NCT00969475

Brief Summary

The purpose of this study is to determine if fractional carbon dioxide laser treatment of a fresh wound at the time of surgery, decreases scar formation. Scar revision is commonly done at 6-10 weeks following surgery. Therefore, it may be more beneficial, for both the patient and physician, to perform scar revision at the time of surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

2 months

First QC Date

August 29, 2009

Last Update Submit

September 13, 2009

Conditions

Scars

Keywords

scar revisionintraoperativefractional carbon dioxide laser

Outcome Measures

Primary Outcomes (1)

  • Evidence of scar improvement as assessed by blinded-observer and patient ratings.

    At two and six weeks following the procedure

Study Arms (2)

Control

NO INTERVENTION

Half of each subject's wound will not be treated.

Laser resurfacing

EXPERIMENTAL

Half of each subject's wound will be treated with a fractional CO2 laser.

Device: Lumenis fractional carbon dioxide laser

Interventions

Lumenis fractional carbon dioxide laserDEVICE

intra-operative laser resurfacing at time of wound closure

Also known as: Lumenis
Laser resurfacing

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing skin cancer surgery
  • Will have a straight-line incision
  • Fluent in English
  • Must reside in the Los Angeles vicinity for the duration of the study

You may not qualify if:

  • Non-English speakers
  • Pregnant or cognitively impaired subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moy-Fincher Medical Group

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Ozog, MD

    Moy-Fincher Medical Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Telia DeBoyes

CONTACT

tdeboyes@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2009

First Posted

September 1, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

US(1)