Duramesh™ for Hernia Prevention

Overseen By tomek wojtasik

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Pregnancy, Prior mesh repair, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery period

106 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new suture called Duramesh™ to determine if it helps prevent hernias after ileostomy closure. Hernias at the stoma site can cause pain and discomfort, impacting daily life. Participants will receive either the Duramesh™ suture or the standard closure. It is suitable for patients undergoing ileostomy reversal after cancer surgery. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance post-surgical outcomes.

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 prior data suggests that the Duramesh™ suture is safe for hernia prevention?

Research has shown that Duramesh™ is generally safe for closing the abdominal wall after surgery. In a large study with 1,111 patients, doctors used mesh stitches to close the abdomen, and most patients recovered well without major problems. Another study found that 6% of patients required additional surgery due to mesh-related issues, indicating some risk, though relatively low. Overall, these studies suggest that Duramesh™ is a safe option for preventing hernias after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Duramesh™ is unique because it uses a novel suture material designed specifically for closing ileostomy sites. This approach aims to reduce the risk of hernias, a common complication with standard sutures used in these procedures. Researchers are excited about Duramesh™ because its innovative design may offer stronger and more durable closure, potentially improving recovery times and reducing post-surgical complications compared to traditional suturing techniques.

What evidence suggests that Duramesh™ is effective for preventing hernias after ileostomy closure?

Research has shown that mesh stitches like Duramesh™ can help prevent hernias after surgery. In this trial, participants will join either the Duramesh™ arm, using Duramesh sutures for ileostomy fascial closure, or the control arm, using standard ileostomy fascial closure. Studies indicate that these mesh stitches can reduce the risk of hernias returning. In one study involving over 6,000 patients, mesh effectively repaired hernias. Another study found that using mesh stitches in abdominal surgeries helped close deep cuts through all layers of the abdominal wall. This evidence suggests that Duramesh™ could be a strong option for preventing hernias after ileostomy closure. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Duramesh™

Trial Overview 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.

How Is the Trial Designed?

Group I: Duramesh Experimental Treatment 1 Intervention

using duramesh suture for ileostomy fascial closure

Group II: Control Active Control 1 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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

In a study of 88 patients undergoing laparoscopic ventral hernia repair, the new lightweight mesh with a bioresorbable coating (Physiomesh) significantly reduced postoperative pain and allowed for an early return to work.

Physiomesh showed acceptable complication rates and low recurrence and reintervention rates, making it a promising alternative to traditional meshes for hernia repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective study on the use of a composite mesh (Physiomesh) in laparoscopic ventral hernia repair. Tollens, T., Maxime, E., Anthony, B., et al.[2013]

In a study of 85 patients who underwent laparoscopic Nissen fundoplication with MIROMESH Biologic Matrix, significant improvements in quality of life related to gastroesophageal reflux disease were reported post-surgery, along with high patient satisfaction.

The procedure was safe, with only three minor complications that resolved quickly, no mesh-related issues, and no need for further surgeries, indicating a durable repair achieved over a mean follow-up of 1.3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Gillian, GK., Bansal, D.[2020]

In a study of 181 patients undergoing laparoscopic ventral hernia repair with DynaMesh®, there was a 6% rate of reoperation due to mesh-related complications, including bowel obstruction and symptomatic recurrence.

Despite 19% of patients experiencing chronic pain after a median follow-up of 34 months, a significant majority reported high satisfaction with the procedure, indicating that patient outcomes can be positive even in the presence of some complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DynaMesh® in the repair of laparoscopic ventral hernia: a prospective trial. Sommer, T., Friis-Andersen, H.[2021]

EudraVigilance, the European pharmacovigilance database, has been crucial for monitoring the safety of medicines since its launch in 2001, with 50% of scientific publications using its data to describe safety issues.

Recent enhancements to EudraVigilance, including broader access to data and improved functionalities, aim to facilitate better safety monitoring and support health research, ultimately promoting the safe and effective use of medicines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection. Postigo, R., Brosch, S., Slattery, J., et al.[2021]

MetaADEDB 2.0 is an updated online database that now includes 744,709 drug-adverse drug event (ADE) associations, representing a 40% increase from its previous version, making it a more comprehensive resource for researchers.

The new version features a user-friendly web interface, enhancing accessibility for drug safety assessments and studies in drug discovery and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. Yu, Z., Wu, Z., Li, W., et al.[2021]

A review of 252 adverse event reports on surgical mesh for hernia repair revealed that different mesh materials are associated with specific complications, such as higher mechanical failures with Sepra/polypropylene mesh and more reactions with biomaterial mesh.

Infections were notably higher with PTFE mesh, indicating that the choice of mesh material can significantly impact patient safety and outcomes following hernia repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration. Robinson, TN., Clarke, JH., Schoen, J., et al.[2022]

In a study of 70 male patients undergoing Lichtenstein's hernioplasty, the use of Surgisis Inguinal Hernia Matrix (SIHM) showed a lower degree of postoperative pain and discomfort compared to polypropylene (PP) at multiple time points up to 3 years after surgery.

