Abdominal Wall Closure After Laparotomy in Oncologic Surgery (REBUILD)

AbSolutions Med

Status: Enrolling

Conditions: Laparotomy

Treatments: Device: REBUILD Bioabsorbable

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05041530

CTP-0001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

REBUILD

Experimental group

Description:

Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo oncologic laparotomy per the standard of care. The abdominal wall will be closed with REBUILD Bioabsorbable and suture of the surgeon's choice.

Treatment:

Device: REBUILD Bioabsorbable