Surgical Incision Clinical Trial
Official title:
The REBUILD Trial: A Prospective, Multi-Center, Single Arm Study Using REBUILD for Abdominal Wall Closure
NCT number | NCT05687942 |
Other study ID # | CTP-0002 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2023 |
Est. completion date | June 2026 |
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | June 2026 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Health Care Campus | Haifa |
Lead Sponsor | Collaborator |
---|---|
AbSolutions Med Inc. | Cogent Technologies Corporation |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy Measure distance between the rectus abdominus muscles | The primary efficacy endpoint is a maximum distance between the RAMs at 1-month after surgery < 2.5 cm (binary outcome). | Day 30 (+14/-7 days) | |
Primary | Serious device related adverse events | The primary safety endpoint is serious device-related adverse events through 1-month follow-up. | Day 30 (+14/-7 days) |
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