Back to resultsPrevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery
Primary Purpose
Wound Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevena Incision Management System
Dermabond
Sponsored by
About this trial
This is an interventional prevention trial for Wound Infection
Eligibility Criteria
Inclusion Criteria:
- In need of elective vascular procedure requiring ≥8 cm groin incision.
- Able to provide consent
- Able to care for wound or have support person to complete wound care
- Willing to comply with follow-up
Exclusion Criteria:
None
Sites / Locations
- Kaleida Health, Gates Vascular Institute
- State University of New York at Buffalo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Prevena
Dermabond
Arm Description
Prevena Incision Management System for vascular surgical groin wounds
Dermabond for vascular surgical groin wounds
Outcomes
Primary Outcome Measures
Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond
The primary effectiveness endpoint is 30 day healing of the randomized groin incision, with any wound infection or failure to heal. Szilagyi wound infection grade quantified on an ordinal scale will be used to assess the healing (None, Grade I: Infection contained to the dermis, Grade II: Infection extending into the subcutaneous tissue but the arterial graft is not involved, Grade III: Infection of the arterial graft or native vessel underlying the incision).
Healing is assessed by complete sealing of the incision with no residual separation or drainage. All of the incisions were primarily closed, so a healed incision would have no gaps between the skin edges. This is a visual inspection.
Szilagi is an assessment of the grade of wound infection for those that did not heal. It is well recognized and published, and noted as above for patients with vascular exposure.
Secondary Outcome Measures
Cost of Care
Comparison of cost of treatment between the two arms
Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection
Physician office visits for diagnosis of Infection or visiting nurse visits for diagnosis of infection ONLY were assessed.
Full Information
NCT ID
NCT02836990
First Posted
July 11, 2016
Last Updated
December 23, 2020
Sponsor
State University of New York at Buffalo
Collaborators
3M
1. Study Identification
Unique Protocol Identification Number
NCT02836990
Brief Title
Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery
Official Title
Prevena™ Incision Management System Versus Dermabond in the Prevention of Groin Wound Infections in Patients Undergoing Vascular Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision Management System versus Dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond and the other half will receive the Prevena Incision Management System for their groin wounds.
Detailed Description
Dermabond and the Prevena Incision Management System are both FDA approved wound care products. Prevena is a negative pressure system which holds the wound together and removes exudate and debris from the site to prevent infection. Dermabond is a surgical glue which holds the wound together to prevents infection. Prevena is more expensive to apply. However, the hypothesis is that the Prevena System will decrease infection rates and therefore, decrease the ultimate cost of the health care needed after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prevena
Arm Type
Active Comparator
Arm Description
Prevena Incision Management System for vascular surgical groin wounds
Arm Title
Dermabond
Arm Type
Active Comparator
Arm Description
Dermabond for vascular surgical groin wounds
Intervention Type
Device
Intervention Name(s)
Prevena Incision Management System
Other Intervention Name(s)
Prevena
Intervention Description
A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections
Intervention Type
Device
Intervention Name(s)
Dermabond
Intervention Description
A surgical skin adhesive used to prevent surgical wound infections
Primary Outcome Measure Information:
Title
Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond
Description
The primary effectiveness endpoint is 30 day healing of the randomized groin incision, with any wound infection or failure to heal. Szilagyi wound infection grade quantified on an ordinal scale will be used to assess the healing (None, Grade I: Infection contained to the dermis, Grade II: Infection extending into the subcutaneous tissue but the arterial graft is not involved, Grade III: Infection of the arterial graft or native vessel underlying the incision).
Healing is assessed by complete sealing of the incision with no residual separation or drainage. All of the incisions were primarily closed, so a healed incision would have no gaps between the skin edges. This is a visual inspection.
Szilagi is an assessment of the grade of wound infection for those that did not heal. It is well recognized and published, and noted as above for patients with vascular exposure.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Cost of Care
Description
Comparison of cost of treatment between the two arms
Time Frame
30 days
Title
Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection
Description
Physician office visits for diagnosis of Infection or visiting nurse visits for diagnosis of infection ONLY were assessed.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In need of elective vascular procedure requiring ≥8 cm groin incision.
Able to provide consent
Able to care for wound or have support person to complete wound care
Willing to comply with follow-up
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Harris, MD
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaleida Health, Gates Vascular Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
State University of New York at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18929355
Citation
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Results Reference
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
17512763
Citation
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PubMed Identifier
16429897
Citation
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Results Reference
background
PubMed Identifier
18774446
Citation
Bandyk DF. Vascular surgical site infection: risk factors and preventive measures. Semin Vasc Surg. 2008 Sep;21(3):119-23. doi: 10.1053/j.semvascsurg.2008.05.008.
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Dosluoglu HH, Loghmanee C, Lall P, Cherr GS, Harris LM, Dryjski ML. Management of early (<30 day) vascular groin infections using vacuum-assisted closure alone without muscle flap coverage in a consecutive patient series. J Vasc Surg. 2010 May;51(5):1160-6. doi: 10.1016/j.jvs.2009.11.053. Epub 2010 Mar 31.
Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.
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Citation
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Citation
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Citation
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Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery
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