), and one case of cheek asymmetry among those treated with MFU/MRF and PLLA injections (overall incidence: 1.7%). No adverse events such as infection, necrosis, burn, filler migration, or unexpected premature loss of filler were reported. While limited by its retrospective design and the inclusion of only two dermatology clinics, which restricts the generalizability of the findings, our study highlights the favorable long-term safety profile of combining MFU and MRF with cosmetic injectables. Our study offers reassurance to clinicians and patients considering these approaches., Competing Interests: Declarations. IRB approval status: This study was approved by IRB committee by Korea National Institute for Bioethics Policy (P01-202312-01-006). Patient consent: The authors have obtained written consent from all patients for their photographs and medical information to be published in print and online and with the understanding that this information may be publicly available. Competing interests: The authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Poly-l-lactic acid (PLLA) injectables have gained increasing attention in aesthetic medicine due to their biocompatibility and long-lasting effects. Although their primary application centers around facial rejuvenation, their potential for off-label use in other body areas has been investigated, demonstrating promising outcomes in terms of both efficacy and safety., Aim: This study aims to assess the safety and efficacy of a novel 630 mg PLLA-based filler (GANA X), in buttocks treatment., Methods: Six physicians treated 51 patients for buttock aesthetic treatment across six different medical facilities in Italy. A survey was filled by both physicians and patients regarding treatment safety, efficacy, and change in quality of life., Results: We reported minor or mild adverse events, self-resolving within the next few days. Both physicians and patients confirmed notable aesthetic improvements following treatment, varying from moderate to significant enhancement. These effects endured throughout follow-up visits spanning up to 24 months. Patient-reported outcomes indicated elevated self-esteem and improved quality of life posttreatment., Conclusions: The high level of satisfaction reported by both physicians and patients highlights the efficacy and tolerability of GANA X filler for buttocks treatment, encouraging their use and research for off-label body areas., (© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: Dermal fillers have gained widespread popularity for facial cosmetic enhancement and anti-aging treatments. Recently, polycaprolactone (PCL) and polynucleotides (PN) fillers have emerged as promising options owing to their safety and long-lasting effects., Objectives: This study aimed to compare the efficacy and safety of a novel PCL-based dermal filler (DLMR01) with purified PN filler (RJR: Rejuran) in correcting crow's feet wrinkles., Materials and Methods: A randomized, evaluator-blinded, prospective split-face study was conducted with 218 healthy Asian participants. The primary outcome was in the improvement rate of the Crow's Feet Grading Scale (CFGS) at rest after 12 weeks. Secondary outcomes included the improvement rate of the CFGS at expression and rest at earlier time points, changes in CFGS, and the Global Aesthetic Improvement Scale (GAIS) assessment., Results: The results showed that DLMR01 was not inferior to RJR in improving crow's feet wrinkles, with a significantly higher CGFS improvement rate at week 12. Both fillers demonstrated good safety profiles, with mild and tolerable adverse events. No serious adverse events were reported during the study period., Conclusion: DLMR01, a PCL-based dermal filler, showed effectiveness and safety in improving wrinkles described as crow's feet. The study suggests that DLMR01 could be a promising option for noninvasive anti-aging treatments., (© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: Poly-D,L-lactic acid (PDLLA) is used for tear trough rejuvenation but can cause complications like nodular reactions. This report describes using a radiofrequency device to manage these nodules., Case Presentation: A 42-year-old woman developed firm, non-inflammatory nodules 3 weeks after receiving PDLLA (Juvelook) injections in the tear trough area. The nodules were firm and not associated with erythema or tenderness., Intervention: The monopolar radiofrequency device was used directly on the nodules with 150 shots at an energy level 115 J, 28.75 J/cm². The treatment resulted in complete resolution of the nodules within 24 hours., Results: The radiofrequency treatment effectively resolved the nodular reaction without recurrence, highlighting the device's compatibility with the unique structure of Juvelook's PDLLA., Conclusion: Radiofrequency therapy is effective for managing nodular reactions following PDLLA injections. Further research is needed to optimise protocols and improve the safety of biostimulator treatments in cosmetic procedures., (© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: Injectable fillers for soft tissue augmentation stand out as one of the most favored procedures in the field of aesthetic medicine, especially in addressing the clinical signs of skin aging. Among soft tissue fillers, non-permanent fillers have been safely used in numerous medical applications for several decades., Aims: The aim of this post-market observational, open-label, uncontrolled, multicentered, prospective study (PMS) was to evaluate the effects of an injectable poly-L-lactic acid-based collagen stimulator (Lanluma®, the study product)., Participants/methods: This analysis is based on the clinical outcomes data (safety and effectiveness) collected from investigators and participants between the first injection (T0, September 2022) and 9 months thereafter (T3, June 2023) in the treatment of five body-contouring areas., Results: Overall, 70 participants had 99 treatment sessions of the neck (31%), upper arm (20%), hand (17%), thigh (16%) and décolleté (15%). Lumps (neck, upper arm, hand) and nodules (neck, hand, thigh) were the most frequent adverse events (AEs) reported by investigators. All were treatment related. None were serious, severe or fatal. No AEs were reported following treatment of the décolleté. Both investigators and participants reported high levels of satisfaction during the nine-month follow-up period with the treatments in five body areas., Conclusions: These positive clinical outcomes can be attributed to a proper implementation of best practices and recommendations, and the rheological properties of the study product. This 9-month follow-up analysis should be reconsidered in light of the study's objectives for the final analysis at the 25-month follow-up., (© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: Poly-l-lactic acid (PLLA-SCA; Sculptra) was approved in 1999 in Europe and 2004 in United States as a collagen biostimulator. It is a freeze-dried preparation containing 150 mg PLLA-SCA per vial and, since approval, has been recommended to be reconstituted 72 h before treatment, which can hinder its use in clinical practice. In 2021, the manufacturer authorized the reconstitution of PLLA-SCA immediately before use., Objective: To evaluate adverse events in patients treated with immediately reconstituted PLLA-SCA on the face, body, and scars., Method: This was a retrospective analysis of medical records of patients treated with immediately reconstituted PLLA-SCA for aesthetic purposes from January 1, 2021, to December 31, 2021, at two medical centers., Results: A total of 274 treatment sessions were conducted on 167 patients (ranging from 1 to 5 sessions per patient). Of these, 228 sessions (151 patients) targeted the face, 39 sessions (22 patients) addressed the body, and 7 sessions (5 patients) focused on scars. The mean final concentration of PLLA-SCA was 15.30 mg/mL for the face, 8.35 mg/mL for the body, and 10.53 mg/mL for scars. The majority of injections were administered with a blunt cannula (face: 87.3%, body: 100%, scars: 57%), and in 6 out of 7 scar treatments, PLLA-SCA was additionally applied topically after fractional treatment. One patient developed a PLLA-SCA nodule 30 days after facial treatment, which resolved after two saline injections. The most common adverse events were bruising (face: 6.57%, body: 7.69%) and mild pain (face: 3.07%). No events required further intervention., Conclusion: This study reports an adverse event profile with immediately reconstituted PLLA-SCA, used on the face, body, and scars, similar to that reported with PLLA-SCA reconstituted 72 h prior to use., Trial Registration: This was a retrospective study of medical records at two medical centers, and trial registration was not required., (© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: Dermal fillers are widely used for facial rejuvenation and esthetic enhancement, offering temporary solutions for aging and volume loss. Despite their general safety, a rare but severe complication associated with these fillers is visual impairment, including blindness. This underscores the need for a thorough understanding of risks associated with various filler materials. Historical cases of blindness following filler injections date back to 1963, with increasing reports linked to the expansion of the cosmetic filler industry. While hyaluronic acid (HA) and autologous fat have been extensively studied, other fillers such as calcium hydroxylapatite and poly-l-lactic acid (PLLA) are less understood., Objective: This systematic review aims to address gaps in the literature by providing a comprehensive overview of visual impairment caused by fillers other than HA and autologous fat. We systematically examine the prevalence, causes, clinical features, and treatment outcomes associated with these less common fillers., Materials and Methods: A comprehensive literature search was conducted across databases including PubMed, Scopus, and Google Scholar using terms related to visual impairment and dermal fillers. Studies published between 2014 and 2021, including observational studies and case reports, were included. Studies were selected based on predefined inclusion and exclusion criteria, and a PRISMA flow diagram was used to illustrate the study selection process., Results: The review identifies and summarizes cases of visual impairment associated with calcium hydroxylapatite, poly-d,l-lactic acid (PDLLA), and PLLA fillers. Key findings reveal that visual impairment following these fillers is rare but can occur suddenly or within a few days of the procedure. Cases of delayed onset up to two weeks are also noted, emphasizing the need for extended post-procedure monitoring., Discussion: The review highlights unique insights into the risks associated with non-HA fillers, such as the heightened risk in the periorbital region and other facial areas. It explores mechanisms of complications, including retrograde flow of emboli leading to retinal ischemia. The discussion also covers emergency protocols and preventative measures, providing valuable guidance for managing and mitigating risks., Conclusions: Visual impairment caused by fillers other than HA and autologous fat, while rare, represents a serious complication that requires careful attention. This review contributes new perspectives on the differential risks of various fillers, symptom onset variability, and anatomical risk factors. Emphasizing the importance of proper patient selection, technique, and monitoring, it calls for further research to better understand and prevent these complications, ultimately aiming for safer and more effective use of soft-tissue fillers.

