Experimental: ABRO™ Binder Arm for Intra-Abdominal Abscess (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.

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

Intra-Abdominal Abscess
Internal bleeding
Peritonitis
Abdominal Infection
Sepsis
Abdominal Compartment Syndrome
Abdominal Aortic Aneurysm
Abdominal Trauma
Abdominal Abscess
Candida Peritonitis

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

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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