Safety and Efficacy of Different Intervals of Pulsed Dye Laser Sessions on Improvement of Surgical Scars
Primary Purpose
Scar
Status
Withdrawn
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
pulsed dye laser therapy
Sponsored by
About this trial
This is an interventional prevention trial for Scar focused on measuring scar, surgery, lasers
Eligibility Criteria
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
Sites / Locations
- Center for research and training in skin diseases and leprosy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
A
B
C
Arm Description
pulsed dye laser and dynamic cooling device at 3 weeks intervals
pulsed dye laser and dynamic cooling device at 6 weeks intervals
dynamic cooling device
Outcomes
Primary Outcome Measures
pigmentation, pliability, width and height of surgical scars
Secondary Outcome Measures
1- Clinical appearance of surgical scars 2- Patient's satisfaction (scar erythema, scar thickness and scar induration) 3- Adverse events
Full Information
NCT ID
NCT00506090
First Posted
July 23, 2007
Last Updated
October 4, 2009
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00506090
Brief Title
Safety and Efficacy of Different Intervals of Pulsed Dye Laser Sessions on Improvement of Surgical Scars
Official Title
The Effect of Different Intervals of 595-nm Pulsed Dye Laser Sessions on Improvement of Surgical Scars: A Double Blind Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Because of unsatisfactory results of previous trial which assessed the effect of different onset times of PDL on surgical scars.
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 intervals of pulsed dye laser sessions on improvement of surgical scars.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar
Keywords
scar, surgery, lasers
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
pulsed dye laser and dynamic cooling device at 3 weeks intervals
Arm Title
B
Arm Type
Active Comparator
Arm Description
pulsed dye laser and dynamic cooling device at 6 weeks intervals
Arm Title
C
Arm Type
Sham Comparator
Arm Description
dynamic cooling device
Intervention Type
Procedure
Intervention Name(s)
pulsed dye laser therapy
Intervention Description
Treatment will begin on the day of suture removal. 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 at 3 weeks intervals for 6 sessions. Another part will be treated with pulsed dye laser and dynamic cooling device at 6 weeks intervals for 6 sessions. Only dynamic cooling device will be used for remaining part serving as control.
Primary Outcome Measure Information:
Title
pigmentation, pliability, width and height of surgical scars
Time Frame
baseline, middle of the study, 1 and 3 months after the last treatment session
Secondary Outcome Measure Information:
Title
1- Clinical appearance of surgical scars 2- Patient's satisfaction (scar erythema, scar thickness and scar induration) 3- Adverse events
Time Frame
1 and 3 months after the last treatment session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Firooz, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for research and training in skin diseases and leprosy
City
Tehran
ZIP/Postal Code
14166
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
12534515
Citation
Nouri K, Jimenez GP, Harrison-Balestra C, Elgart GW. 585-nm pulsed dye laser in the treatment of surgical scars starting on the suture removal day. Dermatol Surg. 2003 Jan;29(1):65-73; discussion 73. doi: 10.1046/j.1524-4725.2003.29014.x.
Results Reference
background
PubMed Identifier
16393593
Citation
Conologue TD, Norwood C. Treatment of surgical scars with the cryogen-cooled 595 nm pulsed dye laser starting on the day of suture removal. Dermatol Surg. 2006 Jan;32(1):13-20. doi: 10.1111/1524-4725.2006.32002.
Results Reference
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PubMed Identifier
11207693
Citation
Paquet P, Hermanns JF, Pierard GE. Effect of the 585 nm flashlamp-pumped pulsed dye laser for the treatment of keloids. Dermatol Surg. 2001 Feb;27(2):171-4. doi: 10.1046/j.1524-4725.2001.00169.x.
Results Reference
background
PubMed Identifier
7739306
Citation
Alster TS, Williams CM. Treatment of keloid sternotomy scars with 585 nm flashlamp-pumped pulsed-dye laser. Lancet. 1995 May 13;345(8959):1198-200. doi: 10.1016/s0140-6736(95)91989-9.
Results Reference
background
PubMed Identifier
16393594
Citation
Alam M, Pon K, Van Laborde S, Kaminer MS, Arndt KA, Dover JS. Clinical effect of a single pulsed dye laser treatment of fresh surgical scars: randomized controlled trial. Dermatol Surg. 2006 Jan;32(1):21-5. doi: 10.1111/1524-4725.2006.32029.
Results Reference
background
PubMed Identifier
17300600
Citation
Manuskiatti W, Wanitphakdeedecha R, Fitzpatrick RE. Effect of pulse width of a 595-nm flashlamp-pumped pulsed dye laser on the treatment response of keloidal and hypertrophic sternotomy scars. Dermatol Surg. 2007 Feb;33(2):152-61. doi: 10.1111/j.1524-4725.2006.33033.x.
Results Reference
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Safety and Efficacy of Different Intervals of Pulsed Dye Laser Sessions on Improvement of Surgical Scars
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