Background: Complications of temporary and permanent fillers have been extensively studied. However, there is a lack of comparative data regarding poly-L-lactic acid (PLLA), calcium hydroxyapatite (CaHA), and polycaprolactone (PCL) known as collagen biostimulators., Aims: This study addressed the complications of collagen biostimulators concerning their diagnosis, type of product, treatment, and monitoring., Patients/methods: An electronic questionnaire was sent to Brazilian dermatologic ultrasound experts to identify complications related to biostimulators. The type of biostimulator, location of application, number of vials injected, application plan, time between injection treatment and complication, injector profile, treatment, and prognosis were assessed., Results: Fifty-five cases were identified, of which 49.1% were caused by PLLA-Elleva®, 23.6% by CaHA (alone or combined with hyaluronic acid), 20.0% by PLLA-Sculptra®, and 7.3% by PCL. The most affected area was the face (72.7%), with nodules being the most common clinical form (89.1%), generally occurring late (60.0%) (>1 month). Only one case was injected at an incorrect depth (musculoaponeurotic system-SMAS). Despite several treatments, including saline (45.5%), hyaluronidase (25.5%), diluted corticosteroids (23.6%), and energy-based devices (10.9%), only five cases showed complete resolution. Hyaluronidase was beneficial in complications related to fillers when there was an association of calcium hydroxyapatite with hyaluronic acid (p < 0.01)., Conclusions: Complications from collagen biostimulators were more common on the face, typically manifesting about 1 month after treatment. These issues seemed to be related more to the properties of the products rather than inadequate technique. Furthermore, hyaluronidase demonstrated efficacy only in cases where there was an association with HA., (© 2024 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: Vascular adverse events (VAEs) occurring during injections of soft-tissue fillers are still considered a challenging issue for both patients and practitioners. Hyaluronidase can dissolve hyaluronic acid (HA)-based soft-tissue fillers during a VAE. For VAEs induced by non-HA fillers, the absence of an "antidote" is regarded as exceptionally challenging., Methods: This multicenter study describes a case series of three VAEs induced by non-HA fillers, for which ultrasound-guided hyaluronidase injections were incorporated into the treatment approach., Results: Two cases of calcium hydroxylapatite and one case of poly-L-lactic acid-induced VAEs are described, all of which were resolved without necrosis or scarring using a treatment approach with ultrasound-guided hyaluronidase injections., Conclusions: Unlike the mechanical hypothesis, which assumes filler particles travel antegrade to block arterioles in a large skin area, we hypothesize vasoconstriction as the pivot in VAEs. Filler injection-induced spasms could lead to long-lasting vasoconstriction of the perforator arteries stemming from the central facial arteries. Our results underscore that perforasome vasoconstriction might be the leading cause of the ischemia and subsequent necrosis in VAEs and that relaxation of these perforasomes, rather than dissolving the filler material, resolves the clinical symptoms associated with VAEs., (© 2024 the International Society of Dermatology.)

Background: Yanghe Pingchuan decoction (YPD) has been used for asthma treatment for many years in China. We sought to understand the mechanism of YPD, and find more potential targets for YPD-based treatment of asthma., Methods: An ovalbumin-induced asthma model in rats was created. Staining (hematoxylin and eosin, Masson) was used to evaluate the treatment effect of YPD. RNA-sequencing was carried out to analyze global gene expression, and differentially expressed genes (DEGs) were identified. Analysis of the functional enrichment of genes was done using the Gene Ontology database (GO). Analysis of signaling-pathway enrichment of genes was done using the Kyoto Encyclopedia of Genes and Genomes (KEGG) database. Real-time reverse transcription-quantitative polymerase chain reaction was undertaken to measure expression of DEGs., Results: Pathology showed that YPD had an improvement effect on rats with asthma. RNA-sequencing showed that YPD led to upregulated and downregulated expression of many genes. The YPD-based control of asthma pathogenesis may be related to calcium ion (Ca2+) binding, inorganic cation transmembrane transporter activity, microtubule motor activity, and control of canonical signaling (e.g., peroxisome proliferator-activated receptor, calcium, cyclic adenosine monophosphate). Enrichment analyses suggested that asthma pathogenesis may be related to Ca2 + binding and contraction of vascular smooth muscle. A validation experiment showed that YPD could reduce the Ca2 + concentration by inhibiting the Angiopoietin-II (Ang-II)/Phospholipase (PLA)/calmodulin (CaM0 signaling axis., Conclusion: Control of asthma pathogenesis by YPD may be related to inhibition of the Ang-II/PLA/CaM signaling axis, reduction of the Ca 2+ concentration, and relaxation of airway smooth muscle (ASM)., (© 2024. The Author(s).)

