Treatment of Surgical Scars With Fractional Photothemolysis Versus Pulse Dye Laser
Primary Purpose
Post Surgical Scars
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser treatment
Sponsored by
About this trial
This is an interventional treatment trial for Post Surgical Scars focused on measuring Fraxel, Pulsed dye laser, Surgical scars
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years old;
- Be otherwise healthy;
- Be treated by Dr. Kouba for a skin cancer surgery or plastic surgery procedure
- Agree to attend up 6 sessions post Mohs surgery (2-4 laser treatment sessions and 2 follow-up visits post-laser)
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
- Agree to follow and undergo all study-related procedures.
Exclusion Criteria:
- Patients who do not meet the criteria above and/or who fail to follow their post-operative instructions or make both of their post-operative clinic appointments.
- The control for this study will be the side of the scar treated with the V-Beam Pulse Dye Laser
- We will be speaking to patients at Henry Ford Dermatology regarding participation in our study. We will ensure that all patients understand the voluntary nature of their participation in the study. They will sign informed consent. In addition, we will be asking patients to give us their assessment of which side of their surgical wound had better improvement, the side treated with Fraxel laser versus the side treated with V-Beam Pulse Dye Laser.
Sites / Locations
- Department of Dermatology, Henry Ford Medical Center, 6530 Farmington Rd
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fraxel
PDL
Arm Description
Fraxel laser treatment
Pulsed dye laser treatment
Outcomes
Primary Outcome Measures
Overall cosmetic appearance, relative to adjacent skin and side effects.
Secondary Outcome Measures
skin matches surrounding skin, no scar formation visible, skin pigmentation and/or texture of scarred region is markedly different from surrounding skin).
Full Information
NCT ID
NCT00685243
First Posted
May 23, 2008
Last Updated
April 6, 2023
Sponsor
Henry Ford Health System
Collaborators
American Academy of Cosmetic Surgery
1. Study Identification
Unique Protocol Identification Number
NCT00685243
Brief Title
Treatment of Surgical Scars With Fractional Photothemolysis Versus Pulse Dye Laser
Official Title
Treatment of Surgical Scars With Fractional Photothemolysis Versus Pulse Dye Laser
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 2008 (Actual)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
American Academy of Cosmetic Surgery
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the efficacy of the Fraxel SR laser to improve the cosmetic appearance of surgical scars, both in terms of pigmentary and textural changes.
Evaluate the efficacy of the V-Beam Pulse Dye laser, a standard non-ablative laser which is utilized for the treatment of the erythematous and telangiectasia component of surgical scars.
Comparison of the outcome of the half of the surgical scar treated with Fraxel SR laser versus the outcome of the contralateral half of the surgical scar which will be treated with the V-Beam Pulse Dye Laser.
Detailed Description
RATIONALE FOR THE PROJECT
Surgical scars are a challenging condition to treat. The aesthetic outcome of surgical scars is of great importance to patients and physicians after reconstructive surgery. The current approaches for the treatment of surgical scars range from non-invasive approaches to aggressive treatments with re-excision or ablative resurfacing lasers. Fractional photothemolysis is a new technology whereby only microthermal zones of injury to the skin are created which triggers the wound healing response, leading to skin repair mechanisms to improve the appearance and textural changes associated with surgical scars.
Fractional photothemolysis (Fraxel SR laser, Reliant technologies, Inc) is a new technology whereby only microthermal zones of injury to the skin are created which triggers the wound healing response, leading to skin repair mechanisms to improve the appearance and textural changes associated with surgical scars. Fractionated resurfacing, with its significant proven efficacy in improving textural and pigmenatary abnormalities with a benign side effect profile, represents a promising novel treatment for surgical scars.
Aim:
Comparison of the outcome of the half of the surgical scar treated with Fraxel SR (Reliant Technologies, Inc.) laser versus the outcome of the contralateral half of the surgical scar which will be treated with the V-Beam Pulse Dye Laser
SIGNIFICANCE:
The cosmetic outcome of surgical scars is of paramount importance to surgeons and patients treated with both cosmetic and reconstructive surgery. It is impossible for surgeons to predict the wound healing properties of individual patients and particular anatomic sites and thus, there is little certainty that can be offered to patients about the cosmetic outcome of their surgical scars.
SUBJECTS IN THE PROJECT:
Inclusion Criteria:
For inclusion, the subject must:
Be at least 18 years old;
Be otherwise healthy;
Be treated by Dr. Kouba for a skin cancer surgery or plastic surgery procedure
Agree to attend up 6 sessions post Mohs surgery (2-4 laser treatment sessions and 2 follow-up visits post-laser)
Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
Agree to follow and undergo all study-related procedures.
Exclusion criteria:
A. Patients who do not meet the criteria above and/or who fail to follow their post-operative instructions or make both of their post-operative clinic appointments.
B. The control for this study will be the side of the scar treated with the V-Beam Pulse Dye Laser
C. We will be speaking to patients at Henry Ford Dermatology regarding participation in our study. We will ensure that all patients understand the voluntary nature of their participation in the study. They will sign informed consent. In addition, we will be asking patients to give us their assessment of which side of their surgical wound had better improvement, the side treated with Fraxel laser versus the side treated with V-Beam Pulse Dye Laser.
PROJECT DESIGN AND PROCOTOL:
A comparison trial of surgical scars treated with Fraxel SR Laser (Reliant Technologies, Inc.) versus V-Beam Pulse Dye Laser (Candela Corporation) in 15 patients who underwent Mohs surgery and resultant cosmetic surgical reconstruction at Henry Ford Health System Department of Dermatology.
At a minimum of 2 months post surgical reconstruction, patients will be eligible for inclusion in this research study. During each 2 weeks of the study, one side of the surgical scar will be treated with Fraxel SR (Reliant Technologies, Inc.) and the other half will be treated with the V-Beam Pulse Dye Laser (Candela Corporation) for aesthetic improvement of the scar
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Surgical Scars
Keywords
Fraxel, Pulsed dye laser, Surgical scars
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fraxel
Arm Type
Active Comparator
Arm Description
Fraxel laser treatment
Arm Title
PDL
Arm Type
Active Comparator
Arm Description
Pulsed dye laser treatment
Intervention Type
Procedure
Intervention Name(s)
Laser treatment
Other Intervention Name(s)
-Fraxel SR Laser (Reliant Technologies, Inc.), -V-Beam Pulse Dye laser (Candela Corporation)
Intervention Description
Fraxel and pulsed dye laser
Primary Outcome Measure Information:
Title
Overall cosmetic appearance, relative to adjacent skin and side effects.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
skin matches surrounding skin, no scar formation visible, skin pigmentation and/or texture of scarred region is markedly different from surrounding skin).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years old;
Be otherwise healthy;
Be treated by Dr. Kouba for a skin cancer surgery or plastic surgery procedure
Agree to attend up 6 sessions post Mohs surgery (2-4 laser treatment sessions and 2 follow-up visits post-laser)
Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
Agree to follow and undergo all study-related procedures.
Exclusion Criteria:
Patients who do not meet the criteria above and/or who fail to follow their post-operative instructions or make both of their post-operative clinic appointments.
The control for this study will be the side of the scar treated with the V-Beam Pulse Dye Laser
We will be speaking to patients at Henry Ford Dermatology regarding participation in our study. We will ensure that all patients understand the voluntary nature of their participation in the study. They will sign informed consent. In addition, we will be asking patients to give us their assessment of which side of their surgical wound had better improvement, the side treated with Fraxel laser versus the side treated with V-Beam Pulse Dye Laser.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kouba, MD, PhD
Organizational Affiliation
Department of Dermatology, Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Henry Ford Medical Center, 6530 Farmington Rd
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8192370
Citation
Alster TS. Improvement of erythematous and hypertrophic scars by the 585-nm flashlamp-pumped pulsed dye laser. Ann Plast Surg. 1994 Feb;32(2):186-90. doi: 10.1097/00000637-199402000-00015.
Results Reference
background
PubMed Identifier
16581684
Citation
Behroozan DS, Goldberg LH, Dai T, Geronemus RG, Friedman PM. Fractional photothermolysis for the treatment of surgical scars: a case report. J Cosmet Laser Ther. 2006 Apr;8(1):35-8. doi: 10.1080/14764170600607251.
Results Reference
background
Learn more about this trial
Treatment of Surgical Scars With Fractional Photothemolysis Versus Pulse Dye Laser
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