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Evaluation of the Effect of Local Propolis Application on the Healing of Pressure Ulcers

Evaluation of the Effect of Local Propolis Application on the Healing of Pressure Sores

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06936228
Enrollment
62
Registered
2025-04-20
Start date
2022-04-12
Completion date
2024-11-30
Last updated
2025-04-20

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

Conditions

Pressure Sore

Keywords

Pressure ulcer, Propolis application, Apitherapy

Brief summary

The study was conducted to evaluate the effect of local propolis application in patients with pressure ulcers. A total of 62 patients were included in this randomized controlled experimental study, with 31 patients in the propolis group and 31 in the control group. While the control group received the clinic's standard wound care treatment protocol, the propolis group was administered 30% pure propolis extract in addition to the standard wound care treatment protocol. For data collection, the following tools were used: the Introductory Characteristics Form, which includes patients' socio-demographic and medical information; the Propolis Application Follow-up Form; the Pressure Ulcer Healing Assessment Scale; pain assessment tools including the Visual Analog Scale (VAS) for conscious patients and the Face Pain Scale for unconscious patients; Katz's Index of Activities of Daily Living; and the Charlson Comorbidity Index (CCI).

Interventions

DIETARY_SUPPLEMENTPropolis spray

The product obtained from 30% pure Anatolian propolis was applied once daily.

Sponsors

Karadeniz Technical University
CollaboratorOTHER
Ordu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

The patient or their caregiver is able to communicate verbally, Hospitalized in palliative care or intensive care units for at least one week, Has a Stage 1, 2, or 3 pressure ulcer according to NPUAP (13), The wound has not been closed by a physician, Agrees to participate in the study, Expected to stay in the hospital for at least 21 days.

Exclusion criteria

The patient or their caregiver is unable to communicate verbally, Has a Stage 4 or unstageable pressure ulcer according to NPUAP, The wound has been closed by a physician, Does not agree to participate in the study, Expected to stay in the hospital for less than 21 days.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Pressure Ulcer Healing: PUSH (Pressure Ulcer Scale for Healing)21-day follow-upIt was developed by the EPUAP (European Pressure Ulcer Advisory Panel) to monitor changes in pressure ulcers. It includes three subdimensions: tissue type, exudate amount, and pressure ulcer area. To calculate the pressure ulcer area, the length and width of the wound are multiplied, resulting in a value in cm². This value is then evaluated on a 10-point scale. The amount of exudate is scored as follows: none - 0 points, slight - 1 point, moderate - 2 points, and heavy - 3 points. The third subdimension, tissue type, is scored as follows: 4 points if there is necrotic tissue, 3 points if there is no necrotic tissue but eschar is present, 2 points if granulation tissue is present and the wound is clean, 1 point if epithelialization is observed, and 0 points if the wound is completely closed. The total score, ranging from 0 to 17, provides information about the condition of the ulcer. An increase in the score indicates greater severity of the ulcer.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026