Nasolabial folds (NLFs) are the most pronounced sign of facial aging. This study explored the efficacy and safety of polycaprolactone gel in treating Chinese patients with moderate-to-severe NLFs. Patients with moderate-to-severe NLF who wished to be treated by dermal fillers were recruited from three centers between July 2017 and September 2019. The randomizing ratio was 1:1 in the polycaprolactone group (polycaprolactone injection) or control group (sodium hyaluronate gel injection). The primary endpoint was the effectiveness rate of Wrinkle Severity Rating Score (WSRS) scores at 12 months after injection. The full-analysis set (FAS) and safety sets had 80 patients in the polycaprolactone group and control group, respectively. In the FAS, the effectiveness rate at 12 months in the polycaprolactone group was 88.8% compared with 23.8% in controls ( P  < 0.001). The improvement in WSRS sustained during 12 months in the polycaprolactone group, while gradually vanished in the control group since 3 months after surgery. The global aesthetic improvement scale (GAIS) by investigator assessments was improved, much improved, or very much improved in all patients during follow-up, while the proportion of patients with a "no change" assessment gradually increased during follow-up after 6 months in the control group. The rates of injection-related adverse event (AE) and serve injection-related AE were 8.8 versus 11.3% and 0 versus 1.3% in the polycaprolactone group and control groups, respectively. Polycaprolactone gel injection is effective and safe to treat moderate-to-severe NLFs in Chinese patients., Competing Interests: None declared., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background: Injectable poly- l -lactic acid (PLLA) is a new type of biodegradable dermal filler that has been utilized for soft tissue filling. However, there is no convenient and reliable method to assess the long-term safety of PLLA filler., Objective: To assess the long-term safety of PLLA injection into nasolabial folds by high-frequency ultrasound and to select the ultrasonic probes with the most appropriate frequency., Materials and Methods: After a 30-month PLLA injection into the deep dermis of the nasolabial fold, subjects were examined by high-frequency ultrasound with the 20 MHz and 50 MHz probes., Results: Twenty subjects with nasolabial fold contour deficiency were enrolled in this study. After a 30-month PLLA injection in nasolabial folds, PLLA degraded entirely in 16 subjects (16/20, 80%), and abnormal echo in the skin was observed in 4 subjects (4/20, 20%) caused by undegraded PLLA microparticles, PLLA microparticles deposition, fibrous nodules, and granuloma. The 20-MHz probe is more appropriate than the 50-MHz probe for evaluating the adverse effects of PLLA injection., Conclusion: High-frequency ultrasound is a rapid, reliable, and noninvasive method to monitor the degradation condition of PLLA and the formation of papules and nodules associated with PLLA injection., (Copyright © 2022 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Facial pores, visible topographic change of skin representing enlarged openings of pilosebaceous follicles, are common aesthetic concern. The aim of this study was to examine the efficacy of polycaprolactone (PCL) filler on enlarged facial pores and skin texture improvement. A total of seven participants with enlarged facial pores were included in the study and underwent deep dermal injection of PCL based filler (Ellanse M, Sinclair Pharma; London, United Kingdom). Skin quality measurements including skin evenness, red areas, UV spots, wrinkles and pore numbers evaluated with an automated aesthetic camera (FotoFinder®, Teach Screen Systems software GmbH; Bad Birnbach, Germany) before and 3 months after the injection session. Adverse events during procedure were monitored and recorded. Subjects were asked to report any injection related side effects. The average size of enlarged pores was 33.51 ± 41 before treatment and 20.51 ± 35 after treatment. The difference was statistically significant (P < 0.05). The skin evenness, red areas, UV spots, and wrinkles showed no significant improvement after filler injection. No serious adverse events were reported at follow-up visit. The PCL based filler seems to be notably effective in improvement of enlarged facial pores especially in moderate to severe cases. However, further structured studies with larger sample size and control group could be more beneficial to elucidate the possible efficacy of PCL filler injection on the skin quality characteristics., (© 2022 Wiley Periodicals LLC.)

Poly-L-lactic acid (PLLA) is a synthetic biologic polymer that is suspended in solution and can be injected for soft-tissue augmentation. The most common adverse events generally are transient in nature, such as swelling, tenderness, pain, bruising, and bleeding. Persistent adverse events of PLLA primarily are papule and nodule formation. Injecting PLLA into the anterior neck is an off-label procedure and may cause a higher incidence of nodule formation.

Background: There is a significant emphasis on minimally invasive whole-body rejuvenation throughout the world. Recently, gluteal aesthetics have become an increasingly common patient concern. Although the application of poly-L-lactic acid (PLLA) to the face is already well known, there are relatively fewer publications on its use in other corporeal regions. This study aims to extend previous findings by evaluating the efficacy and safety of PLLA in the treatment of contour (including lifting) deformities of the buttock region., Methods: This was a prospective, multicenter (3 sites), single cohort, open-label clinical trial. Thirty female subjects were treated with PLLA in the bilateral buttocks, with three treatment sessions, each spaced one month apart and followed for six months after completion of the treatment regimen. At each visit, various safety and clinical efficacy parameters were collected, these included: Global Assessment of Improvement Scale (GAIS), subject satisfaction, skin hydration, elasticity, scaliness, roughness, and 3-dimensional imagery., Results: Six months following the last treatment, 84.00% of patients were rated as having &ldquo;improved&rdquo; or more on the physician assessed GAIS, accompanied by a 96.00% patient satisfaction rate. Approximately three vials of PLLA, per buttock and treatment were used. There were no serious adverse events throughout the duration of the trial, nor adverse events related to the investigational device. The most common subject-reported adverse events included pain during treatment (Mean: 70.97%) and bruising (Mean: 28.80%). Objective improvements were persistent after treatment in measurements of skin elasticity (improved 63.5% - 82.5% from weeks 16-32), hydration (increased ~11 Corneometer&reg; units by week 16), roughness (decreased 36.95% at week 32), and scaliness (desquamation; decreased 60.41% at week 32)., Conclusions: PLLA is safe and effective for the indication of buttock contouring and improving parameters of skin health. PLLA can provide long-lasting effects with a high level of patient and physician satisfaction. J Drugs Dermatol. 2022;21(3):304-308. doi:10.36849/JDD.5924.

Abstract: Polyactide (PLA) barrier is one of the most commonly used materials to prevent the formation of postoperative adhesion. Even though previous studies supported the anti-adhesion efficacy of PLA barrier, there have been limited reports focusing on the associated foreign body reaction. We sought to investigate the potential complication of PLA barrier placement that could lead to unnecessary intervention.This is a retrospective study of colorectal cancer patients with laparoscopic surgery. Cases with stage IV unresectable disease, poor Eastern Cooperative Oncology Group Performance, death within 3 months after the surgery, and insufficient record were excluded. A total of 296 cases were identified in our study and 220 patients received PLA film placement. We compared the incidence of foreign body reaction between the patients with and without PLA film.Among PLA film group, 16 cases had signs of local recurrence on the follow-up image studies. The subsequent operation found 10 patients had no cancerous lesions but only foreign-body-associated granulomas. The incidence of foreign body reaction mimicking local recurrence on image study was 4.5% with high false positive rate of 62.5% on positron emission tomography scan in patients with PLA film. There were only 2 cases without the antiadhesive barrier developed signs of recurrence during active surveillance. Both cases were later confirmed to have malignant peritoneal seeding.The PLA film was associated with rare foreign body reaction that could interfere the accuracy of follow-up program and result in unnecessary surgical intervention. Hence, we recommend avoiding the use of the PLA barrier., Competing Interests: The authors have no funding and conflicts of interest to disclose., (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

