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

Sponsor
Heidy F. Ahmed (Other)
Overall Status
Completed
CT.gov ID
NCT05853237
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
14.6
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: laser therapy for wound management
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 caregroup 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 (Participant, Outcomes 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
Primary Purpose:
Treatment
Official Title:
Class iv Versus Class Iiib Laser Therapy on Median Sternotomy Healing After Coronary Artery Bypass Graft: a Randomize Control Trail
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Dec 24, 2022
Actual Study Completion Date :
Jan 19, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. PUSH pressure ulcer scaling healing score for wound healing [two consecutive months]

    measure wound surface area in cm 2

  2. PUSH pressure ulcer scaling healing score for wound healing [two consecutive months]

    measure wound exudate in percent

Secondary Outcome Measures

  1. VAS visual analogue scale [two consecutive months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kasr Al Aini University Hospital Giza Egypt 12556

Sponsors and Collaborators

  • Heidy F. Ahmed

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Heidy F. Ahmed, physical therapy doctor wound care specialist at Al kasr Al Anini university hospital, Cairo , Egypt, Cairo University
ClinicalTrials.gov Identifier:
NCT05853237
Other Study ID Numbers:
  • P.T.REC/012/003308
First Posted:
May 10, 2023
Last Update Posted:
May 10, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Heidy F. Ahmed, physical therapy doctor wound care specialist at Al kasr Al Anini university hospital, Cairo , Egypt, Cairo University
Coronary arteries bypass grafting
high level laser therapy
Low-level laser therapy
Median sternotomy healing
Additional relevant MeSH terms:
Wound Infection
Wounds and Injuries

Study Results

No Results Posted as of May 10, 2023