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Binder

Experimental: ABRO™ Binder Arm for Sepsis (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

Summary

This trial is testing a new device called ABRO™ to help close open abdominal wounds in patients who can't have their abdomen closed immediately after surgery. The device supports the abdominal wall to keep the wound edges together, making it easier to close the wound and reducing complications. The ABRO™ device is similar to another device that has been used for managing open abdomens by keeping wound edges together.

Eligible Conditions
  • Sepsis
  • Abdominal Abscess
  • Abdominal Aortic Aneurysm
  • Abdominal Compartment Syndrome
  • Peritonitis
  • Abdominal Injury
  • Abdominal Infection
  • Abdominal Trauma

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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total number of patients who experience complete abdominal closure with sutures without the use of mesh and/or component separation.

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.

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Who is running the clinical trial?

Unity Health TorontoLead Sponsor
554 Previous Clinical Trials
454,151 Total Patients Enrolled
3 Trials studying Sepsis
520 Patients Enrolled for Sepsis
Joao Rezende-Neto, MDPrincipal InvestigatorUnity Health Toronto
~22 spots leftby Sep 2025
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