NCT01637870

Negative Pressure Wound Therapy After Cesarean Delivery

Negative Pressure Wound Therapy to Prevent Post Operative Wound Complications Following Cesarean Delivery in Women at High Risk for Wound Complications

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Abbey Hardy-Fairbanks · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Puerperal Infection, Postpartum
• Wound Complications
• Wound Seroma
• Caesarean Section Wound Separation
• Wound Infection

Interventions

Type	Name	Description
DEVICE	Prevena negative pressure wound system	Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-07-11
• Last updated: 2018-04-18
• Results posted: 2018-04-18

Locations

1 site across 1 country: United States