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Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden

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ClinicalTrials.gov Identifier: NCT03306628
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE October 4, 2017
First Posted Date  ICMJE October 11, 2017
Last Update Posted Date December 24, 2018
Actual Study Start Date  ICMJE November 15, 2017
Estimated Primary Completion Date August 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
Change in Vancouver Scar Scale Score [ Time Frame: 1 Week to Post Laser 1-Year ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03306628 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
Official Title  ICMJE Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Skin Scarring
Intervention  ICMJE 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).
Study Arms  ICMJE
  • Experimental: Early Laser Therapy
    a group which will receive laser therapy to one breast incision at the first post-operative visit
    Intervention: Other: CO2 Laser Administration
  • Experimental: Late Laser Therapy
    a group which will receive laser therapy to one breast incision 6 weeks after surgery
    Intervention: Other: CO2 Laser Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 26, 2019
Estimated Primary Completion Date August 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Catherine Motosko 646 501 4480 Catherine.Motosko@med.nyu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03306628
Other Study ID Numbers  ICMJE 17-01153
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexes Hazen, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP