The REBUILD Trial: Closure of the Abdominal Wall

Exclusion Criteria

• •1. Patient has BMI \> 40
• •2. Patients with available imaging measuring abdominal wall thickness \< 5.7 mm or \> 16.5 mm
• •3. Patient is scheduled for a palliative procedure or has a life expectancy of less than 12-months
• •4. Patient has mesh at the site of deployment
• •5. Patient has an ostomy within the planned midline closure site (4 cm either side of midline)
• •6. Patient has a CDC wound classification of Class IV
• •7. Patient has devitalized tissue present at the intended surgical site
• •8. 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)
• •9. Patient is on any medication that the investigator determines creates a high risk for complications (e.g., antithrombotic, steroid, IV chemotherapy, immunosuppressive agent)
• •10. Patient has history of radiation therapy targeting the abdominal wall
• •11. Patient is participating in a concurrent investigational medical device study
• •12. Patient is pregnant or planning on becoming pregnant during the study period
• •13. Patient has a history of psychological condition, drug, or alcohol misuse which may interfere with their ability to be compliant with post-operative visits