NCT06242925

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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: 1. Age 2. Diagnosis: trauma case vs acute general surgery cases, 3. Assessment of severity: Injury severity scores (ISS) for Trauma cases and APACHEII score for acute general surgery cases Outcome Data: 1. 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). 2. 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) 3. Percentage of patients requiring additional device, such as Whitman's patch to maintain fascial closure. (this is also considered failure of the ABCLO device) 4. 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) 5. Percentage of patients developing pressure ulcers (as a possible complication of the device) 6. 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) 7. Total cost per patient before and after application of the ABCLO from ICU admission to closure of the abdomen.

Conditions

• Open Abdomen

Interventions

Type	Name	Description
DEVICE	AbCLO (Abdominal Wall Closure) 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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-02-05
• Last updated: 2025-04-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study