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Effect of Externally Implantable Tissue Expansion Device on Scar Length

NCT ID: NCT00798798

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Implantable Tissue Expansion Device

Will apply externally implantable tissue expansion device for 2 days

Group Type EXPERIMENTAL

Externally Implantable Tissue Expansion Device

Intervention Type DEVICE

Will Apply Externally Implantable Tissue Expansion Device for 2 Days

Interventions

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Externally Implantable Tissue Expansion Device

Will Apply Externally Implantable Tissue Expansion Device for 2 Days

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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MA-STU2545

Identifier Type: -

Identifier Source: org_study_id