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

NCT06936228 | Completed DMC

• 2 other identifiers: Çiğdem KuralayÇiğdem KURALAY
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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).

Conditions

Pressure Sore

Keywords

Pressure ulcer; Propolis application; Apitherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1 Propolis

EXPERIMENTAL

Propolis was applied in addition to standard wound treatment administered in the hospital for 21 days.

Dietary Supplement: Propolis spray

2 control

NO INTERVENTION

The control group received standard wound care treatment administered in the hospital for 21 days, and the researcher did not intervene in any way.

Interventions

Propolis spray DIETARY_SUPPLEMENT

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

1 Propolis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ordu University: lead
• Karadeniz Technical University: collaborator

Study Sites (1)

Sağlık Bakanlığı Ordu Üniversitesi Eğitim ve Araştırma Hastanei

Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 20, 2025
• Study Start: April 12, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)