Duramesh™ for Hernia Prevention
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwestern University
Disqualifiers: Pregnancy, Prior mesh repair, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak. Ileostomy will be reversed with restoration of continuity in majority of patients. Stoma site incisional hernias after ileostomy closure are complex hernias that can be associated with abdominal pain, discomfort, and a diminished quality of life. Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure. The Aim of this study is to evaluate Duramesh™ suture vs standard closure on rates of hernia formation after ileostomy closure.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Duramesh™ for Hernia Prevention is an effective treatment?
The available research does not provide specific data on Duramesh™ for Hernia Prevention. However, it discusses the use of mesh in hernia repair, which is similar to Duramesh™. One study with over 6,000 patients shows that using mesh in hernia repair reduces the chance of the hernia coming back. Another study on bioabsorbable mesh, which is a type of mesh that dissolves in the body, found no hernia recurrences in a small group of high-risk patients. These findings suggest that mesh treatments, like Duramesh™, can be effective in preventing hernias.
12345What safety data is available for Duramesh™ used in hernia prevention?
The provided research does not specifically mention Duramesh™ or Duramesh Mesh Suture. However, it includes general safety data on surgical meshes used in hernia repair, highlighting complications such as infection, mechanical failure, and pain. The studies reviewed adverse events from the FDA's database and other sources, but none directly reference Duramesh™. Therefore, specific safety data for Duramesh™ is not available in the provided research.
678910Is Duramesh™ a promising treatment for hernia prevention?
The provided research articles do not mention Duramesh™ or provide specific information about its effectiveness. Therefore, based on the available information, we cannot determine if Duramesh™ is a promising treatment for hernia prevention.
111121314Eligibility Criteria
This trial is for patients who have had an ileostomy, a type of surgery that creates an opening in the abdomen to divert waste. It's specifically for those facing stoma site incisional hernias after their ileostomies are closed. Participants should not currently have any other conditions that would interfere with the study.Inclusion Criteria
I am having my ileostomy closed after cancer surgery.
I am scheduled for regular cancer scans after surgery.
Patient accepts participation and gives informed consent
+2 more
Exclusion Criteria
Data from adults unable to consent will not be analyzed in this study
Patient is enrolled in another hernia study
Patient is unable / unwilling to provide informed consent
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo ileostomy closure using either Duramesh™ suture or standard closure technique
Immediate post-surgery period
Follow-up
Participants are monitored for hernia formation and infection rates after ileostomy closure
1 year
Participant Groups
The study is testing whether using Duramesh™, a special non-absorbable suture material, can reduce the rate of hernia formation compared to standard suturing techniques after ileostomy closure. Patients will be randomly assigned to either receive Duramesh™ or standard closure.
2Treatment groups
Experimental Treatment
Active Control
Group I: DurameshExperimental Treatment1 Intervention
using duramesh suture for ileostomy fascial closure
Group II: ControlActive Control1 Intervention
standard ileostomy fascial closure
Duramesh™ is already approved in United States for the following indications:
🇺🇸 Approved in United States as Duramesh for:
- General soft tissue approximation and/or ligation in clean (CDC Class I) wounds, including tendon repair and midline laparotomy closure
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern University Feinberg School of MedicineChicago, IL
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
References
DynaMesh® in the repair of laparoscopic ventral hernia: a prospective trial. [2021]To investigate mesh-related complications in patients undergoing laparoscopic ventral hernia repair using DynaMesh®.
Updates in abdominal wall management. [2017]The field of abdominal wall hernia surgery continues to evolve at a rapid pace. Surgeons dealing with abdominal wall hernias must constantly stay abreast as new biomaterials and surgical techniques evolve. Increasing knowledge related to hernia formation and factors affecting outcomes will help surgeons prevent hernias and individualize hernia repair techniques and biomaterials based on specific clinical situations and patient characteristics. This review outlines some new advances in abdominal wall hernia management focusing on hernia prevention, preoperative strategies to improve outcomes, available biomaterials and mesh products used in hernia repair, new surgical techniques, and improving ways to evaluate outcomes and perform continuous quality improvement in hernia repair.
Modifying hernia mesh design to improve device mechanical performance and promote tension-free repair. [2019]Approximately 348,000 ventral hernia repairs are performed annually in the United States and the incisional hernia recurrence rate is approximately 20% as a result of suture and mesh device failure. Device failure is related to changes at the suture/tissue interface that leads to acute or chronic suture pull-through and surgical failure. To better manage mechanical tension, we propose a modified mesh design with extensions and demonstrate its mechanical superiority.
