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Negative Pressure Wound Therapy After Cesarean Delivery

This study is currently recruiting participants.
Verified December 2012 by University of Iowa
Sponsor:
Collaborator:
Kinetic Concepts, Inc.
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01637870
First received: July 6, 2012
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Cesarean Delivery
Postpartum Infection
Wound Complications
Wound Seroma
Wound Separation
Wound Infection
 Device: Prevena negative pressure wound system
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Wound complication rate [ Time Frame: Up to 6 weeks from time of surgery ] [ Designated as safety issue: No ]
    Wound infection, separation or deep infection


Estimated Enrollment: 100
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)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old or older
  • Having a cesarean delivery
  • Has one or more of the following conditions:
  • BMI > 30
  • Anemia
  • Preeclampsia (sever or mild)
  • HELLP
  • Urgent procedure
  • Rupture of membranes prior to surgery for > 4 hours
  • Chorioamnionitis
  • Hypertension
  • Diabetes (Gestational or pre-gestational)
  • Dense adhesive disease

Exclusion Criteria:

  • Age < 18 years old
  • Unable to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637870

Contacts
Contact: Sara Tikkanen, MD 319-356-2291 sara-tikkanen@uiowa.edu
Contact: Abbey J Hardy-Fairbanks, MD 319-356-2291 abbey-hardy-fairbanks@uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Sara Tikkanen, MD     319-356-2291     sara-tikkanen@uiowa.edu    
Contact: Abbey J Hardy-Fairbanks, MD     319-356-2291     abbey-hardy-fairbanks@uiowa.edu    
Principal Investigator: Sara Tikkanen, MD            
Sponsors and Collaborators
University of Iowa
Kinetic Concepts, Inc.
Investigators
Principal Investigator: Sara Tikkanen, MD University of Iowa
  More Information

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01637870     History of Changes
Other Study ID Numbers: 201109727
Study First Received: July 6, 2012
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Cesarean delivery
Postpartum infection
Wound complications
Wound seroma
 Wound separation
Wound infection
Negative pressure

Additional relevant MeSH terms:
Wound Infection
Seroma
Infection
 Wounds and Injuries
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013