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A COMBINED USE OF A COLLAGENASE-CONTAINING OINTMENT AND A HYDROGEL DRESSING IN THE TREATMENT OF VENOUS LEG ULCERS: A CASE SERIES

Authors: R. Polignano, A. Pavanelli, P.Terriaca Angiology Dpt Camerata Hospital - ASL 10 Florence Italy (polignan@dada.it)

Introduction.
Chronic venous leg ulceration may be considered a social disease, with a reported national prevalence rate of 0.1 to 0.3 % in the total population and of 5% in the elderly. The cost of treating the ailment is also considerable. Most patients are treated in nursing homes or at home, the total cost of treatment being mainly applicable to the direct costs of healthcare professionals. To achieve adequate wound bed preparation of necrotic leg ulcers, autolytic as well as enzymatic debridement is carried out, both methods being well tolerated and easy to perform on an outpatient basis. Enzymatic agents need to be applied every day and this can be a limiting factor in home care, since visits are carried out 1 to 3 times a week in our Region.

Aim of the study.
The purpose of our study was to overcome the need for daily management of lower limb ulcerations and to test the efficacy of a combination of autolytic and enzymatic debridement in sloughy ulcers.

Materials and Methods.
A Collagenase-based ointment (NORUXOLÓ) was used as a primary medication in direct contact with the wound bed. A hydrogel (INTRASITETM gel/conformable) was applied either in combination with the ointment or as a “protective” secondary dressing, in order to promote a moist environment or to cover sites that were difficult to reach with the ointment. Dressing changes, the technical compatibility of which was experimentally confirmed, were carried out 2/3 times a week. We should point out that with regard to NORUXOLÓ, this was an off-label use, which we performed deviating from the recommended daily application of the drug. We treated six patients aged 49 - 72 suffering from chronic leg ulcerations of venous or mixed origin, but with no sign of critical ischemia. Three patients (group A) were affected by small size ulcers (4.6 cm2 average) with a fibrinous adhesive bed and had been treated unsuccessfully for 3 months prior to this treatment regime. The other 3 patients (group B) were characterized by large size ulcers (from over 28 cm2 to over 120 cm2) that had been in existence from 8 to 12 months; these ulcers had previously been treated alternatively with hydrocolloids, hydrogels and films for a considerable period of time, but without satisfactory results. All patients, when indicated, underwent compression therapy. The treatment was carried out until full debridement in Group B or until the complete healing of ulcers in Group A

Results.
Patients in Group A achieved complete healing in 4 – 7 weeks, had no complications or significant management problems. Patients in Group B. showed an excellent debridement after 5 weeks in all 3 cases.

Conclusions.
The small number of patients included in the study meant that statistical analysis was not possible. However, the results indicated that the combined use of Collagenase and a hydrogel could be recommended in all cases of ulcers with non-viable tissue. The combination of Collagenase and hydrogel is especially recommended in wounds that respond slowly to autolytic debridement. It is also a good solution when the daily application of Collagenase is impossible for logistical reasons.