Mesh in Elective Hernia Repair: 10-Year Experience with over 6,000 Patients. [2021]The use of mesh in hernia repair has faced intense scrutiny, leading patients to become fearful of its use, despite its benefits in reducing hernia recurrence. We report a single institutional experience in performing hernia repair with mesh in terms of hernia-specific outcomes, mesh-related complications, and patient-reported quality of life.
Outcomes of Open Complex Ventral Hernia Repairs With Retromuscular Placement of Poly-4-Hydroxybutyrate Bioabsorbable Mesh. [2020]Purpose. Optimal technique and mesh selection still debated for complex ventral hernias. Limited data exists on bioabsorbable meshes in high-risk patients. We evaluated our experience. Methods. Retrospective review was conducted following institutional review board approval for ventral hernia repairs using a single bioabsorbable mesh between February 2014 and November 2017. Patient and hernia details characterized. Outcomes evaluated. Results. 20 ventral hernia repairs identified, 10 males, 10 females. Mean body mass index was 35 ± 7.4 kg/m2, and mean age 47 ± 13 years. Comorbid conditions were diabetes 35% and hypertension 40%. Fifty-five percent had American Society of Anesthesiologist scores of 3. Hernia Characteristics: Ventral Hernia Working Group Grade 3 hernias were 80%, and remainder grade 2. Forty percent of hernias were Centers for Disease Control class III, and remainder were class I and II. The mean defect size was 533 cm2 ± 500. Repair for prior open abdomens was 45%, recurrent hernias 20%, incisional 15%, incarcerated 10%, incisional with parastomal 5%, and primary ventral 5%. Concomitant bowel procedures in 8, (40%). All cases had retromuscular mesh placement (transversus abdominus release 65%, Rives-Stoppa 35%). Surgical site occurrences were 20% (surgical site infection 10%, seroma 10%). Overall hospital stay 5 ± 3 days. Ileus occurred in 20%. One postoperative death due to fatal arrhythmia. There were no recurrences with mean follow-up 21.1 months. Conclusions. Complex hernia repairs using bioabsorbable mesh were conducted in a small cohort of high-risk patients. These data demonstrate good outcomes with limited morbidity and mortality. There were no recurrences.
Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration. [2022]Mesh material affects complications following hernia repair. Medical device reports on the use of surgical mesh for hernia repair were reviewed from the Food and Drug Administration's (FDA) Manufacturer User Facility Device Experience Database from January 1996 to September 2004. We analyzed 252 adverse event reports related to the use of surgical mesh for hernia repair. Adverse events included infection (42%, 107 reports), mechanical failure (18%, 46), pain (9%, 23), reaction (8%, 20), intestinal complications (7%, 18), adhesions (6%, 14), seroma (4%, 9), erosion (2%, 6), and other (4%, 9). Compared to all other mesh types, Sepra/polypropylene mesh had more mechanical failures (80 vs 14%, p
Retrospective Review and Prospective Follow-up of 85 Consecutive Patients Treated With a Novel Hepatic-derived Surgical Mesh for Hiatal Hernia Repair: Outcomes, Surgical Complications, and Revisions. [2020]This study examined outcomes, surgical complications, and revisions in patients treated with laparoscopic Nissen fundoplication for hiatal hernia and substantial gastroesophageal reflux disease. In total, 85 consecutive patients who underwent hernia repair with MIROMESH Biologic Matrix, a novel hepatic-derived surgical mesh served as subjects. Subjects were contacted by phone, consented, and participated in an Institutional Review Board-approved structured phone interview. Responses were acquired from 73 of the 85 patients. The gastroesophageal reflux disease health-related quality of life showed significant improvement postoperatively. Subjects reported high satisfaction with the procedure. The use of proton pump inhibitors was significantly reduced. Three minor complications were reported; these were quickly resolved without further sequelae. There were no mesh-related complications. No subjects reported further surgery. Placement of the surgical mesh, during surgery, to reinforce the hiatal repair was easy and safe. Excellent outcomes and no revisions a mean of 1.3 years after surgery suggest that a durable repair had been achieved.
An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh. [2019]To assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States.
EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection. [2021]The analysis of safety data from spontaneous reporting systems has a proven value for the detection and analysis of the risks of medicines following their placement on the market and use in medical practice. EudraVigilance is the pharmacovigilance database to manage the collection and analysis of suspected adverse reactions to medicines authorised in the European Economic Area. EudraVigilance first operated in December 2001, with access to the database being governed by the EudraVigilance access policy. We performed a literature search including data up to December 2016 to demonstrate how the data from EudraVigilance has been used in scientific publications. We describe the results, including by type of publication, research topics and drugs involved. In 50% of the publications, the data are used to describe safety issues, in 44% to analyse methodologies used in pharmacovigilance activities and in 6% to support clinical perspectives. We also outline a description of the use of the database by the European Union regulatory network. Driven by the full implementation of the 2010 pharmacovigilance legislation, EudraVigilance has undergone further enhancements together with a major revision of its access policy, taking into account the use of the new individual case safety report standard developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and the International Organization for Standardization. The aim of the broadened access is to facilitate more effective safety monitoring of authorised medicines, to make more data available for research and to provide better access to information on suspected adverse reactions for healthcare professionals and patients. In November 2017, the new full functionalities of EudraVigilance were launched, including the extensive web access to data on suspected adverse drug reactions and the possibilities for academic research institutions to request a more extensive dataset for the purposes of health research. The main objective of this article is to describe the new access to the database together with the opportunities that this new access can bring for research. It is intended to promote an appropriate use of the data to support the safe and effective use of medicines.
MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]MetaADEDB is an online database we developed to integrate comprehensive information on adverse drug events (ADEs). The first version of MetaADEDB was released in 2013 and has been widely used by researchers. However, it has not been updated for more than seven years. Here, we reported its second version by collecting more and newer data from the U.S. FDA Adverse Event Reporting System (FAERS) and Canada Vigilance Adverse Reaction Online Database, in addition to the original three sources. The new version consists of 744 709 drug-ADE associations between 8498 drugs and 13 193 ADEs, which has an over 40% increase in drug-ADE associations compared to the previous version. Meanwhile, we developed a new and user-friendly web interface for data search and analysis. We hope that MetaADEDB 2.0 could provide a useful tool for drug safety assessment and related studies in drug discovery and development.
Retrospective study on the use of a composite mesh (Physiomesh) in laparoscopic ventral hernia repair. [2013]The ideal mesh suited for intraperitoneal placement should address both requirements of tissue separation on the visceral surface and tissue integration on the parietal surface. Meshes with bioresorbable coatings have recently been demonstrated to be successful. In this article, the results are shown of a study with a new type of tissue-separating lightweight mesh with a bioresorbable coating (Physiomesh; Ethicon, Somerville, NJ) in laparoscopic ventral hernia repair. In this single-center retrospective analysis, 88 patients (50 men, 38 women) undergoing hernia surgery between November 16, 2010 and August 10, 2012 at the Imelda Hospital Bonheiden were included. Patients were asked to score their pre- and postoperative pain (1 month after surgery) on a visual analogue scale (VAS), as well as the chronic postoperative pain (pain at more than 6 months after surgery). The time period after which patients were pain free and after which they could return to work was also noted. Our results demonstrate that Physiomesh is a good alternative to the existing meshes leading to significant pain reduction, early return to work, acceptable complications, and low recurrence and reintervention rates.
Inguinal hernia repair with porcine small intestine submucosa: 3-year follow-up results of a randomized controlled trial of Lichtenstein's repair with polypropylene mesh versus Surgisis Inguinal Hernia Matrix. [2009]The aim of this study was to evaluate the safety and efficacy of Lichtenstein's hernioplasty using Surgisis Inguinal Hernia Matrix (SIHM; Cook, Bloomington, Indiana) compared with polypropylene (PP; Angiologica, Pavia, Italy).
Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial. [2018]Patients' need to improve outcomes and to reduce the number of complications triggers the development of new materials and surgery concepts. Currently, there are many implants and fixation systems dedicated for intraperitoneal onlay mesh procedure. The aim of this study was to compare two different mesh/fixation system concepts (PH: Physiomesh/Securestrap and VS: Ventralight ST/SorbaFix) for laparoscopic ventral hernia repair with respect to pain.
[Preliminary results of a new technique for inguinal hernia repair]. [2006]An original technique for the treatment of inguinal hernia is described: this operative technique consists of a Marlex (mono-filament knitted polypropylene) mesh sutured in the preperitoneal space under the fascia trasversalis.