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

Tufts University

Status: Active, not recruiting

Conditions: Open Abdomen

Treatments: Device: AbCLO (Abdominal Wall Closure) Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06242925

STUDY00003444

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults more than 18 years of age, and less than 100 years of age
2. 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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

ABCLO Group

Experimental group

Description:

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).

Treatment:

Device: AbCLO (Abdominal Wall Closure) Device

Historical Controls

No Intervention group

Description:

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.