Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden

NCT ID: NCT03306628

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2019-08-26

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.

Conditions

Skin Scarring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Laser Therapy

a group which will receive laser therapy to one breast incision at the first post-operative visit

Group Type: EXPERIMENTAL

CO2 Laser Administration

Intervention Type: OTHER

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).

Late Laser Therapy

a group which will receive laser therapy to one breast incision 6 weeks after surgery

Group Type: EXPERIMENTAL

CO2 Laser Administration

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• Patients undergoing bilateral breast reduction surgery

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexes Hazen, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

17-01153

Identifier Type: -

Identifier Source: org_study_id