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Skin Temperature Reduction With Hilotherm Device

NCT05789290 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-10-16

No results posted yet for this study

Summary

Cryotherapy after surgery is widely utilised and has numerous practical applications for post-operative rehabilitation. Previous research has suggested that during cold therapy, the skin temperature of the knee should be reduced to 10-15°C to maximise the therapeutic benefits of cooling while avoiding the risk of cold injuries such as nerve damage and frostbite. The temperature to which a cryocompression device should be set in order to achieve a skin temperature within the therapeutic range of 10-15°C is unknown. Furthermore, there is evidence to suggest that the temperature setting of the device does not equal that to which the skin is reduced. Therefore, it is not sufficient to assume that the temperature setting of a cryocompression device accurately reflects the achieved skin temperature. Modern cryotherapy devices mostly consist of some sort of cuff that can be wrapped around the knee, with a connecting tube to a central unit that supplies and circulates cold water to and from the cuff in order to cool the intended body part. The Hilotherm is one such device for use in this way, but its ability to reduce skin temperature to within the target therapeutic range is unknown. The aim of this study is to determine whether the Hilotherm device is capable of reducing skin temperature of the knee to within the 10-15℃ therapeutic range during a standard 30-minute treatment.

Conditions

  • Temperature Change, Body

Interventions

DEVICE

Hilotherm cryocompression device

An electronic device that is capable of circulating warm or cooled water at a user-selected temperature between 10-30℃. Water is circulated from a central unit, through a tube, to a cuff wrapped around the intended therapy area (the knee). A treatment lasts for 30-minutes, at which point the device is turned off and the cuff is removed from the limb of the user.

Sponsors & Collaborators

  • Physiolab Technologies Ltd

    collaborator INDUSTRY

  • University of Winchester

    lead OTHER

Principal Investigators

  • James Faulkner, PhD · University of Winchester

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05789290 on ClinicalTrials.gov