DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery

NCT04312165 | Withdrawn DMC FDA Device

• 1 other identifier: HP-00083440
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Hernia Incisional; Suture, Complication

Keywords

mesh; suture; laparotomy; incisional hernia; prevention

Outcome Measures

Primary Outcomes (1)

• Rate of surgical site infection

  hematoma, seroma, dehiscence, fistula, bowel obstruction, removal infected mesh suture, return to OR, readmission, mortality

  30 days

Secondary Outcomes (18)

• Intraoperative endpoints

  day zero, time of implantation

• Rate of incisional hernia formation

  within 12 months

• Quality of life patient reported outcomes

  1 month

• Quality of life patient reported outcomes

  3 month

• Quality of life patient reported outcomes

  6 months

Study Arms (2)

Duramesh Laparotomy Closure

EXPERIMENTAL

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.

Device: Duramesh Laparotomy Closure

Control group-Conventional suture closure

ACTIVE COMPARATOR

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.

Device: Conventional suture closure

Interventions

Duramesh Laparotomy Closure DEVICE

Closure of midline laparotomy incision with experimental suture

Also known as: mesh suture

Duramesh Laparotomy Closure

Conventional suture closure DEVICE

Closure of midline laparotomy incision with standard suture

Also known as: polydiaxanone, PDS

Control group-Conventional suture closure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead

Study Sites (2)

University of Maryland Shock Trauma

Baltimore, Maryland, 21201, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LCDR, Staff Surgeon Plastic and Reconstructive Surgery

Model Details: 2:1 randomization between Duramesh closure and standard suture closure

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 18, 2020
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

US (2)