Prophylactic Reinforcement of Ventral Abdominal Incisions Trial (PREVENT)
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|ClinicalTrials.gov Identifier: NCT03911700|
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : May 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Open Midline Laparotomy||Device: Phasix™ Mesh||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||477 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy|
|Actual Study Start Date :||December 12, 2019|
|Estimated Primary Completion Date :||October 2027|
|Estimated Study Completion Date :||October 2029|
Experimental: Phasix™ Mesh
Prophylactic onlay placement of mesh.
Device: Phasix™ Mesh
Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).
No Intervention: Primary Suture Closure
Standard Fascial closure.
- Rate of Incisional Hernia [ Time Frame: 36-Months ]The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group)
- Rate of Incisional Hernia [ Time Frame: 60-Months ]Rate of incisional hernia at each follow up time point
- Rate of Device-related Adverse Events (AEs) [ Time Frame: 60-Months ]Rate of Device-related Adverse Events (AEs)
- Length of surgical procedure in minutes [ Time Frame: Study Day 0 ]Length of surgical procedure in minutes
- Length of time for wound closure in minutes [ Time Frame: Study Day 0 ]Length of time for wound closure in minutes
- Length of hospital stay in days [ Time Frame: Through hospital stay, typically 3 days ]Length of hospital stay in days
- Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®) [ Time Frame: 60-Months ]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.
- Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©) [ Time Frame: 60-months ]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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911700
|Contact: Craig Wisman, MDemail@example.com|
|Contact: Amanda Resendes, MBA||401-825-8581||Amanda.Resendes@crbard.com|
|Principal Investigator:||William Hope, MD||New Hanover Regional Medical Center|