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

NCT01661348 | Withdrawn

• 1 other identifier: Prevena-Smith
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

Cesarian section; Pregnancy; Incision management

Outcome Measures

Primary Outcomes (1)

• Rate of Wound Infections

  The percent of patients with wound infections will be summarized at the 5-7 day post-operative assessment, the 14-21 day post-operative assessment, and the 6-week follow-up visit. The rate of wound infections will be evaluated at each time point.

Study Arms (2)

Prevena System placement

Subjects randomized to this group will receive standard skin preparation and closure followed by application of Prevena Incision Management System (Kinetic Concepts, Inc; San Antonio, TX) negative pressure wound therapy unit (experimental group).

Standard of care postoperative care

Subjects randomized to this group will receive a standard surgical skin preparation, closure, and dressing (control group).

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All eligible patients will be approached for consent to participate in the study prior to surgical procedure.

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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Study Officials

• Katherine M Smith, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Elise Eckhardt, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: August 9, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

US (1)