A Clinical Investigation With BARRIER® EasyWarm® (EasyWarm01)

A Prospective, Open, Non-comparative, Single-centre Investigation to Study the Effect of BARRIER® EasyWarm® Active Self-warming Blanket on Skin- and Body Core Temperatures in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: BARRIER EasyWarm

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 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
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • /Sahlgrenska University Hospital/Clinical Trial Center/Gothia Forum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BARRIER EasyWarm; This is an open, non randomised, single arm study	Device: BARRIER EasyWarm; Application of BARRIER EasyWarm for 10 hours. The treatment with the investigational device will be according to the instruction stated on the investigational device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin temperature	Relative change in average skin temperature (ºC)	10 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	30 minutes, 5 hours and 10 hours

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): April 29, 2021
• Study Completion (Actual): April 29, 2021

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Healthy volunteers; Body temperature; EasyWarm
• Other Study ID Numbers: EasyWarm01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No