Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

Not Applicable

Recruiting

• Conditions: Open Midline Laparotomy

• Registration Number: NCT03911700
• Lead Sponsor: C. R. Bard

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-11
• Study Start: 2019-12-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-23
• Primary Completion: 2029-12
• Study Completion: 2031-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 477

Inclusion Criteria

1. Must be ≥ 18 years of age
2. Elective, open midline laparotomy ≥ 5 cm
3. Willing and able to provide written informed consent
4. Hernia risk equal to moderate or greater

Exclusion Criteria

1. Previous hernia repair
2. Emergent surgery
3. Creation of skin flaps is preplanned
4. Preplanned 2nd surgery
5. Active skin pathology
6. Life expectancy less than 36 months
7. Pregnant or planning to become pregnant
8. Receiving a medication/medical condition that may adversely affect wound healing
9. ASA Class > IV
10. Enrolled in another clinical trial
11. Site personnel directly involved with this trial
12. Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
13. Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
14. Two separate incisions are created
15. Prior onlay mesh
16. Surgeon is unable to fully close the fascia
17. The surgery requires more than a single piece of mesh
18. Contraindication to placement of mesh
19. CDC Class IV/Active Infection
20. Breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of Device-related Adverse Events (AEs)	60-Months	Rate of Device-related Adverse Events (AEs)
Length of surgical procedure in minutes	Study Day 0	Length of surgical procedure in minutes
Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®)	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©)	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".
Rate of Incisional Hernia	60-Months	Rate of incisional hernia at each follow up time point
Length of time for wound closure in minutes	Study Day 0	Length of time for wound closure in minutes
Length of hospital stay in days	Through hospital stay, typically 3 days	Length of hospital stay in days

Trial Locations

Locations (41)

Dignity Health; 🇺🇸 Phoenix, Arizona, United States

Keck Medical Center of USC; 🇺🇸 Los Angeles, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

St. Francis Hospital and Medical Center; 🇺🇸 Hartford, Connecticut, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

OSF Saint Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of Kentucky Research Foundation; 🇺🇸 Lexington, Kentucky, United States

Tulane University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

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