PREVENT Trial: Phasix™ Mesh to Prevent Incisional Hernias After Midline Laparotomy

This study is testing whether using a special surgical mesh called Phasix™ can help prevent hernias after abdominal surgery. Patients who have open abdominal surgery (a midline laparotomy) are randomly assigned to receive either the mesh or the standard method of closing the incision with stitches. The goal is to see if the mesh provides better support and reduces the chances of a hernia forming after surgery.

Study Status

Enrollment Period

Eligibility Criteria

Age
Adult (18 - 64)
Older adult (65+)
Accepts Healthy Volunteers
No
Gender
Any

Contact Information

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Who Qualifies for this Study?

Davol Inc.

Title

Prophylactic Reinforcement of Ventral Abdominal Incisions Trial (PREVENT): Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy (DVL-HE-018)

Description

This is a multi-center randomized trial of Phasix™ Mesh compared to standard suture closure in preventing incisional hernia after having open midline laparotomy. The purpose of this trial is to determine whether Phasix™ Mesh helps prevent incisional hernias that sometimes occur after abdominal surgery by strengthening the closure of tissue and/or incision following surgery.

Study Overview

Conditions / Diseases

Hernias

Department / Organizations

Surgery - General

Principal Investigator

Jennifer Silinsky, M.D.

ClinicalTrials.gov

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