20 Participants Needed

AbCLO Device for Open Abdomen

(AbCLO Trial)

Recruiting at 1 trial location
RD
MA
Overseen ByMohammed A. Bawazeer, MD, FACS, FRCSC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Tufts Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.16789

Who Is on the Research Team?

MA

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.
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: ABCLO GroupExperimental Treatment1 Intervention
Group II: Historical ControlsActive Control1 Intervention

Find a Clinic Near You

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

The sentinel placement of an open abdomen negative pressure unit. [2021]
Use of a vacuum-assisted device to facilitate abdominal closure. [2022]
Vacuum with mesh is a feasible temporary closure device after fascial dehiscence. [2013]
Management of the open abdomen using combination therapy with ABRA and ABThera systems. [2021]
Successful Use of Negative Pressure Wound Therapy for Abdominal Wall Necrosis Caused by a Perforated Ascending Colon Using the ABThera System. [2022]
The open abdomen in trauma, acute care, and vascular and endovascular surgery: comprehensive, expert, narrative review. [2023]
[Laparostoma-Avoidance and treatment of complications]. [2021]
Closure of the open abdomen. [2011]
Case Report: Delayed Primary Wound Closure After Extensive Abdominal Wall Resection for Infection and Malignancy Using TopClosure®. [2021]
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