A prospective study on the use of a non-adhesive gelling foam dressing on exuding leg ulcers.
OBJECTIVE
This non-comparative phase II study aimed to evaluate the safety and performance of a non-adhesive gelling foam dressing (GFD-N) in leg ulcer management.


METHODS
Forty-six subjects with moderately to heavily exuding leg ulcers were treated with a regimen including GFD-N. Dressings were changed at least every seven days for four weeks or until healing.


RESULTS
Mean GFD-N wear time was 3.2 days per subject. Mean wound area decreased from 10.1 cm2 at baseline to 5.1 cm2 at four weeks (p<0.001) and healed in five subjects (11%). The surrounding skin improved or remained stable in all but one subject. When compared with pre-study dressings, ulcer pain decreased for GFD-N, both with the dressing in place (p<0.001) and on dressing removal (p<0.001). Of final investigator ratings for 45 subjects, most were 'excellent' for ease of application (89%), ease of removal (96%), conformability (67%) and overall performance (58%). Five subjects experienced adverse events; none were serious or dressing-related.


CONCLUSIONS
This small study demonstrates that GFD-N was safe, effective and convenient for wound healing, exudate management, pain/comfort and ease of use.
Vanscheidt
W
W
Dermatologische Gemeinschaftspraxis, University Freiburg, Germany.
Münter
K C
KC
Klövekorn
W
W
Vin
F
F
Gauthier
J-P
JP
Ukat
A
A
D000328:Adult; D000368:Aged; D001458:Bandages; D005122:Exudates and Transudates; D005260:Female; D005782:Gels; D006801:Humans; D007871:Leg Ulcer / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D011446:Prospective Studies; D014945:Wound Healing
D005782:Gels