In this research we subjected samples of poly(L-lactide) (PLLA) extruded film to ultraviolet (193 nm ArF excimer laser) radiation below the ablation threshold. The modified film was immersed in Simulated Body Fluid (SBF) at 37 °C for 1 day or 7 days to obtain a layer of apatite ceramic (CaP) coating on the modified PLLA surface. The samples were characterized by means of optical profilometry, which indicated an increase in average roughness (Ra) from 25 nm for the unmodified PLLA to over 580 nm for irradiated PLLA incubated in SBF for 1 day. At the same time, the water contact angle decreased from 78° for neat PLLA to 35° for irradiated PLLA incubated in SBF, which suggests its higher hydrophilicity. The obtained materials were investigated by means of cell response fibroblasts (3T3) and macrophage-like cells (RAW 264.7). Properties of the obtained composites were compared to the unmodified PLLA film as well as to the UV-laser irradiated PLLA. The activation of the PLLA surface by laser irradiation led to a distinct increase in cytotoxicity, while the treatment with SBF and the deposition of apatite ceramic had only a limited preventive effect on this harmful impact and depended on the cell type. Fibroblasts were found to have good tolerance for the irradiated and ceramic-covered PLLA, but macrophages seem to interact with the substrate leading to the release of cytotoxic products.

Study Objective: To evaluate suture complication rates and surgical outcomes according to the nonabsorbable suture materials used in vaginal uterosacral ligament suspension (USLS) surgery. Multifilament polyester (polyethylene terephthalate [PET]) and monofilament polypropylene (PP) sutures were compared., Design: Retrospective cohort study., Setting: Single teaching hospital., Patients: Total of 229 patients who underwent transvaginal USLS and completed a 1-year follow-up., Interventions: Use of PET and PP sutures for transvaginal USLS procedures., Measurements and Main Results: PP sutures were used in 149 patients, and PET sutures were used in 80 patients. The suture-related complication rates, including granulation tissue and suture erosion at the vaginal apex, were significantly higher in the PET suture group than in the PP suture group (46.3% vs 20.1%, p <.01). However, there was no significant difference in the rates of surgical failure (defined as the presence of vaginal bulging symptoms, apical descent ≥ half of the total vaginal length, anterior or posterior vaginal wall descent beyond the hymen, or retreatment for prolapse) between the 2 groups (p = .84)., Conclusion: Compared with the use of multifilament PET sutures, the use of monofilament PP sutures in transvaginal USLS may reduce suture-related complications without increasing surgical failure rates., (Copyright © 2020 AAGL. Published by Elsevier Inc. All rights reserved.)

Background: Age-related changes affecting facial areas can be corrected using minimally invasive dermal fillers. The use of polycaprolactone-dermal filler (PCL-filler) in aesthetics is increasing., Objective: To evaluate the long-term safety and efficacy of the PCL-filler, in a European, multicenter, prospective study., Materials and Methods: Subjects (n = 90) with moderate/severe nasolabial folds (Wrinkle Severity Rating Scale [WSRS]: 3 to 4) were treated on Day 0 with a single injection of similar volume on each side; safety and efficacy assessments were performed over an 18-month period. In 1 of the 3 study centers, safety was evaluated at 30 months., Results: At Month 12 (M12; primary endpoint), 84% of subjects showed a ≥1-point improvement on the WSRS (M6: 92%; M18: 64%). From the investigator/subject's evaluation, from Day 7 to M12, Global Aesthetic Improvement was reported for >90% of subjects, with the effect maintained for up to 18 months in >80% of patients. Subjects/investigators reported high satisfaction and skin quality improvement. Most of the immediate injection-site reactions disappeared after 2 to 4 days. No severe or unexpected adverse events were reported., Conclusion: This study demonstrated the long-term safety and efficacy of the PCL-filler, with safety confirmed for up to 30 months., (Copyright © 2021 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Dermal fillers such as hyaluronic acid, poly-l-lactic acid, and polymethyl-methacrylate are often used to treat cutaneous defects such as lipoatrophy. However, concern exists regarding their use in patients with a connective tissue disease (CTD) because of a theoretical risk of disease reactivation or exacerbation. Evidence regarding their use in patients with CTD also remains limited., Objective: This review intends to summarize and evaluate the available literature regarding the use of dermal fillers in patients with CTD., Materials and Methods: A literature search until May 2020 was conducted through PubMed, Ovid MEDLINE, and Ovid Embase to identify articles discussing the treatment of cutaneous defects secondary to CTD. Articles discussing the use of autologous fat transfer alone were excluded., Results: Twenty-three articles were reviewed. The amount of available evidence varies between the type of CTD and type of filler with morphea having the most published evidence out of the CTDs discussed and hyaluronic acid having the most published evidence out of the fillers discussed. Most studies demonstrated positive results with no report of disease reactivation or exacerbation., Conclusion: Despite limited available evidence, dermal fillers seem to be safe as an adjunctive treatment for cutaneous defects in patients with CTD., (Copyright © 2021 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Skin laxity of the upper knee and lower thigh is a common complaint among patients., Objective: This is a randomized, double-blinded, split-body, placebo-controlled study to evaluate the safety and efficacy of poly-L-lactic acid (PLLA) for treatment of upper knee skin laxity., Materials and Methods: Twenty female subjects between the ages of 30 and 65 years with upper knee laxity were enrolled. The patients were randomized to receive 3 treatments of PLLA in 1 knee, whereas the other knee received 3 treatments of bacteriostatic water., Results: Statistically significant improvement as rated on the physician global aesthetic improvement scale was seen at Day 56 after final treatment in the active knee when compared with the placebo knee. This improvement was sustained at Day 84 and Day 168 after final treatment visits. No statistically significant difference was seen between the active and placebo knees on the subject global aesthetic score or the subject satisfaction scale., Conclusion: Based on our study, PLLA may be a safe and effective modality in addressing upper knee skin laxity. Larger studies with longer follow-up times and a validated knee laxity scale are needed to further determine if and how much improvement can be achieved.

Synapses are touted as the main structural and functional components of neural cells within in the nervous system, providing tissue connectivity and integration via the formation of perineuronal nets. In the present study, we evaluated the synaptogenic activity of electrospun PLGA and PLGA-PEG nanofibers on human SH-SY5Y cells after 14 days in vitro. Electrospun PLGA and PLGA-PEG nanofibers were fabricated and physicochemical properties were examined using the HNMR technique. The cells were classified into three random groups, i.e., control (laminin-coated surface), PLGA, and PLGA-PEG. Scaffolds' features, cell morphology, attachment, and alignment were monitored by SEM imaging. We performed MTT assay to measure cell survival rate. To evaluate neurite formation and axonal outgrowth, cells were stained with an antibody against β-tubulin III using immunofluorescence imaging. Antibodies against synapsin-1 and synaptophysin were used to explore the impact of PLGA and PLGA-PEG scaffolds on synaptogenesis and functional activity of synapses. According to SEM analysis, the PLGA-PEG scaffold had less thick nanofibers compared with the PLGA scaffold. Cell attachment, expansion, neurite outgrowth, and orientation were promoted in the PLGA-PEG group in comparison with the PLGA substrate (p < 0.05). MTT assay revealed that both scaffolds did not exert any neurotoxic effects on cell viability. Notably, PLGA-PEG surface increased cell viability compared to PLGA by time (p < 0.05). Immunofluorescence staining indicated an increased β-tubulin III level in the PLGA-PEG group days coincided with axonal outgrowth and immature neuron marker after seven compared with the PLGA and control groups (p < 0.05). Based on our data, both synaptogenesis and functional connectivity were induced in cells plated on the PLGA-PEG surface that coincide with the increase of synapsin-1 and synaptophysin in comparsion with the PLGA and control groups (p < 0.05). Taken together, our results imply that the PLGA-PEG nanofibers could provide the desirable microenvironment to develop perineuronal net formation, contributing to efficient synaptogenesis and neuron-to-neuron crosstalk.

