Randomized and controlled prospective study protocol on use of the adhesive elastic tape for the control of hand oedema in patients with a wrist fracture treated in a cast

Abstract

Abstract Background Wrist fractures are a common occurrence affecting patients of all ages. Wrist fracture patients often develop oedema and the presence of cast increases the risk. The use of an adhesive elastic tape is indicated for the oedema control, but there is no definitive evidence of its effectiveness. This study aims to evaluate the effectiveness of the tape in the hand oedema control of wrist fracture patients with forearm cast. Methods Randomized controlled trial with blinded data processing. We will apply the tape to the intervention group after the plaster application, the control group will receive the standard treatment. We will evaluate the circumference difference between baseline (T0) and the 7-day follow-up (T1) of both the thumb and of the remaining 4 fingers merged together. Moreover, re-attendance data to the Orthopedic Emergency Room due to “intolerance to the plaster cast” will be checked. Sample size calculations resulted in a total of 220 (110 per group). Ethical approval for the study has been obtained. Discussion We aim to demonstrate that the use of tape improves the tolerability of the cast by reducing the oedema formation, the feeling of constriction and pain. Trial registration ClinicalTrial.gov Identifier: NCT04683887.