N/A Completed N=26

Safety and Feasibility of Prima-Temp Thermometer Patch

Erythema · Edema · Papules White · Eruption

Source: ClinicalTrials.gov NCT01587014 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcomePrimary: Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch — 1 Adverse event

Summary

The purpose of this study is to test the safety and feasibility of the Prima-Temp Thermometer Patch in determining baseline temperatures of research subjects in a hospital intensive care unit (ICU). Primary Objective: Assess safety of the Prima-Temp temperature patch with nursing staff skin site assessments. Secondary Objective: Establish individual subject baseline temperature using intermittent temperature measurements (every 5 minutes) with the Prima-Temp thermometer patch and wireless transmission of the data to a receiver box and HIPAA compliant, centrally located personal computer (PC) and compare research subject's baseline temperature with temperatures taken in the ICU in the normal course of care.

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch	1	—
SECONDARY Determine Research Subject's Baseline Temperature.	—	—

Eligibility Criteria

Inclusion Criteria

Men and women of any race.
Men of age > 18 years
Women with no childbearing potential (age > 50, age ≥ 18 s/p hysterectomy)
Arm circumference >23 cm and < 38 cm

Exclusion Criteria

Patient with known or documented adhesive, Tegaderm allergies.
Abnormal axillary integument such as rashes, burns, laceration.
Hidradenitis suppurativa and/or dermatologic diseases that might interfere with the evaluation of the test site reactions.
Non-English speakers
Pregnant women
Patient requiring hypothermic therapy, with the exception of non-steroidal anti-inflammatory treatment (acetaminophen, ibuprofen, aspirin, etc).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01587014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.