A Non-Traumatic Binder for Temporary Abdominal Wall Closure

NCT03815370 | Unknown

• 1 other identifier: 17-249
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

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; Abdominal Aneurysm; Abdominal Compartment Syndrome; Peritonitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total number of patients who experience complete abdominal closure with sutures without the use of mesh and/or component separation.

  The primary outcome will measure the total number of patients who experience complete abdominal closure with sutures without the use of mesh and/or component separation.

  Outcome measures will record when closure of the abdomen takes place up to 11 days after randomization.

Study Arms (2)

Usual Care

PLACEBO COMPARATOR

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.

Device: Placebo Comparator: Usual Care

Device: ABRO™Binder Arm

EXPERIMENTAL

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

Device: Experimental: ABRO™ Binder Arm

Interventions

Experimental: ABRO™ Binder Arm DEVICE

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: ABRO™Binder Arm

Placebo Comparator: Usual Care DEVICE

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.

Usual Care

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (4)

Royal Columbian Hospital

New Westminster, British Columbia, V3L3W7, Canada

NOT YET RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

NOT YET RECRUITING

QEII Health Sciences Center

Halifax, Nova Scotia, B3H3G1, Canada

NOT YET RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

RECRUITING

MeSH Terms

Conditions

Abdominal Injuries; Intraabdominal Infections; Abdominal Abscess; Aortic Aneurysm, Abdominal; Intra-Abdominal Hypertension; Peritonitis; Wounds and Injuries; Infections

Condition Hierarchy (Ancestors)

Abscess; Suppuration; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Joao Rezende-Neto, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joao Rezende, MD

CONTACT

416-864-5284; Rezendenetoj@smh.ca

Sandy Trpcic

CONTACT

416-864-6060; TrpcicS@smh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is impossible for the participant or anyone within the patients circle of care to be blinded in this study, as it is clear if the abdominal binder is on the participant or not. There is no way to blind in this interventional study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 the new abdominal binder device called ABRO™.

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: January 24, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: March 30, 2023
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

CA (4)