Evaluation of a lipidocolloid wound dressing in the local management of leg ulcers.
OBJECTIVE
To evaluate the efficacy, tolerance and acceptability of Urgotul and DuoDERM E dressings in the local management of venous or mixed-aetiology leg ulcers.


METHODS
This was a prospective multicentre randomised phase IV clinical trial conducted open-label in parallel groups. It involved 20 investigating centres, including hospital dermatology and vascular medicine departments, and private practices. Dermatologists and angiologists/phlebologists took part. Subjects were adult, non-immunosuppressed patients presenting with a non-infected, non-malignant leg ulcer of predominantly venous origin (ABPI > 0.8). Ulcers were between 4cm2 and 40cm2 in size, with granulation tissue covering more than 50% of their surface area. Ulcer duration ranged from three to 18 months. Patients were followed-up by the investigating physician for eight weeks on a weekly basis; this included clinical examination, wound area tracings and photographs. Nurses (hospital or visiting) assessed exudate volume and clinical appearance at dressing changes.


RESULTS
Ninety-one patients were included: 47 in the Urgotul group and 44 in the DuoDERM E group. Baseline patient demographic data and wound characteristics were comparable in the two groups. After eight weeks of treatment wound surface area had reduced by a mean of 61.3% in the Urgotul group and 52.1% in the DuoDERM E group (NS); dressings were changed more frequently in the DuoDERM E group (2.54 +/- 0.57 times per week versus 2.31 +/- 0.45 in the Urgotul group, p = 0.047). Thirty-three local adverse events were recorded in 27 patients: 10 in the Urgotul group and 23 in the DuoDERM E group (p = 0.039). Nurses reported better acceptability for the Urgotul dressing, based on pain on removal, maceration and odour (p < 0.0001).


CONCLUSIONS
Both dressings showed similar efficacy for the local treatment of venous leg ulcers. Nevertheless, medical and nursing staff reported better tolerance and acceptability for the Urgotul dressing.
Meaume
S
S
Department of Geriatrics, Hôpital Charles Foix, Ivry/Seine, France. sylvie.meaume@cfx.ap-hop-paris.fr
Ourabah
Z
Z
Cartier
H
H
Granel-Brocard
F
F
Combemale
P
P
Bressieux
J M
JM
Bohbot
S
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D047070:Bandages, Hydrocolloid / Q000592:standards*; D002266:Carboxymethylcellulose Sodium; D003102:Colloids / Q000627:therapeutic use*; D005122:Exudates and Transudates; D005260:Female; D006801:Humans; D007871:Leg Ulcer / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009730:Nursing Assessment; D015403:Nursing Evaluation Research; D009812:Odorants; D010342:Patient Acceptance of Health Care / Q000523:psychology; D011446:Prospective Studies; D017592:Skin Care / Q000379:methods / Q000451:nursing / Q000592:standards; D016896:Treatment Outcome; D014945:Wound Healing
D003102:Colloids; C087325:Granuflex E; D002266:Carboxymethylcellulose Sodium