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NCT Number: NCT01637870

Negative Pressure Wound Therapy After Cesarean Delivery

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.

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Key information

Conditions

Major Puerperal Infection, Postpartum Caesarean Section Wound Separation Infections Wound Complications Wound Infection Wound Seroma

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevena negative pressure wound system

Device

Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication

Primary outcomes

  1. Wound Complication Rate

    Time frame: Up to 6 weeks from time of surgery

    Wound infection, separation or deep infection

Sponsors and collaborators

Lead sponsor

Abbey Hardy-Fairbanks

Other

Collaborators

  • Kinetic Concepts, Inc.

Registry information

Official study title

Negative Pressure Wound Therapy to Prevent Post Operative Wound Complications Following Cesarean Delivery in Women at High Risk for Wound Complications

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2012
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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