DuraMesh Laparotomy Study

DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery

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. The study will be performed at University of Maryland Shock Trauma Center and Walter Reed National Military Medical Center. One hundred (100) patients will be randomized (2:1) to Duramesh laparotomy closure versus conventional suture closure.

After the patient has been confirmed to be a candidate for the trial, randomization will be performed in the operating room upon completion of the index abdominal procedure. Duramesh will be provided for patients assigned to the Duramesh treatment arm. Patients will be followed for 1 year following laparotomy closure at follow-up intervals of 1 month, 3 months, 6 months, and 12 months.

Study Overview

• Status: Withdrawn
• Conditions: Laparotomy; Suture; Complications, Mechanical; Hernia Incisional
• Intervention / Treatment: Device: Duramesh suturable mesh for laparotomy closure; Device: Conventional suture for laparotomy closure

Detailed Description

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 have their abdominal wall laparotomy incision closed with size 0 Duramesh suturable mesh. Patients randomized to conventional laparotomy closure will be closed using size

1 slowly-absorbing (PDS) single strand or looped suture, based on surgeon preference.

While it would be preferable to identify a single conventional suture to serve as the control group, polling of potential participating surgeons demonstrated a preference for both single strand and looped sutures to be available for use in the conventional suture closure group. Both Duramesh and conventional sutures will be placed using a standardized closure technique that incorporates 1cm wide bites and 1cm spacing, as this is the established technique for trauma and emergency laparotomy closure at both participating institutions. An effort to quantify suture to wound length ratio will be made in an effort to confirm standardization of closure technique between groups. The small-bites surgical closure technique popular in Europe has not been adopted by trauma and emergency surgeons at either institution given concerns related to early dehiscence and the inability to extrapolate the STITCH trial data to a US trauma population. The surgeons at both institutions do not believe it acceptable to generalize the European trial with a mean BMI of 24 to the United States population, nor do they believe it wise to close the abdominal wall with a 2-0 polydioxanone suture, as this technique trended towards a higher rate of acute fascial dehiscence (burst abdomen).

All patients will be assessed for post-operative complications ( i . e . , infection, seroma, hematoma), a t 1 , 3 , 6 , and 12 months p o s t o p e r a t i v e l y . Patient will also be assessed for incisional hernia formation at the same post-operative time points (1, 3, 6, 12 months). Hernia outcomes will be based on physical examination, with ultrasound used for any uncertainties. While surveillance imaging has been shown to be more sensitive for hernia detection, the primary purpose of this study is to compare the safety profile of Duramesh laparotomy closure to standard closure technique. Surveillance imaging for hernia identification is not a part of standard clinical practice at the participating study sites. The rate of clinically relevant hernias found on physical exam will be used to inform future efficacy studies, where routine surveillance imaging will be incorporated into the study design.

In addition to the patients undergoing primary laparotomy closure following an open trauma or emergency abdominal surgery, an additional subset of 20 patients undergoing delayed primary closure of an open abdomen will also be studied. These patients represent a particularly challenging clinical problem, for which there is no standard approach to repair. All 20 study patients undergoing delayed primary closure of an open abdomen will be closed with #1 or #2 Duramesh and followed according to the same post-operative protocol as those undergoing primary laparotomy closure. This subgroup is too small for randomization to provide useful data for comparison, and thus will be used to provide only a descriptive analysis of this early experience with delayed Duramesh closure of the open abdomen. The safety of Duramesh closure in this patient population can be extrapolated from the previously referenced experience of mesh strip closures in contaminated incisional hernias.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Midline laparotomy greater than 5 cm in length
• Urgent or emergent surgery following trauma
• Urgent or emergent surgery for diverticulitis
• Large or small bowel obstruction, acute abdomen, or intra-abdominal hemorrhage.
• Open abdomen after midline laparotomy.

Exclusion Criteria:

• Prior hernia repair or existing abdominal mesh
• 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duramesh suturable mesh for laparotomy closure; Patients undergoing a midline laparotomy for trauma or emergency surgery will be closed with Duramesh suturable mesh.	Device: Duramesh suturable mesh for laparotomy closure; Patients undergoing laparotomy will be closed with Duramesh suturable mesh
Experimental: Conventional suture closure for laparotomy closure; Patients randomized to conventional laparotomy closure will be closed using size 1 slowly-absorbing polydiaxonone (PDS) single strand or looped suture, based on surgeon preference.	Device: Conventional suture for laparotomy closure; Patients undergoing laparotomy will be closed with conventional polydiaxonone suture
Experimental: Open abdomen group closed in delayed fashion with Duramesh; Patients undergoing delayed primary closure of an open abdomen will also be studied. 20 study patients undergoing delayed primary closure of an open abdomen will be closed with Number 1 or Number 2 Duramesh	Device: Duramesh suturable mesh for laparotomy closure; Patients undergoing laparotomy will be closed with Duramesh suturable mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection	Superficial or deep infection of the surgical site	1 month
Surgical site infection	Superficial or deep infection of the surgical site	3 months
Surgical site infection	Superficial or deep infection of the surgical site	6 months
Surgical site infection	Superficial or deep infection of the surgical site	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site occurrence	Any complication related to the surgical site, including hematoma, seroma, dehiscence, fistula, small bowel obstruction, exposed suture, return to the operating room, readmission, or mortality	1 month
Surgical site occurrence	Any complication related to the surgical site, including hematoma, seroma, dehiscence, fistula, small bowel obstruction, exposed suture, return to the operating room, readmission, or mortality	3 months
Surgical site occurrence	Any complication related to the surgical site, including hematoma, seroma, dehiscence, fistula, small bowel obstruction, exposed suture, return to the operating room, readmission, or mortality	6 months
Surgical site occurrence	Any complication related to the surgical site, including hematoma, seroma, dehiscence, fistula, small bowel obstruction, exposed suture, return to the operating room, readmission, or mortality	12 months
Intraoperative and hospitalization endpoints	Details regarding abdominal wall closure	Within 30 days
Intraoperative and hospitalization endpoints	Length of hospital stay	Within 30 days
Intraoperative and hospitalization endpoints	Length of the laparotomy incision and length of suture remnant	Within 30 days
Intraoperative and hospitalization endpoints	Size of Duramesh used	Within 30 days
Hernia formation	Clinical development of an incisional hernia	anytime within 12 months
Patient reported outcomes	NRS pain scale	3 months
Patient reported outcomes	NRS pain scale	6 months
Patient reported outcomes	HerQles	6 months
Patient reported outcomes	SF-36	6 months
Patient reported outcomes	HerQles	12 months
Patient reported outcomes	SF-36	12 months
Patient reported outcomes	NRS pain scale	12 months

Collaborators and Investigators

• Sponsor: Mesh Suture Inc.
• Collaborators: University of Maryland; Walter Reed National Military Medical Center; Uniformed Services University of the Health Sciences
• Investigators: Principal Investigator: Jason M Souza, MD, Walter Reed Army Institute of Research (WRAIR); Study Director: Thomas Scalea, MD, U Maryland Shock Trauma

Publications and helpful links

General Publications

• Dumanian GA, Lanier ST, Souza JM, Young MW, Mlodinow AS, Boller AM, Mueller KH, Halverson AL, McGee MF, Stulberg JJ. Mesh sutured repairs of contaminated incisional hernias. Am J Surg. 2018 Aug;216(2):267-273. doi: 10.1016/j.amjsurg.2017.10.025. Epub 2017 Oct 25.
• Lanier ST, Dumanian GA, Jordan SW, Miller KR, Ali NA, Stock SR. Mesh Sutured Repairs of Abdominal Wall Defects. Plast Reconstr Surg Glob Open. 2016 Sep 28;4(9):e1060. doi: 10.1097/GOX.0000000000001060. eCollection 2016 Sep.
• Dumanian GA, Tulaimat A, Dumanian ZP. Experimental study of the characteristics of a novel mesh suture. Br J Surg. 2015 Sep;102(10):1285-92. doi: 10.1002/bjs.9853. Epub 2015 Jul 8.
• Souza JM, Dumanian ZP, Gurjala AN, Dumanian GA. In vivo evaluation of a novel mesh suture design for abdominal wall closure. Plast Reconstr Surg. 2015 Feb;135(2):322e-330e. doi: 10.1097/PRS.0000000000000910.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 25, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 0001 (Cancer Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: As per the sponsor wishes

Drug and device information, study documents

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