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Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden

Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03306628
Enrollment
0
Registered
2017-10-11
Start date
2017-11-15
Completion date
2019-08-26
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Scarring

Keywords

Skin Scarring, keloids, hypertrophic scars, CO2 laser therapy

Brief summary

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.

Interventions

OTHERCO2 Laser Administration

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).

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Vancouver Scar Scale Score1 Week to Post Laser 1-YearTotal 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026