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NCT Number: NCT06242925

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Open Abdomen Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Los Angeles County + University of Sothern California Medical Center, Los Angeles, California, United States

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About this study

This is a multi-center matched prospective cohort study. It will be performed in collaboration between 2 centers in the USA: Tufts Medical Center (TMC) and Los Angeles County + University of Southern California (LAC + USC) Medical Center.

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).

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.

The total sample size is 80 patients, 20 in the treatment arm (15 from TMC and 5 from LAC+USC) and 60 in the control arm (45 from TMC and 15 from LAC+USC). The treatment arm will be matched to historical control based on the following pre-specified variables:

  • Age
  • Diagnosis: trauma case vs acute general surgery cases,
  • Assessment of severity: Injury severity scores (ISS) for Trauma cases and APACHEII score for acute general surgery cases

Outcome Data:

  • Primary Outcome: Proportion of patients achieved primary facial closure within 14 days. (This is defined as approximation of the fascia on either side of the midline to perform suture closure without using any mesh or additional procedures. From our experience, most open abdomen is usually closed within 7-10 days. We decided to put any closure more than 14 days is considered failure of the device).
  • Proportion of patients that require component separation and/or mesh closure to obtain fascial closure, (if we need to use mesh or do additional procedure to close the abdomen, this is considered failure rate of the ABCLO device)
  • Percentage of patients requiring additional device, such as Whitman's patch to maintain fascial closure. (this is also considered failure of the ABCLO device)
  • The time from inclusion to complete abdominal wall fascial closure (as defined above) prior to discharge. (Duration of patients that require the abdomen to be open)
  • Percentage of patients developing pressure ulcers (as a possible complication of the device)
  • Duration of mechanical ventilation, ICU length of stay and hospital length of stay (to examine the indirect effects of primary fascial closure on these outcomes)
  • Total cost per patient before and after application of the ABCLO from ICU admission to closure of the abdomen.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AbCLO (Abdominal Wall Closure) Device

Device

They will receive the standard of care (Lahey bag covering the bowel, 2 drains in the subcutaneous tissue and Ioban covering everything). The AbClO device has two Rectus Muscle Splints (RMS) to stabilize the rectus abdominis (preventing buckling of these muscles and stabilize the circumferential dynamic retainer (CDR)). The CDR is passed behind the patient's back. The RMSs are positioned on the abdominal wall approximately 2 cm lateral to the wound edges on each side. Additional padding can be applied underneath the RMS. The CDR is passed between the cross bar and the locking strip of each RMS and stretched until taut. The locking strips are locked in position. Four tensioners bridge across the OA from one RMS to the other. Gauze packs should be interposed between the undersurface of the tensioners and the surface of the temporary abdominal coverage to prevent friction. The Tensioners are tightened progressively until complete facial closure.

Primary outcomes

  1. Primary Fascial Closure

    Time frame: 14 days

    Proportion of patients achieved primary facial closure within 14 days. (This is defined as approximation of the fascia on either side of the midline to perform suture closure without using any mesh or additional procedures.

Secondary outcomes

  1. The need for additional procedure to perform fascial closure

    Time frame: 14 days

    Proportion of patients that require component separation and/or mesh closure to obtain fascial closure

  2. The need for additional device

    Time frame: 14 days

    Percentage of patients requiring additional device, such as Whitman's patch to maintain fascial closure

  3. Duration of open abdomen

    Time frame: 14 days

    The time from inclusion to complete abdominal wall fascial closure (as defined above) prior to discharge.

  4. Device complications

    Time frame: 14 days

    Percentage of patients developing pressure ulcers

  5. Duration of mechanical ventilation

    Time frame: 14 days

    The duration from intubation to liberation off mechanical ventilator.

  6. ICU length of stay and Hospital length of stay

    Time frame: 14 days

    ICU length of stay from admission to leaving the ICU. Hospital length of stay from admission to discharge

  7. cost

    Time frame: 14 days

    Total cost per patient before and after application of the ABCLO from ICU admission to closure of the abdomen

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • InentoRR MD
  • LAC+USC Medical Center

Registry information

Official study title

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

Acronym: AbCLO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2024
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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