DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hernia Incisional, Suture, Complication

Intervention / Treatment
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* Device: Duramesh Laparotomy Closure
* Device: Conventional suture closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2:1 randomization between Duramesh closure and standard suture closure
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duramesh Laparotomy Closure<br>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<br>* Closure of midline laparotomy incision with experimental suture<br>* Other names: mesh suture;|
| Active Comparator: Control group-Conventional suture closure<br>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<br>* Closure of midline laparotomy incision with standard suture<br>* Other names: PDS;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mesh, suture, laparotomy, incisional hernia, prevention