DuraMesh Laparotomy Study

NCT03966768 | Withdrawn DMC FDA Device

• 1 other identifier: 0001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Laparotomy; Suture; Complications, Mechanical; Hernia Incisional

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• Surgical site occurrence

  1 month

• Surgical site occurrence

  3 months

• Surgical site occurrence

  6 months

• Surgical site occurrence

  12 months

• Intraoperative and hospitalization endpoints

  Within 30 days

Study Arms (3)

Duramesh suturable mesh for laparotomy closure

EXPERIMENTAL

Patients undergoing a midline laparotomy for trauma or emergency surgery will be closed with Duramesh suturable mesh.

Device: Duramesh suturable mesh for laparotomy closure

Conventional suture closure for laparotomy closure

EXPERIMENTAL

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

Open abdomen group closed in delayed fashion with Duramesh

EXPERIMENTAL

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

Interventions

Duramesh suturable mesh for laparotomy closure DEVICE

Patients undergoing laparotomy will be closed with Duramesh suturable mesh

Duramesh suturable mesh for laparotomy closure; Open abdomen group closed in delayed fashion with Duramesh

Conventional suture for laparotomy closure DEVICE

Patients undergoing laparotomy will be closed with conventional polydiaxonone suture

Conventional suture closure for laparotomy closure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior hernia repair or existing abdominal mesh
• Metastatic cancer
• Pregnancy
• Immunosuppression.

Sponsors & Collaborators

• Mesh Suture Inc.: lead
• Uniformed Services University of the Health Sciences: collaborator
• Walter Reed National Military Medical Center: collaborator
• University of Maryland: collaborator

Related Publications (4)

• 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.

  PMID: 29108644 BACKGROUND

• 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.

  PMID: 27757361 BACKGROUND

• 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.

  PMID: 26154703 BACKGROUND

• 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.

  PMID: 25626817 BACKGROUND

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Jason M Souza, MD

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

• Thomas Scalea, MD

  U Maryland Shock Trauma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 29, 2019
• Study Start: October 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share