Clinical trial NCT01637870: Negative Pressure Wound Therapy After Cesarean Delivery
Official title: Negative Pressure Wound Therapy to Prevent Post Operative Wound Complications Following Cesarean Delivery in Women at High Risk for Wound Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Puerperal Infection, Postpartum
Wound Complications
Wound Seroma
Caesarean Section Wound Separation
Wound Infection
Keywords: Cesarean delivery
Postpartum infection
Wound complications
Wound seroma
Wound separation
Wound infection
Negative pressure
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Kinetic Concepts, Inc.
First posted: 2012-07-11
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* Having a cesarean delivery
* Has one or more of the following conditions:
* BMI \> 30
* Anemia
* 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

Primary outcomes:
measure: Wound Complication Rate
timeFrame: Up to 6 weeks from time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Sara Tikkanen, MD
role: PRINCIPAL_INVESTIGATOR
References: