Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

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.

Study Overview

• Status: Terminated
• Conditions: Scar Prevention
• Intervention / Treatment: 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
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Ronald L. Moy, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Thin skin; Single fractional CO2 treatment at surgical area closure procedure on thin skin	Device: Lumenis UltraPulse single fractional CO2 laser treatment thin skin
EXPERIMENTAL: Thick skin; Single fractional CO2 treatment at surgical area closure procedure on thick skin	Device: Single fractional CO2 treatment at surgical area closure procedure on thick skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Scar appearance by blinded evaluation of photographs of the three month follow-up visit	three month follow-up

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (ESTIMATE): April 9, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 25, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: CO2 fractional laser; Scar prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: LUM-ABU-UP-13-01