DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery

DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery: A Prospective Clinical Trial to Evaluate the Safety and Efficacy of DuraMesh Laparotomy Closure Following Trauma or Emergency Surgery and for Delayed Primary Closure of the Abdomen

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.

Study Overview

• Status: Withdrawn
• Conditions: Suture, Complication; Hernia Incisional
• Intervention / Treatment: Device: Duramesh Laparotomy Closure; Device: Conventional suture closure

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Shock Trauma
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Duramesh Laparotomy Closure; Closure of midline laparotomy incision with experimental suture; Other Names: mesh suture
Active Comparator: 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.	Device: Conventional suture closure; Closure of midline laparotomy incision with standard suture; Other Names: PDS; polydiaxanone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of surgical site infection	hematoma, seroma, dehiscence, fistula, bowel obstruction, removal infected mesh suture, return to OR, readmission, mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative endpoints	length of surgery procedure, length of hospital stay, length of laparotomy incision	day zero, time of implantation
Rate of incisional hernia formation	clinical or radiographic evidence of hernia formation	within 12 months
Quality of life patient reported outcomes	SF-36 questionnaire, Scale 0-100, 100 implies no disability	1 month
Quality of life patient reported outcomes	SF-36 questionnaire, Scale 0-100, 100 implies no disability	3 month
Quality of life patient reported outcomes	SF-36 questionnaire, Scale 0-100, 100 implies no disability	6 months
Quality of life patient reported outcomes	SF-36 questionnaire, Scale 0-100, 100 implies no disability	12 months
Abdominal wall function patient reported outcomes	HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function	1 month
Abdominal wall function patient reported outcomes	HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function	3 months
Abdominal wall function patient reported outcomes	HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function	6 months
Abdominal wall function patient reported outcomes	HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function	12 months
Pain patient reported outcome	Numerical pain rating scale, Scale 0-10, 0 implies no pain	1 month
Pain patient reported outcome	Numerical pain rating scale, Scale 0-10, 0 implies no pain	3 months
Pain patient reported outcome	Numerical pain rating scale, Scale 0-10, 0 implies no pain	6 months
Pain patient reported outcome	Numerical pain rating scale, Scale 0-10, 0 implies no pain	12 months
Visual analog scale pain, patient reported outcome	Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain	1 month
Visual analog scale pain, patient reported outcome	Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain	3 months
Visual analog scale pain, patient reported outcome	Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain	6 months
Visual analog scale pain, patient reported outcome	Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain	12 months

Collaborators and Investigators

• Sponsor: Uniformed Services University of the Health Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 14, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: laparotomy; prevention; suture; mesh; incisional hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Pathological Conditions, Anatomical; Emergencies; Hernia; Incisional Hernia
• Other Study ID Numbers: HP-00083440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes