Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial

Cesarean Section Clinical Trial

— Prevena-C  

Official title:

Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean: a Multicenter Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03009110
• Other study ID #: IRB ID #: 201603062
• Secondary ID: 1R01HD086007-01A
• Status: Terminated
• Phase: N/A
• Start date: February 8, 2017
• Est. completion date: November 13, 2019

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1624
• Est. completion date: November 13, 2019
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cesarean Section
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

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

Locations

Country	Name	City	State
United States	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	Saint Louis	Missouri
United States	Mercy Hosptial St Louis	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	3M, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Types and Frequency of Different Bacteria Including Methicillin-resistant Staphylococcus Aureus	Types and frequency of different bacteria including methicillin-resistant Staphylococcus aureus.	30 days postoperatively
Other	Incremental Cost Per SSI Prevented	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.	30 days postoperatively
Other	Incremental Cost Per Quality-Adjusted Life-year	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.	30 days postoperatively
Other	Risk Factors for Surgical Site Infections in Obese Women	Based on combined cohort. Results of the risk factor analysis will be published separately from the effectiveness and safety data.	30 days postoperatively
Primary	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	Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)	As defined according to the CDC's National Healthcare Safety Network criteria.	30 days postoperatively
Secondary	Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)	As defined according to the CDC's National Healthcare Safety Network criteria.	30 days postoperatively
Secondary	Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)	Frequency of wound hematoma, seroma, separation (other wound complications). Hematoma, seroma, separation (2cm or more).	30 days postoperatively
Secondary	Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).	Frequency of a composite of any wound complication including SSI, hematoma, seroma, separation (2cm or more). SSI, hematoma, seroma, separation (2cm or more).	30 days postoperatively
Secondary	Patient Pain Score	On a scale of 0 (least) - 10 (most).	At discharge, an average of 4 days postoperatively
Secondary	Patient Pain Score	On a scale of 0 (least) - 10 (most).	At postoperative day 30
Secondary	Patient Satisfaction Score	On a scale of 0 (least) - 10 (most).	At discharge, an average of 4 days postoperatively
Secondary	Patient Satisfaction Score	On a scale of 0 (least) - 10 (most).	At postoperative day 30
Secondary	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)	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).	30 days postoperatively
Secondary	Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events)	Frequency of skin blistering, erythema, wound bleeding (measures of adverse skin events).	30 days postoperatively