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临床试验/CTRI/2024/04/065532
CTRI/2024/04/065532尚未招募3 期

The Effectiveness Of Prophylactic Dressing For Prevention Of Onset Of Pressure Ulcer, Compared With No Dressing In High Risk Critical Care Unit Patients: A Randomized Controlled Trial

Tata Medical Center Kolkata1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年4月21日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
Effectiveness of the application of prophylactic dressing among the experimental group to prevent the onset of pressure ulcer,

研究概览

简要总结

Background:

The onset of pressure ulcers (PU) is produced by pressure exerted upon over a bony prominence.

Pressure ulcers are considered adverse events that further complicate the critical state of patients hospitalized with high-complexity problems, causing deaths associated to infection and sepsis.

Pressure injuries have a varying incidence rate of 1% to 40 % and a global prevalence of nearly 20%, with the highest incidence rates observed in intensive care units (ICUs) .

The physical characteristics of hydrocolloid and foam dressings aid in the prevention of pressure injuries.

Studies of PU prevalence in hospitals in Colombia reveal a variation between 2.2% and 10%. Data indicate that 60% of ulcers are developed in intensive and chronic care units during the first two weeks of hospitalization and their risk increases by 74% along with other comorbidities.

Current management strategies target protective dressings to prevent pressure injuries. Dressings are accessible and easily implemented devices.

Purpose:

In our Hospital (175 bedded) on 2017 Hospital Acquired Pressure Ulcer (HAPU) was quite high. As pressure ulcer is a core Nursing Quality Indicator, we had reinforced skin assessment, back care and position changing or repositioning. We came to a decision in our Monthly Nursing Quality Meeting (MNQM) to apply Hydrocolloid dressing patches prophylactically on pressure points and change the same after 72 hours along with other standard HAPU preventive measures. We had started applying the same from 2018 and there was a steady reduction of occurrence HAPU among our oncology patients. But this issue of this application always remain debatable among other disciplines, as they are concerned about the cost of the dressing materials and   the sole efficacy of the dressing material.And the application of prophylactic dressing could not be generalized among all the high risk patients of our hospital.

The objectives for the following research are as follows:

1.To assess whether prophylactic dressings reduce onset of PU in high risk CCU patients compared with no dressings in high risk CCU patients.

2.To evaluate whether no dressing alone reduces the onset of PU in high risk CCU patients.

3.To find out the association between the onset of PU and the selective demographic variables of the high risk CCU patients.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.CCU patients aged 18 years or older.
  • 2.Patients at high PU risk within 6 hours of entry to CCU.
  • 3.CCU patients with an expected length of stay of at least 3 days.

排除标准

  • 1.Patients with known allergies to the prophylactic dressings.
  • 2.Patients with existing pressure ulcer.
  • 3.Patients who cannot be repositioned owing to medical reasons.
  • 4.Patients on end of life care.

结局指标

主要结局

Effectiveness of the application of prophylactic dressing among the experimental group to prevent the onset of pressure ulcer,

时间窗: 3days

次要结局

  • Correlation with selected demographic variables.(6 Months)

研究者

发起方
Tata Medical Center Kolkata
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Chitra Sengupta

Tata Medical Center, Kolkata

研究点 (1)

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