Comparing Aloe Vera Gel and Rosemary Oil in Pressure Injury Prevention

Pressure Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05578638
• Other study ID #: mans u
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 2023

Study information

• Verified date: November 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury

Intervention

Combination Product:
• Aloe Vera rosemary tropical application
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
• aloevera tropical application
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
• rosemary tropicalapplication
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

Locations

Country	Name	City	State
Egypt	Faculty of Nursing Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Primary	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	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
Primary	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	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
Primary	change in skin temperature at pressure points	Skin temperature will be measured using infrared thermometer	will be measured at baseline and at the end of the study (after 10 days)
Primary	change in pain level at pressure points	pain will be measured using 0-10 visual analogue scale	will be measured at baseline and at the end of the study (after 10 days)