Negative Pressure Wound Therapy After Cesarean Delivery
Primary Purpose
Major Puerperal Infection, Postpartum, Wound Complications, Wound Seroma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevena negative pressure wound system
Sponsored by
About this trial
This is an interventional prevention trial for Major Puerperal Infection, Postpartum focused on measuring Cesarean delivery, Postpartum infection, Wound complications, Wound seroma, Wound separation, Wound infection, Negative pressure
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
Sites / Locations
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Negative pressure pump
Arm Description
Will have the Prevena negative pressure wound system placed at the time of surgery.
Outcomes
Primary Outcome Measures
Wound Complication Rate
Wound infection, separation or deep infection
Secondary Outcome Measures
Full Information
NCT ID
NCT01637870
First Posted
July 6, 2012
Last Updated
March 19, 2018
Sponsor
Abbey Hardy-Fairbanks
Collaborators
Kinetic Concepts, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01637870
Brief Title
Negative Pressure Wound Therapy After Cesarean Delivery
Official Title
Negative Pressure Wound Therapy to Prevent Post Operative Wound Complications Following Cesarean Delivery in Women at High Risk for Wound Complications
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abbey Hardy-Fairbanks
Collaborators
Kinetic Concepts, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Negative pressure pump
Arm Type
Experimental
Arm Description
Will have the Prevena negative pressure wound system placed at the time of surgery.
Intervention Type
Device
Intervention Name(s)
Prevena negative pressure wound system
Intervention Description
Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication
Primary Outcome Measure Information:
Title
Wound Complication Rate
Description
Wound infection, separation or deep infection
Time Frame
Up to 6 weeks from time of surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Tikkanen, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Negative Pressure Wound Therapy After Cesarean Delivery
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