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临床试验/NCT05578638
NCT05578638招募中不适用

A Randomized Prospective Clinical Study on the Effect of Aloe Vera Gel and Rosmery Oil for Skin Ulcer Protection in Orthopedic Wards

Mansoura University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
128
试验地点
1
主要终点
change in pain level at pressure points

研究概览

简要总结

Most patients admitted to the orthopedic ward are at risk of developing pressure ulcers. Today, the tendency to use medicinal herbs in pressure ulcer treatment has increased due to the variety of effective compounds and their fewer side effects.

详细描述

Aloe Vera is medicinal plant that has been used to treat skin problems since 1500 BC Many studies have shown that using Aloe Vera to treat various wounds such as psoriasis, mouth ulcers, diabetic ulcers herpes and bed sores has had positive effects. in addition, Rosemary has therapeutic properties and has been used in the folk medicine, pharmaceutical, and cosmetics industries, mainly for its antioxidant, anti-inflammatory and vasodilatation properties, which are attributed to the presence of carnosol/carnosic and ursolic acids. Besides it therapeutic uses, rosemary has potential applications in cosmetic formulations and in the treatment of pathological and non-pathological conditions, such as cellulite, alopecia, ultraviolet damage, and aging.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • willingness to participate in research, lack of skin diseases (such as psoriasis, fungal illness, freckles), patients that are at risk of moderate to severe bedsores according to nursing diagnosis and Braden scoring tool and scored less than 13-14; the absence of PI on admission; the probability of length of stay should be above 10 days

排除标准

  • a decrease in hemoglobin levels during the study to lower than 12 in men and less than 10 mg/dl in women, anemia, hyperthermia during the study and sensitivity to Aloe Vera or Rosemary.

结局指标

主要结局

change in pain level at pressure points

时间窗: will be measured at baseline and at the end of the study (after 10 days)

pain will be measured using 0-10 visual analogue scale

change in skin temperature at pressure points

时间窗: will be measured at baseline and at the end of the study (after 10 days)

Skin temperature will be measured using infrared thermometer

incidence of stage 1 pressure ulcers

时间窗: Before applying sprays, Patients will be evaluated by pairs of observers (trained nurse and specialist) at 9:00 am for the presence of PIs at the tenth day, after intervention

The NPUAP scale is staging system since 1989 as one of the most widely used classification systems for the PI that describes the depth of the wound caused by PIs. In accordance with the panel, the PIs are divided into the original 4 stages and adding 2 stages on deep tissue injury and unstageable PIs. In this work, skin redness without discoloration by finger pressure in area of interest was considered as PIs stage I

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mohamed elsayed hamed elzeky

lecturer at medical surgical nursing

Mansoura University

研究点 (1)

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