MedPath

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.

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
NameTimeMethod
Rate of Incisional Hernia36-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
NameTimeMethod
Rate of Device-related Adverse Events (AEs)60-Months

Rate of Device-related Adverse Events (AEs)

Length of surgical procedure in minutesStudy 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 Hernia60-Months

Rate of incisional hernia at each follow up time point

Length of time for wound closure in minutesStudy Day 0

Length of time for wound closure in minutes

Length of hospital stay in daysThrough 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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Dignity Health
🇺🇸Phoenix, Arizona, United States
Mitzy Vazquezgamez
Contact
602-406-5260
mitzy.vazquezgamez@commonspirit.org
Hahn Soe-Lin, MD
Principal Investigator

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