Comparing Aloe Vera Gel and Rosemary Oil in Pressure Injury Prevention

September 18, 2024 updated by: mohamed elsayed hamed elzeky, Mansoura University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Recruiting
        • faculty of nursing Mansoura university
        • Contact:
        • Contact:
          • Amal F Soliman, Lecturer
        • Contact:
          • Amgad E.A Salem, Teaching assistant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control group
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
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
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
incidence of stage 1 pressure ulcers
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
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
incidence of stage 1 pressure ulcers
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
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
incidence of stage 1 pressure ulcers
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
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
change in skin temperature at pressure points
Time Frame: will be measured at baseline and at the end of the study (after 10 days)
Skin temperature will be measured using infrared thermometer
will be measured at baseline and at the end of the study (after 10 days)
change in pain level at pressure points
Time Frame: 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
will be measured at baseline and at the end of the study (after 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • mans u

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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