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NCT Number: NCT05853237

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

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.

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Key information

Conditions

Wound Infections Wound Heal Wound Infection Wounds and Injuries

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Al Aini University Hospital

Giza, 12556, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laser therapy for wound management

Device

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

Primary outcomes

  1. PUSH pressure ulcer scaling healing score for wound healing

    Time frame: two consecutive months

    measure wound surface area in cm 2

  2. PUSH pressure ulcer scaling healing score for wound healing

    Time frame: two consecutive months

    measure wound exudate in percent

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Heidy F. Ahmed

Other

Registry information

Official study title

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

Acronym: wounds

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 10, 2023
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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