AbCLO Device for Open Abdomen

(AbCLO Trial)

Recruiting at 1 trial location

Overseen By Mohammed A. Bawazeer, MD, FACS, FRCSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts Medical Center

Disqualifiers: Pregnancy, Abdominal wall loss, Ventral hernia, Mesh repair, Burns

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 14 days

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the AbCLO Device for Open Abdomen treatment?

The ABThera Open Abdomen Negative Pressure Therapy System, a similar treatment, has been shown to be effective in managing open abdomen conditions by promoting wound healing and achieving temporary abdominal closure. Additionally, the use of vacuum-assisted devices has facilitated successful abdominal wall closure in a significant number of patients. ^{1 2 3 4 5}

How is the AbCLO Device treatment different from other treatments for open abdomen?

The AbCLO Device for open abdomen is unique because it focuses on early and effective closure of the abdominal wall, potentially reducing complications associated with prolonged open abdomen conditions. Unlike traditional methods, it may offer a more dynamic and immediate approach to closing the abdomen, which can help in faster recovery and lower the risk of complications like infections and fistula formation. ^{1 6 7 8 9}

Research Team

Mohammed A. Bawazeer, MD

Principal Investigator

Tufts Medical Center

Eligibility Criteria

This trial is for patients who have an 'open abdomen' after emergency surgery due to trauma or acute conditions. They should not have been treated with the AbCLO device before and must be compared to past cases at the same center.

Inclusion Criteria

I had emergency surgery for a severe abdominal issue and was left with an open abdomen.

Exclusion Criteria

Burn patients

Pregnant patients

I had a ventral hernia before my abdomen was surgically opened.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AbCLO device in addition to standard care for open abdomen management

14 days

Daily monitoring in hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of primary fascial closure and complications

4 weeks

Weekly follow-up visits

Treatment Details

Interventions

• Abdominal Wall Closure Device

Trial Overview The study tests if the AbCLO device can improve chances of successfully closing the abdominal wall in open abdomen cases, as opposed to previous methods used (historical controls).

Participant Groups

Group I: ABCLO Group Experimental Treatment 1 Intervention

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).

Group II: Historical Controls Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

InentoRR MD

Collaborator

Trials

1

Recruited

20+

LAC+USC Medical Center

Collaborator

Trials

13

Recruited

31,400+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The sentinel placement of an open abdomen negative pressure unit. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Use of a vacuum-assisted device to facilitate abdominal closure. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Vacuum with mesh is a feasible temporary closure device after fascial dehiscence. [2013]

4. Canada pubmed.ncbi.nlm.nih.gov

Management of the open abdomen using combination therapy with ABRA and ABThera systems. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Successful Use of Negative Pressure Wound Therapy for Abdominal Wall Necrosis Caused by a Perforated Ascending Colon Using the ABThera System. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The open abdomen in trauma, acute care, and vascular and endovascular surgery: comprehensive, expert, narrative review. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

[Laparostoma-Avoidance and treatment of complications]. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Closure of the open abdomen. [2011]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Delayed Primary Wound Closure After Extensive Abdominal Wall Resection for Infection and Malignancy Using TopClosure®. [2021]