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Negative Pressure Wound Therapy After Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT01637870
Recruitment Status : Completed
First Posted : July 11, 2012
Results First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Kinetic Concepts, Inc.
Information provided by (Responsible Party):
Abbey Hardy-Fairbanks, University of Iowa

Brief Summary:

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

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 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)
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
Study Start Date : August 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Wound Complication Rate [ Time Frame: Up to 6 weeks from time of surgery ]
    Wound infection, separation or deep infection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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)
  • Hemolysis, elevated liver enzymes and low platelets (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637870


Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Abbey Hardy-Fairbanks
Kinetic Concepts, Inc.
Investigators
Principal Investigator: Sara Tikkanen, MD University of Iowa

Responsible Party: Abbey Hardy-Fairbanks, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01637870     History of Changes
Other Study ID Numbers: 201109727
First Posted: July 11, 2012    Key Record Dates
Results First Posted: April 18, 2018
Last Update Posted: April 18, 2018
Last Verified: March 2018

Keywords provided by Abbey Hardy-Fairbanks, University of Iowa:
Cesarean delivery
Postpartum infection
Wound complications
Wound seroma
Wound separation
Wound infection
Negative pressure

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wounds and Injuries
Wound Infection
Seroma
Puerperal Infection
Inflammation
Pathologic Processes
Pregnancy Complications, Infectious
Pregnancy Complications
Puerperal Disorders