A Clinical Investigation With BARRIER® EasyWarm® (EasyWarm01)

Molnlycke Health Care

Status: Completed

Conditions: Healthy Volunteers

Treatments: Device: BARRIER EasyWarm

Study type: Interventional

Funder types: Industry

Identifiers

NCT04813809

EasyWarm01

Details and patient eligibility

About

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 temperatures. The investigation will enroll approximately 20 healthy volunteers in one investigation site and each subject will be evaluated for up to 10 hours in one visit.

Full 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 temperatures.

The investigation will enroll approximately 20 healthy volunteers in one investigation site. Each subject will be evaluated for up to 10 hours in one visit on site. Body core- and skin reference temperatures will be established before applying the blanket. After reference temperature assessments, the BARRIER EasyWarm is positioned on the subject with the neckline at the collarbone. Skin temperatures will be assessed with an IR camera and body core temperatures will be assessed with an ear thermometer at 30 min, 1 hour, 2, 3, 4, 5, 6, 7, 8, 9, and 10 hours post blanket application. Subject perception of heat from the blanket will be assessed at 30 minutes, 5 hours and 10 hours post blanket application by means of a five graded question.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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.

2. Impaired circulation/vascular disease

3. Impaired sensitivity/neuropathy

4. Active skin disease

5. Female with temperature variations due to menopause

6. Pregnancy or lactation at time of study participation.

7. Person not suitable for the investigation according to the clinician's judgement.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

BARRIER EasyWarm

Experimental group

Description:

This is an open, non randomised, single arm study

Treatment:

Device: BARRIER EasyWarm