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Effectiveness of Bromelain and Hyalgen Combination in Healing Pressure Ulcers in Intensive Care Unit Patients at Labbafinejad Hospital

Efficacy of Bromelain and Heallagen Combination in Improving Bed Sores in Patients in Labafi Nejad Hosoital Intensive Care unit

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190215042716N7
Enrollment
60
Registered
2024-10-17
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study focuses on pressure ulcers (also known as bedsores or pressure sores) in patients admitted to the Intensive Care Unit (ICU). Pressure ulcers are localized injuries to the skin and/or underlying tissue, usually over a bony prominence, resulting from prolonged pressure on the skin. These injuries commonly occur in patients with limited mobility, such as those in intensive care. Pressure ulcers are classified into stages (I-IV) based on their severity, with stage I being the least severe

Interventions

Intervention 1: Intervention group: Patients in this group receive all routine pressure ulcer care (similar to the control group) plus the following combination treatment:Hyalgen powder: Administered

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients admitted to the ICU for medical or surgical reasons. Patients diagnosed with stage one to four pressure ulcers (pressure injuries) through clinical assessment. Patients or their legally authorized representatives who provide informed consent. Patients aged 18 years and older.

Exclusion criteria

Exclusion criteria: Patients with known contraindications or allergies to bromelain or hylargen. Patients with severe coagulation disorders or active bleeding disorders. Patients with severe hepatic or renal failure Pregnant or breastfeeding women. Patients unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
Reduction in pressure ulcer size and severity. Timepoint: Baseline, 7 days, 14 days. Method of measurement: Method of measurement:Pain levels: Visual Analog Scale (VAS) and patient self-reportComplications: Clinical assessment and documentation of any wound-related complicationsQuality of life: Short Form-36 (SF-36) health survey questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNavid Shafigh

Shahid Beheshti University of Medical Sciences

n.shafigh@sbmu.ac.ir+98 21 7759 0148

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026