The REBUILD Trial: Closure of the Abdominal Wall (NCT05687942) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The REBUILD Trial: Closure of the Abdominal Wall
Israel40 participantsStarted 2023-03
Plain-language summary
The main objective of this clinical trial is to demonstrate the safety and efficacy of REBUILD when used to support abdominal wall closure after laparotomy. The main question it aims to answer are whether the device when used to support suture in abdominal wall closure safely maintains apposition of the abdominis rectus muscles within a pre-defined distance.
Participants will undergo standard of care laparotomy and the investigational device will be used to support the suture used to close the abdominal wall. Participants will have an MRI at 1-month after surgery to measure the distance between the abdominus rectus muscles.
Who can participate
Age range22 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient is 22-80 years of age
✓. Patient is undergoing a midline laparotomy procedure
✓. Patient is able to provide written informed consent
✓. Patient is able and willing to comply with all study requirements
Exclusion criteria
✕. Patient has BMI \> 40
✕. Patients with available imaging measuring abdominal wall thickness \< 5.7 mm or \> 16.5 mm
✕. Patient is scheduled for a palliative procedure or has a life expectancy of less than 12-months
✕. Patient has mesh at the site of deployment
✕. Patient has an ostomy within the planned midline closure site (4 cm either side of midline)
✕. Patient has a CDC wound classification of Class IV
What they're measuring
1
Efficacy Measure distance between the rectus abdominus muscles
. Patient has devitalized tissue present at the intended surgical site
✕. Patient has any co-morbid conditions determined by the investigator to place them at a high risk of complications (e.g., severe cardiovascular disease, congestive heart failure NYHA Class III or IV, end-stage renal failure, liver cirrhosis, connective tissue disorder, poorly managed diabetes)