Study of Skin and Muscle Parameters Using a Skin Sensor

NCT01722929 | Completed Results DMC

• 1 other identifier: STU69718
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Wounds

Outcome Measures

Primary Outcomes (1)

• Measure Temperature at 3 Time Points

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

Study Arms (2)

Skin sensor on surgery side

EXPERIMENTAL

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.

Device: Skin sensor

Skin sensor on non-surgery side

ACTIVE COMPARATOR

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.

Device: Skin sensor

Interventions

Skin sensor DEVICE

Skin sensor on non-surgery side; Skin sensor on surgery side

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Results Point of Contact

• Title: Murad Alam, MD
• Organization: Northwestern University

m-alam@northwestern.edu

312-695-4761

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 7, 2012
• Study Start: June 4, 2013
• Primary Completion: September 16, 2013
• Study Completion: September 16, 2013
• Last Updated: December 6, 2021
• Results First Posted: December 4, 2017

Record last verified: 2021-12

Locations

US (1)