DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery
- Conditions
- Hernia IncisionalSuture, Complication
- Interventions
- Device: Duramesh Laparotomy ClosureDevice: Conventional suture closure
- Registration Number
- NCT04312165
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Duramesh Laparotomy Closure 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. Control group-Conventional suture closure 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.
- Primary Outcome Measures
Name Time Method Rate of surgical site infection 30 days hematoma, seroma, dehiscence, fistula, bowel obstruction, removal infected mesh suture, return to OR, readmission, mortality
- Secondary Outcome Measures
Name Time Method Rate of incisional hernia formation within 12 months clinical or radiographic evidence of hernia formation
Quality of life patient reported outcomes 12 months SF-36 questionnaire, Scale 0-100, 100 implies no disability
Visual analog scale pain, patient reported outcome 12 months Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Intraoperative endpoints day zero, time of implantation length of surgery procedure, length of hospital stay, length of laparotomy incision
Abdominal wall function patient reported outcomes 12 months HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Pain patient reported outcome 12 months Numerical pain rating scale, Scale 0-10, 0 implies no pain
Trial Locations
- Locations (2)
University of Maryland Shock Trauma
🇺🇸Baltimore, Maryland, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States