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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

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.

Condition or disease Intervention/treatment Phase
Skin Scarring Other: CO2 Laser Administration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : August 26, 2019
Estimated Study Completion Date : August 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: Early Laser Therapy
a group which will receive laser therapy to one breast incision at the first post-operative visit
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).

Experimental: Late Laser Therapy
a group which will receive laser therapy to one breast incision 6 weeks after surgery
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).




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306628


Contacts
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Contact: Catherine Motosko 646 501 4480 Catherine.Motosko@med.nyu.edu

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Catherine Motosko    646-501-4480    Catherine.Motosko@med.nyu.edu   
Principal Investigator: Alexes Hazen, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Alexes Hazen, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03306628     History of Changes
Other Study ID Numbers: 17-01153
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NYU Langone Health:
Skin Scarring
keloids
hypertrophic scars
CO2 laser therapy

Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes