search
Back to results

Comparing Aloe Vera Gel and Rosemary Oil in Pressure Injury Prevention

Primary Purpose

Pressure Injury

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aloe Vera rosemary tropical application
aloevera tropical application
rosemary tropicalapplication
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Faculty of Nursing Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

aloe Vera group

rosemary group

aloe Vera rosemary compound

control group

Arm Description

10 ml of the spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days

10 ml of the spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days

10 ml of the spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days

Outcomes

Primary Outcome Measures

incidence of stage 1 pressure ulcers
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
incidence of stage 1 pressure ulcers
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
incidence of stage 1 pressure ulcers
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
change in skin temperature at pressure points
Skin temperature will be measured using infrared thermometer
change in pain level at pressure points
pain will be measured using 0-10 visual analogue scale

Secondary Outcome Measures

Full Information

First Posted
October 3, 2022
Last Updated
January 3, 2023
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT05578638
Brief Title
Comparing Aloe Vera Gel and Rosemary Oil in Pressure Injury Prevention
Official Title
A Randomized Prospective Clinical Study on the Effect of Aloe Vera Gel and Rosmery Oil for Skin Ulcer Protection in Orthopedic Wards
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aloe Vera group
Arm Type
Experimental
Arm Description
10 ml of the spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days
Arm Title
rosemary group
Arm Type
Experimental
Arm Description
10 ml of the spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days
Arm Title
aloe Vera rosemary compound
Arm Type
Experimental
Arm Description
10 ml of the spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Combination Product
Intervention Name(s)
Aloe Vera rosemary tropical application
Intervention Description
10 ml of the Aloe Vera rosemary spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days
Intervention Type
Combination Product
Intervention Name(s)
aloevera tropical application
Intervention Description
10 ml of the Aloe Vera spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days
Intervention Type
Combination Product
Intervention Name(s)
rosemary tropicalapplication
Intervention Description
10 ml of the rosemary spray will be rubbed two times per day during the skin care on the areas at risk for PIs, including the patient's sacrum area, hip areas and heels area. This action will continue for 10 days
Primary Outcome Measure Information:
Title
incidence of stage 1 pressure ulcers
Description
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
Time Frame
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 third day, after intervention
Title
incidence of stage 1 pressure ulcers
Description
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
Time Frame
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 seventh day, after intervention
Title
incidence of stage 1 pressure ulcers
Description
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
Time Frame
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
Title
change in skin temperature at pressure points
Description
Skin temperature will be measured using infrared thermometer
Time Frame
will be measured at baseline and at the end of the study (after 10 days)
Title
change in pain level at pressure points
Description
pain will be measured using 0-10 visual analogue scale
Time Frame
will be measured at baseline and at the end of the study (after 10 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Faculty of Nursing Mansoura University
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed E.H Elzeky, phd
Phone
01017860949
Email
mohamadelzeky@mans.edu.eg
First Name & Middle Initial & Last Name & Degree
Amal F Soliman, Lecturer
First Name & Middle Initial & Last Name & Degree
Amgad E.A Salem, Teaching assistant

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing Aloe Vera Gel and Rosemary Oil in Pressure Injury Prevention

We'll reach out to this number within 24 hrs