The Effect of Different Intervals of 595-nm Pulsed Dye Laser Sessions on Improvement of Surgical Scars: A Double Blind Randomised Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- pigmentation, pliability, width and height of surgical scars
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
pulsed dye laser and dynamic cooling device at 3 weeks intervals
Intervention: pulsed dye laser therapy (Procedure)
B
pulsed dye laser and dynamic cooling device at 6 weeks intervals
Intervention: pulsed dye laser therapy (Procedure)
C
dynamic cooling device
Intervention: pulsed dye laser therapy (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- 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)