Trial Outcomes & Findings for Study of Skin and Muscle Parameters Using a Skin Sensor (NCT NCT01722929)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Baseline, 48 hours from baseline, and 2 weeks from baseline

Results posted on

2021-12-06

Participant milestones
Measure	Surgery Side and Non-surgery Side This is a split-body, parallel-designed study. All study participants had the skin sensor (the same intervention) placed near the site of their surgery wound, and also on a site without any surgery wound. Since this is split-body design with one intervention, participant flow will be limited to all study participants as one group to not double-count the number of participants.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Study of Skin and Muscle Parameters Using a Skin Sensor

Baseline characteristics by cohort
Measure	Surgery Side and Non-surgery Side n=4 Participants All study participants had the skin sensor placed near the site of their surgery wound, and also on a site without any surgery wound.
Age, Continuous	69.75 years STANDARD_DEVIATION 12.21 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

Timeframe: Baseline, 48 hours from baseline, and 2 weeks from baseline

Outcome measures
Measure	Skin Sensor on Surgery Side n=4 Participants Skin sensor will be placed on the side that had surgery. Sensor on surgery side. This is a split-body study. All participants will have the skin senor on both the surgery side and a non-surgery side.	Skin Sensor on Non-surgery Side n=4 Participants Skin sensor will be placed on the contralateral side from surgery site. Sensor on non-surgery side This is a split-body study. All participants will have the skin senor on both the surgery side and a non-surgery side.
Measure Temperature at 3 Time Points Baseline	29.89 Degrees Celsius Standard Deviation 0.09	31.13 Degrees Celsius Standard Deviation 0.17
Measure Temperature at 3 Time Points 48 hrs from Baseline	31.87 Degrees Celsius Standard Deviation 0.35	32.02 Degrees Celsius Standard Deviation 0.15
Measure Temperature at 3 Time Points 2 Weeks from Baseline	33.01 Degrees Celsius Standard Deviation 0.03	33.45 Degrees Celsius Standard Deviation 0.13

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Northwestern University

Phone: 312-695-4761