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NCT Number: NCT07537101

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baqubah Teaching Hospital

Baqubah, Diyala Governorate, Iraq

Location contact

Jameel yousif, master

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Family's unwillingness for the patient to continue participation
  • 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.
  • Spinal cord injury cases
  • death or patient transmission in less than 48 hrs. after admission to the ICU.

Treatment and study plan

combined Aloe Vera-Peppermint gel

Combination Product

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Abd-Alredha, master

CONTACT

[email protected]

+9647700752984

Sponsors and collaborators

Lead sponsor

Ali Abd-Alredha Hussein

Other

Registry information

Official study title

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

Acronym: APG-PI

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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