Effect of Externally Implantable Tissue Expansion Device on Scar Length

December 1, 2021 updated by: Murad Alam, Northwestern University
The purpose of this study is to assess whether brief use of an externally implantable tissue expansion device following excisional skin cancer surgery will significantly reduce the diameter of the final wound defect, and hence the length of the final linear primary closure. The secondary objective is to assess the functional benefits, if any, associated with use of the tissue expander.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Subjects ages 18-80 years old
  • Subjects who are undergoing an excision of a large cutaneous lesion
  • Subjects with an immediate post-excision wound defect at least 2.5 cm in diameter
  • Subjects undergoing surgery on the trunk or extremities
  • The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
  • Subjects who are willing to undergo no other treatments for the scars for the duration of the study.

Exclusion Criteria

  • Subjects with scalp wounds
  • Subjects who are unable to understand the protocol or give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implantable Tissue Expansion Device
Will apply externally implantable tissue expansion device for 2 days
Device: Externally Implantable Tissue Expansion Device
Will Apply Externally Implantable Tissue Expansion Device for 2 Days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surface area (in cm2) of subject's scar
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Treating physicians will note any adverse effects
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 26, 2008

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • MA-STU2545

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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