Background: Poly-L-lactic acid (PLLA) is a well-established biostimulator that induces neocollagenesis, allowing for volume loss correction. Although PLLA is FDA approved to treat mid-to-lower facial wrinkling, it has grown increasingly popular as a nonsurgical, minimally invasive procedure for soft-tissue volume augmentation of other extremities. However, research detailing PLLA buttock injections is still lacking., Objective: The purpose of this study is to determine the safety and efficacy of PLLA for buttock augmentation., Materials and Methods: A clinical retrospective review of 60 patients (ages 23-54 years) were followed for 2 years by 2 investigators. Patients underwent 1 to 3 treatments, spaced 4 to 6 weeks apart, and received 2 to 12 vials per session (based on the patient budget). Pretreatment and post-treatment photographs were assessed by the primary and secondary investigator in blinded and double-blinded surveys, respectively. The Global Aesthetic Improvement Scale was used to quantify improvements in volume, skin texture, and cellulite dimpling., Results: Poly-L-lactic acid allows for visible volume amplification, improved skin texture, and softened cellulite dimpling in the buttocks when at least 20 vials are used., Conclusion: Poly-L-lactic acid is safe and effective for overall aesthetic enhancement of the buttocks if used in adequate quantity (minimum 20 vials) for all women, independent of age or the number of sessions.

Resorbable surgical materials are often used in the pediatric population to provide fixation in the growing skeleton. Although foreign body reactions to poly-D-L-lactic acid (PDLLA) plates and screws have been previously reported in other fields, to date PDLLA polymers have been well-tolerated in the setting of craniofacial surgery. The authors report a case of a previously healthy 4-month-old patient with Crouzon syndrome who underwent a frontal-orbital advancement with resorbable PDLLA plates and screws and subsequently experienced extensive foreign body reactions and wound healing complications.

Modification of Polylactic acid (PLA), a biopolymer, is a strategy still to be fully explored for the next generation of bioresorbable vascular stent (BVS) biomaterials. With this focus, inclusions upto 5% of Polycaprolactone (PCL) and Magnesium in PLA were tested in the rat subcutaneous model and their cellular and tissue interactions characterized, specifically with respect to inflammatory response, angiogenesis and capsularization. The cytokines IL6, TNF Alpha and IL-1Beta were estimated in the peri-implant tissue, all of which showed a non-significant difference between the non-implanted animals and those containing PLA by 8 weeks, speaking to the benign nature of PLA as an implant biomaterial. Both modified materials, had increased macrophage counts and cytokine levels, except IL6 at 8 weeks. Vascularization only at 8 weeks in PLA PCL containing tissue was significantly higher than pure PLA, which may be more carefully controlled along with the material hydrophobicity for possible efforts towards therapeutic angiogenesis. Capsule thickness, measured by staining with both Hematoxylin & Eosin and Masson's Trichome did not show any differences between materials, including PLA., (Copyright © 2020 Elsevier GmbH. All rights reserved.)

Objective: To evaluate the short and long-term results of in situ prosthetic graft treatment using rifampicin-soaked silver polyester graft in patients with aortic infection., Material and Method: All the patients surgically managed in our center for an aortic infection were retrospectively analyzed. The primary endpoint was the intra-hospital mortality, secondary outcomes were limb salvage, persistent or recurrent infection, prosthetic graft patency, and long-term survival., Results: From January 2004 to December 2015, 18 consecutive patients (12 men and 6 women) were operated on for aortic infection. Six mycotic aneurysms and 12 prosthetic infections, including 8 para-entero-prosthetic fistulas, were treated. In 5 cases, surgery was performed in emergency. During the early postoperative period, we performed one major amputation and two aortic infections were persistent. Intra-hospital mortality was 27.7%. The median follow-up among the 13 surviving patients was 26 months. During follow-up, none of the 13 patients presented reinfection or bypass thrombosis., Conclusion: This series shows that in situ revascularization with rifampicin-soaked silver polyester graft for aortic infection have results in agreement with the literature in terms of intra-hospital mortality with a low reinfection rate., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Background: In this study, a physical properties test and preclinical evaluation were performed on two polycaprolactone (PCL)-based dermal filler formulas., Objective: This study was performed to compare the rheological characteristics, preclinical efficacy, and safety of a new PCL filler, SF-01, with a licensed PCL filler., Methods: First, the viscoelasticity of the PCL filler was evaluated. Next, hairless mice were injected with fillers and evaluated for efficacy with a folliscope and PRIMOS LITE . Histological evaluation was conducted for 6 months to evaluate safety., Results: In this evaluation, SF-01 was superior to a licensed PCL filler in initial volume increase rate and in vivo durability, and the migration of the injected filler was not confirmed. The elasticity (G*, G') and viscosity (G'') are also expected to be lower than those of a licensed PCL filler, thereby resulting in less foreign body sensation in the living body., Conclusion: SF-01 (porous PCL microsphere-based dermal filler) has been confirmed to be superior in durability and shape retention compared to the licensed PCL filler (nonporous PCL microsphere-based dermal filler), and the in vivo safety is equivalent., (© 2019 Wiley Periodicals, Inc.)

Background : Dorsal hand volume loss results in the perception of aging appearance. Several volumizing fillers have been used for this correction. Objective : To report restoration of dorsal hand volume using cannula delivery of Polycaprolactone (PCL) microspheres and to assess efficacy, duration, and safety up to 3 years post treatment. Method : Fifteen patients with volume loss of their hands were evaluated by clinical examination, photography and a hand volume grading scale. PCL was injected by 25 G cannula after locating dorsal veins using a viewing laser to avoid intravascular injections. Patients' satisfaction and grade of severity were reevaluated at early (3-6 months) and late (12-18 months) timepoints following the procedure. A second treatment was offered if desired by the patient. Results : Eight participants required one treatment session to achieve satisfaction. Five had two treatments. Patients requiring a second treatment were reassessed after 12 months. All patients had improvements on the severity score by the end of the evaluation period. Side effects were minimal and transient. No patients developed bruising. Conclusion : PCL injections are reliable method for hand volumization. Results persisted for up to 3 years in some patients. Laser vein viewer and cannula delivery ensure uniform injections and avoid intravascular injuries.

