Abdominal Wall Closure After Laparotomy in Oncologic Surgery

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

Detailed Description
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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.

Official Title
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A Prospective, Multi-Center, Single Arm, Feasibility Study Using REBUILD Bioabsorbable™ for Closure of the Abdominal Wall After Oncologic Laparotomy

Conditions
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Laparotomy

Intervention / Treatment
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* Device: REBUILD Bioabsorbable


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18-75 years of age Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy Patient is able to provide written informed consent Patient is able and willing to comply with all study requirements Exclusion Criteria: Patient is scheduled for a palliative procedure Patient has had previous failed surgical repair of a ventral or incisional hernia Patient has a current infection at the intended surgical site 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multi-center, single-arm, feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REBUILD<br>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. | Device: REBUILD Bioabsorbable<br>* REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | The number of device-related adverse events | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparotomy, Abdominal Wall Closure