Effectiveness of a Combined Aloe Vera-Peppermint Gel on Prevention Pressure Injuries Among Intensive Care Unit Patients (APG-PI)

April 25, 2026 updated by: Ali Abd-Alredha Hussein

Effectiveness of a Combined Aloe Vera-Peppermint Gel on Prevention Pressure Injuries Among Intensive Care Unit Patients: A Randomized Controlled Trial

The goal of this clinical trails is to learn if a combined Aloe Vera-Peppermint gel work to prevent pressure injuries (bedsores) in ICU patients.

Does applying this natural gel reduce the incidence of pressure injuries compared to standard care?

participants will be randomly assigned to either receive the gel application (Aloe Vera-Peppermint gel) or the standard hospital nursing care.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • 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 Contact

Study Locations

  • Iraq
    • Diyala Governorate
      • Baqubah, Diyala Governorate, Iraq
        • Baqubah Teaching Hospital
        • Contact:
          • Jameel yousif, master

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ICU patients aged 18 years or older.
  2. Admission to the ICU without pressure injury according to the NPUAP scale on the first day of hospitalization.
  3. Unconsciousness, being under sedation or assisted ventilation.
  4. Patients that are at risk of moderate to severe PIs according to Braden scoring tool and scored less than 13-14.
  5. No Diarrhea, serum Albumin level below 3.5 g/dl, no edema.
  6. No limit of changes in body position with multiple injuries.
  7. Family consent to participate in the study.
  8. The patient has no history of autoimmune diseases, renal failure, or diabetes, does not use immunosuppressive medications, and has no evidence of vascular disease.
  9. All patients receiving standardized care (repositioning and pressure-relieving mattress).

Exclusion Criteria:

  1. Family's unwillingness for the patient to continue participation
  2. Sensitivity to Aloe Vera-Peppermint Gel after use on a patient's forearm (area of 2 × 2 cm) and this area was evaluated for the presence of redness, swelling and warmth within 45 min.
  3. Spinal cord injury cases
  4. death or patient transmission in less than 48 hrs. after admission to the ICU.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Patients in this group will receive a topical application of the combined Aloe Vera-Peppermint gel on pressure-prone areas. The gel will be applied twice daily, in addition to the standard nursing care protocol for pressure injury prevention.
Combination product: combined Aloe Vera-Peppermint gel
Topical gel containing a combination of natural Aloe vera extract and peppermint oil. The intervention involves applying a thin layer of the gel to pressure-prone areas such as the sacrum and heels to prevent the development of pressure injuries. The application is performed twice daily during the patient's stay in the ICU.
No Intervention: control group
Patients in this group will receive the standard nursing care protocol for pressure injury prevention as practiced in the ICU, which includes regular repositioning, skin assessment, cleansing, moisturizing, and use of pressure-relieving devices. No experimental Aloe Vera-Peppermint gel will be applied to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of pressure injuries
Time Frame: From the date of ICU admission until 10 days
The number of participants who develop any new pressure injury during their ICU stay. Pressure injuries include Stage I, Stage II, Stage III, Stage IV, Unstageable, and Deep Tissue Pressure Injury, as defined by the National Pressure Injury Advisory Panel (NPIAP). Assessment will be performed daily by trained nursing staff using the Braden Scale and comprehensive clinical skin examination of pressure-prone areas.
From the date of ICU admission until 10 days

Collaborators and Investigators

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

Sponsor

Ali Abd-Alredha Hussein

Investigators

  • Study Director: Mohammed Baqer Al-Jubouri, PhD, University of Baghdad / College of Nursing

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 (Estimated)

June 5, 2026

Primary Completion (Estimated)

December 28, 2026

Study Completion (Estimated)

April 20, 2027

Study Registration Dates

First Submitted

April 11, 2026

First Submitted That Met QC Criteria

April 11, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 25, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 94

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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