Objective: Experimental assessment of the effect of modified and unmodified surgical suture material on abdominal adhesive process., Material and Methods: The study was performed on male rats of the Wistar subpopulation. There were 5 animals in each group. In all animals, midline abdominal incision was followed by suturing the parietal peritoneum with modified and unmodified suture material. All animals were euthanized with carbon dioxide vapors in 14 days after surgery. Macro- and microscopic assessment of severity of abdominal adhesive process was carried out. Two types of preparation of excised complexes 'peritoneum-suture material-adhesion' were applied for histological examination: paraffin sections and embedding in epoxy resin. Specimens were stained by Van Gieson and with methylene blue solution. Histological specimens were examined using Axio Imager A1 light microscope (Zeiss, Germany)., Results: Polypropylene filaments result extensive adhesions occupying about 75% of the area. Adhesions have a dense structure with signs of vascularization. Modification of suture material with solution of polyhydroxybutyrate/hydroxyvalerate and heparin reduce severity of adhesions. The use of modified suture material was followed by adhesions with more loose structure, no signs of vascularization. Adhesions occupied less than 25% of the area. Histological examination of excised complexes 'peritoneum-suture material-adhesion' revealed accumulation of inflammatory cells around the unmodified suture material, while there were no signs of tissue inflammatory process around the modified sutures., Conclusion: Application of polyhydroxybutyrate/hydroxyvalerate and heparin on the surface of surgical sutures is an effective method for prevention of abdominal adhesions.

Poly-l-lactic acid (PLLA) is widely used in clinic, for example, as biodegradable coronary artery stents. However, inflammatory responses in endothelial cells associated with PLLA degradation are relatively undefined. We previously reported inflammation in human aortic endothelial cells (HAEC) in vitro and in vivo. Here, we further assessed inflammatory injury, including cell migration, cell function, and inflammatory cytokines expressed in HAEC treated with PLLA and curcumin by CCK-8, wound healing assay, ELISA, and Western blot. Significant inhibition of cell migration, remarkable dysfunction, and inflammatory responses were found in HAEC treated with PLLA degradation extract, and these effects were alleviated by Cur treatment. These findings indicated that cautious evaluation of biodegradable polymers should be performed, and Cur represents a promising anti-inflammatory agent for alleviating endothelial dysfunction and inflammation caused by PLLA degradation. In addition, Cur should be further studied experimentally in in vivo experiments on animal models as a potential therapeutic to reduce thrombosis of biodegradable polymer stents., (© 2019 Wiley Periodicals, Inc.)

Background: Current therapeutic materials for spina bifida repair showed a limited number of options in the market, and none of them have all the requirements as the ideal patch. In fact, sometimes the surgical procedures pose substantial challenges using different patches to fully cover the spina bifida lesion. For this purpose, a tailored patch made of poly (L-lactic acid) and poly (ε-caprolactone) blend was designed and validated in vitro to accomplish all these requirements but was never tested in vivo., Material and Methods: In our present study, the designed patch was analyzed in terms of rejection from the animal when implanted subcutaneously and as a dural substitute in the spinal cord. Inflammatory reaction (Iba1), astrogliosis (GFAP), was analyzed and functional interaction with spinal cord tissue assessing the (%motor-evoked potentials /compound motor action potential) by electrophysiology., Results: No evidence of adverse or inflammatory reactions was observed in both models of subcutaneous implantation, neither in the neural tissue as a dural substitute. No signs of astrogliosis in the neural tissue were observed, and no functional alteration with improvement of the motor-evoked potential's amplitude was detected after 4 wk of implantation as a dural substitute in the rat spinal cord., Conclusions: Designed patch used as a dural substitute will apparently not produce inflammation, scar formation, or tethering cord and not induce any adverse effect on regular functions of the spinal cord. Further studies are needed to evaluate potential improvements of this novel polymeric patch in the spinal cord regeneration using spina bifida models., (Copyright © 2019. Published by Elsevier Inc.)

BACKGROUND: Poly-L-lactic acid (PLLA) is increasingly used for a range of indications, from HIV lipodystrophy to gluteal augmentation; however, there is no clear consensus on appropriate product preparation and use. OBJECTIVE: To establish current practices for PLLA reconstitution and usage in the USA. METHODS AND MATERIALS: A 19-question survey pertaining to the reconstitution and use of PLLA was distributed to members of the American Board of Cosmetic Surgery and American Board of Facial Cosmetic Surgery and at several cosmetic conferences. 410 questionnaires were returned anonymously over a 3-month period. The results were collated and analyzed. RESULTS: The commonest indication for PLLA was HIV lipodystrophy (46.8%), followed by gluteal augmentation (42.4%). For the face, the majority used a dilution of 9-10 mL (60.4%). For the gluteal region, the majority used a dilution greater than 21 mL (51.3%). Most respondents reconstituted PLLA in sterile water (59.8%) more than 21 hours before use (51.0%) and added lidocaine to the solution (94.7%). Most physicians used topical anesthetic cream (83.2%), manual agitation (85.8%) and recommended self-massage post-treatment (99.6%). CONCLUSION: There is considerable variation in PLLA reconstitution and use. Further well-designed studies are needed to establish the safest, most effective ways to use this product. J Drugs Dermatol. 2019;18(9):880-886.

Purpose: To Compare the extent and intensity of adhesions formed between the intra-abdominal organs and the intraperitoneal implants of polypropylene mesh versus polypropylene/polyglecaprone versus polyester/porcine collagen used for correction of abdominal wall defect in rats., Methods: After the defect in the abdominal wall, thirty Wistar rats were placed in three groups (ten animals each) for intraperitoneal mesh implant: polypropylene group, polypropylene/polyglecaprone group, and polyester/porcine collagen group. The macroscopic evaluation of the extent and intensity of adhesions was performed 21 days after the implant., Results: The polypropylene group had a higher statistically significant impairment due to visceral adhesions (p value = 0.002) and a higher degree of intense adherence in relation to polypropylene/polyglecaprone and polyester/porcine collagen groups (p value<0.001). The polyester/porcine collagen group showed more intense adhesions than the polypropylene/polyglecaprone group (p value=0.035)., Conclusions: The intraperitoneal implantation of polypropylene meshes to correct defects of the abdominal wall caused the appearance of extensive and firm adhesions to intra-abdominal structures. The use of polypropylene/polyglecaprone or polyester/porcine collagen tissue-separating meshes reduces the number and degree of adhesions formed.

Background: Numerous fillers are increasingly used for augmentation of volume loss and relaxation of facial wrinkles. Collagen stimulators are the latest next-generation dermal fillers that can induce neocollagenesis. To investigate biophysical characteristics, safety, and efficacy of newly developed polydioxanone (PDO) filler in comparison with poly-l lactic acid (PLLA) and polycaprolactone (PCL) fillers., Methods: In vitro assay, morphology of particles, and rheological property of fillers were measured. A total of 24 female hairless mice (SKH1-Hr hr ) were randomly divided into three groups and injected with PDO, PLLA, or PCL fillers. Durability of fillers was assessed at 0, 3 days, and 1, 4, 8, 12 weeks after injection using folliscope and PRIMOS. To determine biocompatibility and neocollagenesis, histologic evaluation was performed at 1, 4, 8, and 12 weeks after injection. Efficacy was also evaluated based on skin surface roughness changes using PRIMOS in a hairless mouse photoaging model., Results: In the particle morphology test, PDO microspheres had an irregular surface and were spherical and uniformly sized. PDO filler demonstrated similar neocollagenesis and inflammatory response to other collagen stimulators. PDO filler showed better biodegradability than PLLA and PCL fillers. In the hairless mouse photoaging model, there was a statistically significant decrease in skin surface roughness after PDO filler injection., Conclusions: Our data suggest that newly developed collagen stimulating PDO filler might be a safe and effective option for correction of volume loss and rejuvenation of photoaging skin., (© 2019 Wiley Periodicals, Inc.)

