A Clinical Investigation With BARRIER® EasyWarm®

Healthy Volunteers Clinical Trial

— EasyWarm01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04813809
• Other study ID #: EasyWarm01
• Status: Completed
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: April 29, 2021

Study information

• Verified date: May 2021
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 29, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
Sweden	/Sahlgrenska University Hospital/Clinical Trial Center/Gothia Forum	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin temperature	Relative change in average skin temperature (ºC)	10 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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