OBJECTIVE: To evaluate the performance (efficacy and safety) of an absorbent dressing impregnated with silver salts (UrgoCell Silver) in the management of leg ulcers with clinical signs of critical colonisation. METHOD: This was a prospective multicentre non-comparative phase III clinical trial. Patients were assessed weekly for up to four weeks. Assessment included clinical assessment of critical colonisation (severe spontaneous pain between dressing changes, erythema, oedema, malodour and heavy exudate), wound area tracing and photography. Acceptability was documented by the nursing staff when dressings were changed between two weekly evaluations. RESULTS: Forty-five leg ulcers were included. At baseline the mean number of clinical signs of critical colonisation per ulcer was 3.6 +/- 0.7, which decreased to 1.2 +/- 1.2 at the end of the fourth week of follow-up (an average reduction of 2.3 +/- 1.3, p < 0.001). Oedema, malodour, erythema and spontaneous pain disappeared at the fourth week in 80%, 70%, 69% and 65% of the treated ulcers respectively. Compared with baseline, the mean reduction in ulcer area was 35.0 +/- 58.0% (median 33%, p < 0.001) after the four weeks treatment. Granulation tissue covered a mean 77% of the ulcer surface area at four weeks, compared with 41% at baseline. Only three local events were documented: contact dermatitis, a burning sensation and erythema. CONCLUSION: The results suggest that the test dressing had a favourable influence on the wound prognosis, and was well tolerated and accepted in the treatment of venous leg ulcers with clinical signs of critical colonisation.
OBJECTIVE: To evaluate the performance (efficacy and safety) of an absorbent dressing impregnated with silver salts (UrgoCell Silver) in the management of leg ulcers with clinical signs of critical colonisation. METHOD: This was a prospective multicentre non-comparative phase III clinical trial. Patients were assessed weekly for up to four weeks. Assessment included clinical assessment of critical colonisation (severe spontaneous pain between dressing changes, erythema, oedema, malodour and heavy exudate), wound area tracing and photography. Acceptability was documented by the nursing staff when dressings were changed between two weekly evaluations. RESULTS: Forty-five leg ulcers were included. At baseline the mean number of clinical signs of critical colonisation per ulcer was 3.6 +/- 0.7, which decreased to 1.2 +/- 1.2 at the end of the fourth week of follow-up (an average reduction of 2.3 +/- 1.3, p < 0.001). Oedema, malodour, erythema and spontaneous pain disappeared at the fourth week in 80%, 70%, 69% and 65% of the treated ulcers respectively. Compared with baseline, the mean reduction in ulcer area was 35.0 +/- 58.0% (median 33%, p < 0.001) after the four weeks treatment. Granulation tissue covered a mean 77% of the ulcer surface area at four weeks, compared with 41% at baseline. Only three local events were documented: contact dermatitis, a burning sensation and erythema. CONCLUSION: The results suggest that the test dressing had a favourable influence on the wound prognosis, and was well tolerated and accepted in the treatment of venous leg ulcers with clinical signs of critical colonisation.