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.
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
477
Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).
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)
Time frame: 36-Months
Rate of Incisional Hernia
Rate of incisional hernia at each follow up time point
Time frame: 60-Months
Rate of Device-related Adverse Events (AEs)
Rate of Device-related Adverse Events (AEs)
Time frame: 60-Months
Length of surgical procedure in minutes
Length of surgical procedure in minutes
Time frame: Study Day 0
Length of time for wound closure in minutes
Length of time for wound closure in minutes
Time frame: Study Day 0
Length of hospital stay in days
Length of hospital stay in days
Time frame: 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.
Time frame: 60-Months
Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dignity Health
Phoenix, Arizona, United States
RECRUITINGKeck Medical Center of USC
Los Angeles, California, United States
WITHDRAWNUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
ACTIVE_NOT_RECRUITINGSt. Francis Hospital and Medical Center
Hartford, Connecticut, United States
WITHDRAWNEmory University
Atlanta, Georgia, United States
TERMINATEDOSF Saint Francis Medical Center
Peoria, Illinois, United States
ACTIVE_NOT_RECRUITINGIndiana University
Indianapolis, Indiana, United States
ACTIVE_NOT_RECRUITINGUniversity of Kentucky Research Foundation
Lexington, Kentucky, United States
RECRUITINGTulane University School of Medicine
New Orleans, Louisiana, United States
RECRUITING...and 34 more locations
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".
Time frame: 60-months