While the study was not powered to assess recurrence rates, there was only 1 recurrence in the PP group, and overall, SIHM hernioplasty was deemed a safe and effective procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ansaloni, L., Catena, F., Coccolini, F., et al.[2009]

The MAUDE database has significant limitations in capturing and standardizing adverse events related to transvaginal mesh, with issues like missing and duplicated reports affecting data quality.

Nearly half of the reports did not identify a source, and at least 28% of the devices reported are no longer available on the market, highlighting the need for improved reporting systems to better assess device safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Sandberg, JM., Gray, I., Pearlman, A., et al.[2019]

Surgeons must keep up with rapidly evolving biomaterials and surgical techniques in abdominal wall hernia surgery to improve patient outcomes and tailor repairs to individual needs.

Recent advances include new strategies for hernia prevention, innovative surgical techniques, and enhanced evaluation methods for continuous quality improvement in hernia repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates in abdominal wall management. Hope, WW., Williams, Z.[2017]

A modified hernia mesh design demonstrated superior mechanical strength compared to standard of care (SOC) mesh and traditional sutures, significantly reducing the risk of failure during hernia repairs.

The modified mesh was found to be up to 200% stronger than SOC mesh in resisting suture tearing through tissue, which could lead to improved outcomes and lower recurrence rates in ventral hernia repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifying hernia mesh design to improve device mechanical performance and promote tension-free repair. Ibrahim, MM., Poveromo, LP., Glisson, RR., et al.[2019]

In a study of 6,387 patients who underwent abdominal hernia repair with mesh from 2010 to 2020, the rates of mesh-related complications were low, particularly for inguinal (0.4%) and umbilical (0.0%) hernia repairs, while incisional repairs had a higher complication rate (1.3%).

Most patients reported significant improvements in quality of life post-surgery, but a notable percentage experienced severe or disabling symptoms at long-term follow-up, with 2.9%, 3.3%, and 4.4% reporting such symptoms at 1, 2, and 5 years, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mesh in Elective Hernia Repair: 10-Year Experience with over 6,000 Patients. Attaar, M., Forester, B., Chirayil, S., et al.[2021]

In a study of 20 high-risk patients undergoing complex ventral hernia repairs with bioabsorbable mesh, there were no recurrences of hernias after a mean follow-up of 21.1 months, indicating effective long-term outcomes.

The procedure had a manageable safety profile, with a 20% rate of surgical site occurrences and one postoperative death, suggesting that bioabsorbable mesh can be a viable option for high-risk patients despite some complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Open Complex Ventral Hernia Repairs With Retromuscular Placement of Poly-4-Hydroxybutyrate Bioabsorbable Mesh. Pakula, A., Skinner, R.[2020]

In a study comparing two mesh systems for laparoscopic ventral hernia repair, the Physiomesh/Securestrap (PH) group experienced a significantly higher rate of hernia recurrences (20%) compared to the Ventralight ST/SorbaFix (VS) group, which had no recurrences in the first 6 months.

Patients using the PH system reported significantly greater pain intensity at 3 months post-surgery compared to those using the VS system, indicating that the VS system may be a safer and more effective option for reducing postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial. Pawlak, M., Hilgers, RD., Bury, K., et al.[2018]

In a study of 202 patients undergoing inguinal hernia repair using a new technique with Marlex mesh, only one recurrence (1%) was observed after six months, indicating high efficacy and safety of the method.

The technique is noted for being simple, quick, and causing less discomfort compared to traditional sutured herniorrhaphy, while also providing protection against femoral hernias, a common complication of other repair methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary results of a new technique for inguinal hernia repair]. Gramegna, A., Trimarchi, A., Nocita, E., et al.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12120353/

Mesh Suture and Mesh Strips to Prevent Incisional Hernia ... We evaluated clinical outcomes for mesh suture and its precursor, mesh strip, in clinical trials of abdominal wall closure or ventral hernia repair.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10809794/

Duramesh registry study: short-term outcomes using mesh ... The 5 most common use cases for mesh suture were ventral hernia repair (26%, N = 97), fascial closure at the time of laparotomy (25%, N = 93), ...

3. frontierspartnerships.org frontierspartnerships.org/journals/journal-of-abdominal-wall-surgery/articles/10.3389/jaws.2025.14573/full

Mesh Suture and Mesh Strips to Prevent Incisional Hernia ... We evaluated clinical outcomes for mesh suture and its precursor, mesh strip, in clinical trials of abdominal wall closure or ventral hernia repair.

4. journals.lww.com journals.lww.com/prsgo/fulltext/2025/05000/outcomes_following_implantation_with_mesh_suture_.58.aspx

Outcomes Following Implantation With Mesh Suture In total, 1111 patients received mesh suture by 86 surgeons. Most cases involved full-thickness abdominal wall closures (88.2%). Further ...

5. withpower.com withpower.com/trial/phase-incisional-hernia-2024-e9250

Duramesh™ for Hernia Prevention 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, ...

6. withpower.com withpower.com/trial/phase-incisional-hernia-2024-e9250?condition=&query=Sutures&overallStatus=Recruiting&hasNoPlacebo=false

Duramesh™ for Hernia Prevention In a study of 181 patients undergoing laparoscopic ventral hernia repair with DynaMesh®, there was a 6% rate of reoperation due to mesh-related complications, ...