跳至主要内容
临床试验/CTRI/2024/12/078361
CTRI/2024/12/078361尚未招募不适用

Innovative easy to wear vest dressing for the trunk - A prospective study assessing a Multi-Layered Dressing Combining Nano Silver, Foam, and Activated Charcoal

Triage Meditech Pvt Ltd1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年12月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Primary outcomes:

研究概览

简要总结

Patients meeting the inclusion criteria will be recruited in the study and the first dressing will be done when the patients reports to the Burns emergency, wound will be cleaned with the normal saline then patient will be recruited consecutively recruited in the Group 1 and Group 2.

In Group 1 they will be dressed using innovative wound dressing for the vest the dressing will be applied on day 0, and changed on day 3-5 based upon the soakage, at the time of the dressing application the ease of dressing will be recorded on a Likert scale by the health care provider. At the time dressing between day 3-5 patients pain levels during dressing change will be recorded on a VAS scale between 0-10, need for any pain killer during the dressing will also be recorded, The wound healing will also be assessed at each dressing on Bates Jensen scoring system. The dressing change will happen on day 0, 3, 7,11 15, 21 depending upon the wound exudates, if the wound is deep and the patients need the surgical intervention then the details of the surgical intervention will also be recorded and even after surgical intervention same dressing will be continued.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Adult burn patients (aged 18+) with a BMI (≥23) and trunk injuries requiring dressing changes.
  • Degree of burn should be Second and Third degree.

排除标准

  • Patients with known allergies to any materials used in the dressing and associated skin disease.
  • Patients requiring specialized dressings or treatment protocols that differ from the study intervention.

结局指标

主要结局

Primary outcomes:

时间窗: 1. The wound healing will also be assessed at each dressing on Bates Jensen scoring system. The dressing change will happen on day 0, 3,7,11,15 and 21 depending upon the wound exudate. | 2.At the time of dressing between day 3-5 patients pain during dressing will recorded on a visual analog scale between 0-10, need for any pain killer during the dressing will also be recorded.

1. Time to wound healing as per Bates Jensen score.

时间窗: 1. The wound healing will also be assessed at each dressing on Bates Jensen scoring system. The dressing change will happen on day 0, 3,7,11,15 and 21 depending upon the wound exudate. | 2.At the time of dressing between day 3-5 patients pain during dressing will recorded on a visual analog scale between 0-10, need for any pain killer during the dressing will also be recorded.

2. Pain during the intervention will be assessed using Visual Analog Scale (VAS).

时间窗: 1. The wound healing will also be assessed at each dressing on Bates Jensen scoring system. The dressing change will happen on day 0, 3,7,11,15 and 21 depending upon the wound exudate. | 2.At the time of dressing between day 3-5 patients pain during dressing will recorded on a visual analog scale between 0-10, need for any pain killer during the dressing will also be recorded.

次要结局

  • 1. Frequency of dressing will be measured.(2. Health care provider comfort with dressing application will be assessed)

研究者

发起方
Triage Meditech Pvt Ltd
申办方类型
Other [Specializing in the manufacturing and distribution of wound care solutions. ]
责任方
Principal Investigator
主要研究者

Dr. SHIVANGI SAHA

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

研究点 (1)

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