Mesh Suture for Internal Load Bearing Closures

Suture, Complication Clinical Trial

Official title:

Mesh Suture for Internal Load Bearing Closures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03940560
• Other study ID #: 001
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Wigmore Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine whether Mesh Suture achieves an acceptable safety and efficacy profile in load bearing internal tissue approximations. Mesh Suture has a novel design that permits tissue ingrowth and limits suture pull-through--items important for internal high-tension repairs

Description:

Sutures are flexible linear elements that appose tissues and are "self-holding" with a surgically created knot. When tissues are under tension, such as the closure of an abdominal wall after laparotomy, the sutures cut through the tissues in what is known as "suture pull-through" and create incisional hernias. The hernia rate after primary laparotomy depends on the patient population, but is over 10%. In some high-risk populations, even with a small 3 cm laparoscopy incision, the hernia rate is over 30%. In primary hernia repair, use of sutures alone yields a 60% hernia recurrence rate at 10 years. Mesh has become commonplace in order to decrease incisional hernia recurrence rates in primary hernia repairs.

A novel mesh suture, designed at Northwestern University (Chicago, IL) by Dr. Gregory Dumanian, has shown improved outcomes in pre-clinical animal models and these results are included at the end of this document. Dr. Dumanian has employed the concept of using a mesh-like suture already in his clinical practice. He has cut strips from an FDA-approved piece of hernia mesh, and used them as sutures, tying them with knots.

Based on improved outcomes in pre-clinical and analogous clinical data in comparison to standard suture, Dr. Dumanian now proposes the use of a medical grade mesh suture of his design and fabrication in the load bearing internal tissue approximations. These are internal permanent sutures and will not be removed. They are made of the identical material (polypropylene) used in standard sutures.

Mesh Sutures are larger than standard sutures and they automatically flatten to help resist suture pull-through. Tissue ingrowth around the filaments and into the suture improves their hold.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Deep orthopedic soft tissue approximation

Exclusion Criteria:

• Pregnancy

• Age less than 1 year old

• Repair of skin or other epithelial surfaces

• Poor subcutaneous tissues

• Ongoing infection

Related Conditions & MeSH terms

• Inflammation
• Suture, Complication
• Suture; Complications, Infection or Inflammation
• Suture; Complications, Mechanical

Intervention

Device:
• Duramesh Suturable Mesh
Use of Duramesh Suturable Mesh for internal load bearing closures

Locations

Country	Name	City	State
Armenia	Wigmore Clinic	Yerevan

Sponsors (1)

Lead Sponsor	Collaborator
Wigmore Clinic

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery healing complication, acute	Number of patients with infection, drainage, seroma, wound disruption over the mesh suture closure	30 days
Secondary	Surgery healing complication, delayed	Number of patients with infection, drainage, seroma, wound disruption, sinus over the mesh suture closure	Within 12 months