Negative Pressure Wound Therapy After Cesarean Delivery

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

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.

Study Overview

• Status: Completed
• Conditions: Wound Infection; Major Puerperal Infection, Postpartum; Wound Complications; Wound Seroma; Caesarean Section Wound Separation
• Intervention / Treatment: Device: Prevena negative pressure wound system

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
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Complication Rate	Wound infection, separation or deep infection	Up to 6 weeks from time of surgery

Collaborators and Investigators

• Sponsor: Abbey Hardy-Fairbanks
• Collaborators: Kinetic Concepts, Inc.
• Investigators: Principal Investigator: Sara Tikkanen, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Wound infection; Cesarean delivery; Postpartum infection; Wound complications; Wound seroma; Wound separation; Negative pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Disease Attributes; Pregnancy Complications; Puerperal Disorders; Pregnancy Complications, Infectious; Infections; Communicable Diseases; Wounds and Injuries; Wound Infection; Seroma; Puerperal Infection
• Other Study ID Numbers: 201109727