Effect of Externally Implantable Tissue Expansion Device... | NCT00798798

Studies
Effect of Externally Implantable Tissue Expansion Device on Scar Length

NCT00798798

Sponsor

Northwestern University

Status

Withdrawn

Last Update Posted

Dec 3, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Skin Lesion

Interventions

Externally Implantable Tissue Expansion Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inability to recruit eligible subjects

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Nov 24, 2008

First Submission Date that Met QC Criteria

Nov 24, 2008

First Posted Date

Nov 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2021

Last Update Posted Date

Dec 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Implantable Tissue Expansion Device	Experimental	Will apply externally implantable tissue expansion device for 2 days	Device: Externally Implantable Tissue Expansion Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Externally Implantable Tissue Expansion Device	Device	Will Apply Externally Implantable Tissue Expansion Device for 2 Days	Implantable Tissue Expansion Device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Murad Alam, MD	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University Dermatology		Chicago	Illinois	60611	United States