Negative Pressure Wound Therapy After Cesarean Delivery
Recruitment status was: Recruiting
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.
|Cesarean Delivery Postpartum Infection Wound Complications Wound Seroma Wound Separation Wound Infection||Device: Prevena negative pressure wound system||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Negative Pressure Wound Therapy to Prevent Post Operative Wound Complications Following Cesarean Delivery in Women at High Risk for Wound Complications|
- Wound complication rate [ Time Frame: Up to 6 weeks from time of surgery ]Wound infection, separation or deep infection
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Negative pressure pump
Will have the Prevena negative pressure wound system placed at the time of surgery.
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
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 use a group of historical controls collected for 6 consecutive months prior to initiation of the study. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637870
|Contact: Sara Tikkanen, MDemail@example.com|
|Contact: Abbey J Hardy-Fairbanks, MDfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Sara Tikkanen, MD 319-356-2291 email@example.com|
|Contact: Abbey J Hardy-Fairbanks, MD 319-356-2291 firstname.lastname@example.org|
|Principal Investigator: Sara Tikkanen, MD|
|Principal Investigator:||Sara Tikkanen, MD||University of Iowa|