Negative Pressure Wound Therapy After Cesarean Delivery

Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637870
• Other study ID #: 201109727
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: March 19, 2018
• Start date: August 2012
• Est. completion date: February 2013

Study information

• Verified date: March 2018
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Caesarean Section Wound Separation
• Communicable Diseases
• Infection
• Major Puerperal Infection, Postpartum
• Puerperal Infection
• Seroma
• Wound Complications
• Wound Infection
• Wound Seroma
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Abbey Hardy-Fairbanks	Kinetic Concepts, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Complication Rate	Wound infection, separation or deep infection	Up to 6 weeks from time of surgery