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A randomised trial of rigid stump dressing following trans-tibial amputation for peripheral arterial insufficiency
Woodburn KR, Sockalingham S, Gilmore H, Condie ME, Ruckley CV, Scottish Vascular Audit Group Scottish Physiotherapy Amputee Research Group
Prosthetics and Orthotics International 2004 Apr;28(1):22-27
clinical trial
4/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: A multicentre randomised controlled trial to determine the effect of a rigid plaster dressing applied at the time of trans-tibial amputation on the number of days to casting for a prosthesis, and the incidence of post-operative stump infection. METHODS: Patients requiring trans-tibial amputation were randomised to one of 2 groups: In group 1 (intervention) a rigid above-knee plaster dressing was applied at operation and patients were managed according to a standard protocol. Group 2 (control) had the individual surgeons' usual non-rigid dressing regime. Rehabilitation data were extracted from the national physiotherapy database. On completion of the trial a questionnaire was sent to all participants. RESULTS: 14 surgeons in 7 centres enrolled 154 patients, with 96 ultimately cast for a prosthesis. Patients who received a rigid dressing (n = 78) had reduced days to casting (median 36, confidence interval 30 to 47) when compared with other dressings (n = 76) (median 42, confidence interval 36 to 45), these differences did not reach statistical significance. There was no significant difference in post-operative infection rates in the two groups. 64% of surgeons, and all physiotherapists and vascular nurses responding to the post-trial questionnaire felt that the rigid dressing was an improvement on their normal regime and wished to continue with the technique. CONCLUSIONS: Despite a median reduction of 6 days in time to casting in patients treated with a rigid post-operative dressing this failed to reach statistical significance. The majority of participants who replied to the post-trial questionnaire expressed a wish to continue using the rigid dressing technique. To confirm that the trends shown in this trial are statistically valid a larger trial is needed.

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