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Negative Pressure Wound Therapy After Cesarean Delivery

NCT01637870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2018-04-18

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Kinetic Concepts, Inc.

    collaborator INDUSTRY

  • Abbey Hardy-Fairbanks

    lead OTHER

Principal Investigators

  • Sara Tikkanen, MD · University of Iowa

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01637870 on ClinicalTrials.gov