Negative Pressure Wound Therapy After Cesarean Delivery

NCT ID: NCT01637870

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-02-28

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Negative pressure pump

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

Group Type: EXPERIMENTAL

Prevena negative pressure wound system

Intervention Type: DEVICE

Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kinetic Concepts, Inc.

INDUSTRY

Sponsor Role: collaborator

Abbey Hardy-Fairbanks

OTHER

Sponsor Role: lead

Responsible Party

Abbey Hardy-Fairbanks

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sara Tikkanen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

201109727

Identifier Type: -

Identifier Source: org_study_id