Clinical trial NCT05687942: The REBUILD Trial: Closure of the Abdominal Wall
Official title: The REBUILD Trial: A Prospective, Multi-Center, Single Arm Study Using REBUILD for Abdominal Wall Closure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgical Incision
Keywords: abdominal wall closure
hernia
laparotomy
suture tension
REBUILD
Lead sponsor: AbSolutions Med Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cogent Technologies Corporation
First posted: 2023-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy Measure distance between the rectus abdominus muscles
timeFrame: Day 30 (+14/-7 days)
measure: Serious device related adverse events
timeFrame: Day 30 (+14/-7 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References: