Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden

Not Applicable

Withdrawn

• Conditions: Skin Scarring
• Interventions: Other: CO2 Laser Administration

• Registration Number: NCT03306628
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-09
• Study First Posted: 2017-10-11
• Study Start: 2017-11-15
• Primary Completion: 2019-08-26
• Study Completion: 2019-08-26
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late Laser Therapy	CO2 Laser Administration	a group which will receive laser therapy to one breast incision 6 weeks after surgery
Early Laser Therapy	CO2 Laser Administration	a group which will receive laser therapy to one breast incision at the first post-operative visit

Primary Outcome Measures

Name	Time	Method
Change in Vancouver Scar Scale Score	1 Week to Post Laser 1-Year	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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States