Rate of Vaginal Cuff Dehiscence When Using Vicryl (Poliglactyn 910) Compared to PDS (Polydioxanone) for Vaginal Cuff Closure in Laparoscopic Hysterectomy.

Objective: To compare the vaginal cuff dehiscence (VCD) rates using Vicryl (Poliglactyn 910) and Polydioxanone (PDS) in patients who underwent laparoscopic hysterectomy. Materials and methods: A retrospective, monocentric study was conducted, including all patients undergoing laparoscopic hysterectomy at the Department of Obstetrics and Gynaecology, Azienda di Rilievo Nazionale e di Alta Specializzazione (ARNAS) Garibaldi Nesima, Catania, between January 2014 and December 2021. Patients underwent hysterectomy for benign gynecologic pathologies (endometriosis, leiomyomas, or benign pelvic pathologies) or malignant gynecologic pathologies (endometrium cancer, complex endometrial hyperplasia, ovarian cancer, cervix cancer, or uterine carcinosarcoma). The Z-score calculation was performed to find eventual statistically significant differences between the two populations regarding VCD rates. Results: Laparoscopic vaginal cuff closure was performed, with Vicryl sutures in 202 patients and PDS sutures in 184 women. Demographic and baseline characteristics were not significantly different in the two groups. VCD occurred in three patients in the Vicryl group and did not occur in the PDS group. The three cases of VCD were precipitated by intercourses that occurred within 90 days of surgery. However, there was not a significant statistical difference between the two groups regarding VCD (p = 0.09). Conclusions: Vicryl and PDS sutures seem to be similar for vaginal cuff closure in laparoscopic hysterectomy. The VCD rate was low, and the observed differences between the Vicryl and PDS groups did not reach statistical significance. Further research through prospective studies is essential.

Comparative effects of various absorbable threads in a rat model.

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.

Outcome of facial rejuvenation with polydioxanone thread for Asians.

BACKGROUND: Techniques in rejuvenating the aging face have evolved, involving various types of threads. Facial rejuvenation with absorbable polydioxanone is popular in aesthetic clinics in Korea. AIM: The purpose of this study was to describe our polydioxanone thread method and to evaluate the outcomes of facial rejuvenation. PATIENTS/METHODS: A retrospective chart review was performed over a 12-month period. Thirty-five Asian patients were included. All participants underwent thread-lifting using polydioxanone. On each side, five 360° spiral cog threads were used in the procedure. The results were evaluated using photography and patient satisfaction. RESULTS: Thirty-three patients (94.3%) were satisfied with the outcomes. Objective outcomes using photography were categorized as very much improved (68.6%), much improved (25.7%), and improved (5.7%). Subjective outcomes using patients' satisfaction were categorized as excellent, very good, good, fair, and poor. The incidence of complications was low, and the complications resolved spontaneously without any surgical interventions. Asymmetry, however, was noted. CONCLUSIONS: Using our technique, we could achieve the desired facial rejuvenation. Our method demonstrated an excellent success rate in patients with moderate degree laxity. We believe that facial rejuvenation with polydioxanone thread for Asians is a safe and effective treatment method.

Non-surgical rhinoplasty using filler, Botox, and thread remodeling: Retro analysis of 332 cases.

BACKGROUND: Non-surgical nasal job has been practiced and published with doubtful concerns about efficiency and safety among physicians and aesthetic surgeons. AIM: of the work to share our experiences in non-surgical rhinoplasty using filler, Botox, and thread with presentation of aesthetic and complication outcome. PATIENT AND METHODS: Retrospective analysis of the aesthetic and complication outcomes and techniques for non-surgical remodeling rhinoplasty using fillers, Botox, and PDO absorbable threads in 332 cases. RESULTS: Non-surgical nasal remodeling provides temporary correction of small nasal deformities with achieved satisfactory aesthetic outcome and very low incidence of complications. CONCLUSION: Non-surgical nasal remodeling with injection precautions could work efficiently and safely in outpatient clinic with good temporary results up to 6 months.

The intraoperative use of polydioxanone foil to reduce the risk of sino-orbital fistula formation in orbital exenteration.

BACKGROUND: Orbital exenteration is a radical surgical procedure resulting in deformity. It involves removal of the globe, optic nerve, extra-ocular muscles, orbital fat, lacrimal gland, and peri-osteum. Sino-orbital fistula (SOF) formation is a common documented post-operative complication, usually connecting the orbit and the ethmoid sinus. SOFs can cause leaks of serous fluid, and act as an entry site for pathogens into the orbit leading to socket infection and breakdown. METHODS: This retrospective study analyzed exenterations performed over a 22-year period (1993-2015) at the National Ocular Oncology Service Centre for Scotland. PDS is a crystalline, biodegradable polyether-ester that is strong with good shape-memory and flexibility. Orbital exenterations with and without the use of PDS foil were compared in terms of SOF formation. RESULTS: A total of 30 exenterations were performed during the study period. A total of 29 were analyzed. Choroidal malignant melanoma was the most common indication for performing orbital exenteration (n = 7, 24.14%). The most common post-operative complications seen were SOF (n = 8, 27.59%). A total of 8 out 21 (38.10%) cases not using PDS developed SOFs. By contrast, none of nine patients receiving PDS plates developed SOFs (p = 0.0332). CONCLUSIONS: This is the first study to compare SOF rate in patients undergoing exenteration with and without the use of PDS foil. PDS foil is a safe material, which has effectively reduced the incidence of SOF formation.

[Remote results of eversion carotid endarterectomy depending on the suture material used]. / Otdalennye rezul'taty éversionnoi karotidnoi éndarteréktomii v zavisimosti ot ispol'zuemogo shovnogo materiala.

BACKGROUND: It is known that namely long-term presence of suture material as the only foreign body in autologous conditions may lead to restenosis in the remote period. Such hypothesis was put forward based on good results of reconstructive cardiovascular operations in case of using absorbable suture material. OBJECTIVE: Our study was aimed at comparative analysis of remote results of using absorbable suture material polydioxanone and non-absorbable suture material polypropylene in eversion carotid endarterectomy. PATIENTS AND METHODS: Over the period from 2002 to 2007, at the Department of Vascular Surgery of the Institute of Surgery named after A.V. Vishnevsky performed a total of 408 carotid reconstructions according to the eversion technique. The study was based on comparative analysis of the remote results of this procedure in two groups of patients: the first group consisted of 121 patients in whom replantation of the internal carotid artery into the common carotid artery was performed using absorbable suture material polydioxanone with the metric sizes 5-0 and 6-0 and the second group comprising 135 patients in whom similar manipulations were performed using non-absorbable suture material polypropylene with the metric size 6-0. In the course of the study it turned out that the remote results might also be influenced by the metric size of polydioxanone, therefore the first group was further subdivided into subgroups: polydioxanone 5-0 - 79 patients and polydioxanone 6-0 - 42 patients. RESULTS: At baseline, with statistically significant differences by the gender, incidence of unstable atherosclerotic plaque, diameter of the ipsilateral internal carotid artery ≤4 mm, the groups of patients turned out to be in the remote period statistically significantly comparable by such parameters as frequency of the development of a pseudoaneurysm, restenosis of the internal carotid artery, ipsilateral stroke, restenosis-associated stroke, and by survival. However, when comparing the subgroup of patients wherein polydioxanone 6-0 was used and the second group with the initially statistically significant differences by incidence of unstable atherosclerotic plaque and myocardial infarction, in the remote period there was a statistically significant decrease in the incidence rate of restenosis of the internal carotid artery in the first case. CONCLUSIONS: The obtained findings suggested that the absorbable suture material polydioxanone with the metric size 6-0 might be considered as quite a substantiated alternative to the used in cardiovascular surgery non-absorbable suture material polypropylene. Polydioxanone with the metric size 6-0 made it possible to remove or considerably decrease the incidence rate of the development of restenosis of the internal carotid artery after eversion carotid endarterectomy.

Use of an Absorbable Urethral Stent for the Management of a Urethral Stricture in a Stallion.

OBJECTIVE: To describe the successful management of a urethral stricture with an absorbable stent in a stallion. STUDY DESIGN: Clinical report. ANIMALS: Stallion with a urethral stricture. RESULTS: A 12-year-old Thoroughbred breeding stallion was evaluated for acute onset of colic. Uroperitoneum because of presumptive urinary bladder rupture, with urethral obstruction by a urethrolith, was diagnosed. The uroperitoneum was treated conservatively. The urethrolith was removed through a perineal urethrotomy. Approximately 15 weeks after urethrolith removal, the stallion presented with a urethral stricture. The stricture was unsuccessfully treated with an indwelling urinary catheter and 4 attempts at balloon dilation. Eight weeks after diagnosis of stricture, an absorbable polydioxanone (20 mm × 80 mm) urethral stent was implanted under percutaneous, ultrasound guidance. Urethroscopy was performed at 70, 155, and 230 days after stent placement and the endoscope passed through the affected site without complication. Urethroscopy at 155 days showed the stent had been reabsorbed. Follow-up 20 months after stent placement reports the stallion was able to void a normal urine stream. CONCLUSIONS: Absorbable urethral stent placement was a feasible treatment for urethral stricture in this stallion.

