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Mesh Suture for Internal Load Bearing Closures

NCT ID: NCT03940560

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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suture suture pull-through suture sinus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Safety and efficacy study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Duramesh Suturable Mesh

Use of Duramesh Suturable Mesh for internal load bearing closures

Group Type EXPERIMENTAL

Duramesh Suturable Mesh

Intervention Type DEVICE

Use of Duramesh Suturable Mesh for internal load bearing closures

Interventions

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Duramesh Suturable Mesh

Use of Duramesh Suturable Mesh for internal load bearing closures

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wigmore Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Garen Koloyan, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Wigmore Clinic

Locations

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Wigmore Clinic

Yerevan, , Armenia

Site Status

Countries

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Armenia

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id