Clinical trial NCT03009110: Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial
Official title: Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean: a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Wound Infection
Cesarean Section
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: 3M
First posted: 2017-01-04
Enrollment: 1624
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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)

Primary outcomes:
measure: Number of Participants With Superficial or Deep Surgical Site Infections (SSIs)
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)
timeFrame: 30 days postoperatively
measure: Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)
timeFrame: 30 days postoperatively
measure: Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)
timeFrame: 30 days postoperatively
measure: Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).
timeFrame: 30 days postoperatively
measure: Patient Pain Score
timeFrame: At discharge, an average of 4 days postoperatively
measure: Patient Pain Score
timeFrame: At postoperative day 30
measure: Patient Satisfaction Score
timeFrame: At discharge, an average of 4 days postoperatively
measure: Patient Satisfaction Score
timeFrame: At postoperative day 30
measure: 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)
timeFrame: 30 days postoperatively
measure: Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events)
timeFrame: 30 days postoperatively
Other outcomes:
measure: Types and Frequency of Different Bacteria Including Methicillin-resistant Staphylococcus Aureus
timeFrame: 30 days postoperatively
measure: Incremental Cost Per SSI Prevented
timeFrame: 30 days postoperatively
measure: Incremental Cost Per Quality-Adjusted Life-year
timeFrame: 30 days postoperatively
measure: Risk Factors for Surgical Site Infections in Obese Women
timeFrame: 30 days postoperatively
Locations:
city: Birmingham
country: United States
facility: University of Alabama Medical Center
state: Alabama
city: Indianapolis
country: United States
facility: Eskenazi Hopsital
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Center
state: Louisiana
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hosptial St Louis
state: Missouri
Study officials:
affiliation: Indiana University School of Medicine
name: Methodius G Tuuli, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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
citation: 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.
citation: 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.