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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.)

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.

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.

Objective: To evaluate the effect of a self-gripping mesh (Progrip) on the incidence of chronic postoperative inguinal pain (CPIP) and recurrence rate after Lichtenstein hernioplasty., Background: Chronic pain is the most common complication of inguinal hernioplasty. One of the causes may be the use of sutures to secure the mesh., Methods: Adult male patients undergoing Lichtenstein hernioplasty for a primary unilateral inguinal hernia were randomized to a self-gripping polyester mesh or a sutured polyester mesh. Follow-up took place after 2 weeks, 3, 12, and 24 months. Pain and quality of life were assessed using the Verbal Rating Scale, Visual Analog Scale, and Short Form 36. CPIP was defined as moderate pain lasting at least 3 months postoperatively., Results: There were 165 patients in the Progrip mesh group and 166 patients in the sutured mesh group. The incidence of CPIP was 7.3% at 3 months declining to 4.6% at 24 months and did not differ between both groups. Pain and quality of life scores were significantly improved after 2 years. Hernia recurrence rate after 24 months was 2.4% for the Progrip mesh and 1.8% for the sutured mesh (P = 0.213). The mean duration of surgery was significant shorter with the Progrip mesh (44 vs 53 minutes, P < 0.001)., Conclusions: The self-gripping Progrip mesh does not reduce CPIP rates. Outcomes of the Progrip mesh are comparable to the Lichtenstein technique with the additional advantage of a reduced operation time. NCT01830452.

Background: Delayed wound dehiscence (DWD) typically occurs 2 to 7 weeks postoperatively and is characterized by wound gapping and drainage at a surgical site which has initial normal wound healing. This wound problem clinically mimics deep surgical site infection and, after eventual skin healing, leaves a cosmetically unattractive widened, atrophic surgical scar., Methods: A single-center, retrospective analysis was completed of 252 knees, over a 13-year period, in 194 patients (average age, 14.9 y) undergoing patellar realignment surgery. All knees in this study were treated through an anterior midline knee incision from mid-patella to the tibial tubercle. At wound closure either a 2-0 polyglactin 910 (Vicryl) group (V) or polydioxane (PDS) group (P) suture was used for subcutaneous reapproximation and then the skin was closed with a 4-0 subcuticular Poliglecaprone 25 and IRGACARE (Monocryl) suture. Wound complications were recorded and analyzed by subcutaneous suture type, severity, size of involvement, duration, and treatment type., Results: Of the 252 knees, there were 132 knees in the V group and 120 in the P group. A total of 195 surgeries were primary surgeries and 57 knees were through previous surgical scars. Eleven patients had surgeries in which 1 knee was in each study group. Overall there were 6.1% (8/132) of the V group and 1.7% (2/120) of the P group with DWD (P=0.11); hence there was a trend toward more DWD with Vicryl than PDS, but this did not meet statistical significance. Mean time to resolution of wound dehiscence was 26 days for V group and 46 days for the P group. The length of incision was demonstrated to be a statistically significant independent risk factor for the development of DWD, irrespective of suture type., Conclusions: The frequency of DWD in anterior knee incisions in our study population was 6.1% in the polyglactin 910 (Vicryl) group and 1.7% in the polydioxane (PDS) group. Although this analysis did not achieve statistical significance, a 3.5 times decrease in DWD when PDS was used is considered by the authors to be clinically significant. The authors have definitively switched from Vicryl to PDS for the subcutaneous skin closure at the knee in patients aged 20 years and younger in the push to make wound complications a nonevent., Level of Evidence: Level IV.

Background: The development of chronic nodules and granulomatous inflammation after filler injections has been attributed to bacterial biofilm infection. The authors aimed to investigate the relationship between filler and bacterial biofilm using a combined in vitro and in vivo study., Methods: In vitro assays to investigate the ability of filler materials to support the growth of Staphylococcus epidermidis biofilm and the effect of multiple needle passes through a biofilm-contaminated surface were designed. Analysis of clinical biopsy specimens from patients presenting with chronic granulomas following filler administration using a number of laboratory tests for biofilm was performed., Results: All fillers (i.e., hyaluronic acid, polyacrylamide gel, and poly-L-lactic acid) supported the growth of S. epidermidis biofilm in vitro. Multiple needle passes through a biofilm-contaminated surface resulted in significantly increased contamination of filler material by a factor of 10,000 (p < 0.001). Six clinical samples from five patients all demonstrated bacterial biofilm. The mean number of bacteria was found to be 2.2 × 10 bacteria/mg tissue (range, 5.6 × 10 to 3.7 × 10 bacteria/mg tissue). Microbiome analysis detected a predominance of Pseudomonas, Staphylococcus, and Propionibacterium as present in these samples., Conclusions: Filler material can support the growth of bacterial biofilm in vitro. Multiple needle passes can significantly increase the risk of filler contamination. Biofilm appears to be associated with high numbers in clinical samples of patients presenting with chronic granulomatous inflammation. Strategies to reduce the risk of bacterial contamination need to be further studied and translated into clinical practice., Clinical Question/level of Evidence: Therapeutic, V.

A 55-year-old woman developed no light perception vision in her right eye 5 days after an injection of polylactic acid cosmetic filler into her right forehead. Diffuse corneal edema and anterior chamber inflammation prohibited any view to the posterior segment to identify the cause of her profound vision loss. MRI of the orbits with diffusion-weighted imaging showed hyperintensity of the right optic nerve with signal reduction on apparent diffusion coefficient mapping, consistent with ischemia. Our patient also was found to have acute infarctions in the distribution of the right anterior cerebral artery on MRI of the brain despite having no permanent focal neurologic deficits aside from vision loss.

Introduction: OSTEOTRANS MX (Takiron Co, Ltd, Osaka, Japan) is a resorbable osteosynthetic material composed of an unsintered hydroxyapatite/poly-L-lactide composite, and its osteoconductive capacity has been documented. The authors here report their clinical experience using OSTEOTRANS MX., Methods: The authors treated 35 patients (19 men, 16 women; age, 14-88 years; mean ± standard deviation, 38.4 ± 19.9 years) with maxillofacial fractures. The authors used standard surgery to stabilize fractures in all patients, fitting resorbable plates (thickness, 1.0 or 1.4 mm) and screws (diameter, 2 mm) according to Arbeitsgemeinschaft für Osteosynthesefragen/Association (AO) for the Study of Internal Fixation guidelines., Results: All patients eventually achieved satisfactory healing with favorable restoration of form and function without foreign body reaction. Complications occurred in 3 patients-plate exposure in 2 and discomfort in 1. However, fracture sites healed in all patients. Scanning electron microscopy revealed that the devices bonded directly to the bone without interposition of nonmineralized tissue., Conclusion: OSTEOTRANS MX is a useful material with few complications. Its osteoconductive bioactivity is advantageous for the early functional improvement of maxillofacial fractures., Competing Interests: The authors report no conflicts of interest. ZMC, zygomaticomaxillary complex.

The drug-eluting stent platform has a limited surface area, and a polymer carrier matrix is coated to enable sufficient loading of drugs. The development of a suitable polymer has been challenging because it must exhibit biocompatibility with the intravascular milieu. The use of biodegradable polymers seems to be attractive because it enables drug release as it degrades and is eventually eliminated from the body leaving the permanent metallic stent polymer-free. The aim of this study was to investigate the biocompatibility of biodegradable polymers using the human monocyte cell line. Cultured monocytes differentiated into functional macrophages (THP-1) were incubated with various polymers including poly-L-lactide (PLA), polycaprolactone (PCL), or poly-D, L-lactide-co-glycolide (PLGA) for up to 5 days. Exposure of cells to the polymers resulted in macrophage-polymer adhesion and induced marked pro-oxidant species as measured by calcein AM uptake assay and flow cytometric analysis of 2',7'-dichlorofluorescin fluorescence, respectively. Real-time reverse-transcription polymerase chain reaction and Western blot analysis of expression of nicotinamide-adenine dinucleotide phosphate (NADPH) oxidases revealed enhanced expression of NADPH oxidase subunits in response to PLA and PLGA compared with that of PCL. Flow cytometric analysis of fluorescein isothiocyanate-Annexin V and propium iodide-stained PLA and PGLA polymer-exposed THP-1 cells showed early and late apoptotic changes. Similarly, exposure to the PLA and PGLA polymers, but not to the PCL polymer, resulted in enhanced staining for cleaved poly(ADP-ribose) polymerase-1, a protein fragment produced by caspase cleavage. These results indicate that biodegradable polymers are associated with cell adhesion, NADPH oxidase-induced generation of reactive oxygen species and excess apoptosis.

