DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery

NCT ID: NCT04312165

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2025-05-31

Brief Summary

The proposed project aims to evaluate the safety of DuraMesh™ suture for laparotomy closure in an emergent setting, while also providing preliminary efficacy data with regard to incisional hernia prevention. Conventional techniques for laparotomy closure in the setting of an emergency laparotomy or delayed abdominal closure suffer from a lack of durability, with incisional hernia rates of 30-34% reported. While prophylactic planar mesh placement has emerged as a cost-effective strategy to prevent hernia formation in the clean, elective laparotomy setting, higher rates of surgical site complications and increased technical complexity preclude its use in the emergency or contaminated setting. Utilized exactly like conventional suture without any change in surgical closure technique, DuraMesh™ provides the durability of planar mesh reinforcement without the marked increase in foreign material or added surgical complexity. As a result, DuraMesh™ is the only hernia prevention strategy that can be forward-deployed in support of the injured warfighter. While this study is specifically targeted to a gap in the care of the injured warfighter, the potential benefits extend well beyond the military applications. With over 2 million laparotomies performed annually in the United States, and approximately 20% of these resulting in an incisional hernia, the need for an alternative abdominal wall closure strategy is equally dire in the civilian setting. This clinical trial represents an opportunity to drive the needed paradigm shift towards prevention, rather than costly management of incisional hernias. The investigators anticipate this work will rapidly lead to further research, including providing the preliminary data necessary to launch a multi-center randomized controlled trial to assess the clinical efficacy of DuraMesh™ for hernia prevention in both the emergent and elective operative settings.

Detailed Description

This is a multisite randomized control proof-of-concept trial to evaluate the safety of DuraMesh™ laparotomy closure in the trauma and emergency laparotomy setting. Approximately 120 patients will be randomized (2:1) to DuraMesh™ laparotomy closure versus conventional suture closure. #1 DuraMesh™ will be provided for patients assigned to the DuraMesh™ treatment arm. Patients will participate in a one-year follow-up regime (2 weeks,1 month, 3 months, 6 months and 12 months).

Primary Laparotomy Closure Treatment 1) Study Group - DuraMesh™ Laparotomy Closure (DLC) Treatment 2) Control Group - Conventional Suture Closure (CSC)

Patients undergoing a midline laparotomy for trauma or emergency surgery will be randomized to either #1 DuraMesh™ suture or conventional laparotomy closure using size #1 slowly-absorbing (PDS) single strand or looped suture, based on surgeon preference. All patients will be assessed for post-operative complications at 2 weeks, 1 month, 3 months, 6 months, and 12 months postoperatively. Patients will also be assessed for incisional hernia formation at the same post-operative time points (2 weeks,1 month, 3 months, 6 months, 12 months). Hernia outcomes will be based on physical examination, with ultrasound used for any uncertainties.

Conditions

Hernia Incisional; Suture, Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Duramesh Laparotomy Closure

Patients undergoing a midline laparotomy for trauma or emergency surgery will be randomized to either #1 Duramesh suture or standard suture, which is a #1 slowly-absorbing PDS single strand or looped suture based on surgeon preference.

Group Type: EXPERIMENTAL

Duramesh Laparotomy Closure

Intervention Type: DEVICE

Closure of midline laparotomy incision with experimental suture

Control group-Conventional suture closure

Patients undergoing a midline laparotomy for trauma or emergency surgery will be randomized to either #1 Duramesh suture or standard suture, which is a #1 slowly-absorbing PDS single strand or looped suture based on surgeon preference.

Group Type: ACTIVE_COMPARATOR

Conventional suture closure

Intervention Type: DEVICE

Closure of midline laparotomy incision with standard suture

Interventions

Duramesh Laparotomy Closure

Closure of midline laparotomy incision with experimental suture

Intervention Type: DEVICE

Conventional suture closure

Closure of midline laparotomy incision with standard suture

Intervention Type: DEVICE

Other Intervention Names

mesh suture; polydiaxanone; PDS

Eligibility Criteria

Inclusion Criteria

• Midline laparotomy 5 cm (2 inches) long
• Urgent or emergent surgery following trauma
• Urgent or emergent surgery for diverticulitis
• Urgent or emergent surgery for large or small bowel obstruction
• Urgent or emergent surgery for exploratory laparotomy for acute abdomen
• Urgent or emergent surgery for exploratory laparotomy for intraabdominal hemorrhage

Exclusion Criteria

• Inability to provide informed consent
• Prior Hernia repair or existing ventral hernia mesh EXCLUDING inguinal hernias
• Metastatic cancer
• Pregnancy
• Immunosuppression

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uniformed Services University of the Health Sciences

FED

Sponsor Role: lead

Responsible Party

Gregory Dumanian

LCDR, Staff Surgeon Plastic and Reconstructive Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Maryland Shock Trauma

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

HP-00083440

Identifier Type: -

Identifier Source: org_study_id