About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 2 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. Patient is 22-80 years of age
2. Patient is undergoing a midline laparotomy procedure
3. Patient is able to provide written informed consent
4. Patient is able and willing to comply with all study requirements
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