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Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial (Prevena-C)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03009110
Recruitment Status : Terminated (DSMB recommendation following interim analysis)
First Posted : January 4, 2017
Last Update Posted : November 18, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
KCI USA, Inc.
Information provided by (Responsible Party):
Method Tuuli, Indiana University

Brief Summary:
The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface via a single-use, battery-powered, portable device - to decrease surgical site infections (SSIs) in obese women.

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Cesarean Section Device: Prophylactic NPWT Device: Standard Dressing Not Applicable

Detailed Description:

Experimental evidence suggests that NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing bacterial contamination. Obesity (body mass index [BMI] ≥30kg/m2) increases the risk for both cesarean delivery and SSIs compared to non-obese women. The increased risk of SSIs is in part due to the increased thickness of the subcutaneous space, allowing collection of exudates and increasing tension on wound edges, promoting the growth of bacteria, and leading to wound infection and breakdown. Thus, prophylactic NPWT may be particularly effective in this patient population.

During the 5-year project period, investigators from 4 collaborating perinatal centers in the United Stated (two university and two community) will randomize 2850 obese women undergoing cesarean delivery to receive either prophylactic negative pressure wound therapy with the Prevena device or standard wound dressing. Women will be followed up to 30 days postoperatively to ascertain study outcomes.

The primary outcome for the trial is superficial or deep SSI after cesarean according to the CDC's National Healthcare Safety Network definitions. The investigators will also assess other wound complications, adverse events potentially attributable to NPWT and cost-effectiveness as measured by incremental cost per case of SSI prevented and per quality-adjusted life year (QALY).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1625 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean: a Multicenter Randomized Trial
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : November 13, 2019
Actual Study Completion Date : November 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prophylactic NPWT
Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.
Device: Prophylactic NPWT
The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.
Other Name: Prevena

Active Comparator: Standard Dressing
Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.
Device: Standard Dressing
Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.




Primary Outcome Measures :
  1. Frequency of superficial or deep surgical site infections [ Time Frame: 30 days postoperatively ]
    As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.


Secondary Outcome Measures :
  1. Frequency of superficial, deep or organ space SSIs (individual types of SSIs) [ Time Frame: 30 days postoperatively ]
    As defined according to the CDC's National Healthcare Safety Network criteria.

  2. Frequency of organ space SSIs (endometritis, intraabdominal abscess) [ Time Frame: 30 days postoperatively ]
    As defined according to the CDC's National Healthcare Safety Network criteria.

  3. Frequency of wound hematoma, seroma, separation (other wound complications) [ Time Frame: 30 days postoperatively ]
    Hematoma, seroma, separation (2cm or more).

  4. Frequency of a composite of any wound complication including SSI, hematoma, seroma, separation (2cm or more). [ Time Frame: 30 days postoperatively ]
    SSI, hematoma, seroma, separation (2cm or more).

  5. Patient pain score [ Time Frame: At discharge, an average of 4 days postoperatively ]
    On a scale of 0 - 10.

  6. Patient pain score [ Time Frame: At postoperative day 30 ]
    On a scale of 0 - 10.

  7. Patient satisfaction score [ Time Frame: At discharge, an average of 4 days postoperatively ]
    On a scale of 0 - 10.

  8. Patient satisfaction score [ Time Frame: At postoperative day 30 ]
    On a scale of 0 - 10.

  9. Patient satisfaction with aesthetics score [ Time Frame: At postoperative day 30 ]
    On a scale of 0 - 10.

  10. Frequency of physician office visit, emergency room visit, attendance at wound clinic, use antibiotics, hospital readmission for wound related problems (measures of healthcare resource utilization) [ Time Frame: 30 days postoperatively ]
    Physician office visit, emergency room visit, wound clinic, antibiotics, hospital readmission for wound related problems.

  11. Frequency of skin blistering, erythema, wound bleeding (measures of adverse skin events) [ Time Frame: 30 days postoperatively ]
    skin blistering, erythema, wound bleeding


Other Outcome Measures:
  1. Types and frequency of different bacteria including methicillin-resistant Staphylococcus aureus [ Time Frame: 30 days postoperatively ]
    Based on routine clinical wound culture data

  2. Incremental cost per SSI prevented [ Time Frame: 30 days postoperatively ]
    Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.

  3. Incremental cost per Quality-Adjusted Life-year [ Time Frame: 30 days postoperatively ]
    Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.

  4. Risk factors for surgical site infections in obese women [ Time Frame: 30 days postoperatively ]
    Based on combined cohort. Results of the risk factor analysis will be published separately from the effectiveness and safety data.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Gestational age ≥23weeks
  • BMI≥30 Pre-pregnancy or BMI at first prenatal visit
  • Planned or unplanned cesarean delivery

Exclusion Criteria:

  • Non-availability for postoperative follow-up
  • Contraindication to NPWT applicable to women undergoing cesarean: Pre-existing infection around incision site, Bleeding disorder, Therapeutic anticoagulation, Irradiated skin, Allergy to any component of the dressing (e.g. silver, acrylic, silicone, adhesive tape)

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): NCT03009110


Locations
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United States, Alabama
University of Alabama Medical Center
Birmingham, Alabama, United States, 35233
United States, Indiana
Eskenazi Hopsital
Indianapolis, Indiana, United States, 46202
Methodist Hospital
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States, 70115
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63108
Mercy Hosptial St Louis
Saint Louis, Missouri, United States, 63141
Sponsors and Collaborators
Indiana University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
KCI USA, Inc.
Investigators
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Principal Investigator: Methodius G Tuuli, MD, MPH Indiana University School of Medicine
Publications:
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Responsible Party: Method Tuuli, Professor of Obstetrics and Gynecology, Indiana University
ClinicalTrials.gov Identifier: NCT03009110    
Other Study ID Numbers: IRB ID #: 201603062
1R01HD086007-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Wound Infection
Surgical Wound Infection
Surgical Wound
Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes