N/A
N=105
Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery
Wound Infection
Bottom Line
View on ClinicalTrials.gov: NCT02836990 ↗Enrolled (actual)
105
Serious AEs
5.0%
Results posted
Dec 2020
Primary outcome: Primary: Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond — 41; 54 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prevena Incision Management System (Device); Dermabond (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond |
41; 54 | — |
| SECONDARY Cost of Care |
— | — |
| SECONDARY Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection |
7; 7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02836990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.