Donor Site Healing Response to Low Level Laser Therapy Following Skin Graft Surgery

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

2022-11-01

Study Completion Date

2023-04-30

Brief Summary

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PURPOSE:

The purpose of the study is to evaluate the effect of (LLLT) on donor site wound healing following skin graft surgery.

BACKGROUND:

The skin graft is a beneficial reconstructive technique for accelerating wound healing .Managing donor site after graft harvesting is very important, and often, patients have more discomfort at the donor site than the recipient burn site itself.Using techniques that accelerate wound healing may enhance patient satisfaction.

Low-level laser therapy (LLLT) has been used in several medical fields, including healing of diabetic, surgical, and pressure ulcers.

Accelerating the healing process and reducing pain during healing are beneficial for the following reasons: faster return to work, lower risk of wound infection, improved quality of life, and possibly reduced need for analgesia.

HYPOTHESES:

It is hypothesized that:

Low level laser therapy has a positive effect on donor site wound healing following skin graft surgery in burned patients.

RESEARCH QUESTION:

Is low level laser therapy has a positive effect on donor site healing following skin graft surgery in burned patients?

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Detailed Description

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Conditions

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Skin Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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laser group

active low level laser therapy and conventional medical treatment.

Group Type EXPERIMENTAL

low level laser therapy

Intervention Type DEVICE

They recieved LLLT 1 session daily, 3 session per week for 3 weeks,with the following parameters( 650 nm wavelength, 150 mw power output, 0.25 cm2 radiation area, 0.6 W/cm2 power density, continuous mode, 2 j/ cm2, 90 seconds / cm2) in addition to the conventional medical treatment and traditional wound care (dressing)

placebo group

placebo laser and conventional medical treatment

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BEHAVIORAL

They received placebo laser 1 session daily, 3 session per week for 3 weeks in addition to the conventional medical treatment and traditional wound care (dressing)

Interventions

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low level laser therapy

They recieved LLLT 1 session daily, 3 session per week for 3 weeks,with the following parameters( 650 nm wavelength, 150 mw power output, 0.25 cm2 radiation area, 0.6 W/cm2 power density, continuous mode, 2 j/ cm2, 90 seconds / cm2) in addition to the conventional medical treatment and traditional wound care (dressing)

Intervention Type DEVICE

placebo

They received placebo laser 1 session daily, 3 session per week for 3 weeks in addition to the conventional medical treatment and traditional wound care (dressing)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients are both males and females.
* Their Age will be range between 20-40 years.
* All patients suffering from third degree burn with TBSA for burn will be ranged from 20% to 35%.
* All patients undergoing split thickness skin graft surgery.
* All patients will begin the treatment program from the 1st day post operative
* All patients enrolled to the study will have their informed consent.
* All patients have donor sites from the thigh.

Exclusion Criteria

* • Patients with associated diseases (Diabetes mellitus, infectious diseases, autoimmune disease) that will interfere with the healing process.

* Patients taking medication that alter the healing process (e.g., corticosteroids, chemotherapy or radiation.
* Pregnancy or epilepsy.
* Elderly patients.
* Subjects who have photosensitive problems
* History of trauma or accidental injuries.
* Skin diseases.
* History of surgery on particular donor site.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes