Status:
WITHDRAWN
Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
Lead Sponsor:
NYU Langone Health
Conditions:
Skin Scarring
Eligibility:
FEMALE
21-80 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03306628
Start Date
November 15 2017
End Date
August 26 2019
Last Update
January 6 2020
Active Locations (1)
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1
New York University School of Medicine
New York, New York, United States, 10016