Study Design: A prospective randomized clinical study. OBJECTIVE.: To assess fusion, clinical outcome, and complications., Summary of Background Data: Resorbable poly-L- lactide-co-D,L-lactide (PLDLLA) cages intended to aid spinal interbody fusion have been introduced into clinical practice within the last decade. Although early case series show promising results with respect to fusion rate, worries persist with regards to efficacy and potential risks of early failure of these implants. Despite widespread clinical application this is the first randomized prospective study to assess clinical and radiologic outcomes of PLDLLA cage compared with a traditionally applicable counterpart., Methods: Twenty-six patients were randomly assigned to undergo instrumented posterior lumbar interbody fusion whereby either a nonresorbable poly-ether-ether-ketone (PEEK) cage or a resorbable PLDLLA cage was implanted to aid fusion. Fusion rate, subsidence, and clinical outcome based on visual analog scale scores for leg pain and back pain, as well as Oswestry Disability Index and SF-36 questionnaires were documented and analyzed. Complications and adverse events were recorded., Results: Fusion rate was significantly higher with the PEEK cage compared with PLDLLA cage (Fisher exact test, P = 0.0302). Rate of subsidence was significantly higher with the PLDLLA cage compared to PEEK cage (Fisher exact test, P = 0.0414). The PEEK group demonstrated greater improvement in the Oswestry Disability Index compared with the PLDLLA group (Fisher exact test, P = 0.1414). Two cases of mild to moderate osteolysis were seen in the PLDLLA group., Conclusion: Our results strongly suggest that PLDLLA cage proffers a lower rate of fusion compared with PEEK cage, and also confirms that the efficacy of PLDLLA cage in enhancing interbody spinal fusion is yet to be established. The higher rate of subsidence and occurrence of osteolysis seen in association with PLDLLA cages in this study remain worrisome.

Study Design: Experimental study., Objective: To evaluate and compare the performances of 2 bioresorbable products, Mesofol (a caprolactone/lactide film) and Lactosorb (a polylactide film), as barriers to postoperative peridural adhesions and fibrosis., Summary of Background Data: Postoperative peridural adhesions from scar tissue may be an inciting cause of chronic pain and dysfunction in "failed back" syndrome. Many biocompatible products and drugs, as well as autografts have been tested as antiadhesion barriers with varying success., Methods: The bioresorbable film products were used to cover large laminectomy defects in 11 sheep. Three laminectomy defects were created, with 2 randomly assigned treatment sites and 1 control site in each animal. A tear was created in the dura allowing cerebrospinal fluid leakage to assess for impaired dural healing. Performance of the film barriers was assessed at 10 weeks postoperative by gross scar and tenacity scoring by 3 blinded, independent observers in 7 animals. Histology was performed in 4 animals. New Methylene blue dye myelography and magnetic resonance imaging were performed to assess for cerebrospinal fluid leakage. Magnetic resonance imaging was also used to evaluate the imaging characteristics of adhesions., Results: All 3 products evaluated showed a benefit to prevention of postoperative peridural adhesion; the performance of Mesofol was deemed superior to either of the 2 Lactosorb products. The handling characteristics of all products were compatible with clinical usage. Impairment to healing of dural tears or active inflammation was not identified with any product., Conclusion: The results of this investigation support previous studies on the benefit of polylactide film barriers, like Lactosorb, for reducing peridural adhesion following spinal surgery. The performance of Mesofol in this investigation suggests that it may provide improved antiadhesion properties in comparison to the polylactide products. Safety issues related to impaired dural healing was not identified in either product.

Objective: To study the suitability of resorbable polylactides for reconstruction in middle ear surgery., Experimental Animals: Twenty-four chinchillas., Interventions: Twenty chinchillas were operated on using 2 types of polylactides inserted into the middle ear and outer ear canal, 10 animals in each group. At 6 months, the animals were killed, and their temporal bones were removed for sectioning. Degree of inflammation, fibrosis, degradation of polylactide material, and new bone formation were assessed histologically., Main Outcome Measures: Polylactide implants caused only a mild local inflammation, with no difference between the 2 materials tested., Conclusion: Polylactide acid-based middle ear implants were successfully used in the reconstructive middle ear surgery. Resorption occurred without complications.

