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

Sponsor:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00506363

Purpose

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.

Condition	Intervention
Scar	Procedure: pulsed dye laser therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Scars

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:

pigmentation, pliability, width and height of surgical scars [ Time Frame: baseline, middle of the study, 1 and 3 months after the last treatment session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	January 2008
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506363

Locations

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

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Principal Investigator:

Alireza Firooz, MD

Tehran University of Medical Sciences

More Information

Publications:

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.

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.

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.

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.

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.

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.

Responsible Party:	Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00506363 History of Changes
Other Study ID Numbers:	423/2224-B
Study First Received:	July 23, 2007
Last Updated:	October 4, 2009
Health Authority:	Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:

scar
surgery
lasers

Additional relevant MeSH terms:

Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012