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RecruitingNCT05578638Updated Sep 20, 2024

Comparing Aloe Vera Gel and Rosemary Oil in Pressure Injury Prevention

An interventional study of Aloe Vera rosemary tropical application and aloevera tropical application in Pressure Injury, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-09-20.

Sponsored by Mansoura University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Nov 2022; still recruiting 3 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pressure Injury
03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's planned enrollment of 128 is above the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
128 participants (estimated)

Study arms

  • Experimental
    aloe Vera group

    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

    Combination Product: aloevera tropical application

  • Experimental
    rosemary group

    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

    Combination Product: rosemary tropicalapplication

  • Experimental
    aloe Vera rosemary compound

    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

    Combination Product: Aloe Vera rosemary tropical application

  • No intervention
    control group

Interventions

  • Combination productAloe 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

  • Combination productaloevera 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

  • Combination productrosemary 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

06

What researchers measure

Primary outcomes

  1. 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

    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

  2. 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

    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

  3. 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

    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

  4. change in skin temperature at pressure points

    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)

  5. change in pain level at pressure points

    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)

07

Study locations

1 of 1 sites recruiting
  • Faculty of Nursing Mansoura University
    Mansoura, Egypt
    • mohamed E.H Elzeky, phd · Contact · mohamadelzeky@mans.edu.eg · 01017860949
    • Amal F Soliman, Lecturer · Contact
    • Amgad E.A Salem, Teaching assistant · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05578638
Lead sponsor
Mansoura University
Responsible party
mohamed elsayed hamed elzeky (lecturer at medical surgical nursing, Mansoura University) — Principal investigator
First posted
Oct 13, 2022
Start date
Nov 1, 2022
Primary completion
Apr 30, 2024
Completion
Dec 2024 (estimated)
Last update
Sep 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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