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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05853237
Acronym
wounds
Enrollment
45
Registered
2023-05-10
Start date
2021-11-01
Completion date
2023-01-19
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound, Wound Heal, Wound Infection

Keywords

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

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.

Interventions

DEVICElaser therapy for wound management

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

Sponsors

Heidy F. Ahmed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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

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 care

Eligibility

Sex/Gender
MALE
Age
45 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
PUSH pressure ulcer scaling healing score for wound healingtwo consecutive monthsmeasure wound surface area in cm 2

Secondary

MeasureTime frameDescription
VAS visual analogue scaletwo consecutive monthsvisual analogue scale of the pain in numbers from 1-10(10 max pain and 1 min pain)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026