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Not yet recruitingNCT07537101APG-PIUpdated Apr 30, 2026

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

An interventional study of combined Aloe Vera-Peppermint gel in Pressure Injury, sponsored by Ali Abd-Alredha Hussein. Not yet recruiting at 1 site in Iraq. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Ali Abd-Alredha Hussein · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pressure Injury

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • Combination productcombined 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.

05

What researchers measure

Primary outcomes

  1. incidence of pressure injuries

    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.

    Time frame: From the date of ICU admission until 10 days

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Study locations

1 site
  • Baqubah Teaching Hospital
    Baqubah, Diyala Governorate, Iraq
    • Jameel yousif, master · Contact
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07537101
Lead sponsor
Ali Abd-Alredha Hussein
Responsible party
Ali Abd-Alredha Hussein (ph.D candidate, University of Baghdad) — Sponsor-investigator
First posted
Apr 17, 2026
Start date
Jun 5, 2026 (estimated)
Primary completion
Dec 28, 2026 (estimated)
Completion
Apr 20, 2027 (estimated)
Last update
Apr 30, 2026

Study contacts

Ali Abd-Alredha, master
Contact
Ali.hussein2102m@conursing.uobaghdad.edu.iq
+9647700752984
Mohammed Baqer Al-Jubouri, PhD
study director · University of Baghdad / College of Nursing

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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