Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden

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.

Study Overview

• Status: Withdrawn
• Conditions: Skin Scarring
• Intervention / Treatment: Other: CO2 Laser Administration

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Laser Therapy; a group which will receive laser therapy to one breast incision at the first post-operative visit	Other: CO2 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).
Experimental: Late Laser Therapy; a group which will receive laser therapy to one breast incision 6 weeks after surgery	Other: CO2 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Alexes Hazen, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Anticipated): August 26, 2019
• Study Completion (Anticipated): August 26, 2019

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 9, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Skin Scarring; keloids; hypertrophic scars; CO2 laser therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: 17-01153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No