Effect of Nd-YAG Laser on Hypertrophic Scar

Hypertrophic Scar Clinical Trial

— Nd-YAG  

Official title:

Efficacy of a Long-Pulsed 1064 nm Nd:YAG Laser (Neodymium-doped Yttrium Aluminium Garnet) for Hypertrophic Scars: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06347081
• Other study ID #: P.T.REC/012/00449
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

IInclusion 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).

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy

Intervention

Procedure:
• Nd- YAG laser at 532nm wavelength
Nd-YAG laser at 532nm wavelength every 2 weeks for 14 sessions. patients will also receive standard medical care, nursing, physiotherapy

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypertrophic scar maturation	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.	before treatment,12 weeks, and then 28 weeks of the treatment.
Primary	hypertrophic scar volume	Scar volume was determined using the negative-positive moulage method.	before treatment,12 weeks, and then 28 weeks of the treatment.