Background & Objectives: For improved male contraception, a new polymeric drug molecule - Reversible Inhibition of Sperm under Guidance (RISUG) has been synthesized and has been found to be effective, safe and reversible in various animal species. Phase-I and phase-II clinical trials have confirmed its safety and contraceptive efficacy. The present study was undertaken as a multicentric-limited phase-III clinical trial to test the efficacy and safety of RISUG in human volunteers., Methods: One hundred and thirty nine young males each having at least two children and living with wife were given 120 μl of RISUG as bilateral vas intraluminal injection. After the single-dose administration, the individuals were followed in respect of general health and semen parameters. Their wives were also followed particularly to determine onset of pregnancy., Results: During the six month follow up, the health of male volunteers and their wives was normal with no significant adverse effects. Temporary scrotal enlargement and mild scrotal and inguinal region pain were manifested in most individuals and resolved within one month without any routine activity impairment. In six individuals, there was injection procedure failure and azoospermia was not achieved. The other 133 individuals had either severe oligozoospermia or azoospermia at the first semen examination one month following RISUG injection; 82.7 per cent individuals had continued azoospermia in the month following first semen examination onwards and the rest 17.3 per cent manifested azoospermia within three to six months., Interpretation & Conclusions: RISUG intravasal injection appears to be a safe clinical procedure with no significant adverse effects and has high sustained contraceptive efficacy. The localized intervention and continued contraceptive action on single-dose administration were significant features of the RISUG technology., Competing Interests: None

Background: Protein-bound uremic toxins indoxyl sulfate (IS) and p-cresyl sulfate (PCS) have been associated with cardiovascular morbidity and mortality in patients with CKD. However, direct evidence for a role of these toxins in CKD-related vascular calcification has not been reported., Methods: To study early and late vascular alterations by toxin exposure, we exposed CKD rats to vehicle, IS (150 mg/kg per day), or PCS (150 mg/kg per day) for either 4 days (short-term exposure) or 7 weeks (long-term exposure). We also performed unbiased proteomic analyses of arterial samples coupled to functional bioinformatic annotation analyses to investigate molecular signaling events associated with toxin-mediated arterial calcification., Results: Long-term exposure to either toxin at serum levels similar to those experienced by patients with CKD significantly increased calcification in the aorta and peripheral arteries. Our analyses revealed an association between calcification events, acute-phase response signaling, and coagulation and glucometabolic signaling pathways, whereas escape from toxin-induced calcification was linked with liver X receptors and farnesoid X/liver X receptor signaling pathways. Additional metabolic linkage to these pathways revealed that IS and PCS exposure engendered a prodiabetic state evidenced by elevated resting glucose and reduced GLUT1 expression. Short-term exposure to IS and PCS (before calcification had been established) showed activation of inflammation and coagulation signaling pathways in the aorta, demonstrating that these signaling pathways are causally implicated in toxin-induced arterial calcification., Conclusions: In CKD, both IS and PCS directly promote vascular calcification via activation of inflammation and coagulation pathways and were strongly associated with impaired glucose homeostasis., (Copyright © 2019 by the American Society of Nephrology.)

Background: Skin diseases can develop upon disadvantageous microclimate in relation to skin contact with textiles of supporting devices. Increased temperature, moisture, mechanical fracture, pressure, and inflammatory processes often occur mutually and enhance each other in their adverse effects. Therefore, the early prevention of skin irritations by improvement of microclimatic properties of skin in contact with supporting devices is important., Materials and Methods: In this study, the microclimate under occlusion with polyester, cotton, chloroprene rubber, and silicone textiles, used for supporting devices, was analyzed by determining several characteristic physiologic skin parameters in vivo, including temperature, moisture, and transepidermal water loss (TEWL). This is achieved by comparing a miniaturized in vivo detection device with several established optical and sensory methods in vivo., Results: A highly significant TEWL decrease was found after polyester, chloroprene rubber, and silicone application. The application of all materials showed highly significant decrease in skin surface temperature, with chloroprene rubber showing the lowest. Similarly, all materials showed highly significant increase in relative moisture, where the highest increase was found for chloroprene rubber and silicone and the lowest increase for cotton. The cutaneous carotenoid concentration of chloroprene rubber, silicone, and polyester decreased. A manipulation of the surface structure of the stratum corneum was recognized for all materials except for cotton by laser scanning microscopy., Conclusion: The skin parameters temperature, relative moisture, antioxidant status, and TEWL can effectively characterize the microclimatic environment during occlusion with medical supporting materials. These parameters could potentially be used to develop standardized testing procedures for material evaluation., (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Hydroxyapatite and poly-L-lactide plates are often used for maxillofacial surgery. These plates take 3 to 4 years to resorb completely, leading to the possibility of a foreign-body reaction. A 20-year-old woman who developed a foreign-body reaction to the plates was reported. Based on review of the relevant literature, foreign-body reactions have often been reported with this plate. Long-term follow-up is warranted to evaluate patients using this plate in maxillofacial surgery.

In aesthetic medicine, there has been an ongoing search for an ideal dermal filler to offer zero complication rate. Polycaprolactone-based dermal filler (PCL) has been available since 2009. The purpose of the paper was to present a case of granuloma as a complication of PCL injection, which has not been reported so far by other researchers. A 68-year-old female was injected with PCL. One year later, nodules accompanied by bluish skin discoloration developed within the injection site. Ultrasound and histopathology studies were performed. The examinations confirmed the presence of foreign body granuloma after PCL, which makes it the first reported case worldwide. The published data analyses showed general lack of studies and case reports to address this issue. The PCL, like an injection of any soft tissue filler, may lead to serious complications, such as granuloma formation. This makes further research legitimate and necessary.

Background: Conventional procedures including botulinum toxin and filler injections have their limitations in improving deep wrinkles and decreasing tissue laxity, and possess the propensity for vascular accidents. Absorbable thread is a recently commercialized field, but there is little evidence on comparative superiority., Objectives: We observed the effects of polydiaxanone (PDO) threads with different number of strands in relation to collagen production and histopathology in a rat model., Materials and Methods: Dorsal skin of rat was divided into five different compartments and four different PDO threads and monofilament poly-lactic acid (PLA) thread were inserted. Tissue samples were obtained at week 1, 2, and 12 after the procedure for histopathologic review and real-time PCR for quantification of collagen., Results: Multiple PDO filaments produced more collagen at 2 weeks. Single-stranded PLA thread insertion resulted in more Col1α1 levels than the double PDO thread and also showed the most Col1α3 production at week 2. The amount of collagen showed a sharp decline at week 12. Histologic evaluation showed retained threads surrounded by fibrous capsule-like structure at week 12., Conclusion: We were able to observe more collagen production in multiple stranded PDO threads compared to a single strand and that increasing number of threads leads to more collagen synthesis.

