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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Mesh Suture for Internal Load Bearing Closures

Clinicaltrials.gov identifier NCT03940560

Recruitment Status Active, not recruiting

First Posted May 7, 2019

Last update posted July 14, 2020

Study Description

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

  • Condition or Disease:Suture; Complications, Mechanical
    Suture; Complications, Infection or Inflammation
    Suture, Complication
  • Intervention/Treatment: Device: Duramesh Suturable Mesh
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 53 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Safety and efficacy study
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Mesh Suture for Internal Load Bearing Closures
  • Actual Study Start Date: July 2018
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: April 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Duramesh Suturable Mesh
Use of Duramesh Suturable Mesh for internal load bearing closures
Device: Duramesh Suturable Mesh
Use of Duramesh Suturable Mesh for internal load bearing closures
Outcome Measures
  • Primary Outcome Measures: 1. Surgery healing complication, acute [ Time Frame: 30 days ]
    Number of patients with infection, drainage, seroma, wound disruption over the mesh suture closure
  • Secondary Outcome Measures: 1. Surgery healing complication, delayed [ Time Frame: Within 12 months ]
    Number of patients with infection, drainage, seroma, wound disruption, sinus over the mesh suture closure
Eligibility Criteria
  • Ages Eligible for Study: 1 Year and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

Armenia
Wigmore Clinic
Yerevan

Sponsors and Collaborators

Wigmore Clinic

Investigators

Principal Investigator: Garen Koloyan, MD PhD Wigmore Clinic

More Information
  • Responsible Party: Wigmore Clinic
  • ClinicalTrials.gov Identifier: NCT03940560 History of Changes
  • Other Study ID Numbers: 001
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: July 14, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Wigmore Clinic: suture
    suture pull-through
    suture sinus
  • Additional relevant MeSH terms: Inflammation