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Prophylactic Reinforcement of Ventral Abdominal Incisions Trial (PREVENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03911700
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Open Midline Laparotomy Device: Phasix™ Mesh Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 477 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : October 2027
Estimated Study Completion Date : October 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Phasix™ Mesh
Prophylactic onlay placement of mesh.
Device: Phasix™ Mesh
Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).

No Intervention: Primary Suture Closure
Standard Fascial closure.



Primary Outcome Measures :
  1. Rate of Incisional Hernia [ Time Frame: 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 :
  1. Rate of Incisional Hernia [ Time Frame: 60-Months ]
    Rate of incisional hernia at each follow up time point

  2. Rate of Device-related Adverse Events (AEs) [ Time Frame: 60-Months ]
    Rate of Device-related Adverse Events (AEs)

  3. Length of surgical procedure in minutes [ Time Frame: Study Day 0 ]
    Length of surgical procedure in minutes

  4. Length of time for wound closure in minutes [ Time Frame: Study Day 0 ]
    Length of time for wound closure in minutes

  5. Length of hospital stay in days [ Time Frame: Through hospital stay, typically 3 days ]
    Length of hospital stay in days

  6. Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®) [ Time Frame: 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.

  7. Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©) [ Time Frame: 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".



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be ≥ 18 years of age
  2. Elective, open midline laparotomy ≥ 7 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. Corticosteroids (e.g., prednisone) prior to surgery
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911700


Contacts
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Contact: Craig Wisman, MD 904-295-5260 craig.wisman@bd.com
Contact: Amanda Resendes, MBA 401-825-8581 Amanda.Resendes@crbard.com

Locations
Show Show 26 study locations
Sponsors and Collaborators
C. R. Bard
Investigators
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Principal Investigator: William Hope, MD New Hanover Regional Medical Center
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Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT03911700    
Other Study ID Numbers: DVL-HE-018
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes