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

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).

Study Overview

• Status: Completed
• Conditions: Pressure Sore
• Intervention / Treatment: Dietary supplement: Propolis spray

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ordu, Turkey, 52100
    • Sağlık Bakanlığı Ordu Üniversitesi Eğitim ve Araştırma Hastanei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 Propolis; Propolis was applied in addition to standard wound treatment administered in the hospital for 21 days.	Dietary supplement: Propolis spray; The product obtained from 30% pure Anatolian propolis was applied once daily.
No Intervention: 2 control; The control group received standard wound care treatment administered in the hospital for 21 days, and the researcher did not intervene in any way.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Pressure Ulcer Healing: PUSH (Pressure Ulcer Scale for Healing)	It 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.	21-day follow-up

Collaborators and Investigators

• Sponsor: T.C. ORDU ÜNİVERSİTESİ
• Collaborators: Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Pressure ulcer; Apitherapy; Propolis application
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer; Anti-Infective Agents; Propolis
• Other Study ID Numbers: Çiğdem KURALAY (Registry Identifier: Propolis Application in Pressure Ulcer")

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No