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Lothian and Forth Valley leg ulcer healing trial, part 1: elastic versus non-elastic bandaging in the treatment of chronic leg ulceration |
Callam MJ, Harper DR, Dale JJ, Brown D, Gibson B, Prescott RJ, Ruckley CV |
Phlebology 1992 Dec;7(4):136-141 |
clinical trial |
2/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To determine whether elastic or non-elastic bandaging is more effective in healing chronic venous ulcers. DESIGN: Randomized trial with factorial design and interaction analysis, enabling independent evaluation of both bandaging and dressings within the single-trial format. The duration of treatment was 12 weeks or until ulcer-healing, whichever occurred sooner. SETTING: The Leg Ulcer Clinics of Edinburgh and Falkirk and District Royal Infirmaries, Scotland. PATIENTS: 132 patients with chronic leg ulcers and clinical evidence of chronic venous disease, and excluding those with doppler ultrasound ankle/brachial pressure indices of less than 0.8, diabetes or rheumatoid disease. There were 28 withdrawals who were classified for analysis as treatment failures. INTERVENTIONS: Elastic or non-elastic multilayer bandage systems were applied using similar application techniques by a team of trained nurse specialists. All other treatments were standardized, including the randomization of dressings to either a knitted viscose or a hydrocellular polyurethane dressing. MAIN OUTCOME MEASURE: Complete ulcer healing. RESULTS: In the elastic group 35 out of 65 ulcers (54%) healed within 12 weeks compared with 19 out of 67 (28%) in the non-elastic group (95% confidence limits for percentage healed, 9% to 42%). Ulcer pain was also reported significantly less often in the elastic group (48% of visits versus 29%; p = 0.03). CONCLUSION: When applied by similar multilayer bandaging techniques, elastic bandaging was significantly better than non-elastic bandaging in the treatment of chronic venous leg ulcer.
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