Study of Skin and Muscle Parameters Using a Skin Sensor

Northwestern University

Status: Completed

Conditions: Skin Wounds

Treatments: Device: Skin sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT01722929

STU69718

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Skin sensor on surgery side

Experimental group

Description:

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.

Treatment:

Device: Skin sensor

Skin sensor on non-surgery side

Active Comparator group

Description:

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.

Treatment:

Device: Skin sensor