Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

Study Overview
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Brief Summary
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This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.

Detailed Description
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Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.

Official Title
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Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy

Conditions
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Open Midline Laparotomy

Intervention / Treatment
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* Device: Phasix™ Mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be ≥ 18 years of age Elective, open midline laparotomy ≥ 5 cm Willing and able to provide written informed consent Hernia risk equal to moderate or greater Exclusion Criteria: Previous hernia repair Emergent surgery Creation of skin flaps is preplanned Preplanned 2nd surgery Active skin pathology Life expectancy less than 36 months Pregnant or planning to become pregnant Corticosteroids (e.g., prednisone) prior to surgery ASA Class > IV Enrolled in another clinical trial Site personnel directly involved with this trial Any condition that would preclude the use of the device or the subject form completing the follow-up requirements Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate Two separate incisions are created Prior onlay mesh Surgeon is unable to fully close the fascia The surgery requires more than a single piece of mesh Contraindication to placement of mesh CDC Class IV/Active Infection

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phasix™ Mesh<br>Prophylactic onlay placement of mesh. | Device: Phasix™ Mesh<br>* Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).<br>|
| No Intervention: Primary Suture Closure<br>Standard Fascial closure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Incisional Hernia | The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group) | 36-Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Incisional Hernia | Rate of incisional hernia at each follow up time point | 60-Months | 
| Rate of Device-related Adverse Events (AEs) | Rate of Device-related Adverse Events (AEs) | 60-Months | 
| Length of surgical procedure in minutes | Length of surgical procedure in minutes | Study Day 0 | 
| Length of time for wound closure in minutes | Length of time for wound closure in minutes | Study Day 0 | 
| Length of hospital stay in days | Length of hospital stay in days | Through hospital stay, typically 3 days | 
| Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®) | Health-related quality of life will be measured using the Optum SF-12v2. The questionnaire consists of 12 items weighted and summed to provide physical and mental health scores from the subject's perspective (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better quality of life. | 60-Months | 
| Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©) | EuroQoL-Five Dimensions questionnaire-using Three Levels EQ-5D-3L is a standardized instrument for measuring generic health status. It consists of two components; health status description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves visual analogue scale, asking the subject to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to  the worst health you can imagine, and hundred corresponds to the best health you can imagine. | 60-months |