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

NCT05853237 | Completed DMC

• 1 other identifier: P.T.REC/012/003308
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound; Wound Heal; Wound Infection

Keywords

Coronary arteries bypass grafting; high level laser therapy; Low-level laser therapy; Median sternotomy healing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• VAS visual analogue scale

  two consecutive months

Study Arms (3)

class IV group

EXPERIMENTAL

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

class IIIb

EXPERIMENTAL

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

traditional wound care

ACTIVE COMPARATOR

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

Interventions

laser therapy for wound management DEVICE

comparison between laser effect on post median sternotomy incision compared to traditional wound care

class IIIb; class IV group; traditional wound care

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: all the inclusion criteria are male patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heidy F. Ahmed: lead

Study Sites (1)

Kasr Al Aini University Hospital

Giza, 12556, Egypt

Location

Related Publications (28)

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MeSH Terms

Conditions

Wounds and Injuries; Wound Infection

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Heidy F Ahmed, master

  Kasr al aini

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physical therapy doctor wound care specialist at Al kasr Al Anini university hospital, Cairo , Egypt

Model Details: 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

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 10, 2023
• Study Start: November 1, 2021
• Primary Completion: December 24, 2022
• Study Completion: January 19, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: In the next month of registration.
• Access Criteria: Information will be available upon request through the following e-mail: heidy.fouad@gmail.com.

Locations

EG (1)