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Negative Pressure Wound Therapy

Negative pressure pump for Wound Seroma

N/A
Waitlist Available
Led By Sara Tikkanen, MD
Research Sponsored by Abbey Hardy-Fairbanks
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks from time of surgery
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Postpartum Infection
  • Wound Complications
  • Wound Seroma
  • Caesarean Section Wound Separation
  • Wound Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks from time of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks from time of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Wound Complication Rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Negative pressure pumpExperimental Treatment1 Intervention
Will have the Prevena negative pressure wound system placed at the time of surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prevena negative pressure wound system
2012
N/A
~110

Find a Location

Who is running the clinical trial?

Abbey Hardy-FairbanksLead Sponsor
2 Previous Clinical Trials
275 Total Patients Enrolled
Kinetic Concepts, Inc.Industry Sponsor
17 Previous Clinical Trials
1,928 Total Patients Enrolled
Sara Tikkanen, MDPrincipal InvestigatorUniversity of Iowa
~8 spots leftby Oct 2025