Mesh Suture for Internal Load Bearing Closures

Study Overview
=================
Brief 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

Detailed 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.

Official Title
-----------------
Mesh Suture for Internal Load Bearing Closures

Conditions
-----------------
Suture; Complications, Mechanical, Suture; Complications, Infection or Inflammation, Suture, Complication

Intervention / Treatment
-----------------
* Device: Duramesh Suturable Mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Safety and efficacy study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duramesh Suturable Mesh<br>Use of Duramesh Suturable Mesh for internal load bearing closures | Device: Duramesh Suturable Mesh<br>* Use of Duramesh Suturable Mesh for internal load bearing closures<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery healing complication, acute | Number of patients with infection, drainage, seroma, wound disruption over the mesh suture closure | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery healing complication, delayed | Number of patients with infection, drainage, seroma, wound disruption, sinus over the mesh suture closure | Within 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suture, suture pull-through, suture sinus