[2009] [SAT0235] TREATMENT OF ISCHEMIC ULCERS IN PATIENTS WITH SYSTEMIC SCLEROSIS USING CALCIUM ALGINATE AND COLLAGEN BANDAGES: A RANDOMIZED, CONTROLLED STUDY

S.R. Toffolo, R.N.V. Furtado, A. Klein, S. Watanabe, L.E.C. Andrade, J. Natour Disciplina de Reumatologia, Universidade Federal de São Paulo, São Paulo, Brazil

Background: Backcground: The treatment of ischemic ulcers in systemic sclerosis remains a challenge for rheumatology.
Objectives: Objective: Compare the medium-term effectiveness of two types of bandages for the treatment of ischemic ulcers in patients with systemic sclerosis.
Methods: Methods: A randomized, single blind, controlled study was carried out on patients with systemic sclerosis recruited from the Collagen Disease Clinic of the Universidade Federal de São Paulo (Brazil), with a 12-week follow up. Inclusion criteria: patients with diseases of the systemic sclerosis spectrum, with active ulcers in the upper limbs, periungual capillaroscopy with scleroderma pattern, and age between 18 and 65 years. Exclusion criteria: diabetes mellitus, smoking habit, overlapping with other collagenosis, presence of ulcers in cicatrisation phase or necrosis. Intervention: Randomization was performed through simple lots with confidential allocation to either Group I (calcium alginate+collagen bandages) or Group II (saline solution bandages). The assessment instruments were the larger and smaller ulcer diameter, ulcer area (0-11 weeks); and SF-36 generic quality of life questionnaire, Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, pinch gauge dynamometer and visual analog scale (VAS) (0, 3, 7 and 11 weeks). Statistical significance was set at 5%.
Results: Results: Forty-four ulcers were studied in 24 patients (Group I - 12 patients with 21 ulcers; Group II - 12 patients with 23 ulcers), with an average age of 40.66 year, average duration of disease of 7.35 years; 67% were female and 75% were Caucasian. No statistically significant differences were found between the calcium alginate+collagen and saline solution groups regarding the following variables: smallest diameter, largest diameter, area of ulcer, DASH and VAS. There were statistically significant differences favouring the calcium alginate+collagen group at all evaluation times regarding the following variables: SF36 functional capacity (p = 0.002); SF36 physical aspects (p = 0.002); SF36 pain (p = 0.005); SF36 general health status (p < 0.001); SF36 vitality (p < 0.001); SF36 social aspects (p < 0.001); SF36 emotional aspects (p = 0.006); SF36 mental health (p = 0.01); two-point pinch strength(p < 0.005); tripod pinch strength(p < 002); and key pinch strength(p = 0.001). Ulcer infection was observed in only one patient in the saline solution group.
Conclusion: Conclusion: The use of the calcium alginate+collagen bandages in the treatment of ischemic ulcers in patients with systemic sclerosis proved more effective than saline solution regarding quality of life and pinch strength variables.
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