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CLINICAL STUDY · NCT03911700

Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

Active, not recruitingNot applicableInterventional

Sponsored by C. R. Bard

Condition
Open Midline Laparotomy
Study locations
32 reported sites
Study updated
19 Oct 2026
Source
ClinicalTrials.gov

Overall study status is shown above. Individual hospitals may have a different recruitment status.

THE STUDY

About this study

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.
Full official title
Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
Detailed description
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.

PARTICIPATION

Who may participate

Minimum age
18 Years
Maximum age
Not reported
Sex eligibility
All sexes
Healthy volunteers
Not accepted

Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.

Full inclusion and 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

NEAR YOU

Study locations worldwide

32 sites

Check the individual site’s status and contact the listed study team for current availability.

University of California San Francisco

Not reported

San Francisco, California, 94143, United States

Contact details are not published in this record. Check official study record ↗

OSF Saint Francis Medical Center

Not reported

Peoria, Illinois, 61637, United States

Contact details are not published in this record. Check official study record ↗

University of Kentucky Research Foundation

Not reported

Lexington, Kentucky, 40508, United States

Contact details are not published in this record. Check official study record ↗

Tulane University School of Medicine

Not reported

New Orleans, Louisiana, 70112, United States

Contact details are not published in this record. Check official study record ↗

University of Minnesota

Not reported

Minneapolis, Minnesota, 55455, United States

Contact details are not published in this record. Check official study record ↗

Rutgers Cancer Institute of New Jersey

Not reported

New Brunswick, New Jersey, 08901, United States

Contact details are not published in this record. Check official study record ↗

New York Presbyterian Hospital-Columbia University Medical Center

Not reported

New York, New York, 10032, United States

Contact details are not published in this record. Check official study record ↗

Montefiore Medical Center

Not reported

The Bronx, New York, 10467, United States

Contact details are not published in this record. Check official study record ↗

New Hanover Regional Medical Center

Not reported

Wilmington, North Carolina, 28401, United States

Contact details are not published in this record. Check official study record ↗

University of Pennsylvania

Not reported

Philadelphia, Pennsylvania, 19104, United States

Contact details are not published in this record. Check official study record ↗

Baptist Clinical Research Institute

Not reported

Memphis, Tennessee, 38163, United States

Contact details are not published in this record. Check official study record ↗

Vanderbilt University

Not reported

Nashville, Tennessee, 37232, United States

Contact details are not published in this record. Check official study record ↗

CAMC Health Education and Research Institute, Inc.

Not reported

Charleston, West Virginia, 25304, United States

Contact details are not published in this record. Check official study record ↗

Centre Hospitalier Universitaire de Lille

Not reported

Lille, France, 59000, France

Contact details are not published in this record. Check official study record ↗

Hopitaux Universitaires de Strasbourg

Not reported

Strasbourg, 67000, France

Contact details are not published in this record. Check official study record ↗

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology

Not reported

Berlin, 13353, Germany

Contact details are not published in this record. Check official study record ↗

WHAT IS BEING STUDIED

Treatments and study groups

Interventions

Phasix™ MeshDevice
Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).

Study groups: Phasix™ Mesh

Study groups

Phasix™ MeshExperimental
Prophylactic onlay placement of mesh.

Interventions: Device: Phasix™ Mesh

Primary Suture ClosureNo intervention
Standard Fascial closure.

RESEARCH DETAILS

Study design

Study type
Interventional
Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Study model
Parallel
Masking
None (open label)
Enrolment
477 participants · Actual

TIMELINE & MEASURES

Dates and outcomes

Study started
12 Dec 2019 · Actual
Primary completion
Aug 2028 · Estimated
Study completion
Aug 2031 · Estimated
First registered
11 Apr 2019 · Actual
Last registry update
19 Oct 2026 · Actual
Status last verified
Aug 2026
Primary outcomes (1)

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: 24-Months

Secondary outcomes (7)

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©)

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

STUDY TEAM

Sponsor and contacts

Lead sponsor
C. R. Bard
Sponsor type
Industry
Collaborators
Not reported
Organisation study ID
DVL-HE-018

Central study contacts

No central contact is currently reported. Check the site contacts or the official record.

Study officials
William Hope, MDPrincipal investigator · New Hanover Regional Medical Center

Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.

FURTHER READING

Results, documents and references

No results are posted in this registry record

This does not mean the study has no findings. Results may not yet have been submitted or published here.

No study documents are listed in this record.

Source: ClinicalTrials.gov · Data fetched 21 Oct 2026, 16:25 GMT+0530

Registry data timestamp: 2026-10-20T09:00:04

Registry content is reformatted for readability; original study text is not rewritten. Missing information is labelled “Not reported”. Records are supplied by study sponsors or investigators and can change.

ClinicalTrials.gov does not endorse PharmaBharat. Listing a study does not mean it has been evaluated or approved by a government agency. Information is for research awareness and is not medical advice. Data source terms · Registry disclaimer

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