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

May 8, 2023 updated by: Heidy F. Ahmed

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12556
        • Kasr Al Aini University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: class IV group
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
comparison between laser effect on post median sternotomy incision compared to traditional wound care
Experimental: class IIIb
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
comparison between laser effect on post median sternotomy incision compared to traditional wound care
Active Comparator: traditional wound care
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
comparison between laser effect on post median sternotomy incision compared to traditional wound care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidy F. Ahmed

Investigators

  • Principal Investigator: Heidy F Ahmed, master, Kasr al aini

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

December 24, 2022

Study Completion (Actual)

January 19, 2023

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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