Effect of Nd-YAG Laser on Hypertrophic Scar

NCT ID: NCT06347081

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-02-28

Brief Summary

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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

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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.

Conditions

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Hypertrophic Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

one treatment one control group
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo

Patients received standard medical care, nursing, physiotherapy, and a sham laser during the course of treatment

Group Type PLACEBO_COMPARATOR

Nd- YAG laser at 532nm wavelength

Intervention Type PROCEDURE

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

Laser group

Patients received 532 nm laser radiation in addition to standard medical care, nursing, and physiotherapy.

Group Type ACTIVE_COMPARATOR

Nd- YAG laser at 532nm wavelength

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Noha F. mahmoud

Assis prof of rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Physical Therapy

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P.T.REC/012/00449

Identifier Type: -

Identifier Source: org_study_id

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