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Binder

Experimental: ABRO™ Binder Arm for Abdominal Infection (ABRO Trial)

N/A

Waitlist Available

Led By Joao Rezende-Neto, MD

Research Sponsored by Unity Health Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

ABRO Trial Summary

This trial is comparing the standard method for temporary coverage of an open abdomen (vacuum assisted techniques) to the standard method plus a new abdominal binder device, to see if the device aids in the closure of the abdomen.

Eligible Conditions

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

ABRO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ outcome measures will record when closure of the abdomen takes place up to 11 days after randomization.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~outcome measures will record when closure of the abdomen takes place up to 11 days after randomization.

This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome measures will record when closure of the abdomen takes place up to 11 days after randomization. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

ABRO Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Device: ABRO™Binder ArmExperimental Treatment1 Intervention

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

Group II: Usual CarePlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor

537 Previous Clinical Trials

447,399 Total Patients Enrolled

Joao Rezende-Neto, MDPrincipal InvestigatorUnity Health Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participants in this clinical experiment?

"As per the clinicaltrials.gov listing, this trial is actively enrolling participants. The information was originally posted on April 1st 2019 and has been revised as recently as March 8th 2022."

Answered by AI

How many medical facilities are currently hosting the experiment?

"Currently, 4 different sites are running this trial. These include Toronto, New Westminster, and Vancouver plus one other site. For your convenience in minimizing travel costs, it is beneficial to pick the closest location if you decide to join as a participant."

Answered by AI

How many participants are actively engaged in this research endeavor?

"A total of 140 candidates who meet the eligibility requirements are needed for this trial. Potential participants may sign up at St. Michael's Hospital in Toronto, Ontario or Royal Columbian Hospital in New Westminster, British Columbia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Non-Traumatic Binder for Temporary Abdominal Wall Closure

2019. "A Non-Traumatic Binder for Temporary Abdominal Wall Closure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03815370.