Negative Pressure Wound Therapy After Cesarean Delivery
|ClinicalTrials.gov Identifier: NCT01637870|
Recruitment Status : Completed
First Posted : July 11, 2012
Results First Posted : April 18, 2018
Last Update Posted : April 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Puerperal Infection, Postpartum Wound Complications Wound Seroma Caesarean Section Wound Separation Wound Infection||Device: Prevena negative pressure wound system||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Negative Pressure Wound Therapy to Prevent Post Operative Wound Complications Following Cesarean Delivery in Women at High Risk for Wound Complications|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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
- Wound Complication Rate [ Time Frame: Up to 6 weeks from time of surgery ]Wound infection, separation or deep infection
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637870
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Sara Tikkanen, MD||University of Iowa|