Negative Pressure Wound Therapy to Prevent Post Operative Wound Complications Following Cesarean Delivery in Women at High Risk for Wound Complications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Wound Complication Rate
Study Overview
Brief Summary
This study is aimed at determining whether or not the use of a wound suction device placed on the cesarean incision instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The study will first look at the infection and wound complication rate in women 6 months prior to the start date of the study by reviewing charts of women who have undergone a cesarean section. The study involves placing a single use, portable wound vacuum over the cesarean section incision and keeping it in place for 72h. The investigators will then compare the rates of wound infection and wound complications between these two groups.
It is our hypothesis that negative pressure wound systems will decrease the wound infection and complication rate in this high risk population.
Detailed Description
Infectious complications have been found to be five times higher in women undergoing a cesarean delivery compared to a vaginal delivery. Known risk factors for wound complications are obesity, premature rupture of membranes, diabetes mellitus, hypertensive disorders, emergency cesarean delivery, twin delivery, chorioamnionitis, increased surgical blood loss and preeclampsia.
This study is aimed at determining whether or not the use of a suction device placed on the wound instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The investigators will compare the results from the participants of this study to an existing data set of historical controls who underwent cesarean delivery. The study involves placing a single use, portable negative wound pressure system kept in place while in the hospital after surgery (on average 48-72 hours) in women who meet criteria for increased risk of wound complications. The investigators will then compare the rates of wound infection and wound complications between these two groups.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years old or older
- •Having a cesarean delivery
- •Has one or more of the following conditions:
- •BMI > 30
- •Preeclampsia (sever or mild)
- •Hemolysis, elevated liver enzymes and low platelets (HELLP)
- •Urgent procedure
- •Rupture of membranes prior to surgery for > 4 hours
- •Chorioamnionitis
- •Hypertension
- •Diabetes (Gestational or pre-gestational)
- •Dense adhesive disease
Exclusion Criteria
- •Age < 18 years old
- •Unable to give informed consent
Arms & Interventions
Negative pressure pump
Will have the Prevena negative pressure wound system placed at the time of surgery.
Intervention: Prevena negative pressure wound system (Device)
Outcomes
Primary Outcomes
Wound Complication Rate
Time Frame: Up to 6 weeks from time of surgery
Wound infection, separation or deep infection
Secondary Outcomes
No secondary outcomes reported
Investigators
Abbey Hardy-Fairbanks
Associate Professor
University of Iowa