Skin Wounds
Conditions
Brief summary
The aim of this study is to assess the role of skin sensors in obtaining reliable and accurate serial measurements of skin parameters in the context of cutaneous skin wound healing.
Interventions
DEVICESkin sensor
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participants had the skin sensor measure temperature both near a surgery site and also near a non-surgery site. There is one intervention (skin sensor) and the participants were assigned to both arms surgery side and non-surgery side in parallel.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and Females age 18 and over * Recent (post-operative day 0-90) skin surgery of the trunk,extremities, head or neck for minor skin problems resulting in sutured wounds or open granulating wounds. * Otherwise good general health as assessed by the investigator * The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Exclusion criteria
* Under 18 years of age * Pregnancy or Lactation * Subjects who are unable to understand the protocol or to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure Temperature at 3 Time Points | Baseline, 48 hours from baseline, and 2 weeks from baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgery Side and Non-surgery Side All study participants had the skin sensor placed near the site of their surgery wound, and also on a site without any surgery wound. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Surgery Side and Non-surgery Side |
|---|---|
| Age, Continuous | 69.75 years STANDARD_DEVIATION 12.21 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Measure Temperature at 3 Time Points
Time frame: Baseline, 48 hours from baseline, and 2 weeks from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skin Sensor on Surgery Side | Measure Temperature at 3 Time Points | 48 hrs from Baseline | 31.87 Degrees Celsius | Standard Deviation 0.35 |
| Skin Sensor on Surgery Side | Measure Temperature at 3 Time Points | Baseline | 29.89 Degrees Celsius | Standard Deviation 0.09 |
| Skin Sensor on Surgery Side | Measure Temperature at 3 Time Points | 2 Weeks from Baseline | 33.01 Degrees Celsius | Standard Deviation 0.03 |
| Skin Sensor on Non-surgery Side | Measure Temperature at 3 Time Points | Baseline | 31.13 Degrees Celsius | Standard Deviation 0.17 |
| Skin Sensor on Non-surgery Side | Measure Temperature at 3 Time Points | 48 hrs from Baseline | 32.02 Degrees Celsius | Standard Deviation 0.15 |
| Skin Sensor on Non-surgery Side | Measure Temperature at 3 Time Points | 2 Weeks from Baseline | 33.45 Degrees Celsius | Standard Deviation 0.13 |
Comparison: A mixed ANOVA was performed with the arms as a between factor and the three times as the within factor.p-value: <0.0001Mixed Models Analysis