The REBUILD Trial: Closure of the Abdominal Wall
Surgical Incision
About this trial
This is an interventional prevention trial for Surgical Incision focused on measuring abdominal wall closure, hernia, laparotomy, suture tension, REBUILD
Eligibility Criteria
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 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) Patient is on any medication that the investigator determines creates a high risk for complications (e.g., antithrombotic, steroid, IV chemotherapy, immunosuppressive agent) Patient has history of radiation therapy targeting the abdominal wall Patient is participating in a concurrent investigational medical device study Patient is pregnant or planning on becoming pregnant during the study period Patient has a history of psychological condition, drug, or alcohol misuse which may interfere with their ability to be compliant with post-operative visits
Sites / Locations
- Rambam Health Care Campus
Arms of the Study
Arm 1
Experimental
REBUILD
REBUILD is an investigational medical device (bioabsorbable anchor and deployment instruments) used with third party suture to close the abdominal wall. As the suture and Anchor absorb, abdominal wall forces gradually transfer to the organizing scar, one of the tenets of successful wound tensile strength acquisition. After full absorption, no permanent material remains that would otherwise alter normal anatomy, anisotropic properties, or compliance of the abdominal wall (Deeken, 2017).