ScarsNCT00969475
The Effects of Fractional Carbon Dioxide (CO2) Laser Treatment Prior to Wound Closure
A study testing Lumenis fractional carbon dioxide laser in people with Scars, run by Moy-Fincher Medical Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Scars
- What is being tested?
- Lumenis fractional carbon dioxide laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-English speakers
- Pregnant or cognitively impaired subjects
Trial locations and contacts
1 site in 1 country.
Telia DeBoyes contact
United States1 site
Moy-Fincher Medical Group
Los Angeles, California, 90095
310-794-7422
David Ozog, MD
About this study
Official title: The Effects of Fractional CO2 Resurfacing Prior to Complex Wound Closure
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.
- Conditions
- Scars
- Being tested
- Lumenis fractional carbon dioxide laser
- Keywords
- scar revision, intraoperative, fractional carbon dioxide laser
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumenis fractional carbon dioxide laserDevice
Also called Lumenis
intra-operative laser resurfacing at time of wound closure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Lumenis fractional carbon dioxide laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of scar improvement as assessed by blinded-observer and patient ratings.
Measured: At two and six weeks following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moy-Fincher Medical Group
- Sponsor type
- University, hospital or other
- Investigators
- David Ozog, MD, Principal investigator, Moy-Fincher Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969475
- Sponsor's protocol ID
- MF-01
- Status last verified
- Sep 2009
- First submitted
- 29 Aug 2009
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fractional CO2 Resurfacing Prior to Complex Wound Closure
- ClinicalTrials.gov ID
- NCT00969475
- Acronym / sponsor ID
- MF-01
- Conditions
- Scars
- Keywords
- scar revision, intraoperative, fractional carbon dioxide laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Moy-Fincher Medical GroupUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 1 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Half of each subject's wound will not be treated. |
| Laser resurfacing | Experimental | Device: Lumenis fractional carbon dioxide laserHalf of each subject's wound will be treated with a fractional CO2 laser. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Non-English speakers
- Pregnant or cognitively impaired subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumenis fractional carbon dioxide laserAlso: Lumenisintra-operative laser resurfacing at time of wound closure | Device | Laser resurfacing |
Primary outcome
Evidence of scar improvement as assessed by blinded-observer and patient ratings.
Time frame: At two and six weeks following the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Telia DeBoyes contact
David Ozog, MD principal investigator
Moy-Fincher Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumenis fractional carbon dioxide laser in people with Scars, run by Moy-Fincher Medical Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Telia DeBoyes (tdeboyes@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of scar improvement as assessed by blinded-observer and patient ratings. (time frame: At two and six weeks following the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.