Active — Not RecruitingNot Applicable

Assessment of a Non-invasive Device in the Management of Open Abdomen (AbCLO)

United States20 participantsStarted 2024-02-01

Plain-language summary

The goal of this multicenter, prospective Cohort Interventional study is to perform a pilot study of the AbCLO (Abdominal Wall Closure) device in patients with Open Abdomen. The main question it aims to answer is: • Does the Abdominal Wall Closure Device (AbCLO) increase the likelihood of primary facial closure in cases of open abdomen when compared to historical controls? Participants will be cases of open abdomen who underwent emergency surgery for Trauma or Acute Care Surgery, will have the AbCLO device. These will be compared to historical controls managed at the same center.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults more than 18 years of age, and less than 100 years of age
✓. 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.

Exclusion criteria

✕. Pregnant patients
✕. Patients who lost any portion of the abdominal wall that preclude primary abdominal wall closure
✕. Patient who previously had a ventral hernia before having an open abdomen
✕. Patient who already had a previous mesh repair
✕. Burn patients

What they're measuring

Primary Fascial Closure

Timeframe: 14 days

Trial details

NCT IDNCT06242925

SponsorTufts Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Open Abdomen trials