Study of Skin and Muscle Parameters Using a Skin Sensor

Not Applicable

Completed

• Conditions: Skin Wounds
• Interventions: Device: Skin sensor

• Registration Number: NCT01722929
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-07
• Study Start: 2013-06-04
• Primary Completion: 2013-09-16
• Study Completion: 2013-09-16
• Results First Submitted: 2017-09-13
• Results First Submitted QC: 2017-10-31
• Results First Posted: 2017-12-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

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Exclusion Criteria

• Under 18 years of age
• Pregnancy or Lactation
• Subjects who are unable to understand the protocol or to give informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skin sensor on non-surgery side	Skin sensor	Skin sensor will be placed on the contralateral side from surgery site.This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body.
Skin sensor on surgery side	Skin sensor	Skin sensor will be placed on the side that had surgery. This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body.

Primary Outcome Measures

Name	Time	Method
Measure Temperature at 3 Time Points	Baseline, 48 hours from baseline, and 2 weeks from baseline

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States