Recruiting

Observational StudyA Non-Traumatic Binder for Temporary Abdominal Wall Closure

Sponsor:

Unity Health Toronto

Code:

NCT03815370

Conditions

Abdominal Trauma

Abdominal Injury

Abdominal Infection

Abdominal Sepsis

Abdominal Abscess

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Experimental: ABRO™ Binder Arm

Placebo Comparator: Usual Care

Study Details

Brief 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

Study ID

NCT03815370

Start date

Apr 1, 2019

Status verified date

Mar, 2022

Completion date

Mar 30, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Mechanically ventilated patients, managed with the OA strategy.
16 years of age or older

Exclusion Criteria:

Patients who are pregnant
Loss of any portion of the abdominal wall that could preclude primary closure
Burn patients
BMI greater than 40 kg/m2

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: Device: ABRO™Binder Arm

Intervention is the usual care (listed above) plus a novel new abdominal binder device called ABRO™

Interventions

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.

Placebo Comparator: Usual Care

Primary outcome measure

Total number of patients who experience complete abdominal closure with sutures without the use of mesh and/or component separation. [ Time Frame: Outcome measures will record when closure of the abdomen takes place up to 11 days after randomization. ]

Central Contacts and Locations

Central contacts

Joao Rezende, MD

416-864-5284 Rezendenetoj@smh.ca

Sandy Trpcic

416-864-6060 TrpcicS@smh.ca

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1W8

Contacts

Sandy Trpcic

416-864-6060 trpcics@smh.ca

Principal Investigator:

Joao Rezende-Neto, MD, PhD

More Information

Sponsor

Unity Health Toronto

Last update posted

Mar 10, 2022

Last verified

Mar, 2022

Keywords

Abdominal trauma/injury
Abdominal sepsis/infection
Open Abdomen
Abdominal binder
Abthera
VAC
ABRO

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2022-03-10.