Abstract
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 30–47) when compared with other dressings (n=76) (median 42, confidence interval 36–45), 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.