The REBUILD Trial: Closure of the Abdominal Wall

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.

Inclusion Criteria:Patient is 22-80 years of agePatient is undergoing a midline laparotomy procedurePatient is able to provide written informed consentPatient is able and willing to comply with all study requirementsExclusion Criteria:Patient has BMI > 40Patients with available imaging measuring abdominal wall thickness < 5.7 mm or > 16.5 mmPatient is scheduled for a palliative procedure or has a life expectancy of less than 12-monthsPatient has mesh at the site of deploymentPatient has an ostomy within the planned midline closure site (4 cm either side of midline)Patient has a CDC wound classification of Class IVPatient has devitalized tissue present at the intended surgical sitePatient 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 wallPatient is participating in a concurrent investigational medical device studyPatient is pregnant or planning on becoming pregnant during the study periodPatient has a history of psychological condition, drug, or alcohol misuse which may interfere with their ability to be compliant with post-operative visits