Safety and performance of a new non-adhesive foam dressing for the treatment of diabetic foot ulcers.
OBJECTIVE
This study aimed to document the safety and performance of a new non-adhesive foam dressing (Biatain Non-adhesive Dressing, Coloplast A/S) in the treatment of established foot ulcers in patients with diabetes.


METHODS
This was an open non-comparative prospective study. Participants had an ankle brachial pressure index score of over 0.4 (neuro-ischaemic) and an ulcer bigger than 1 cm2 and less than 8 cm2 in any direction. The treatment period was six weeks.


RESULTS
Thirty-five out of 37 patients completed the study. The mean wound area reduced from 5.4 cm2 to 2.5 cm2. Relative wound area reduced from 100% at baseline to 40% at week 6. 'Wearing comfort' improved throughout the study (p = 0.039). Maceration remained stable or improved. None of the four reported adverse events were device related.


CONCLUSIONS
This study demonstrates that treatment of diabetic foot ulcers with Biatain Non-adhesive Dressing results in considerable wound area reduction and prevents any deterioration in maceration. The dressing is safe and effective in the management of these ulcers.
Lohmann
M
M
Coloplast A/S, Wound Care Division, Humlebaek, Denmark. ML02@bbh.hosp.dk
Thomsen
J K
JK
Edmonds
M E
ME
Harding
K G
KG
Apelqvist
J
J
Gottrup
F
F
D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D047070:Bandages, Hydrocolloid; D003102:Colloids / Q000627:therapeutic use*; D003718:Denmark; D017719:Diabetic Foot / Q000451:nursing*; D005122:Exudates and Transudates; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009730:Nursing Assessment; D011140:Polyurethanes; D011446:Prospective Studies; D012449:Safety; D012720:Severity of Illness Index; D017592:Skin Care / Q000295:instrumentation / Q000379:methods / Q000451:nursing; D013548:Sweden; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D014945:Wound Healing
D003102:Colloids; D011140:Polyurethanes