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

Wound Heal Clinical Trial

— wounds  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05853237
• Other study ID #: P.T.REC/012/003308
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: January 19, 2023

Study information

• Verified date: May 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 19, 2023
• Est. primary completion date: December 24, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wound
• Wound Heal
• Wound Infection
• Wounds and Injuries

Intervention

Device:
• laser therapy for wound management
comparison between laser effect on post median sternotomy incision compared to traditional wound care

Locations

Country	Name	City	State
Egypt	Kasr Al Aini University Hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Heidy F. Ahmed

Country where clinical trial is conducted

Egypt, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PUSH pressure ulcer scaling healing score for wound healing	measure wound surface area in cm 2	two consecutive months
Primary	PUSH pressure ulcer scaling healing score for wound healing	measure wound exudate in percent	two consecutive months
Secondary	VAS visual analogue scale	visual analogue scale of the pain in numbers from 1-10(10 max pain and 1 min pain)	two consecutive months