Negative Pressure Wound Therapy After Cesarean Delivery

Not Applicable

Completed

• Conditions: Major Puerperal Infection, Postpartum; Wound Seroma; Wound Infection; Wound Complications; Caesarean Section Wound Separation
• Interventions: Device: Prevena negative pressure wound system

• Registration Number: NCT01637870
• Lead Sponsor: Abbey Hardy-Fairbanks

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 Timeline

• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Study Start: 2012-08
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2015-05-26
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-19
• Last Update Submitted: 2018-03-19
• Results First Posted: 2018-04-18
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Negative pressure pump	Prevena negative pressure wound system	Will have the Prevena negative pressure wound system placed at the time of surgery.

Primary Outcome Measures

Name	Time	Method
Wound Complication Rate	Up to 6 weeks from time of surgery	Wound infection, separation or deep infection

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States