The Use of the Prevena Incision Management System to Reduce Post-operative Cesarean Delivery Wound Complications

Withdrawn before enrolling

Conditions studied: Pregnancy

In brief

Aim 1: Assess the effectiveness of the Prevena Incision Management System in decreasing postoperative surgical site infections in the obese parturient undergoing non-emergent cesarean delivery. Aim 2: Assess patient satisfaction after using the Prevena Incision Management System following a non-emergent cesarean delivery. Our overall long term goal is to reduce morbidity and incidence of surgical site infection (SSI) in obese parturient who undergo non-emergent cesarean delivery.

Key facts

Study ID: NCT01661348
Run by: University of Oklahoma
People needed: 0
Starts: 2012-07-01
Expected to finish: 2014-07-01
Last updated by the study team: 2013-10-16

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Women greater than or equal to 18-years-of-age having a non-emergent Cesarean delivery, primary or repeat procedure, without evidence of active infection at the time of the procedure
Patient with BMI ≥ 30 kg/m2 at the time of hospital admission
Patient able to provide informed consent for study
Patient able to complete follow-up

You may not qualify if…

Males
Females under the age of 18
Known sensitivity to silver due to the presence of silver in the skin interface layer of the Prevena
Patients unable to consent
Patients in active labor
Patients with a diagnosis of preterm premature rupture of membranes
Patients with known or suspected infection at the time of Cesarean delivery
Patients with a contraindication to use of the Prevena Incision Management System

Where it is running

University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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