Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial

NCT ID: NCT03009110

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1624 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-08
• Study Completion Date: 2019-11-13

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).

Conditions

Surgical Wound Infection; Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prophylactic NPWT

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Standard Dressing

Intervention Type: DEVICE

Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.

Interventions

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.

Intervention Type: DEVICE

Standard Dressing

Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.

Intervention Type: DEVICE

Other Intervention Names

Prevena

Eligibility 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)

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

3M

INDUSTRY

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

David Haas

Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Methodius G Tuuli, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

University of Alabama Medical Center

Birmingham, Alabama, United States

Eskenazi Hopsital

Indianapolis, Indiana, United States

Methodist Hospital

Indianapolis, Indiana, United States

Ochsner Baptist Medical Center

New Orleans, Louisiana, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Mercy Hosptial St Louis

St Louis, Missouri, United States

Countries

United States

References

Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: a pilot study. Surg Innov. 2014 Aug;21(4):345-9. doi: 10.1177/1553350613503736. Epub 2013 Sep 20.

Reference Type: BACKGROUND

PMID: 24056202 (View on PubMed)

Swift SH, Zimmerman MB, Hardy-Fairbanks AJ. Effect of Single-Use Negative Pressure Wound Therapy on Postcesarean Infections and Wound Complications for High-Risk Patients. J Reprod Med. 2015 May-Jun;60(5-6):211-8.

Reference Type: BACKGROUND

PMID: 26126306 (View on PubMed)

Bullough, L, Wilkinson, D., Burns, S, Wan, L, Changing wound care protocols to reduce postoperative caesarean section infection and readmission, Wounds , 2014 (10), 1 : 72 - 76. 46

Reference Type: BACKGROUND

Chaboyer W, Anderson V, Webster J, Sneddon A, Thalib L, Gillespie BM. Negative Pressure Wound Therapy on Surgical Site Infections in Women Undergoing Elective Caesarean Sections: A Pilot RCT. Healthcare (Basel). 2014 Sep 30;2(4):417-28. doi: 10.3390/healthcare2040417.

Reference Type: BACKGROUND

PMID: 27429285 (View on PubMed)

Tuuli MG, Liu J, Tita ATN, Longo S, Trudell A, Carter EB, Shanks A, Woolfolk C, Caughey AB, Warren DK, Odibo AO, Colditz G, Macones GA, Harper L. Effect of Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing on Surgical-Site Infection in Obese Women After Cesarean Delivery: A Randomized Clinical Trial. JAMA. 2020 Sep 22;324(12):1180-1189. doi: 10.1001/jama.2020.13361.

Reference Type: DERIVED

PMID: 32960242 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01HD086007-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB ID #: 201603062

Identifier Type: -

Identifier Source: org_study_id