4716 Clinical Performance Studies Following the Improvement of a Foam Wound Dressing

Cindy Zehrer, RN, MS, CCRA , 3M Health Care, Clinical Research, St. Paul, MN
David Holm , 3M Health Care, Product Development Specialist, St Paul, MN
Shelley Walters , 3M Health Care, Senior Biostatistician, St Paul, MN
CLINICAL PERFORMANCE STUDIES FOLLOWING THE IMPROVEMENT OF A FOAM WOUND DRESSING
PURPOSE:  Effective management of moisture in low to high exuding wounds is critical for optimized wound healing, and quality of life.  Since the level of exudate changes during dressing wear and/or between dressing changes, the performance of wound dressings for exudate management is oftentimes unacceptable.  For a low exuding wound, poor dressing performance can result in the wound bed drying out, and for a high exuding wound, peri-wound maceration and skin breakdown may occur. To meet this challenge, one healthcare manufacturer has modified their foam wound dressing improving the exudate management properties for wounds with varying levels of exudate. 
METHODOLOGY:  Bench test studies included measurement of dressing absorbency, and both dry and wet moisture vapor transmission rates according to ASTM E-96-80 using a modified Payne cup method.   A human randomized-block design study (24 subjects) involved the injection of artificial wound fluid (10.2 ml/day for 2 days) through a catheter under the dressings. Skin condition and weight of the dressing upon removal of the dressing were monitored.
RESULTS:  Dry and wet moisture vapor transmissions rates for the modified foam dressing were 1,100 +/- 100 g/m2/day and 12,800 +/- 1900 g/m2/day, respectively.   By comparison, dry and wet moisture vapor transmission rates for the existing foam dressings were 800 +/- 100 g/m2/day and 1,900 +/- 700 g/m2/day, respectively.   Human study results demonstrate the average weight of fluid retained in the modified dressing was significantly lower (median weights 2.7 g vs 9.8 g, Wilcox on Rank Sum test p-value <0.0001) with no difference in skin condition. 
CONCLUSION:  Based on bench and human studies, this reformulation of an existing product demonstrates improved performance for the management of varying levels of wound exudate with both superior absorption and reactive moisture vapor permeability relative to the level of exudate in the wound.
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