Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial

NCT03009110 | Terminated Results DMC FDA Device

• 2 other identifiers: IRB ID #: 2016030621R01HD086007-01A1
• Study Type: interventional
• Target: 1,624
• Locations: 1 country
• Sites: 6

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.

Conditions

Surgical Wound Infection; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Superficial or Deep Surgical Site Infections (SSIs)

  As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.

  30 days postoperatively

Secondary Outcomes (10)

• Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)

  30 days postoperatively

• Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)

  30 days postoperatively

• Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)

  30 days postoperatively

• Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).

  30 days postoperatively

• Patient Pain Score

  At discharge, an average of 4 days postoperatively

Other Outcomes (4)

• Types and Frequency of Different Bacteria Including Methicillin-resistant Staphylococcus Aureus

  30 days postoperatively

• Incremental Cost Per SSI Prevented

  30 days postoperatively

• Incremental Cost Per Quality-Adjusted Life-year

  30 days postoperatively

Study Arms (2)

Prophylactic NPWT

EXPERIMENTAL

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

Standard Dressing

ACTIVE COMPARATOR

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

Interventions

Prophylactic NPWT 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.

Also known as: Prevena

Prophylactic NPWT

Standard Dressing DEVICE

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

Standard Dressing

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indiana University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• 3M: collaborator

Study Sites (6)

University of Alabama Medical Center

Birmingham, Alabama, 35233, United States

Location

Eskenazi Hopsital

Indianapolis, Indiana, 46202, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63108, United States

Location

Mercy Hosptial St Louis

St Louis, Missouri, 63141, United States

Location

Related Publications (5)

• 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.

  PMID: 24056202 BACKGROUND

• 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.

  PMID: 26126306 BACKGROUND

• 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

  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.

  PMID: 27429285 BACKGROUND

• 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.

  PMID: 32960242 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The trial was stopped following a planned interim analysis, raising the possibility that it may be underpowered. The clinical team could not be blinded to the intervention, raising the possibility of bias. No adjustment was made for multiple comparisons, thus secondary end points could have occurred by chance.

Results Point of Contact

• Title: Graham Hogg
• Organization: Indiana University School of Medicine

gahogg@iu.edu

317-962-0415

Study Officials

• Methodius G Tuuli, MD, MPH

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 4, 2017
• Study Start: February 8, 2017
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: June 1, 2023
• Results First Posted: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)