Efficacy of a Long-Pulsed 1064 nm Nd:YAG Laser (Neodymium-doped Yttrium Aluminium Garnet) for Hypertrophic Scars: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- hypertrophic scar maturation
Overview
Brief Summary
A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months.
T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures.
Detailed Description
Background: A hypertrophic scar is a serious health concern in the industrialized world. Objective: The impact of this study was to investigate the effect of the Nd-YAG laser at 532nm wavelength on hypertrophic scars. Patients and methods: Forty male and female patients with hypertrophic scars, ranging in age from fifteen to forty-five, were recruited from the burn patients' clinic within the Faculty of Physical Therapy, Cairo University, for this study. They were randomized into two equivalent groups. Group A (the control group) consisted of 20 patients who were given standard medical care, nursing, physiotherapy, and a sham laser during the course of treatment. In contrast, Group B (the study group) consisted of 20 patients who were given 532 nm laser radiation in addition to standard medical care, nursing, and physiotherapy. Treatment was conducted every 2 weeks for 14 sessions. Outcome measures included Vancouver Scar Scale score and scar volume. The assessment procedures were applied before the initiation of treatment (Pre), after 3 months (Post1) and after 7 months (Post 2) from the beginning of the treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients with hypertrophic scars.
Exclusion Criteria
- •Patients were excluded if they had taken oral retinoids in the last year.
- •Patients had any skin defects.
- •Patients had any history of photosensitivity.
- •Patients experienced active skin diseases in the treatment regions (such as psoriasis, cancer, or autoimmune disease).
Outcomes
Primary Outcomes
hypertrophic scar maturation
Time Frame: before treatment,12 weeks, and then 28 weeks of the treatment.
Changes in the scars' color, vascularity, elevation, and pliability were evaluated and scored using the Vancouver scale (VSS). VSS is from 0 to 14. A lower value indicates a better scar.
hypertrophic scar volume
Time Frame: before treatment,12 weeks, and then 28 weeks of the treatment.
Scar volume was determined using the negative-positive moulage method.
Secondary Outcomes
No secondary outcomes reported
Investigators
Noha F. mahmoud
Assis prof of rehabilitation
Cairo University