NCT00798798

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

December 3, 2021

Status Verified

December 1, 2021

Enrollment Period

2.5 years

First QC Date

November 24, 2008

Last Update Submit

December 1, 2021

Conditions

Skin Lesion

Outcome Measures

Primary Outcomes (1)

  • Surface area (in cm2) of subject's scar

    3 months

Secondary Outcomes (1)

  • Treating physicians will note any adverse effects

    3 months

Study Arms (1)

Implantable Tissue Expansion Device

EXPERIMENTAL

Will apply externally implantable tissue expansion device for 2 days

Device: Externally Implantable Tissue Expansion Device

Interventions

Externally Implantable Tissue Expansion DeviceDEVICE

Will Apply Externally Implantable Tissue Expansion Device for 2 Days

Implantable Tissue Expansion Device

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Dermatology

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Murad Alam, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 26, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

December 3, 2021

Record last verified: 2021-12

Locations

US(1)