Abstract
The safety and efficacy of Collagenase ABC® ointment (containing 250 units/g white petrolatum clostridiopeptidase A) in the debridement of stage III pressure sores in 50 patients were examined in a phase II, prospective, open, uncontrolled study. Ulcer size, odour, pus, inflammation and necrosis were assessed prior to study entry and after a maximum of 28 days’ treatment with the ointment, applied twice daily. All the clinical features assessed (odour, pus, inflammation, necrosis) showed progressive and highly statistically significant reductions throughout the treatment period, most notably with respect to the reduction of necrotic tissue present on the wound. The estimated area of the ulcer showed a small but significant reduction in size. All reported adverse events were recorded as being of ‘doubtful’ relationship to the test therapy, except for one case of pain at the wound site, which was classified as ‘possibly’ related. Laboratory investigations (full blood count, serum biochemistry) revealed no signs of toxicity. In the majority of patients, the ointment was considered ‘reasonably easy to apply’ and of ‘good’ acceptability by the nursing staff responsible for the application of the ointment and on patient monitoring.
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