IN-VITRO and Healthy HUMAN STUDIES ASSESS FOAM Adhesive Dressing Breathability and Fluid Handling PROPERTIES

PURPOSE: 

To assess breathability and fluid handling properties of several marketed foam adhesive wound dressings under simulated high moisture conditions using in-vitro and in-vivo test models.

METHODOLOGY: 

Two in-vitro models assessed breathability:  1) Moisture vapor transmission rates (MVTR) in contact with liquid according to EN 13726-2:2002¹; and 2) continuous infusion of test fluid under the dressing at a rate of 0.75 ml/hr (24 hours per day) for 7 days (126 ml total).  The in-vivo model assessed wear time with 12-24 healthy human subjects in 6 separate studies.  Dressings A-G were  worn on the back and manually injected with 1.0 ml of artificial wound fluid every hour during waking hours (12x per day) over 7 days (up to 87 ml total) or until the dressing failed (delamination, fall off, leakage, lift to pad) and were compared using a Cox regression model. 

RESULTS: 

Dressing A had a liquid contact MVTR of 12,800 +/- 370 g/m²/24 hour. By comparison, the other marketed dressings MVTR values ranged from 800 +/- 400 to 11,400 +/- 700 g/m²/24 hours. 

For the continuous fluid infusion model, Dressing A evaporated approximately 85% of the test fluid over the 7 day period. By comparison, the evaporation amount for the other marketed dressings ranged from approximately 21% to 85%.

For the in-vivo model, the median fluid volume administered until dressing failure was significantly higher for Dressing A (>87 ml) compared to the other marketed dressings (13-44.5 ml). 

CONCLUSION: 

Dressing A has high breathability and fluid handling capacity under simulated high moisture conditions when tested using both in-vitro and in-vivo methods in comparison to other marketed foam adhesive dressings.