Back to resultsNegative Pressure Wound Therapy vs Standard Care Dressing (Prevena)
Primary Purpose
Negative-Pressure Wound Therapy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative pressure wound therapy
standard care dressing
Sponsored by
About this trial
This is an interventional prevention trial for Negative-Pressure Wound Therapy
Eligibility Criteria
Inclusion Criteria:
- Consent for participation from the patient or his legal representative
Exclusion Criteria:
- Currently infected wounds
- Patients with history of immunosupression
- Pregnancy
Sites / Locations
- UTMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Negative pressure wound therapy
standard care dressing
Arm Description
This group of patients will receive negative pressure wound therapy (prevena) as their postoperative wound care method.
This group of patients will receive standard care dressing as their postoperative wound care method.
Outcomes
Primary Outcome Measures
Surgical site infection
The rate of occurrence of signs and symptoms of surgical site infection
Secondary Outcome Measures
length of total hospital stay
number of days of patients hospital stay after the surgery
cost of hospitalization
The total cost in USD of patient's hospitalization
Rate of reoperation
The rate of patients' re-operation after the principal operation
Full Information
NCT ID
NCT03566641
First Posted
April 25, 2018
Last Updated
October 11, 2019
Sponsor
University of Toledo Health Science Campus
1. Study Identification
Unique Protocol Identification Number
NCT03566641
Brief Title
Negative Pressure Wound Therapy vs Standard Care Dressing
Acronym
Prevena
Official Title
A Comparison of Negative Pressure Wound Therapy vs Standard Care, for Vascular, Plastic and General Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment. Not enough data for interim analysis.
Study Start Date
April 28, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo Health Science Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
A comparison between the efficacy of negative pressure wound therapy and the efficacy of standard care dressing
Detailed Description
The aim of our study is to compare the efficacy of negative pressure wound therapy (Prevena) and standard clinical dressing in terms of prevention of postoperative surgical site infection, length of hospital stay, and total cost of hospitalization among vascular, plastic and general surgery patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Negative-Pressure Wound Therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparing the rate of occurrence of surgical site infection, total hospital cost and length of stay between two groups: group 1 represents patients who receive Prevena for postoperative wound care and group 2 represents patients who receive standard care dressing for the same purpose.
Masking
InvestigatorOutcomes Assessor
Masking Description
Out study is a single-blinded randomized clinical trial. The patient will be informed about the type of dressing used for their wound care, but the investigator and the outcome assessor will be blinded for which type of dressing used for each participant patient.
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Negative pressure wound therapy
Arm Type
Experimental
Arm Description
This group of patients will receive negative pressure wound therapy (prevena) as their postoperative wound care method.
Arm Title
standard care dressing
Arm Type
Active Comparator
Arm Description
This group of patients will receive standard care dressing as their postoperative wound care method.
Intervention Type
Device
Intervention Name(s)
Negative pressure wound therapy
Other Intervention Name(s)
Prevena
Intervention Description
The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound.
Intervention Type
Other
Intervention Name(s)
standard care dressing
Other Intervention Name(s)
dray gauze
Intervention Description
The application of a standard care dressing (instead of negative pressure wound therapy) across the surface of wound.
Primary Outcome Measure Information:
Title
Surgical site infection
Description
The rate of occurrence of signs and symptoms of surgical site infection
Time Frame
30-day postoperative period
Secondary Outcome Measure Information:
Title
length of total hospital stay
Description
number of days of patients hospital stay after the surgery
Time Frame
6 months
Title
cost of hospitalization
Description
The total cost in USD of patient's hospitalization
Time Frame
6 months
Title
Rate of reoperation
Description
The rate of patients' re-operation after the principal operation
Time Frame
30-day postoperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consent for participation from the patient or his legal representative
Exclusion Criteria:
Currently infected wounds
Patients with history of immunosupression
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
munier nazzal, md
Organizational Affiliation
UTMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTMC
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Negative Pressure Wound Therapy vs Standard Care Dressing
We'll reach out to this number within 24 hrs