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A Non-Traumatic Binder for Temporary Abdominal Wall Closure

NCT03815370 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-03-10

No results posted yet for this study

Summary

At the end of most abdominal operations, the fascial layer is closed by stitching edges of the wound together. However, because of logistic and/or technical reasons or the patient's critical condition, the surgeon is forced to leave the abdomen open.

The current approach for temporary coverage of abdomen is vacuum assisted techniques (VAT). This technique requires the use of vacuum-assisted drainage to remove blood or watery fluid from a wound or operative site. Although this is the most successful and commonly used procedure, there are some limitations to this method. For example, VAT have little effect on preventing lateral movement of the wound edges. Therefore, VAT it is not the ideal procedure in aiding surgeons to closed the abdomen.

The purpose of this study is to compare usual care (vacuum or non-vacuum methods for temporary coverage of the OA) versus usual care plus a novel new abdominal binder device called ABRO™ that may aid in the closure of patients who undergo open abdomen closure procedures.

Conditions

  • Abdominal Trauma
  • Abdominal Injury
  • Abdominal Infection
  • Abdominal Sepsis
  • Abdominal Abscess
  • Abdominal Aneurysm
  • Abdominal Compartment Syndrome
  • Peritonitis

Interventions

DEVICE

Experimental: ABRO™ Binder Arm

ABRO™ is an abdominal device designed to be positioned superficially on the abdominal skin of patients managed with the Open Abdomen strategy. The device is comprised of two rigid plates to stabilize the abdominal muscles thus preventing buckling of these. Another element of this novel device is the circumferential dynamic retainer (CDR). This one is passed behind the patient's back to provide more stability to the muscles in the abdomen keeping them in position to prevent lateral movement of them.

DEVICE

Placebo Comparator: Usual Care

The current approach for temporary coverage of abdomen is called "vacuum assisted techniques (VAT)". This technique requires the use of vacuum-assisted drainage to remove blood or watery fluid from a wound or operative site.

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Joao Rezende-Neto, MD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2022-12-31
Completion
2023-03-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03815370 on ClinicalTrials.gov