Status:

COMPLETED

A Clinical Investigation With BARRIER® EasyWarm®

Lead Sponsor:

Molnlycke Health Care AB

Conditions:

Healthy Volunteers

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This investigation is a prospective, open, non-comparative, single-center investigation with the aim to investigate the effect of BARRIER EasyWarm active self-warming blanket on skin- and body core te...

Detailed Description

This investigation is a prospective, open, non-comparative, single-center investigation with the aim to investigate the effect of BARRIER EasyWarm active self-warming blanket on skin- and body core te...

Eligibility Criteria

Inclusion

  • Provision of informed consent
  • Adult males and females ≥ 18 years old
  • Able to maintain a supine position up to 10 hours.

Exclusion

  • Diseases/medical treatments that affect normal body temperature control:
  • I. Persons who have/have had thyroid disease or who are treated with medications affecting the thyroid hormones
  • II. Persons being treated with medication affecting normal body temperature control, based on investigator judgement.
  • Impaired circulation/vascular disease
  • Impaired sensitivity/neuropathy
  • Active skin disease
  • Female with temperature variations due to menopause
  • Pregnancy or lactation at time of study participation.
  • Person not suitable for the investigation according to the clinician's judgement.

Key Trial Info

Start Date :

April 14 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 29 2021

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT04813809

Start Date

April 14 2021

End Date

April 29 2021

Last Update

May 11 2021

Active Locations (1)

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1

/Sahlgrenska University Hospital/Clinical Trial Center/Gothia Forum

Gothenburg, Sweden, 41345