Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden

Skin Scarring Clinical Trial

Official title:

Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03306628
• Other study ID #: 17-01153
• Status: Withdrawn
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: August 26, 2019

Study information

• Verified date: January 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 26, 2019
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Skin Scarring

Intervention

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).

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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