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AbCLO Device for Open Abdomen (AbCLO Trial)

N/A

Recruiting

Led By Mohammed A. Bawazeer, MD

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

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

Must have

Admitted to the trauma and acute care surgery service, underwent damage control laparotomy and left with an open abdomen (OA). Trauma or Emergency General Surgery, such as perforated viscus, Bowel obstruction or abdominal compartment syndrome.

Be older than 18 years old

Must not have

Patient who previously had a ventral hernia before having an open abdomen

Patients who lost any portion of the abdominal wall that preclude primary abdominal wall closure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the AbCLO (Abdominal Wall Closure) in patients with an open abdomen who had emergency surgery for Trauma or Acute Care Surgery. The study

Who is the study for?

This trial is for patients who have an 'open abdomen' after emergency surgery due to trauma or acute conditions. They should not have been treated with the AbCLO device before and must be compared to past cases at the same center.

What is being tested?

The study tests if the AbCLO device can improve chances of successfully closing the abdominal wall in open abdomen cases, as opposed to previous methods used (historical controls).

What are the potential side effects?

Since this trial involves a non-invasive device aimed at helping close an open abdomen, side effects may include discomfort, skin irritation around where the device is applied, or potential delays in wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had emergency surgery for a severe abdominal issue and was left with an open abdomen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a ventral hernia before my abdomen was surgically opened.

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I cannot have my abdominal wall closed due to missing parts.

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I have had a previous surgery using mesh.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Fascial Closure

Secondary study objectives

Device complications

Duration of mechanical ventilation

Duration of open abdomen

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ABCLO GroupExperimental Treatment1 Intervention

The cohort (interventional) patients will receive the standard of care (Lahey bag, Ioban and closed suction drains) in addition to the study intervention (AbCLO Device).

Group II: Historical ControlsActive Control1 Intervention

The control group is retrospective patients that were previously managed at the same center, regardless of the technique or the device used to close the OA. At TMC, we have a previously collected data bank of all open abdomen managed at our center. This data bank is approved by IRB. This data bank has 170 patients in total. we will use 45 patients from the data bank to be matched to the interventional group (15 patients) to have a total of 60 patients from TMC. As of LAC+USC Medical Center, they will provide historical controls from the trauma registry.

0 / 4Eligibility criteria met