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临床试验/NCT06356480
NCT06356480已完成1 期

RANDOMIZED CONTROL TRIAL TO COMPARE 1% ACETIC ACID DRESSING VS SALINE DRESSING TO SEE EARLY WOUND HEALING IN DIABETIC WOUNDS.

Dr. Muhammad Naeem1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2023年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
92
试验地点
1
主要终点
Early epithelialization and granulation

研究概览

简要总结

Chronic diabetic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic diabetic wounds

详细描述

Chronic diabetic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic wounds. They pose a major challenge that is cumbersome in terms of wound healing and also add to the cost in terms of quality of life to the patient and is a financial burden for the hospitals. Three main factors have been found to be the causative factors for the development of a chronic wound: firstly, bacterial colonisation or commonly called bioburden; secondly, reperfusion injury; and thirdly, cellular and systemic factors. Most of the wounds if not all of them are contaminated with pathogenic microorganisms, but this itself does not affect the healing of wounds. When the contamination increases to a point of critical colonisation or infection, then the infection or the bioburden in the wound becomes a major contributing factor that impedes wound healing. Chronic wounds do not progress to the proliferative phase of wound healing and undergo a detention in the inflammatory phase of healing because of which there is a continuous influx of neutrophils into the wound area, with the release of free radicals, cytolytic enzymes and inflammatory mediators that cause damage to the invading pathogens as well as to the host tissue. Poor blood supply results in hypoxic conditions in tissues, which can lead to cell death and tissue necrosis. This provides good growing conditions for pathogenic microorganisms leading to the establishment and colonisation of bacteria in the host tissue.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Chronic diabetic wounds
  • All gender
  • age 40-65 years

排除标准

  • Chronic wounds due to trauma, neoplasm, burn
  • peripheral vascular disease
  • Osteomyelitis grade 3 and above.
  • Data collection:

研究组 & 干预措施

1% acetic acid dressing in chronic diabetic wounds

Experimental

1% Acetic acid dressing in chronic diabetic wounds twice daily along with oral antibiotics to see the early epithelialization of the wounds

干预措施: 1% Acetic acid dressing (Biological)

结局指标

主要结局

Early epithelialization and granulation

时间窗: at 48 hours, 72 hours and 07 days

After selection of the patients adequate antibiotics were given as per standard hospital protocol. Patients were assessed for application of 1% acetic acid dressing after every 12 hours for early epithelialization and granulation which will be diagnosed clinically by examining the wound respectively.

次要结局

未报告次要终点

研究者

发起方
Dr. Muhammad Naeem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Muhammad Naeem

Head of the department of surgery

Pak Emirates Military Hospital

研究点 (1)

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