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

Study acronym: AbCLO
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 25, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025 Trial status: Recruiting to Active, Not Recruiting · Site details revised at 2 of 2 sitesv4 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
  2. Primary endpoint revised Start date changed from estimate of Feb 2024 to Feb 1, 2024 · Secondary endpoints: 6 to 7v3 Show 2 more changesShow less
    • Start date changed from estimate of Feb 2024 to Feb 1, 2024
    • Secondary endpoints: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Feb 1, 2024 to Feb 2024v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06242925
Lead Sponsor Tufts Medical Center
Collaborators: InentoRR MD, LAC+USC Medical Center
Conditions Open Abdomen
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov