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Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery

University at Buffalo (UB) logo

University at Buffalo (UB)

Status

Completed

Conditions

Wound Infection

Treatments

Device: Prevena Incision Management System
Device: Dermabond

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02836990
Prevena

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

105 participants in 2 patient groups

Prevena
Active Comparator group
Description:
Prevena Incision Management System for vascular surgical groin wounds
Treatment:
Device: Prevena Incision Management System
Dermabond
Active Comparator group
Description:
Dermabond for vascular surgical groin wounds
Treatment:
Device: Dermabond

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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