Clinical trial NCT04813809: A Clinical Investigation With BARRIER® EasyWarm®
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Body temperature
Healthy volunteers
EasyWarm
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Skin temperature
timeFrame: 10 hours
Secondary outcomes:
measure: Skin temperature 1
timeFrame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 hours
measure: Skin temperature 2
timeFrame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and10 hours
measure: Skin temperature 3
timeFrame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours
measure: Body Core Temperature 1
timeFrame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours
measure: Body Core temperature 2
timeFrame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours
measure: Heat perception
timeFrame: 30 minutes, 5 hours and 10 hours
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: /Sahlgrenska University Hospital/Clinical Trial Center/Gothia Forum
Study officials:
References: