Treatment of Surgical Scars With Fractional Photothemolysis Versus Pulse Dye Laser

April 6, 2023 updated by: David M. Ozog, Henry Ford Health System
  1. Evaluate the efficacy of the Fraxel SR laser to improve the cosmetic appearance of surgical scars, both in terms of pigmentary and textural changes.
  2. 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.
  3. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Be at least 18 years old;
  2. Be otherwise healthy;
  3. Be treated by Dr. Kouba for a skin cancer surgery or plastic surgery procedure
  4. Agree to attend up 6 sessions post Mohs surgery (2-4 laser treatment sessions and 2 follow-up visits post-laser)
  5. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
  6. 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:

  1. 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.
  2. 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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • West Bloomfield, Michigan, United States, 48322
        • Department of Dermatology, Henry Ford Medical Center, 6530 Farmington Rd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Be at least 18 years old;
  2. Be otherwise healthy;
  3. Be treated by Dr. Kouba for a skin cancer surgery or plastic surgery procedure
  4. Agree to attend up 6 sessions post Mohs surgery (2-4 laser treatment sessions and 2 follow-up visits post-laser)
  5. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
  6. Agree to follow and undergo all study-related procedures.

Exclusion Criteria:

  1. 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.
  2. The control for this study will be the side of the scar treated with the V-Beam Pulse Dye Laser
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fraxel
Fraxel laser treatment
Procedure: Laser treatment
Fraxel and pulsed dye laser
Other Names:
  • -Fraxel SR Laser (Reliant Technologies, Inc.)
  • -V-Beam Pulse Dye laser (Candela Corporation)
Active Comparator: PDL
Pulsed dye laser treatment
Procedure: Laser treatment
Fraxel and pulsed dye laser
Other Names:
  • -Fraxel SR Laser (Reliant Technologies, Inc.)
  • -V-Beam Pulse Dye laser (Candela Corporation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall cosmetic appearance, relative to adjacent skin and side effects.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

American Academy of Cosmetic Surgery

Investigators

  • Principal Investigator: David Kouba, MD, PhD, Department of Dermatology, Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (Estimate)

May 28, 2008

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB4812

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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