Study Design: A study of lumbar interbody fusion using polylactic acid-based bioresorbable fusion cages in a goat model., Objective: To evaluate the effect of polylactic acid polymer composition, and internal stabilization on the rate and quality of interbody fusion., Summary of Background Data: A spinal cage should provide an appropriate biomechanical environment to facilitate interbody fusion. Previous studies have shown that bioresorbable polylactic acid-based cages can provide adequate stability for spinal fusion. However, at present and to our knowledge, the best bioresorbable materials, optimal cage stiffness, and desired period over which the cage should biodegrade are unknown., Methods: Interbody fusions were performed at L3-L4 level in 35 skeletally mature Dutch milk goats. Titanium and poly-L-lactide-CO-D,L-lactide (PLDLLA) cages were implanted at random as stand-alone cages. In addition, PLDLLA cages were implanted with anterior fixation. The goats were euthanized at 3, 6, or 12 months. Radiographic, magnetic resonance imaging, histologic, and histomorphometric analyses were performed on retrieved segments. Chemical analysis was used to assess degradation of the retrieved PLDLLA cages. Beforehand, chemical and mechanical degradation of the PLDLLA cages were assessed in vitro., Results: At 3 months, bone graft was almost completely remodeled. Endochondral bone formation was observed in all specimens. At 6 months, 50% of the PLDLLA stand-alone cages and 83% of the PLDLLA anterior fixation cages were fused. At 12 months, 38% of the PLDLLA stand-alone and 83% of the titanium cages realized fusion. A very mild and dispersed foreign body reaction was seen in all PLDLLA specimens. E-beam sterilized PLDLLA cages degraded more rapidly in vivo as compared to both, PLDLLA cages in vitro, and ethylene oxide sterilized poly-L-lactic acid cages in vivo., Conclusions: Within the 3-6-month period, PLDLLA stand-alone cages provided insufficient mechanical stability, which manifested as cracking and deformation of the cages and lower fusion rates. This result implies that within this time, additional stabilization is required; supplemental internal fixation proved sufficient to obtain successful fusion. In all cases, only a mild host response was seen, indicating good biocompatibility.

Background: This study consists of a 5-year experience with 413 maxillary and mandibular resorbable plate osteosyntheses focusing on clinically apparent foreign body reaction (i.e., swelling, osteolyses, and fistulation), indirect implant degradation (i.e., palpability and radiographic reossification), and direct implant degradation (i.e., molecular weight and crystallinity of explants)., Methods: Eighty fracture and reconstruction cases (32 female and 48 male patients, aged 1 to 83 years) were osteofixated with poly(L-lactide-co-glycolide) (PLGA) copolymer (n = 20) (139 PLGA osteosyntheses) or poly(L-lactide-co-DL-lactide) [P(L/DL)LA] (n = 60) [274 P(L/DL)LA osteosyntheses]. Local revisions (n = 30) were performed during secondary operations at 3, 6, 12, 18, or 24 months. Average clinical and radiographic follow-up lasted 29 months (range, 6 to 63 months)., Results: Five patients (6 percent) had apparent foreign body reactions, whereas 75 (94 percent) did not. One P(L/DL)LA mild reaction was effectively treated with cold packs and analgesics, one PLGA and three P(L/DL)LA medium severe reactions were treated with curettage, and one local osteolysis disappeared at 6 months. Implant palpability lasted 12 (PLGA) or 24 months [P(L/DL)LA]. The difference was significant (p < 0.000001). Burr holes reossified at 24 (PLGA) and 36 months [P(L/DL)LA] (p < 0.05). The 85:15 PLGA explants' initial 44,600 molecular weight decreased to 11,000 at 6 months; and scarce powdering granular residuals, too small for molecular weight assessment, were encountered at 12 months. The 70:30 P(L/DL)LA initial molecular weight of 45,000 decreased to 25,000 at 6 months and 8,000 at 18 months and to similar granules at 24 months (p < 0.02). Histology showed macrophages, giant cells, lymphocyte infiltration, little granulocytic infiltration, and minimal bleeding residuals., Conclusions: Both copolymers showed reliable biocompatibility and disintegration. Overall, 6 percent clinically apparent foreign body reactions were controlled conservatively and by local curettage; 85:15 PLGA degraded within 12 months and 70:30 P(L/DL)LA within 24 months, leaving powdering residual granules. Burr holes reossified 12 months later.

Despite recent improvements in analgesia, pain control during dressing changes continues to be a major challenge in patients with burns. We investigated two different dressing modalities to compare how much pain the patient experienced during and after the dressing change. Patients with partial-thickness burns that required only topical wound care were assigned randomly to treatment with Acticoat (Smith and Nephew USA, Largo, FL) or silver sulfadiazine (AgSD). The outcome variable was pain during wound care, which was measured using visual analog pain scores. The mean visual analog pain scores for the wounds treated with Acticoat or AgSD wounds were 3.2 and 7.9, respectively (P < .0001; paired Student's t-test). In 41 of the 47 paired pain score observations, the pain in the wound treated with AgSD was perceived as greater than in the wound treated with Acticoat. Burn wound care with Acticoat is less painful than burn wound care with AgSD in patients with selected partial-thickness burns.

Study Design: Three different types of biodegradable poly(L-lactide-co-D,L-lactide) cages with and without augmentation of a biodegradable poly(propylene glycol-cofumaric acid) scaffold were compared with autograft and metallic cages of the same design and size by determining the stiffness and failure load of the L4-L5 motion segment of cadaveric human spines., Objectives: To determine how these devices limit the range of motion in the lumbar spine compared with a metallic cage. If biomechanically equivalent, biodegradable spinal fusion systems ultimately could reduce local stress shielding and diminish the incidence of clinical complications, including device-related osteopenia, implant loosening, and breakage., Summary of Background Data: Previous studies in dogs and humans have demonstrated vertebral body osteopenia as a result of instrumented spine fusions. To the authors' knowledge, neither an in vitro nor an in vivo biomechanical analysis of a biodegradable interbody fusion system has been performed., Methods: Forty-eight L4-L5 motion segments were isolated from 22 male and 26 female human donors with an average age of 49.6 +/- 2.7 years (range 36-55 years). Cages of similar dimensions and design, including a threaded, hollow, porous titanium BAK cage and three different BIO cages (BIO cage 1, pure polymer; BIO cage 2, polymer plus hydroxyapatite buffer; BIO cage 3, polymer plus nano-sized hydroxyapatite), produced from the same poly(L-lactide-co-D,L-lactide) polymer were tested in a comparative analysis to intact motion segment, interbody implantation of autograft, and a BIO cage augmented with an expandable biodegradable foam-scaffold fashioned from poly(propylene glycol-cofumaric acid)., Results: All cages were able to increase stiffness and failure load of the unstable motion segment significantly (P < 0.01). In comparison with the bone graft, the BAK cage (P < 0.01) and BIO cages 1 and 3 (P < 0.05) were able to increase stiffness and failure load. There was no significant difference between BIO cage 2 and the bone graft. Augmentation of BIO cage 1 with the foaming PPF scaffold resulted in higher stiffness and similar failure load as seen with the BAK cage., Conclusion: By comparison, the in vitro lumbar spinal motion segment stiffness and failure load produced by implantation of a biodegradable interbody fusion cage augmented with an expandable PPF scaffold is similar to that of the titanium BAK cage. This suggests that biodegradable anterior interbody fusion systems could be further developed for clinical applications.

Polymorphonuclear (PMN) cell activation in the presence of synthetic vascular grafts was studied by using flow cytometry to measure CD11/CD18 leukocyte adhesion molecule expression at the cell surface. Polymorphonuclear cells isolated from the blood of 10 healthy human donors were incubated with six knitted polyester vascular prostheses (Vasculour II, Albumin-Coated Graft, Triaxial, Gelatin-Impregnated Gelseal, Dialine I, and Bovine Collagen-Impregnated Dialine II) for 60 min at 37 degrees C. The authors' study demonstrated that CD11/CD18 integrin expression varies among donors for a given vascular prosthesis, and that each donor has his or her own pattern of responsiveness toward synthetic vascular grafts. The current study indicates that PMN activation measured by CD11/CD18 integrin expression is a sensitive method of measuring the blood compatibility of a given foreign surface for a given patient.

Two hundred ten rats were randomized into one of five study groups to compare standard absorbable sutures with a new synthetic absorbable suture. We evaluated Maxon (polyglyconate), Vicryl (polyglactin), chromic catgut (catgut), and PDS (polydioxanone) with respect to tissue inflammatory reaction, knot security, suture tensile strength, and suture absorption. The results indicate that Maxon and PDS elicited a lower degree of chronic inflammation when compared with Vicryl and chromic catgut. The tensile strengths of Maxon and Vicryl significantly exceeded those of PDS and chromic catgut during the critical period of wound healing. Maxon and PDS retained a larger percentage of tensile strength during the long postoperative period, whereas Vicryl and chromic catgut were mostly absorbed. Maxon is an excellent addition to the armamentarium of the gynecologic surgeon.