Open Abdomen Clinical Trial
— AbCLOOfficial title:
Assessment of a Non-invasive Device in the Management of Open Abdomen (AbCLO)- Pilot Study
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Tufts Medical center | Boston | Massachusetts |
United States | Los Angeles County + University of Sothern California Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Tufts Medical Center | InentoRR MD, LAC+USC Medical Center |
United States,
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Rezende-Neto JB, Camilotti BG. New non-invasive device to promote primary closure of the fascia and prevent loss of domain in the open abdomen: a pilot study. Trauma Surg Acute Care Open. 2020 Nov 11;5(1):e000523. doi: 10.1136/tsaco-2020-000523. eCollection 2020. — View Citation
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Fascial Closure | 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. | 14 days | |
Secondary | The need for additional procedure to perform fascial closure | Proportion of patients that require component separation and/or mesh closure to obtain fascial closure | 14 days | |
Secondary | The need for additional device | Percentage of patients requiring additional device, such as Whitman's patch to maintain fascial closure | 14 days | |
Secondary | Duration of open abdomen | The time from inclusion to complete abdominal wall fascial closure (as defined above) prior to discharge. | 14 days | |
Secondary | Device complications | Percentage of patients developing pressure ulcers | 14 days | |
Secondary | Duration of mechanical ventilation | The duration from intubation to liberation off mechanical ventilator. | 14 days | |
Secondary | ICU length of stay and Hospital length of stay | ICU length of stay from admission to leaving the ICU. Hospital length of stay from admission to discharge | 14 days | |
Secondary | cost | Total cost per patient before and after application of the ABCLO from ICU admission to closure of the abdomen | 14 days |
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