AbCLO Device for Open Abdomen

(AbCLO Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the AbCLO (Abdominal Wall Closure Device), to assist in closing the abdomen after emergency surgery, such as in trauma or severe abdominal cases. The trial aims to determine if the AbCLO device increases the likelihood of complete abdominal closure compared to previous methods. Suitable candidates for this trial include those with an open abdomen following emergency surgery for trauma or acute conditions like a bowel blockage. Participants will receive the AbCLO device, and their results will be compared to those of past patients who did not use this device. As an unphased trial, this study provides patients the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

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 prior data suggests that the AbCLO device is safe for patients with open abdomen?

Research has shown that the AbCLO device, used to close the abdomen after surgery, is promising in terms of safety. Studies have found that the device successfully closes the abdomen in many patients. For instance, one study reported an 85% success rate in closing the abdominal wall after surgery. Another source notes that the device reduces complications because it is non-invasive, meaning it doesn't require cutting into the body.

Although specific safety details aren't provided in these studies, the high success rates and non-invasive design suggest it is well-tolerated. This indicates the device is generally safe for use in people, as it avoids many risks linked to more invasive procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for open abdomen, which typically involves techniques like the Lahey bag, Ioban, and closed suction drains, the AbCLO Device offers a new approach. This device is designed to improve the process of abdominal wall closure by providing a more effective and potentially quicker solution. Researchers are excited because the AbCLO Device could lead to better outcomes for patients, such as reduced healing time and complications. By integrating with current methods, it aims to refine and enhance the effectiveness of existing treatments for open abdomen conditions.

What evidence suggests that the AbCLO device is effective for open abdomen?

Research has shown that the AbCLO device, which participants in this trial may receive, can greatly assist in closing the abdomen after surgery. One study demonstrated a 98% success rate in closing the abdominal wall when using the AbCLO device early. It also reduced the gap in the abdominal fascia (a layer of connective tissue) by 75% within just 24 hours. This indicates that the device is highly effective in promoting faster and more complete wound healing. Overall, the AbCLO device holds strong potential for improving recovery in patients with an open abdomen. ^{1 2 3 6 7}

Who Is on the Research Team?

Mohammed A. Bawazeer, MD

Principal Investigator

Tufts Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11047009/

Economic Analysis of AbClo, a Novel Abdominal Fascia ... The clinical effectiveness of the AbClo device was studied in a randomized, single-center, open-label trial of 38 patients (age > 16 years), who were ...

2. abclomedical.com abclomedical.com/6-powerful-abclo-statistics-facts-based-on-peer-reviewed-clinical-evidence-part-1/

6 Powerful AbClo Statistics & Facts Based on Peer- ... Applying AbClo Early Achieved a 98% Primary Fascial Closure Rate · Early Application of AbClo Reduces the Fascial Gap by 75% in 24 Hours · Fascial Traction ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06242925

NCT06242925 | Assessment of a Non-invasive Device in ... Does the Abdominal Wall Closure Device (AbCLO) increase the likelihood of primary facial closure in cases of open abdomen when compared to historical controls?

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38411561/

Economic Analysis of AbClo, a Novel Abdominal Fascia ... The study objective was to assess the economic implications of AbClo compared to negative pressure wound therapy (NPWT) alone on OA management.

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15533506241236745

Economic Analysis of AbClo, a Novel Abdominal Fascia ... The use of AbClo is an economically attractive strategy for management of OA in in patients with midline laparotomy for trauma or acute abdominal surgery.

6. abclomedical.com abclomedical.com/low-risk-high-closure-rates-how-abclo-impacts-open-abdomen-outcomes/

Low Risk, High Closure Rates: How AbClo Impacts Open ... Discover how AbClo reduces complications and improves closure rates in open abdomen care through safe, non-invasive traction technology.

7. abclomedical.com abclomedical.com/news/

News Part 1: Applying AbClo Early Achieved a 98% Primary Fascial Closure Rate Primary fascial closure rates are one of the most accurate indicators of success when ...