Abstract
BackgroundEdema is commonly seen after surgical fixation of ankle fractures. Rest, ice, compression, and elevation (RICE) is an established combination to prevent swelling but hardly able to stimulate lymphatic resorption. Recently, an epicutaneously applied negative pressure suction apparatus (LymphaTouch®) has been introduced to stimulate lymphatic flow. While postoperative recovery, soft tissue, and osseous healing as well as functional outcome are probably linked to the amount of postoperative swelling, estimates on this relative to prevention (RICE) or prevention + stimulated resorption (RICE+) of fluid are scarce.Methods and analysisThis is a single-center, evaluator-blinded randomized pilot trial to investigate postoperative swelling in adults requiring surgical fixation of a closed unilateral ankle fracture. A total of 50 patients will be recruited and randomly assigned to RICE or RICE+ prior to surgery. All patients will undergo evaluator-blinded measurements of the ankle volume the day before surgery and subsequently from the evening of the 2nd postoperative day every 24 h until discharge. RICE will be initiated right after surgery and continued until discharge from the hospital in all patients. Additional application of negative pressure therapy (RICE+) will be initiated on the morning of the 2nd postoperative day and repeated every 24 h until the time of discharge from the hospital. Outcome measures are (i) the relative amount and the time course of the postoperative swelling, (ii) the demand for analgesic therapy (type and amount) together with the perception of pain, (iii) the rate of complications, and (iv) mobility of the ankle joint and the recovery of walking abilities during a 12-weeks follow-up period. Serum and urine samples taken prior to sugery and during postoperative recovery will allow to evaluate the ratio of naturally occurring stable calcium isotopes (δ44/42Ca) as a marker of skeletal calcium accrual.Ethics and disseminationThe protocol was approved by the institutional Ethics Committee (Rostock University Medical Center, Rostock, Germany) in accordance with the Declaration of Helsinki (approval number: A 2020-0092). The results of this study will be actively disseminated through scientific publications and conference presentations.Trial registrationDRKS, DRKS00023739. Registered on 14 December 2020
Highlights
Ankle fractures account for approximately 9% of all fractures, and occur preferentially either in physically active adults or as an osteoporotic fracture in the elderly [1,2,3,4]
The study is designed to assess the effects of the classical RICE concept and the additional application of a devicebased negative pressure therapy (RICE+) with respect to the resorption of lymphedema related to the surgical fixation of an isolated ankle fracture
Standardization of the components of RICE is hard to achieve even in a hospital setting, we record the number of ice packages per day as a marker of the individual preference for cooling but as a surrogate marker of adherence to the baseline therapy, as well
Summary
Background and rationale Ankle fractures account for approximately 9% of all fractures, and occur preferentially either in physically active adults or as an osteoporotic fracture in the elderly [1,2,3,4]. Either accidentally as with the fracture or, in addition, as with surgical fixation, causes the release of inflammatory mediators with concomitant extravasation of fluid, i.e., swelling which in turn induces pain and hampers mobility. Resolving pre- and postoperative swelling is required, the well-established and widely used combination of rest, ice, compression, and elevation (RICE) prevents the formation of edema rather than stimulating lymphatic resorption. Edema is commonly seen after surgical fixation of ankle fractures. Ice, compression, and elevation (RICE) is an established combination to prevent swelling but hardly able to stimulate lymphatic resorption. Soft tissue, and osseous healing as well as functional outcome are prob‐ ably linked to the amount of postoperative swelling, estimates on this relative to prevention (RICE) or prevention + stimulated resorption (RICE+) of fluid are scarce
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