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

NCT ID: NCT00506363

Last Updated: 2009-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

pulsed dye laser and dynamic cooling device on the day of suture removal

Group Type EXPERIMENTAL

pulsed dye laser therapy

Intervention Type PROCEDURE

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.

B

pulsed dye laser and dynamic cooling device 2 months after suture removal

Group Type ACTIVE_COMPARATOR

pulsed dye laser therapy

Intervention Type PROCEDURE

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.

C

dynamic cooling device

Group Type SHAM_COMPARATOR

pulsed dye laser therapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tehran University of Medical Sciences

Principal Investigators

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Alireza Firooz, MD

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

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Center for research and training in skin diseases and leprosy

Tehran, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type BACKGROUND
PMID: 12534515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16393593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11207693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7739306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16393594 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17300600 (View on PubMed)

Davari P, Gorouhi F, Hashemi P, Behnia F, Ghassemi A, Nasiri-Kashani M, Firooz A. Pulsed dye laser treatment with different onset times for new surgical scars: a single-blind randomized controlled trial. Lasers Med Sci. 2012 Sep;27(5):1095-8. doi: 10.1007/s10103-011-1044-5. Epub 2012 Jan 8. No abstract available.

Reference Type DERIVED
PMID: 22228413 (View on PubMed)

Other Identifiers

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423/2224-B

Identifier Type: -

Identifier Source: org_study_id

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