DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery

Suture, Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04312165
• Other study ID #: HP-00083440
• Status: Withdrawn
• Phase: N/A
• Start date: May 2023
• Est. completion date: May 2025

Study information

• Verified date: May 2023
• Source: Uniformed Services University of the Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Hernia
• Hernia Incisional
• Incisional Hernia
• Suture, Complication

Intervention

Device:
• Duramesh Laparotomy Closure
Closure of midline laparotomy incision with experimental suture
• Conventional suture closure
Closure of midline laparotomy incision with standard suture

Locations

Country	Name	City	State
United States	University of Maryland Shock Trauma	Baltimore	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Uniformed Services University of the Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of surgical site infection	hematoma, seroma, dehiscence, fistula, bowel obstruction, removal infected mesh suture, return to OR, readmission, mortality	30 days
Secondary	Intraoperative endpoints	length of surgery procedure, length of hospital stay, length of laparotomy incision	day zero, time of implantation
Secondary	Rate of incisional hernia formation	clinical or radiographic evidence of hernia formation	within 12 months
Secondary	Quality of life patient reported outcomes	SF-36 questionnaire, Scale 0-100, 100 implies no disability	1 month
Secondary	Quality of life patient reported outcomes	SF-36 questionnaire, Scale 0-100, 100 implies no disability	3 month
Secondary	Quality of life patient reported outcomes	SF-36 questionnaire, Scale 0-100, 100 implies no disability	6 months
Secondary	Quality of life patient reported outcomes	SF-36 questionnaire, Scale 0-100, 100 implies no disability	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain patient reported outcome	Numerical pain rating scale, Scale 0-10, 0 implies no pain	1 month
Secondary	Pain patient reported outcome	Numerical pain rating scale, Scale 0-10, 0 implies no pain	3 months
Secondary	Pain patient reported outcome	Numerical pain rating scale, Scale 0-10, 0 implies no pain	6 months
Secondary	Pain patient reported outcome	Numerical pain rating scale, Scale 0-10, 0 implies no pain	12 months
Secondary	Visual analog scale pain, patient reported outcome	Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain	1 month
Secondary	Visual analog scale pain, patient reported outcome	Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain	3 months
Secondary	Visual analog scale pain, patient reported outcome	Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain	6 months
Secondary	Visual analog scale pain, patient reported outcome	Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain	12 months