跳至主要内容
临床试验/NCT05853237
NCT05853237已完成不适用

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

Heidy F. Ahmed2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
PUSH pressure ulcer scaling healing score for wound healing

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

PUSH pressure ulcer scaling healing score for wound healing

时间窗: two consecutive months

measure wound surface area in cm 2

次要结局

  • VAS visual analogue scale(two consecutive months)

研究者

发起方
Heidy F. Ahmed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Heidy F. Ahmed

physical therapy doctor wound care specialist at Al kasr Al Anini university hospital, Cairo , Egypt

Cairo University

研究点 (2)

Loading locations...

相似试验