Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden

Study Overview
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Brief Summary
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This is a prospective, randomized pilot study of patients who will undergo either early or late incisional laser therapy after breast reduction surgery to alleviate scar burden at NYU Langone Medical Center. The purpose of this study is to see how well carbon dioxide (CO2) laser therapy works at preventing scar formation after surgery.CO2 laser therapy is currently being used by dermatologists and plastic surgeons to help with scarring after acne and to rejuvenate the face; its benefits are now being explored by medical professionals in dermatology and cosmetic surgery to prevent scarring after surgery.

Official Title
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Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden

Conditions
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Skin Scarring

Intervention / Treatment
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* Other: CO2 Laser Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of all ethnic origins will be considered, although certain ethnic groups will be preferentially excluded more than others such as black and South Asian patients due to our exclusion criteria related to darker skin individuals (see below). Patients undergoing bilateral breast reduction surgery Exclusion Criteria: Males will be excluded from this study as male patients rarely undergo breast reduction surgery. When males do undergo breast reduction surgery for gynecomastia, it is often unilateral, and is performed with several techniques and incision types that are not typical employed during female breast reduction. Thus, for this study, only female patients will be considered (see below). Any patient enrolled in this study who shows evidence of delayed wound healing, dehiscence, or post operative infection at the first post operative visit will be excluded Patients with darker skin (Fitzpatrick IV and above), which is a well-known contraindication to laser therapy Pregnant patients Patients who have had prior breast surgery Patients who have had prior chest/breast irradiation Patients with the following diseases which interferes with wound healing: prior hypertrophic scarring/keloids, type I or type II Diabetes Mellitus, autoimmune diseases/collagen vascular diseases Patients who are active smokers Patients using blood thinners that cannot be stopped Patients who have used aspirin within a week of the procedure date

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Laser Therapy<br>a group which will receive laser therapy to one breast incision at the first post-operative visit | Other: CO2 Laser Administration<br>* The CO2 fractional laser system will be applied at a pulse energy setting of 50 millijoules and a density of 100 spots/cm2 on one of the breast incisions (either one week after surgery or six weeks after surgery, depending on the randomization group).<br>|
| Experimental: Late Laser Therapy<br>a group which will receive laser therapy to one breast incision 6 weeks after surgery | Other: CO2 Laser Administration<br>* The CO2 fractional laser system will be applied at a pulse energy setting of 50 millijoules and a density of 100 spots/cm2 on one of the breast incisions (either one week after surgery or six weeks after surgery, depending on the randomization group).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vancouver Scar Scale Score | Total of score of each measure below: Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2 Vascularity (0-3) Normal 0 Pink 1 Red 2 Purple 3 Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5 Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 >5 mm 3 | 1 Week to Post Laser 1-Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Scarring, keloids, hypertrophic scars, CO2 laser therapy