A Clinical Investigation With BARRIER® EasyWarm®

Molnlycke Health Care AB20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

BARRIER EasyWarmDEVICE

Application of BARRIER EasyWarm for 10 hours. The treatment with the investigational device will be according to the instruction stated on the investigational device.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

/Sahlgrenska University Hospital/Clinical Trial Center/Gothia Forum

Gothenburg, Sweden

Outcomes

Primary Outcomes

Skin temperature

Relative change in average skin temperature (ºC)

Time frame: 10 hours

Secondary Outcomes

Skin temperature 1

Relative change in average skin temperature at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8 and 9 hours (ºC). Assessed with an IR camera.

Time frame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 hours

Skin temperature 2

Maximum skin temperature at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours (ºC). Assessed with an IR camera.

Time frame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and10 hours

Skin temperature 3

Average skin temperature at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours (ºC). Assessed with an IR camera.

Time frame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours

Body Core Temperature 1

Body core temperature (ºC) at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours. Assessed with an ear thermometer.

Time frame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours

Body Core temperature 2

Relative change in body core temperature (ºC) at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours compared to baseline. Assessed with an ear thermometer.

Time frame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours

Heat perception

Five-point question related to perception of heat from the BARRIER EasyWarm. Assessed at 30 minutes, 5 hours and 10 hours post application. Scale: Cold, cool, not cool or warm, warm, hot.

Data from ClinicalTrials.gov

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