Surgical Incision
Conditions
Keywords
abdominal wall closure, hernia, laparotomy, suture tension, REBUILD
Brief summary
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.
Detailed description
The REBUILD Trial (Protocol CTP-0002) is an investigational medical device study designed to demonstrate the efficacy and safety of REBUILD for abdominal wall closure (AWC). The primary evaluation period will include the first 30 days of follow up. After the 1-month endpoint evaluation period, additional follow-up at 3, 6, 12, and 24-months for post-market analysis and publication will be conducted. All adverse events will be collected and reported for the full duration of the study. * Primary efficacy endpoint will be evaluated based on the measured distance between the rectus abdominis muscles (RAMs) by MRI at 1-month (Day 30 +14/-7 days) post-surgery (Day 0). * Primary safety endpoint will be evaluated based on reported serious device-related adverse events through 1-month (Day 30 +14/-7 days) of follow-up.
Interventions
DEVICEREBUILD
3.1.1. REBUILD is an investigational medical device provided as a sterile, single use set containing 10 suture Anchors and two non-implantable Carriers, with reusable stainless-steel instruments for deployment supplied separately.
Sponsors
Cogent Technologies Corporation
AbSolutions Med Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The scientific rationale for a single-arm study is based on existing data and experience associated with current approaches for managing abdominal closure. Suture techniques and mesh have been extensively studied (Deerenberg EB, 2015) (Jairam, 2017) and several clinical publications serve as historical precedents for the 1-month endpoint (Table 2). The results of this REBUILD Study will thus exist in a broad context of outcomes, allowing significant comparisons in the absence of a concomitant control group.
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Measure distance between the rectus abdominus muscles | Day 30 (+14/-7 days) | The primary efficacy endpoint is a maximum distance between the RAMs at 1-month after surgery \< 2.5 cm (binary outcome). |
| Serious device related adverse events | Day 30 (+14/-7 days) | The primary safety endpoint is serious device-related adverse events through 1-month follow-up. |
Countries
Israel
Contacts
Primary ContactDan Jacobs, MD
Backup ContactKathryn Kelley, RN, BSN
Outcome results
None listed