Scar Prevention Using Fractional Carbon Dioxide Laser Treatment



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:5/3/2014
Start Date:January 2013
Contact:Daniella Bleistein, Msc
Email:daniella.bleistein@lumenis.com
Phone:+972-54-9599353

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In this study the investigators intend to determine the impact of fractional CO2 laser
treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g.
face, hands, arms, thorax, etc.) and on thick skin (abdominoplasty procedure) on scar
formation. The investigators will also evaluate the effect of shallow fractional laser
treatment versus deep parameters settings. If effective treatments could be performed at
time of surgery, this would result in both time and cost saving to the patient and to the
healthcare system and will improve patient's self-image post surgeries.


Inclusion Criteria:

- Male or Females

- At least 18 and no more than 65 years old

- The surgical area closure in these subjects should be at least 4cm

- Type of surgery scheduled:

Site 1: Surgical area closure on thin skin, including areas that require motion (e.g.
face, hands, arms, thorax, etc.) Site 2: Surgical area closure on thick skin
(abdominoplasty procedure)

- Willing to comply with study dosing and complete the entire course of the study

Exclusion Criteria:

- Active bacterial, fungal, or viral infection in the treatment area

- Active cold sores, or herpes in the treatment area

- Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning
beds/booths and/or sunbathing) or expectations of tanning during the time of the
study

- History of skin cancer, unless the surgical procedure of issue is for cancer
treatment purposes.

- History of or the presence of any skin condition/disease that might interfere with
the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema,
psoriasis)

- Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche
Dermatologics)

- History or presenting with a keloid scar

- Any current or recent treatment for cancer, unless the surgical procedure of issue is
for cancer treatment purposes.

- Any uncontrolled systemic disease. A potential subject in whom therapy for a systemic
disease is not yet stabilized will not be considered for entry into the study

- Significant history or current evidence of a medical, psychological or other disorder
that, in the investigator's opinion, would preclude enrollment into the study.

- Subject planning any other cosmetic procedure to the study area during the study
period, other than the treatments that will be performed by the investigator

- Female subject who is pregnant, nursing an infant or is less than 6 months after
termination of breast feeding

- Small surgical closure (<4cm)
We found this trial at
1
site
Beverly Hills, California 90210
?
mi
from
Beverly Hills, CA
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