Treatment of perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with a unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized controlled pilot trial

Treatment of perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with a unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized controlled pilot trial

Abstract Background Edema 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 appar...

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Autores principales: Dagmar-C Fischer, Axel Sckell, Angelina Garkisch, Klaus Dresing, Anton Eisenhauer, Luzia Valentini, Thomas Mittlmeier
Formato: article
Lenguaje:EN
Publicado: BMC 2021
Materias:
Ankle fracture
Rest
Ice
Compression
Elevation
Edema
Medicine (General)
R5-920
Acceso en línea:https://doaj.org/article/a11f331d72404af6ae58488c29a52b28
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spelling oai:doaj.org-article:a11f331d72404af6ae58488c29a52b282021-11-14T12:12:44ZTreatment of perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with a unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized controlled pilot trial10.1186/s40814-021-00944-72055-5784https://doaj.org/article/a11f331d72404af6ae58488c29a52b282021-11-01T00:00:00Zhttps://doi.org/10.1186/s40814-021-00944-7https://doaj.org/toc/2055-5784Abstract Background Edema 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 analysis This 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 dissemination The 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 registration DRKS, DRKS00023739 . Registered on 14 December 2020Dagmar-C FischerAxel SckellAngelina GarkischKlaus DresingAnton EisenhauerLuzia ValentiniThomas MittlmeierBMCarticleAnkle fractureRestIceCompressionElevationEdemaMedicine (General)R5-920ENPilot and Feasibility Studies, Vol 7, Iss 1, Pp 1-9 (2021)
institution DOAJ
collection DOAJ
language EN
topic Ankle fracture
Rest
Ice
Compression
Elevation
Edema
Medicine (General)
R5-920
spellingShingle Ankle fracture
Rest
Ice
Compression
Elevation
Edema
Medicine (General)
R5-920
Dagmar-C Fischer
Axel Sckell
Angelina Garkisch
Klaus Dresing
Anton Eisenhauer
Luzia Valentini
Thomas Mittlmeier
Treatment of perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with a unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized controlled pilot trial
description Abstract Background Edema 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 analysis This 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 dissemination The 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 registration DRKS, DRKS00023739 . Registered on 14 December 2020
format article
author Dagmar-C Fischer
Axel Sckell
Angelina Garkisch
Klaus Dresing
Anton Eisenhauer
Luzia Valentini
Thomas Mittlmeier
author_facet Dagmar-C Fischer
Axel Sckell
Angelina Garkisch
Klaus Dresing
Anton Eisenhauer
Luzia Valentini
Thomas Mittlmeier
author_sort Dagmar-C Fischer
title Treatment of perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with a unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized controlled pilot trial
title_short Treatment of perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with a unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized controlled pilot trial
title_full Treatment of perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with a unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized controlled pilot trial
title_fullStr Treatment of perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with a unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized controlled pilot trial
title_full_unstemmed Treatment of perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with a unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized controlled pilot trial
title_sort treatment of perioperative swelling by rest, ice, compression, and elevation (rice) without and with additional application of negative pressure (rice+) in patients with a unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized controlled pilot trial
publisher BMC
publishDate 2021
url https://doaj.org/article/a11f331d72404af6ae58488c29a52b28
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