Back to resultsEarly Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
Primary Purpose
Skin Scarring
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CO2 Laser Administration
Sponsored by
About this trial
This is an interventional treatment trial for Skin Scarring focused on measuring Skin Scarring, keloids, hypertrophic scars, CO2 laser therapy
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Early Laser Therapy
Late Laser Therapy
Arm Description
a group which will receive laser therapy to one breast incision at the first post-operative visit
a group which will receive laser therapy to one breast incision 6 weeks after surgery
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03306628
Brief Title
Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
Official Title
Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Dr. Hazen is no longer full-time faculty / was not able to find an appropriate PI to take over study.
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
August 26, 2019 (Anticipated)
Study Completion Date
August 26, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Scarring
Keywords
Skin Scarring, keloids, hypertrophic scars, CO2 laser therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Laser Therapy
Arm Type
Experimental
Arm Description
a group which will receive laser therapy to one breast incision at the first post-operative visit
Arm Title
Late Laser Therapy
Arm Type
Experimental
Arm Description
a group which will receive laser therapy to one breast incision 6 weeks after surgery
Intervention Type
Other
Intervention Name(s)
CO2 Laser Administration
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Vancouver Scar Scale Score
Description
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
Time Frame
1 Week to Post Laser 1-Year
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexes Hazen, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
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