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Because of unsatisfactory results of previous trial which assessed the effect of different onset times of PDL on surgical scars.
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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 intervals of pulsed dye laser sessions on improvement of surgical scars.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | pulsed dye laser and dynamic cooling device at 3 weeks intervals |
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| B | Active Comparator | pulsed dye laser and dynamic cooling device at 6 weeks intervals |
|
| C | Sham Comparator | dynamic cooling device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulsed dye laser therapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| pigmentation, pliability, width and height of surgical scars | baseline, middle of the study, 1 and 3 months after the last treatment session |
| Measure | Description | Time Frame |
|---|---|---|
| 1- Clinical appearance of surgical scars 2- Patient's satisfaction (scar erythema, scar thickness and scar induration) 3- Adverse events | 1 and 3 months after the last treatment session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alireza Firooz, MD | Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for research and training in skin diseases and leprosy | Tehran | 14166 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12534515 | Background | 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. | |
| 16393593 | 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. |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 11207693 | 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. |
| 7739306 | 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. |
| 16393594 | 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. |
| 17300600 | 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. |