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临床试验/NCT05874284
NCT05874284已完成早期 1 期

The Effect of Prolotherapy in the Care of Pressure Injuries: A Randomized Controlled Study

Fenerbahce University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年6月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
wound healing time

研究概览

简要总结

The goal of this [type of study: randomized controlled clinical trial] is to [Determining the effect of prolotherapy use on the wound care process]. The main question it aims to answer is:

• [The use of proliferative substances in the care of 1st, 2nd and 3rd stage pressure injuries has a positive effect on the wound healing period].

Participants will [in patients with pressure injuries, wound irrigation with saline and wound irrigation with gelofusin were applied]. Researchers will compare [depth, length and width of the wound].

详细描述

In the study, wound irrigation with saline and wound irrigation with gelofusin will be applied to patients with pressure injuries.

Cleaning of the wound can be done with gases moistened with saline, or irrigation method can be applied with the help of an injector. Sufficient pressure can be provided with an 18G needle attached injector. Irrigation with 50-100cc saline per square centimeter is recommended.

In the experimental group, the wound will be washed with gelofusine as prolotherapy, and the wound will be closed with sterile sponge and fixative tape. In the control group, the wound will be covered with sterile sponge and fixative tape by washing with physiological saline. This process will be repeated 2 times a day and will be repeated and observed for 3 days in line with the literature.

In this study, while the wound is irrigated, the solution will first be drawn into a 50 cc syringe and prepared. A protective cover will be used to prevent the sterile sponge, fixation tape, gloves and solution required for dressing from contaminating the patient bed. The patient will be given an appropriate position according to the location of the wound. The needle of the syringe containing the solution will be removed and kept at a distance of 3 cm from the wound area, and the solution will be slowly poured over the entire wound. When the irrigation process is finished, the wound area will be dried and the wound will be closed with sterile sponge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients with 1st, 2nd and 3rd stage pressure injuries
  • Patients over 18 years of age
  • Patients who volunteered to participate in the study

排除标准

  • Patients without 1st, 2nd and 3rd stage pressure injuries
  • Patients under 18 years of age
  • Patients who did not volunteer to participate in the study
  • Patients allergic to gelofusin solution

研究组 & 干预措施

Experimental group

Experimental

The nasopharyngeal suction with positive pressure method was employed in the sample group. In this method, the infant's head is turned to the side, 1-2 ml of PS is injected into the nostril with a syringe, and then positive pressure is exerted with the help of the end of the oxygen hose from the same nostril, with oxygen or air supply at 5-8 lt/min (if the baby requires oxygen, using an oxygen source) and the nasopharyngeal secretions are removed from the nostril into which PS has been not injected. The oxygen hose is held one centimetre away from the infant's nostril. The researchers prepared a guideline for nasopharyngeal suction with positive pressure based on the literature.

干预措施: Gelofusin (Drug)

结局指标

主要结局

wound healing time

时间窗: 3 days

The change in wound healing time will be examined.

次要结局

未报告次要终点

研究者

发起方
Fenerbahce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rukiye Kokkiz

Research Assistant

Fenerbahce University

研究点 (1)

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