Home › Trials › NCT03911700

Preventing hernias after abdominal surgery with mesh

Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy

Not applicable Interventional C. R. Bard · NCT03911700

This study is testing if using a special mesh instead of regular stitches during abdominal surgery can help prevent hernias in adults who are at risk.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment477 (estimated)
Ages18 Years and up
SexAll
SponsorC. R. Bard Industry-sponsored
Locations44 sites (Phoenix, Arizona and 43 other locations)
Trial IDNCT03911700 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of Phasix™ Mesh implantation during the closure of midline abdominal incisions compared to traditional suture closure. Participants will be randomly assigned to receive either the mesh or standard sutures after undergoing open midline laparotomy surgery. The goal is to determine if the mesh can reduce the incidence of incisional hernias in patients at moderate or higher risk. The study will involve subjects aged 18 and older who meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are undergoing elective open midline laparotomy and are at moderate or greater risk for incisional hernia.

Not a fit: Patients who have previously had hernia repairs or are undergoing emergency surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of incisional hernias in patients undergoing open midline laparotomy.

How similar studies have performed: Other studies have shown promising results with the use of mesh in hernia prevention, suggesting that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 24 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

Where this trial is running

Phoenix, Arizona and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Open Midline Laparotomy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.