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

NCT00506363 | Terminated

• 1 other identifier: 423/2224-B
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 onset times of treatment with pulsed dye laser on improvement of surgical scars.

Conditions

Scar

Keywords

scar; surgery; lasers

Outcome Measures

Primary Outcomes (1)

• pigmentation, pliability, width and height of surgical scars

  baseline, middle of the study, 1 and 3 months after the last treatment session

Secondary Outcomes (1)

• 1- Clinical appearance of scar 2- Patient's satisfaction (scar erythema, scar thickness and scar induration) - Adverse events

  1 and 3 months after the last treatment session

Study Arms (3)

A

EXPERIMENTAL

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

Procedure: pulsed dye laser therapy

B

ACTIVE COMPARATOR

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

Procedure: pulsed dye laser therapy

C

SHAM COMPARATOR

dynamic cooling device

Procedure: pulsed dye laser therapy

Interventions

pulsed dye laser therapy 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.

A; B; C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical scar with minimum length of 6 cm

You may not qualify if:

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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Center for research and training in skin diseases and leprosy

Tehran, 14166, Iran

Location

Related Publications (7)

• 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.

  PMID: 12534515 BACKGROUND

• 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.

  PMID: 16393593 BACKGROUND

• 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.

  PMID: 11207693 BACKGROUND

• 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.

  PMID: 7739306 BACKGROUND

• 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.

  PMID: 16393594 BACKGROUND

• 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.

  PMID: 17300600 BACKGROUND

• 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.

  PMID: 22228413 DERIVED

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alireza Firooz, MD

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: October 6, 2009

Record last verified: 2009-10

Locations

IR (1)