Objective: To evaluate the feasibility, efficacy, and safety of a fully biodegradable poly lactic acid (PLA)-based occluder for atrial septal defect (ASD) closure in an animal model., Methods: ASDs, approximately 12-mm in diameter, were generated in sheep (n = 18) by needle puncture and balloon dilatation. For ASD closure, occluders were implanted by percutaneous transcatheter approach under echocardiographic guidance. Outcomes were evaluated by transthoracic echocardiography, electrocardiography, blood testing, and histology within the follow-up period ranging from 1 month to 2 years., Results: All occluders were successfully implanted. During follow-up, no animal died; rectal temperatures, blood test results, and electrocardiograms were within normal ranges; and transthoracic echocardiograms, macroscopic studies, and histopathological and electron microscopic examination demonstrated that the occluders were well positioned, with no shifting, residual shunts, severe inflammation, thrombus formation, atrioventricular valve insufficiency, cardiac erosion or arrhythmias. The occluders gradually embedded into the endocardial tissue of the hosts with complete endothelialization and disk absorption at 12 months, and a distinct molecular weight decrease of the framework (to 9% of initial) at 24 months after implantation., Conclusions: In a sheep model, the use of totally biodegradable occluders appears feasible, efficacious and safe for ASD closure. Studies in humans are ongoing., (© 2018 Wiley Periodicals, Inc.)

Background: Primary closure of post-operative facial dehiscence (FD) is associated with a high incidence of recurrence, revisional surgery, and incisional hernia. This retrospective study compares outcomes of implantation of non-absorbable intra-abdominal meshes with primary closure of FD. The outcomes of different mesh materials were assessed in subgroup analysis., Methods: A total of 119 consecutive patients with FD were operated (70 mesh group and 49 no mesh group) between 2001 and 2015. Primary outcome parameter was hernia-free survival. Secondary outcome parameters include re-operations of the abdominal wall, intestinal fistula, surgical site infections (SSI), and mortality. Kaplan-Meier analysis for hernia-free survival, adjusted Poisson regression analysis for re-operations and adjusted regression analysis for chronic SSI was performed., Results: Hernia-free survival was significantly higher in the mesh group compared to the no mesh group (P = 0.005). Fewer re-operations were necessary in the mesh group compared to the no mesh group (adjusted incidence risk ratio 0.44, 95% confidence interval [CI] 0.20-0.93, P = 0.032). No difference in SSI, intestinal fistula, and mortality was observed between groups. Chronic SSI was observed in 7 (10%) patients in the mesh group (n = 3 [6.7%] with polypropylene mesh and 4 [28.6%] with polyester mesh). The risk for chronic SSI was significantly higher if a polyester mesh was used when compared to a polypropylene mesh (adjusted odds ratio 8.69, 95% CI 1.30-58.05, P = 0.026)., Conclusion: Implantation of a polypropylene but not polyester-based mesh in patients with FD decreases incisional hernia with a low rate of mesh-related morbidity.

Background: The detection of intraprosthetic thrombus (IPT) deposits is a common finding during follow-up for endovascular abdominal aneurysm repair (EVAR); however, its clinical significance is still debated. The aim of this study was to determine if IPT represents a risk factor for thromboembolic events (TEs; endograft or limb thrombosis, or distal embolization) after EVAR., Methods: A systematic review of English literature was undertaken until November 2017. Studies providing 2-group comparison (patients with IPT development on postoperative computed tomography angiography versus patients without IPT) with extractable outcome data (TE related to IPT and/or risk factors for IPT development) were included. Meta-analysis was performed when comparative data were given in 2 or more articles., Results: Five single-center studies (808 patients) were analyzed. IPT detection at any time during follow-up occurred in 20.8% (168/808) of patients. Extractable data for postoperative TE were available in 4 studies (613 patients): on comparative meta-analysis, IPT was not significantly associated with TE occurrence during follow-up (odds ratio 2.25, 95% confidence interval [CI] 0.50-10.1; P = 0.29). IPT is generally detected during the first year after EVAR (maximum reported median: 12 months, range: 1.2-23). Polyester graft material (odds ratio 2.34, 95% CI 1.53-3.58; P < 0.001) and aorto-uni-iliac configuration of the endograft (odds ratio 3.27, 95% CI 1.66-6.44; P = 0.001) were confirmed as risk factors for IPT formation on meta-analysis. The literature systematic review suggests that IPT formation may be also associated with long main bodies and large necks., Conclusions: IPT detection on postoperative computed tomography angiography was not significantly associated with the occurrence of TE over time. The aorto-uni-iliac configuration and the use of polyester fabric for endografts were confirmed as risk factors for IPT development., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Biomaterials can cause a chronic local inflammation called foreign body reaction, with formation of foreign body giant cells (FBGC) by monocyte/macrophage fusion. However, FBGC appearance and role for biomaterials with different physicochemical properties are not yet fully understood. This study aimed at examining FBGC and inflammatory cells after intramuscular implantation of poly(l-lactide-co-d/l-lactide) (PLA) as membranes and uncoated electro-spun fiber meshes or meshes with a positively charged plasma-polymer coating into rats. After 7, 14 and 56 days, CD68 + and CD163 + macrophages, T lymphocytes, MHC-II + cells, FBGC, and nestin-stained tissue area as regeneration marker were morphometrically analyzed. FBGC occurrence was primarily determined by material morphology, as their numbers for meshes were 10-fold higher during acute and 50-fold higher during chronic inflammation than for membranes but comparable between uncoated and coated meshes. CD68 + macrophages decreased around and within meshes, while CD163 + macrophages and MHC-II + cells increased within meshes. T lymphocytes within meshes were higher for coated meshes, suggesting that the peri-implant tissue immunological response is also influenced by surface chemistry. FBGC were predominantly CD68 + and CD163 - , and nestin-stained tissue area was negatively correlated with CD68 + monocytes/macrophages numbers and positively correlated with CD163 + macrophages numbers, highlighting differing roles in FBGC formation and tissue regeneration. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 106A: 2726-2734, 2018., (© 2018 Wiley Periodicals, Inc.)

Ureteral stents are widely used in the department of urology, while the stent could result in many stent-associated complications, such as encrustation, a forgotten stent and patient discomfort. Thus, we developed a novel gradient degradable ureteral stent, which could degrade gradient in vivo, and assessed its effectiveness of the drainage, degradation and biocompatibility in a beagle dog model. In the present study, the degradation time and cytotoxicity were investigated in vitro. And the beagle dogs were inserted with a degradable stent or a biostable stent, and blood studies, liver function tests, renal function tests, urine studies, X-ray, excretory urograms and computerized tomography were performed at immediately, two weeks, four weeks and six weeks postoperative. The results showed that the drainage of the novel stent is similar to the conventional stent, while the biocompatibility and antibacterial ability of the novel stents are better than the conventional stents. The stents we developed provide an alternative for urologists and more assays would be performed in detail to assess the property of the stents.