Knot Security of 5 Metric (USP 2) Sutures: Influence of Knotting Technique, Suture Material, and Incubation Time for 14 and 28 Days in Phosphate Buffered Saline and Inflamed Equine Peritoneal Fluid.

OBJECTIVES: To evaluate knot security for 3 knot types created in 3 commonly used 5 metric suture materials incubated in physiological and pathological fluids. STUDY DESIGN: In vitro mechanical study. SAMPLE POPULATION: Knotted suture loops (n = 5/group). METHODS: Loops of 3 different suture materials (glycolide/lactide copolymer; polyglactin 910; polydioxanone) were created around a 20 mm rod using 3 knot types (square [SQ], surgeon's [SK], and triple knot [TK]) and were tested to failure in distraction (6 mm/min) after tying (day 0) and after being incubated for 14 and 28 days in phosphate buffered saline (PBS) or inflamed peritoneal fluid. Failure load (N) and mode were recorded and compared. RESULTS: For polydioxanone, significant differences in force to knot failure were found between SQ and SK/TK but not between SK and TK. The force required to break all constructs increased after incubation in phosphate buffered saline (PBS). With glycolide/lactide copolymer no differences in force to knot failure were observed. With polyglactin 910, a significant difference between SQ and TK was observed, which was not seen between the other knot types. Incubation in inflamed peritoneal fluid caused a larger and more rapid decrease in force required to cause knot failure than incubation in PBS. CONCLUSIONS: Mechanical properties of suture materials have significant effects on knot security. For polydioxanone, SQ is insufficient to create a secure knot. Additional wraps above a SK confer extra stability in some materials, but this increase may not be clinically relevant or justifiable. Glycolide/lactide copolymer had excellent knot security.

A technique to correct severe lateral crural concavity: adjunctive use of a polydioxanone plate during lateral crural reverse plasty.

BACKGROUND: Severe lateral crura concavity (LCC) can lead to an important deformity of the nasal tip and to external nasal valve insufficiency. The lower lateral crural reverse plasty represents a valuable technique for the correction of severe LCC, but often requires additional cartilage to gain more alar rim support. METHODS: We describe a modified version of the reverse plasty, in which a polydioxanone plate is sutured as a strut at the dome junction to increase alar rim support. We report our experience with this technique in 10 women (age range 24-56 years). RESULTS: The procedure was performed in eight primary rhinoplasties and in two cases alone without rhinoplasty. All patients had aesthetic complaints, whereas three had obstructive symptoms. Eight patients had unilateral problems. A one-year follow-up was completed in 100 % of patients. There were no surgical complications and all patients had optimal short and long-term aesthetic and functional results. CONCLUSION: Acikel C (Aesthetic Plast Surg 36:862-865, 2012) The adjunctive use of a polydioxanone plate during lateral crural reverse plasty was feasible and led to satisfying functional and cosmetic long-term results in patients with severe LCC. This surgical maneuver appears reproducible and emerges as an alternative way of gaining stronger support during lateral crura reverse plasty while avoiding additional tissue. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

A review of the composition, characteristics, and effectiveness of barrier mesh prostheses utilized for laparoscopic ventral hernia repair.

BACKGROUND: The objective of this review was to provide an overview of the components that comprise each of the eight barrier mesh prostheses commonly utilized for LVHR and to review the current literature related to the characteristics and effectiveness of these materials to guide the general surgeon in selecting the most appropriate material for LVHR. METHODS: Composite prostheses with permanent barriers (Bard™ Composix™ E/X, Bard™ Composix™ L/P, and DUALMESH(®) Biomaterial) were compared to composite prostheses with absorbable barriers (C-QUR™ Mesh, PROCEED™ Surgical Mesh, Bard™ Sepramesh™ IP Composite, Parietex™ Composite, and PHYSIOMESH™) using scanning electron microscopy and a review of the current preclinical and clinical literature. RESULTS: Clinical studies and preclinical animal models have attempted to determine the adhesion characteristics and effectiveness of barrier mesh prostheses available for ventral hernia repair applications. However, it is difficult to make any definitive statements about the adhesion characteristics and effectiveness of these materials because all meshes were not included in all studies and likewise not compared under identical conditions. Overall, Parietex™ Composite and DUALMESH(®) Biomaterial were cited most frequently for improvement of adhesion characteristics, followed closely by Bard™ Sepramesh™ IP Composite and C-QUR™ Mesh. Bard™ Composix™, PROCEED™ Surgical Mesh, and uncoated polypropylene were cited most frequently as having the most tenacious and extensive adhesions. CONCLUSIONS: Differences observed between the various barrier prostheses are likely attributable to the chemical composition of the barrier or the conditions required for resorption and metabolism of the barrier components. It is likely that the components of these barriers incite a wide range of inflammatory responses resulting in the range of adhesion coverage and tenacity observed in the preclinical and clinical studies reviewed. Clinical trials are needed to more appropriately define the clinical effectiveness of these barriers.

Craniosynostosis: posterior two-third cranial vault reconstruction using bioresorbable plates and a PDS suture lattice in sagittal and lambdoid synostosis.

INTRODUCTION: Beginning in 2004, we modified our surgical technique for a cranial vault remodeling in sagittal and lambdoid synostosis. Beginning in the early 1990s, we started using a calvarial vault remodeling technique in sagittal and lambdoid synostosis that involves removing the posterior two thirds of the skull, extending from the coronal suture to below the lambdoid suture to within 1-1.5 cm of the foramen magnum. Up until 2004, the bone fixation evolved from wire fixation, then micro-metallic fixation plates and resorbable sutures. DISCUSSION: Over the last 9 years, we have used a novel technique of absorbable fixation plates and a polydioxanone suture trellis or lattice network, which has reduced operating times significantly and continued to give excellent results. Additional advantages include the absence of a need for molding or protective helmets, the absence of bony defects at the completion of the procedure, the absence of age limitation, and the ability to correct the tightly constricted occiput. CONCLUSION: To date, we have had no significant complications, no return to operating room, and the aesthetics have held up well since its introduction.

How to close a colpotomy? Barbed suture and conventional suture effects on soft tissue: an ex vivo pilot study.

OBJECTIVE: To evaluate the effects of different suture materials and techniques on soft tissue in relation to defined tensions and time points. MATERIALS AND METHODS: Two bovine intestine samples, 4 × 4 cm size and ~3 mm thickness, were adapted with interrupted and continuous techniques using three types of suture materials: Vicryl (polyglactin 910), PDS II (polydioxanone), and V-Loc 180 (knotless, barbed polyglyconate). Four stitches or loops 9 mm apart with three knots, and 10 mm end length were performed by one gynecologist. Forces were applied from 6 newtons (N) to 14 N continuously. Outcome measures included breakage of tissue, tearing of thread, and shortening of the end length of thread. They were evaluated immediately and then at first, third, and fifth minute. RESULTS: Tissue breakage using No. 3/0 suture materials appears in the applied force from 10 N. polydioxanone causes more tissue tearing than polyglactin 910. The least to withstand tension is knotless polyglyconate. Interrupted stitches hold the sutured sites better than continuous stitches in all groups of threads. Shortening of the knotless polyglyconate end length by half took place with 6 N force. CONCLUSION: Simulating reparation of colpotomy, the ex vivo study supports that polyglactin 910 appears better in holding soft tissue than polydioxanone and knotless polyglyconate.

Materials used for reconstruction after orbital floor fracture.

Advances in biotechnology continue to introduce new materials for reconstruction of orbital floor fractures. Which material is best fit for orbital floor reconstruction has been a controversial topic. Individual surgeon preferences have been supported by inconsistent inconclusive data. The purpose of this study was to assess and analyze published evidence supporting various materials used for orbital floor reconstruction and to develop a decision-making algorithm for clinical application. A systematic literature review was performed from which 48 studies were selected after primary and secondary screening based on set inclusion and exclusion criteria. This cumulatively included 3475 separate orbital floor reconstructions. Results revealed risk and benefit profiles for all materials. Autologous calvarial bone grafts, porous polyethylene, and polydioxanone (PDS) were most widely used for orbital floor reconstruction. Increased infection rates were reported with polyglactin 910/PDS composites and silastic rubber. Ocular motility was reduced most with lyophilized dura and PDS. Preoperative and postoperative rates for diplopia and enophthalmos varied among the materials. In conclusion, our results revealed continued inadequate evidence to exclusively support the use of any one biomaterial/implant for orbital floor reconstruction. Results have served to create a decision-making algorithm for clinical application. Our authors propose certain parameters for future studies seeking to demonstrate a comparison between 2 or more materials for orbital floor reconstruction.

