Open Midline LaparotomyPREVENTNCT03911700
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
A study testing Phasix™ Mesh in people with Open Midline Laparotomy, run by C. R. Bard at 32 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Midline Laparotomy
- What is being tested?
- Phasix™ Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 477 participants
- Where
- 32 sitesin 5 countries
- Study dates
- 12 Dec 2019to Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be ≥ 18 years of age
- Elective, open midline laparotomy ≥ 5 cm
- Willing and able to provide written informed consent
- Hernia risk equal to moderate or greater
Who cannot join
- Previous hernia repair
- Emergent surgery
- Creation of skin flaps is preplanned
- Preplanned 2nd surgery
- Active skin pathology
- Life expectancy less than 24 months
Show all 20Show fewer
- Pregnant or planning to become pregnant
- Receiving a medication/medical condition that may adversely affect wound healing
- ASA Class > IV
- Enrolled in another clinical trial
- Site personnel directly involved with this trial
- Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
- Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
- Two separate incisions are created
- Prior onlay mesh
- Surgeon is unable to fully close the fascia
- The surgery requires more than a single piece of mesh
- Contraindication to placement of mesh
- CDC Class IV/Active Infection
- Breastfeeding
Trial locations and contacts
32 sites in 5 countries.
32 sites in 5 countries
United States20 sites
Emory University
Atlanta, Georgia, 30322
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia, 25304
Atrium Health
Charlotte, North Carolina, 28203
The Ohio State University
Columbus, Ohio, 43210
Hartford Hospital
Hartford, Connecticut, 06102
Indiana University
Indianapolis, Indiana, 46202
University of Kentucky Research Foundation
Lexington, Kentucky, 40508
Baptist Clinical Research Institute
Memphis, Tennessee, 38163
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University
Nashville, Tennessee, 37232
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Tulane University School of Medicine
New Orleans, Louisiana, 70112
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Dignity Health
Phoenix, Arizona, 85013
University of California San Francisco
San Francisco, California, 94143
Washington University
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
France6 sites
CHU de Dijon Bourgogne
Dijon, 21079
Centre Hospitalier Universitaire de Lille
Lille, France, 59000
Hôpital Paris St Joseph
Paris, 75014
Hôpital Lyon Sud
Pierre-Bénite, 69495
CHU Reims
Reims, 51092
Hopitaux Universitaires de Strasbourg
Strasbourg, 67000
Germany4 sites
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology
Berlin, 13353
Asklepios Klinik Barmbek
Hamburg, Germany, 22307
Universitätsklinikum Heidelberg
Heidelberg, 69120
Bundeswehrzentralkrankenhaus Koblenz
Koblenz, 56072
About this study
Official title: Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
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.
Read the detailed description
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
- Conditions
- Open Midline Laparotomy
- Being tested
- Phasix™ Mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phasix™ MeshDevice
Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).
| Study group | Role | What they receive |
|---|---|---|
| Phasix™ Mesh | Experimental | Prophylactic onlay placement of mesh. Receives: Device: Phasix™ Mesh |
| Primary Suture Closure | No intervention | Standard Fascial closure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24-Months
Secondary outcomes (7)
Rate of Incisional Hernia
Rate of incisional hernia at each follow up time point
Measured: 60-Months
Rate of Device-related Adverse Events (AEs)
Rate of Device-related Adverse Events (AEs)
Measured: 60-Months
Length of surgical procedure in minutes
Length of surgical procedure in minutes
Measured: Study Day 0
Length of time for wound closure in minutes
Length of time for wound closure in minutes
Measured: Study Day 0
Length of hospital stay in days
Length of hospital stay in days
Measured: 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.
Measured: 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".
Measured: 60-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start12 Dec 2019
- Primary completionAug 2028 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Midline LaparotomyStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Hope, MD, Principal investigator, New Hanover Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911700
- Sponsor's protocol ID
- DVL-HE-018
- Acronym
- PREVENT
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2019
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
- ClinicalTrials.gov ID
- NCT03911700
- Acronym / sponsor ID
- PREVENT / DVL-HE-018
- Conditions
- Open Midline Laparotomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 477 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phasix™ Mesh | Experimental | Device: Phasix™ MeshProphylactic onlay placement of mesh. |
| Primary Suture Closure | No intervention | –Standard Fascial closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be ≥ 18 years of age
- Elective, open midline laparotomy ≥ 5 cm
- Willing and able to provide written informed consent
- Hernia risk equal to moderate or greater
Key exclusion criteria (20 listed)
- Previous hernia repair
- Emergent surgery
- Creation of skin flaps is preplanned
- Preplanned 2nd surgery
- Active skin pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phasix™ MeshPhasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB). | Device | Phasix™ Mesh |
Primary outcome
Rate of Incisional Hernia
Time frame: 24-Months
The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group)
7 secondary outcomes
Rate of Incisional Hernia
Time frame: 60-Months
Rate of Device-related Adverse Events (AEs)
Time frame: 60-Months
Length of surgical procedure in minutes
Time frame: Study Day 0
Length of time for wound closure in minutes
Time frame: Study Day 0
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®)
Time frame: 60-Months
Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©)
Time frame: 60-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Hope, MD principal investigator
New Hanover Regional Medical Center
32 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phasix™ Mesh in people with Open Midline Laparotomy, run by C. R. Bard at 32 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, France, Germany, Austria, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Incisional Hernia (time frame: 24-Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.