Abdominal Wall Closure After Laparotomy in Oncologic Surgery

AbSolutions Med Inc.30 enrolled

Overview

The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.

REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures. In this study, REBUILD will be used in oncology patients undergoing an open, elective, intent-to-cure, laparotomy procedure. The study is a prospective, non-randomized, multi-center study designed to generate descriptive data about the use of REBUILD. The primary safety outcome is reported device-related adverse events. The primary performance outcome is the integrity of the abdominal wall over one year assessed by clinical examination of the abdomen. If available, CT studies performed within 12 months post-procedure will be used to confirm apposition of the medial border of the rectus muscles and integrity of the abdominal wall.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Laparotomy

Interventions

REBUILD BioabsorbableDEVICE

REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient is 18-75 years of age 2. Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy 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 is scheduled for a palliative procedure 2. Patient has had previous failed surgical repair of a ventral or incisional hernia 3. Patient has a current infection at the intended surgical site 4. Patient is participating in a concurrent investigational medical device study 5. Patient is pregnant or planning on becoming pregnant during the study period 6. Patient has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to be compliant with post-operative visits.

Locations (2)

Clinica Medellin

Medellín, Antioquia, Colombia

RECRUITING

Clinica Las Americas

Medellín, Colombia

RECRUITING

Outcomes

Primary Outcomes

Adverse Events

The number of device-related adverse events

Time frame: 12 months

Performance

The number of subjects with abdominal wall integrity at 3-, 6-, and 12-months post-surgery. Abdominal wall integrity will be assessed via clinical examination of the abdomen to identify a fascial defect, bulge, reducible palpable mass, or discomfort with a cough impulse. Standard of care CT or MR imaging that is performed within 12 months of the surgery will be evaluated to confirm apposition of the medial border of the rectus abdominis muscles and integrity of the abdominal wall.

Time frame: 12 months

Central Contacts

Daniel Jacobs, MD

CONTACT

650-303-6140 danj@absolutionsmed.com

Kathryn Kelley, BSN

CONTACT

925-350-5173 kkelley@absolutionsmed.com

Data from ClinicalTrials.gov

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