The REBUILD Trial: Closure of the Abdominal Wall

NCT05687942 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CTP-0002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Incision

Keywords

abdominal wall closure; hernia; laparotomy; suture tension; REBUILD

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

REBUILD

EXPERIMENTAL

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

Interventions

REBUILD DEVICE

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.

Also known as: REBUILD Bioabsorbable, The REBUILD System

REBUILD

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 22-80 years of age
• Patient is undergoing a midline laparotomy procedure
• Patient is able to provide written informed consent
• Patient is able and willing to comply with all study requirements

You may not qualify if:

• Patient has BMI \> 40
• Patients with available imaging measuring abdominal wall thickness \< 5.7 mm or \> 16.5 mm
• Patient is scheduled for a palliative procedure or has a life expectancy of less than 12-months
• Patient has mesh at the site of deployment
• Patient has an ostomy within the planned midline closure site (4 cm either side of midline)
• Patient has a CDC wound classification of Class IV
• Patient has devitalized tissue present at the intended surgical site
• 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)
• Patient is on any medication that the investigator determines creates a high risk for complications (e.g., antithrombotic, steroid, IV chemotherapy, immunosuppressive agent)
• Patient has history of radiation therapy targeting the abdominal wall
• Patient is participating in a concurrent investigational medical device study
• Patient is pregnant or planning on becoming pregnant during the study period
• Patient has a history of psychological condition, drug, or alcohol misuse which may interfere with their ability to be compliant with post-operative visits

Sponsors & Collaborators

• AbSolutions Med Inc.: lead
• Cogent Technologies Corporation: collaborator

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

MeSH Terms

Conditions

Surgical Wound; Hernia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dan Jacobs, MD

CONTACT

650-303-6140; djacobs@absolutionsmed.com

Kathryn Kelley, RN, BSN

CONTACT

925-360-5173; kkelley@absolutionsmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 18, 2023
• Study Start: March 1, 2023
• Primary Completion: September 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)