Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial

Not Applicable

Terminated

• Conditions: Cesarean Section; Surgical Wound Infection
• Interventions: Device: Standard Dressing; Device: Prophylactic NPWT

• Registration Number: NCT03009110
• Lead Sponsor: 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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-04
• Study Start: 2017-02-08
• Primary Completion: 2019-11-13
• Study Completion: 2019-11-13
• Results First Submitted: 2021-02-05
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Results First Posted: 2023-06-01
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1624

Inclusion Criteria

Not provided

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Dressing	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.
Prophylactic NPWT	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Superficial or Deep Surgical Site Infections (SSIs)	30 days postoperatively	As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)	30 days postoperatively	Frequency of wound hematoma, seroma, separation (other wound complications). Hematoma, seroma, separation (2cm or more).
Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).	30 days postoperatively	Frequency of a composite of any wound complication including SSI, hematoma, seroma, separation (2cm or more). SSI, hematoma, seroma, separation (2cm or more).
Patient Pain Score	At postoperative day 30	On a scale of 0 (least) - 10 (most).
Patient Satisfaction Score	At postoperative day 30	On a scale of 0 (least) - 10 (most).
Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events)	30 days postoperatively	Frequency of skin blistering, erythema, wound bleeding (measures of adverse skin events).
Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)	30 days postoperatively	As defined according to the CDC's National Healthcare Safety Network criteria.
Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)	30 days postoperatively	As defined according to the CDC's National Healthcare Safety Network criteria.
Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization)	30 days postoperatively	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).

Trial Locations

Locations (6)

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Mercy Hosptial St Louis; 🇺🇸 Saint Louis, Missouri, United States

Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

University of Alabama Medical Center; 🇺🇸 Birmingham, Alabama, United States

Eskenazi Hopsital; 🇺🇸 Indianapolis, Indiana, United States

Ochsner Baptist Medical Center; 🇺🇸 New Orleans, Louisiana, United States