Clinical trial NCT02836990: 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
Overall status: COMPLETED
Phase: NA
Conditions: Wound Infection
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: KCI USA, Inc
First posted: 2016-07-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. In need of elective vascular procedure requiring ≥8 cm groin incision.
2. Able to provide consent
3. Able to care for wound or have support person to complete wound care
4. Willing to comply with follow-up

Exclusion Criteria:

None

Primary outcomes:
measure: Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond
timeFrame: 30 days
Secondary outcomes:
measure: Cost of Care
timeFrame: 30 days
measure: Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection
timeFrame: 30 days
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Kaleida Health, Gates Vascular Institute
state: New York
city: Buffalo
country: United States
facility: State University of New York at Buffalo
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Linda Harris, MD
role: PRINCIPAL_INVESTIGATOR
References:
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