Evaluation of a new composite dressing for the management of chronic leg ulcer wounds.
OBJECTIVE
A new composite dressing (Versiva, ConvaTec) combines three technologies: hydrocolloid, hydrofibre and a foam-film layer. This study aimed to assess the safety of the dressing in the management of patients with venous leg ulcers. Clinical performance was also assessed.


METHODS
This multicentre, non-randomised, open-label, phase II study assessed the safety (via adverse-effect reporting) and performance, including weartime, absorption, dressing integrity, ease of use and wound progression, of Versiva. Up to 10 dressing changes were assessed within a five-week study period.


RESULTS
In 75 dressing changes of 11 ulcers, the mean wear time was approximately five days. No or minimal leakage was observed in 81% of changes. In 93%, the dressing was 'very easy' to remove, with no trauma to surrounding skin. Most changes (77%) were painless.


CONCLUSIONS
Versiva met or exceeded the investigators' expectations for exudate absorption, protection of peri-wound skin and reduction in wound pain and ulcer area. Healing or marked improvement was observed in 82% of leg ulcers within the five-week study. The relatively long wear-time of five days represents a cost-effective advantage for this dressing compared with other available adhesive foams for the management of chronic wounds.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D047070:Bandages, Hydrocolloid; D002908:Chronic Disease; D003102:Colloids / Q000009:adverse effects / Q000191:economics / Q000592:standards / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012449:Safety; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000145:classification / Q000451:nursing*; D014945:Wound Healing
D003102:Colloids