Back to resultsProspective Observation of Wound Healing With Prevena Incision Management System
Primary Purpose
Scarring
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevena
Standard of Care Dressing
Sponsored by
About this trial
This is an interventional supportive care trial for Scarring focused on measuring Prevena, negative pressure wound therapy, Incisional wound vac
Eligibility Criteria
Inclusion Criteria:
- abdominal procedure with incision >20cm
- must be >18 years of age
Exclusion Criteria:
- <18 years of age
- history of allergy or reaction to adhesives
- pregnant or anticipated pregnancy within 6 months
Sites / Locations
- University of California at Irvine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Prevena
Standard of Care dressing
Arm Description
Incision with prevena device overlying
Prevena device is not used
Outcomes
Primary Outcome Measures
Scarring
Assess quality of scar: hypertrophy, hyperpigmentation, etc
Secondary Outcome Measures
Full Information
NCT ID
NCT01704924
First Posted
October 9, 2012
Last Updated
January 17, 2018
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT01704924
Brief Title
Prospective Observation of Wound Healing With Prevena Incision Management System
Official Title
Prospective Observation of Wound Healing With Prevena Incision Management System
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No study subjects enrolled, Investigator decided to cancel the project
Study Start Date
October 2012 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to assess the quality of wound healing in abdominal scars with and without the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved wound healing with less swelling, bruising, and inflammation, as well as less potential for infection, seroma, and dehiscence.
Detailed Description
The quality of wound healing can be of the utmost importance for patients undergoing large abdominal surgery. Incisional negative pressure wound therapy has been observed to decrease seroma and infection rates in high risk patients. This study aims to quantify the effect, if any, that negative pressure wound therapy has on closed incisions. The technology may provide benefits even in lower risk patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scarring
Keywords
Prevena, negative pressure wound therapy, Incisional wound vac
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prevena
Arm Type
Active Comparator
Arm Description
Incision with prevena device overlying
Arm Title
Standard of Care dressing
Arm Type
Active Comparator
Arm Description
Prevena device is not used
Intervention Type
Device
Intervention Name(s)
Prevena
Intervention Description
Device will be applied at end of procedure over closed incision
Intervention Type
Procedure
Intervention Name(s)
Standard of Care Dressing
Intervention Description
Dressing applied as Standard of Care
Primary Outcome Measure Information:
Title
Scarring
Description
Assess quality of scar: hypertrophy, hyperpigmentation, etc
Time Frame
0-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
abdominal procedure with incision >20cm
must be >18 years of age
Exclusion Criteria:
<18 years of age
history of allergy or reaction to adhesives
pregnant or anticipated pregnancy within 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Evans, MD
Organizational Affiliation
The University of California Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21761149
Citation
Pachowsky M, Gusinde J, Klein A, Lehrl S, Schulz-Drost S, Schlechtweg P, Pauser J, Gelse K, Brem MH. Negative pressure wound therapy to prevent seromas and treat surgical incisions after total hip arthroplasty. Int Orthop. 2012 Apr;36(4):719-22. doi: 10.1007/s00264-011-1321-8. Epub 2011 Jul 15.
Results Reference
background
PubMed Identifier
21804414
Citation
Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5.
Results Reference
background
Links:
URL
http://www.kci1.com/KCI1/prevena
Description
Prevena Product Website
Learn more about this trial
Prospective Observation of Wound Healing With Prevena Incision Management System
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