Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

Lumenis

Status

Terminated

Conditions

Scar Prevention

Treatments

Device: Lumenis UltraPulse single fractional CO2 laser treatment thin skin

Device: Single fractional CO2 treatment at surgical area closure procedure on thick skin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01826942

LUM-ABU-UP-13-01

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)