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

Trial Summary

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. ^{1 2 3 4 5}

What 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. ^{6 7 8 9 10}

Is 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. ^{1 11 12 13 14}

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.

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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 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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

DynaMesh® in the repair of laparoscopic ventral hernia: a prospective trial. [2021]

2. Italy pubmed.ncbi.nlm.nih.gov

Updates in abdominal wall management. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Modifying hernia mesh design to improve device mechanical performance and promote tension-free repair. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Mesh in Elective Hernia Repair: 10-Year Experience with over 6,000 Patients. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Germany pubmed.ncbi.nlm.nih.gov

Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration. [2022]

7. United States 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. [2020]

8. Korea (South) 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. [2019]

9. New Zealand pubmed.ncbi.nlm.nih.gov

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection. [2021]

10. England pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Retrospective study on the use of a composite mesh (Physiomesh) in laparoscopic ventral hernia repair. [2013]

12. United States 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. [2009]

13. Germany pubmed.ncbi.nlm.nih.gov

Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial. [2018]

14. Italy pubmed.ncbi.nlm.nih.gov

[Preliminary results of a new technique for inguinal hernia repair]. [2006]