Negative Pressure Wound Therapy After Cesarean Delivery

NCT01637870 | Completed Results

• 1 other identifier: 201109727
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cesarean delivery; Postpartum infection; Wound complications; Wound seroma; Wound separation; Wound infection; Negative pressure

Outcome Measures

Primary Outcomes (1)

• Wound Complication Rate

  Wound infection, separation or deep infection

  Up to 6 weeks from time of surgery

Study Arms (1)

Negative pressure pump

EXPERIMENTAL

Will have the Prevena negative pressure wound system placed at the time of surgery.

Device: Prevena negative pressure wound system

Interventions

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

Negative pressure pump

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years old
• Unable to give informed consent

Sponsors & Collaborators

• Abbey Hardy-Fairbanks: lead
• Kinetic Concepts, Inc.: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

• Title: Abbey Hardy-Fairbanks, MD
• Organization: University of Iowa Hospitals and Clinics

abbey-hardy-fairbanks@uiowa.edu

319-356-2291

Study Officials

• Sara Tikkanen, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 11, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 18, 2018
• Results First Posted: April 18, 2018

Record last verified: 2018-03

Locations

US (1)