NCT03306628

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2019

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

October 4, 2017

Last Update Submit

January 2, 2020

Conditions

Skin Scarring

Keywords

Skin Scarringkeloidshypertrophic scarsCO2 laser therapy

Outcome Measures

Primary Outcomes (1)

  • 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

    1 Week to Post Laser 1-Year

Study Arms (2)

Early Laser Therapy

EXPERIMENTAL

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

Other: CO2 Laser Administration

Late Laser Therapy

EXPERIMENTAL

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

Other: CO2 Laser Administration

Interventions

CO2 Laser AdministrationOTHER

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).

Early Laser TherapyLate Laser Therapy

Eligibility Criteria

Age21 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

CicatrixKeloidCicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alexes Hazen, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 11, 2017

Study Start

November 15, 2017

Primary Completion

August 26, 2019

Study Completion

August 26, 2019

Last Updated

January 6, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)