Perforating the polydioxanone sheet: avoiding intraorbital hematoma after open treatment of orbital floor fractures.

The surgical treatment of orbital floor fracture, a common facial injury, is not a risk-free procedure. Complications after orbital surgery can include infection, implant migration, mydriasis, epiphora, persistent diplopia, enophthalmos, infraorbital numbness, retrobulbar hemorrhage, and blindness. Blindness has been ascribed to retrobulbar hematoma in almost 50% of cases. In our experience, blood collection above the polydioxanone sheet after the treatment of orbital floor fracture can be caused by the tight adhesion of the sheet to the bony edges of the fracture. Here, we present a simple procedure to avoid this potentially dangerous complication.

Randomized clinical trial comparing polypropylene or polydioxanone for midline abdominal wall closure.

BACKGROUND: Incisional hernia is a frequent complication of abdominal surgery, often requiring surgical intervention. This prospective randomized trial compared suture materials for closure of the fascia after abdominal surgery. METHODS: In 456 patients the abdominal fascia was closed with either non-absorbable (polypropylene; Prolene(®)) or absorbable (polydioxanone; PDS(®)) suture material. Follow-up was by clinical examination and ultrasonography at 6-month intervals. Outcome measures were incisional hernia, surgical-site infection and suture sinus. RESULTS: Some 223 patients were analysed after closure with Prolene(®) and 233 after PDS(®) . Median follow-up was 32 and 31 months respectively. There was no significant difference in the incidence of incisional hernia between the groups: 20·2 per cent (45 of 223) for Prolene(®) and 24·9 per cent (58 of 233) with PDS(®) (P = 0·229). Kaplan-Meier analysis showed a cumulative rate after 4 years of 23·7 and 30·2 per cent for Prolene(®) and PDS(®) respectively (P = 0·222). Secondary outcome measures showed no significant differences. CONCLUSION: The incidence of incisional hernia in both groups was higher than expected from previous literature. There were no significant differences between the two suture methods. REGISTRATION NUMBER: ISRCTN65599814 (http://www.clinical-trials.com).

Comparison of skin adhesive and absorbable intracutaneous suture for the implantation of cardiac rhythm devices.

AIMS: Wound healing is a major determent in the post-surgical course of patients (pts) after pacemaker (PM) and implantable cardioverter defibrillator (ICD) implantation. Insufficient closure may lead to serious complications with pocket infections leading to the device's explantation as the worst case scenario. In addition to the different types of suture and suture clips, a novel topical skin adhesive containing 2-octyl-cyanoacrylate is commercially available. METHODS AND RESULTS: Over a period of 18 months, we prospectively assigned all cases of PM, ICD, and loop recorder implants either to skin adhesive (Group 1) or to absorbable intracutaneous polydioxanon suture (Group 2). Data were analysed with respect to operation time, wound infections, and healing disorders. One hundred and eighty-three pts were randomized into Group 1 [71 PMs, 60 ICD, 15 cardiac resynchronization therapy (CRT), 11 loop recorders, and 26 generator replacements]. One hundred and eighty-five pts were assigned to Group 2 (62 PMs, 70 ICD, 30 CRT, 7 loop recorders, and 16 generator replacements). There were no differences regarding sex, diabetes, renal insufficiency, corticosteroid therapy, oral anticoagulants, and acetylsalicylic asa/clopidogrel (P = n.s.). For the significantly higher amount of CRT devices (P < 0.05) in Group 2, the procedure times are given for surgeries except CRT. It was 49.1 ± 27.7 min for Group 1 and 53.4 ± 31.9 min for Group 2 (P = n.s.). Adverse events as insufficient closure, major and minor bleeding, pocket haematoma, erythema, incrustation, dehiscence, keloid, and explantation due to infection occurred significantly more often in the adhesive group (P = 0.02). The greatest impact on this result had early adverse events as insufficient closure, wound incrustation, and inflammation (9.3 vs. 6.0%; P = 0.02). We did not find any difference in long-term adverse events, infections in particular (2.7 vs. 1.6%; P = 0.47). CONCLUSION: This study shows no benefit using skin adhesive in comparison to absorbable intracutaneous suture regarding surgery times for the implantation of cardiac rhythm devices. The rate of early adverse events after wound closure is higher after skin adhesive but no difference in long-term adverse events occurred.

Efficacy and safety of thread embedding acupuncture on knee osteoarthritis: A randomized, controlled, pilot clinical trial.

INTRODUCTION: Although there are various therapeutic methods for the treatment of knee osteoarthritis, each has its advantages and shortcomings, and a definitive treatment method is yet to be determined. This pilot study is designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of thread embedding acupuncture (TEA) with polydioxanone thread in knee osteoarthritis patients. METHODS AND ANALYSIS: This study is a clinical trial to evaluate the efficacy and safety of TEA for knee osteoarthritis. Forty participants will be recruited at the hospital and after randomization into 2 groups of 20 (experimental and control); they will be treated for 6 weeks. The experimental group will receive TEA treatment 6 times (1 time/week) in 6 weeks on 14 defined knee areas, and the control group, acupuncture treatments 12 times (2 times/week) in 6 weeks on 9 defined acupuncture points. The visual analogue scale (VAS) will be used for the primary efficacy assessment and Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used for the secondary efficacy assessment. The follow-ups before clinical trial, 3 weeks after procedure, 6 weeks after procedure, and 4 weeks after the end of procedure will be done to compare the degree of pain with the control group, which received the acupuncture treatment. CONCLUSION: The trial based on this study will provide clinical information on the efficacy and safety of TEA treatment on knee osteoarthritis. TRIAL REGISTRATION NUMBER: KCT0004844.

Permanent Compared With Absorbable Suture for Vaginal Mesh Fixation During Total Hysterectomy and Sacrocolpopexy: A Randomized Controlled Trial.

OBJECTIVE: To compare mesh and permanent suture exposure rates in the first year after minimally invasive total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh using permanent or delayed absorbable sutures. METHODS: Across five centers in the United States, women were randomized to permanent or delayed absorbable suture for vaginal attachment of a Y-mesh during hysterectomy and sacrocolpopexy for stage II prolapse and worse. The primary outcome was mesh or permanent suture exposure in the first year after surgery. The secondary outcome was to compare a composite measure for success defined as leading edge of prolapse not beyond the hymen and apex not descended more than one third vaginal length, and no subjective bulge and no prolapse retreatment. Patients completed a pelvic examination including the pelvic organ prolapse quantification system and questionnaires at baseline, 6 weeks and 1 year postsurgery. A sample size of 80 per group was planned to compare the rate of mesh or permanent suture exposure in the permanent compared with delayed absorbable groups. RESULTS: From April 2015 to May 2019, 204 patients (n=102 permanent; n=102 delayed absorbable) were randomized. One hundred ninety-eight women had follow-up data, with 182 (93%) completing 1-year follow-up: 95 of 99 (96%) permanent, 87 of 101 (86%) delayed absorbable. The total rate of mesh or permanent suture exposure was 12 of 198 (6.1%): 5.1% for permanent compared with 7.0% for delayed absorbable (risk ratio 0.73, 95% CI 0.24-2.22). The majority (9/12) were asymptomatic. Composite success was 93% for permanent compared with 95% for delayed absorbable suture, P=.43). Six (3.0%) women had a serious adverse event. CONCLUSION: Suture type used for vaginal graft attachment did not influence mesh or permanent suture exposure rates. FUNDING SOURCE: Boston Scientific Corporation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02277925.

Polydioxanone Threads for Facial Rejuvenation: Analysis of Quality Variation in the Market.

BACKGROUND: Beside botulinum-toxin injections and hyaluronic acid fillers, thread lifts have established themselves as the third column of minimally invasive facial rejuvenation. Most commonly, barbed threads for this approach are made out of polydioxanone, a material known for decades from application in resorbable sutures. The clinical efficacy and the putative material safety of polydioxanone have fueled the popularity of thread lifts. METHODS: The present study highlights significant variation among six commercially available threads in microstructure, tensile strength, elasticity, anchoring capacity in human tissue, and biocompatibility. RESULTS: Despite their license to be marketed and sold in the European Union, some products performed significantly worse than others on material testing, and even displayed cytotoxic characteristics. CONCLUSION: The results of this study are highly relevant for clinicians and may be linked to various typical side effects of polydioxanone threads for facial rejuvenation.