Class iv Versus Class Iiib Laser Therapy on Median Sternotomy Healing After Coronary Artery Bybass Graft

Study Overview
=================
Brief Summary
-----------------
LASER therapy is potent physiotherapy modalities, providing better sternotomy healing for patients who have undergone CABG surgery, compared with traditional wound care management alone. HLLT and LLLT were found to be the most effective methods for sternotomy healing post-CABG surgery, with HLLT offering superior performance in the case of the high deep penetration and significance less time needed to deliver the same joules/ cm compared to LLLT used for the wound site.

Detailed Description
-----------------
The aim of this study was to investigate the effects of class IV high-level laser therapy (HLLT) versus class IIIb low level laser therapy (LLLT) on sternotomy healing following coronary artery bypass grafting (CABG) surgery. Forty- five patients male patients who had CABG surgery in the age range of 45-65 years were divided randomly into three equal groups (n = 15). The group HLLT laser received HLLT plus traditional wound management, while the group LLLT laser received LLLT plus traditional wound management. The control group only received a traditional wound management in form of saline irrigation, dressing, and topical bivatracin spray according to hospital protocol. All groups were offered 10 sessions over 4 weeks. HLLT and LLLT were found to be the most effective methods for sternotomy healing post-CABG surgery, with HLLT offering superior performance in the case of the high deep penetration and significance less time needed to deliver the same joules/ cm compared to LLLT used for the wound site.

Official Title
-----------------
Class iv Versus Class Iiib Laser Therapy on Median Sternotomy Healing After Coronary Artery Bypass Graft: a Randomize Control Trail

Conditions
-----------------
Wound, Wound Heal, Wound Infection

Intervention / Treatment
-----------------
* Device: laser therapy for wound management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 45 and 65 years male gender; haemodynamic stability body mass index (BMI) from 18.5 to 29.9 kg/m2 Non-infected sternotomy site Normal ejection fraction to ensure normal vascularity. Exclusion Criteria: included previous thoracic surgery emergency or urgent coronary artery bypass surgery respiratory insufficiency after surgery, manifesting hypoxemia with partial oxygen pressure in arterial blood < 60 mmHg; Ejection fraction < 50% Paramedian sternotomy which may cut wire causing sternal mobilization which is the start of deep wound infection Bilateral mammary harvesting which decrease blood flow to sternum; low cardiac output syndrome with ST segment elevation in multiple electrocardiogram leads, cardiac arrhythmias or hypotension, according to the American College of Cardiology Foundation and American Heart Association other medical conditions, such as diabetes, uncontrolled hypertension and obesity.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: group A receive laser therapy class IV+traditional wound care and group (B): Laser therapy class IIIb + traditional wound care and group C receive only traditional wound care
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: class IV group<br>start from day one surgery for 4 successive weeks, the goal in the phase I (1st 10 days after surgery) is decontamination, improve circulation, pain reduction &wound healing acceleration The goal of phase II (next10 days till complete healing) is improve osteo-integration, pain reduction & enhance superficial collagen production to decrease scarring. The parameters are: Power > 500 mW; fluence 20 joule/ cm2 with (980, 915, 810 nm) and 5 joules/ cm2 by 650 nm; mode (continuous); hand piece radius = 2.5 cm; spot size (Area) = 5 cm; application by scanning not spotting to avoid thermal effect and time of session is 5- 10 minutes | Device: laser therapy for wound management<br>* comparison between laser effect on post median sternotomy incision compared to traditional wound care<br>|
| Experimental: class IIIb<br>Use the same protocol as in HLLT with the same wave lengths but with low power Power = 200- 300 mW; fluence 20 joule/ cm2 with (980, 915, 810 nm) and 5 joules/ cm2 by 650 nm; mode (continuous); hand piece radius = 2.5 cm; spot size (Area) = 5 cm; application by spotting and time of session was 25- 30 minutes. | Device: laser therapy for wound management<br>* comparison between laser effect on post median sternotomy incision compared to traditional wound care<br>|
| Active Comparator: traditional wound care<br>According to the hospital protocol Irrigation of the wound by normal saline, betadine application, bivatracin spray and Change dressing daily to protect the wound from infection | Device: laser therapy for wound management<br>* comparison between laser effect on post median sternotomy incision compared to traditional wound care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PUSH pressure ulcer scaling healing score for wound healing | measure wound surface area in cm 2 | two consecutive months | 
| PUSH pressure ulcer scaling healing score for wound healing | measure wound exudate in percent | two consecutive months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS visual analogue scale | visual analogue scale of the pain in numbers from 1-10(10 max pain and 1 min pain) | two consecutive months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary arteries bypass grafting, high level laser therapy, Low-level laser therapy, Median sternotomy healing