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

Primary Purpose

Wound, Wound Heal, Wound Infection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laser therapy for wound management
Sponsored by
Heidy F. Ahmed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound focused on measuring Coronary arteries bypass grafting, high level laser therapy, Low-level laser therapy, Median sternotomy healing

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Kasr Al Aini University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

class IV group

class IIIb

traditional wound care

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

PUSH pressure ulcer scaling healing score for wound healing
measure wound surface area in cm 2
PUSH pressure ulcer scaling healing score for wound healing
measure wound exudate in percent

Secondary Outcome Measures

VAS visual analogue scale
visual analogue scale of the pain in numbers from 1-10(10 max pain and 1 min pain)

Full Information

First Posted
April 6, 2023
Last Updated
May 8, 2023
Sponsor
Heidy F. Ahmed
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1. Study Identification

Unique Protocol Identification Number
NCT05853237
Brief Title
Class iv Versus Class Iiib Laser Therapy on Median Sternotomy Healing After Coronary Artery Bybass Graft
Acronym
wounds
Official Title
Class iv Versus Class Iiib Laser Therapy on Median Sternotomy Healing After Coronary Artery Bypass Graft: a Randomize Control Trail
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 24, 2022 (Actual)
Study Completion Date
January 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heidy F. Ahmed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound, Wound Heal, Wound Infection
Keywords
Coronary arteries bypass grafting, high level laser therapy, Low-level laser therapy, Median sternotomy healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
he patientsdidnt know the different types of laser which procedure they received & the outcomes assessor done by my supervisors and didn't know which result related to specific group
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
class IV group
Arm Type
Experimental
Arm Description
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
Arm Title
class IIIb
Arm Type
Experimental
Arm Description
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.
Arm Title
traditional wound care
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
laser therapy for wound management
Intervention Description
comparison between laser effect on post median sternotomy incision compared to traditional wound care
Primary Outcome Measure Information:
Title
PUSH pressure ulcer scaling healing score for wound healing
Description
measure wound surface area in cm 2
Time Frame
two consecutive months
Title
PUSH pressure ulcer scaling healing score for wound healing
Description
measure wound exudate in percent
Time Frame
two consecutive months
Secondary Outcome Measure Information:
Title
VAS visual analogue scale
Description
visual analogue scale of the pain in numbers from 1-10(10 max pain and 1 min pain)
Time Frame
two consecutive months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
all the inclusion criteria are male patients
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidy F Ahmed, master
Organizational Affiliation
Kasr al aini
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Al Aini University Hospital
City
Giza
ZIP/Postal Code
12556
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected individual participant data (IPD), all IPD that underlie results in a publication
IPD Sharing Time Frame
In the next month of registration.
IPD Sharing Access Criteria
Information will be available upon request through the following e-mail: heidy.fouad@gmail.com.
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Class iv Versus Class Iiib Laser Therapy on Median Sternotomy Healing After Coronary Artery Bybass Graft

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