Clinical trial NCT03940560: Mesh Suture for Internal Load Bearing Closures
Official title: Mesh Suture for Internal Load Bearing Closures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Suture; Complications, Mechanical
Suture; Complications, Infection or Inflammation
Suture, Complication
Keywords: suture
suture pull-through
suture sinus
Lead sponsor: Wigmore Clinic
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Safety and efficacy study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Surgery healing complication, acute
timeFrame: 30 days
Secondary outcomes:
measure: Surgery healing complication, delayed
timeFrame: Within 12 months
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Wigmore Clinic
Study officials:
affiliation: Wigmore Clinic
name: Garen Koloyan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: