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

Study Overview
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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?

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

Conditions
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Skin Graft

Intervention / Treatment
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* Device: low level laser therapy
* Behavioral: placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laser group<br>active low level laser therapy and conventional medical treatment. | Device: low level laser therapy<br>* 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)<br>|
| Placebo Comparator: placebo group<br>placebo laser and conventional medical treatment | Behavioral: placebo<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of wound surface area at day 1 post-operative (pre-treatment)(baseline measurement) | Measurement of wound surface area by photography and image J software at day 1 | 1 day | 
| Measurement of wound surface area at day 11 post-operative (post-treatment) | Measurement of wound surface area by photography and image J software at day 11 | 11 day | 
| Measurement of wound surface area at day 21 post-operative (post-treatment) | Measurement of wound surface area by photography and image J software at day 21 | 21 day |