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Not yet recruiting NCT07537101

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

No phase Interventional Pressure Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: combined Aloe Vera-Peppermint gel.
Who it may be relevant to
Registry conditions: Pressure Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iraq
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • incidence of pressure injuries [Time frame: From the date of ICU admission until 10 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Iraq · 1 center
  • Baqubah Teaching Hospital — Baqubah

Identifiers

NCT: NCT07537101 · 94

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