The REBUILD Trial: Closure of the Abdominal Wall

The REBUILD Trial: A Prospective, Multi-Center, Single Arm Study Using REBUILD for Abdominal Wall Closure

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Incision
• Intervention / Treatment: Device: REBUILD

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Jacobs, MD; Phone Number: 650-303-6140; Email: djacobs@absolutionsmed.com
• Study Contact Backup: Name: Kathryn Kelley, RN, BSN; Phone Number: 925-360-5173; Email: kkelley@absolutionsmed.com

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
    • Contact: Haim Gilshtein, MD; Phone Number: +050-206-2089; Email: h.gilshtein@rambam.health.gov.il
    • Contact: Ortal Bar On; Phone Number: +972 50-206-1391; Email: O_Bar_On@rambam.health.gov.il
    • Principal Investigator: Haim Gilshtein, MD
    • Sub-Investigator: David Hochstein, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: REBUILD; REBUILD is an investigational medical device (bioabsorbable anchor and deployment instruments) used with third party suture to close the abdominal wall. As the suture and Anchor absorb, abdominal wall forces gradually transfer to the organizing scar, one of the tenets of successful wound tensile strength acquisition. After full absorption, no permanent material remains that would otherwise alter normal anatomy, anisotropic properties, or compliance of the abdominal wall (Deeken, 2017).

Device: REBUILD; 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.; Other Names: REBUILD Bioabsorbable, The REBUILD System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: AbSolutions Med Inc.
• Collaborators: Cogent Technologies Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: January 8, 2023
• First Submitted That Met QC Criteria: January 8, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: laparotomy; hernia; REBUILD; abdominal wall closure; suture tension
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: CTP-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes