Treatment of perioperative swelling by Rest, Ice, Compression and Elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with an unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized pilot-trial

Not Applicable

Recruiting

• Conditions: unilateral closed ankle fracture/

• Registration Number: DRKS00023739
• Lead Sponsor: Zentrum für operative Medizin, Abteilung für Unfall-, Hand- und Wiederherstellungschirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

unilateral closed ankle fracture with indication for surgical fixation
BMI =16kg/m2 and <35 kg/m2
omnivore or lacto-ovo-vegetarian diet
acceptance for being randomized

Exclusion Criteria

open or bilateral ankle fracture
history of secondary lymphedema due to tumoral disease within the last 5 years
pregnancy
dietary patterns other than omnivore or lacto-ovo-vegetarian (e.g. vegan, macrobiotic)
incapability to adhere to follow-up examinations

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The postoperative swelling at time of discharge and after normalization to the healthy leg should bei in patients of the RICE+ and RICE-group 1.2±0.2 vs 1.4±0.2.

Secondary Outcome Measures

Name	Time	Method
need for analgesics beyond the ones routinely prescribed during postoperative recovery<br>individual perception of pain (numeric rating scale)<br><br>Follow-up examinations at time of discharge from the hospital up to 12 weeks afterwards: <br>mobility of the affected joint relative to the healthy site at time of discharge from the hospital<br>cadence, gait velociy and the factor of imbalance (gait symmetry) at time of discharge and 2, 4, 6 and 12 weeks afterwards<br>Calcium accrual to bone during fracture healing (concentration of the naturally occurring stable (non-radioactive) Ca-isotopes 44Ca and 42Ca in serum and urine)