Safety and Efficacy of Different Onset Times of Treatment With Pulsed Dye Laser on Improvement of Surgical Scars

October 4, 2009 updated by: Tehran University of Medical Sciences

The Effect of Different Onset Times of Treatment With 595-nm Pulsed Dye Laser on Improvement of Surgical Scars: A Double Blind Randomised Clinical Trial

The appearance of skin after surgery plays an important role in patient's self confidence and life style. In fact, Keloids and hypertrophic scars are abnormal wound responses appearing in predisposed individuals after surgery. Among different kind of lasers, used to improve the appearance of hypertrophic scars and keloids, pulsed dye laser is now being used successfully in treatment of scars. Pulsed dye laser is effective in improving the color, height, texture, and elasticity of scars. Also, treatment with this technique is noninvasive, minimally uncomfortable, and requires no anesthesia. This study will assess the efficacy and safety of different onset times of treatment with pulsed dye laser on improvement of surgical scars.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

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

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 14166
        • Center for research and training in skin diseases and leprosy

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgical scar with minimum length of 6 cm

Exclusion Criteria:

  • History of light sensitivity or photodermatoses
  • History of adverse reactions to laser treatment

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
pulsed dye laser and dynamic cooling device on the day of suture removal
Procedure: pulsed dye laser therapy
Each scar will be divided into 3 equal parts. One part will be randomly allocated to be treated with pulsed dye laser and dynamic cooling device on the day of suture removal. Another part will be treated with pulsed dye laser and dynamic cooling device 2 months after suture removal. Only dynamic cooling device will be used for remaining part serving as control. Treatment will repeat for 6 sessions at 3 weeks intervals.
Active Comparator: B
pulsed dye laser and dynamic cooling device 2 months after suture removal
Procedure: pulsed dye laser therapy
Each scar will be divided into 3 equal parts. One part will be randomly allocated to be treated with pulsed dye laser and dynamic cooling device on the day of suture removal. Another part will be treated with pulsed dye laser and dynamic cooling device 2 months after suture removal. Only dynamic cooling device will be used for remaining part serving as control. Treatment will repeat for 6 sessions at 3 weeks intervals.
Sham Comparator: C
dynamic cooling device
Procedure: pulsed dye laser therapy
Each scar will be divided into 3 equal parts. One part will be randomly allocated to be treated with pulsed dye laser and dynamic cooling device on the day of suture removal. Another part will be treated with pulsed dye laser and dynamic cooling device 2 months after suture removal. Only dynamic cooling device will be used for remaining part serving as control. Treatment will repeat for 6 sessions at 3 weeks intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pigmentation, pliability, width and height of surgical scars
Time Frame: baseline, middle of the study, 1 and 3 months after the last treatment session
baseline, middle of the study, 1 and 3 months after the last treatment session

Secondary Outcome Measures

Outcome Measure
Time Frame
1- Clinical appearance of scar 2- Patient's satisfaction (scar erythema, scar thickness and scar induration) - Adverse events
Time Frame: 1 and 3 months after the last treatment session
1 and 3 months after the last treatment session

Collaborators and Investigators

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

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Alireza Firooz, MD, Tehran University Of Medical Sciences

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

January 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

July 23, 2007

First Submitted That Met QC Criteria

July 23, 2007

First Posted (Estimate)

July 25, 2007

Study Record Updates

Last Update Posted (Estimate)

October 6, 2009

Last Update Submitted That Met QC Criteria

October 4, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 423/2224-B

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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