Effect of Propolis Application on Burn Healing

Effect of Topical Turkish Propolis Application on Burn Healing in Experimental Burn Model

This experimental study will be carried out at Ege University Laboratory Animals Application and Research Center to identify the efficacy of 10% propolis and 15% propolis on wound healing in a second-degree superficial burn wound.

In the study, 36 adult (8-12 week old) Wistar-Albino rats with a weight of 200-300 grams will be used in each group. Each group will include 6 rats. Stratified randomization will be used to randomize rats according to their gender and weight. After randomization, a burnt area will be created on the back of the rats and dressings will be made every day.

Following the creation of the burn, biopsy samples will be taken on the 3rd, 7th, 14th and 21st days and at the light microscopic level; bulla, erythema, oedema, burn depth, inflammatory cell infiltration, necrosis, ulceration, angiogenesis, neovascularization, fibroblast proliferation, collagenization, epithelization, fibrosis, the number of hair follicles and damage to the skin attachments.

In the immunohistochemical examination of biopsy samples, samples will be taken for the evaluation of superoxide dismutase, malondialdehyde, myeloperoxidase in the evaluation of the tumour necrosis factor-alpha, interleukin-1β and oxidative stress in the EBB period in order to evaluate the acute phase reactants. Fungal and gram staining will be done in order to determine the pathogen reproduction in biopsy samples taken on the 3rd and 7th day. Masson trichrome in order to detect fibrosis in biopsy samples taken on the 14th and 21st day; Hydroxyproline examination will be examined in order to evaluate collagen formation.

Study Overview

• Status: Completed
• Conditions: Burns; Burn Wound
• Intervention / Treatment: Biological: burn wound dressing

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İ̇zmi̇r, Turkey
    • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult (8-12 weeks)
• 200-300 grams
• Wistar-Albino rat
• with 4 second-degree superficial contact burn are at its back.

Exclusion Criteria:

• the death of the rat in the research process

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; It will be accepted as the control group and 4 experimental burn wounds will be created on the back of the rats in the group and no treatment will be given.	Biological: burn wound dressing; st. group: It will be considered as a control group and rats will not be treated.; nd. group: Vehicle group, Propolis vehicle will be applied topically to rats for 21 days.; rd group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days.; th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days.; th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days.; th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.
Active Comparator: 1% Silver Sulfadiazine; 4 experimental burn wounds will be created on the back of the rats in the group and dressing with 1% Silver Sulfadiazine will be done on the back of the rats every day for 21 days.	Biological: burn wound dressing; st. group: It will be considered as a control group and rats will not be treated.; nd. group: Vehicle group, Propolis vehicle will be applied topically to rats for 21 days.; rd group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days.; th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days.; th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days.; th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.
Active Comparator: %0.2 Nitrafurozon; 4 experimental burn wounds will be created on the back of the rats in the group and dressing with %0.2 Nitrafurozon will be done on the back of the rats every day for 21 days.	Biological: burn wound dressing; st. group: It will be considered as a control group and rats will not be treated.; nd. group: Vehicle group, Propolis vehicle will be applied topically to rats for 21 days.; rd group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days.; th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days.; th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days.; th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.
Experimental: 10% Propolis; 4 experimental burn wounds will be created on the back of the rats in the group and dressing with 10% Propolis will be done on the back of the rats every day for 21 days.	Biological: burn wound dressing; st. group: It will be considered as a control group and rats will not be treated.; nd. group: Vehicle group, Propolis vehicle will be applied topically to rats for 21 days.; rd group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days.; th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days.; th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days.; th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.
Experimental: 15% Propolis; 4 experimental burn wounds will be created on the back of the rats in the group and dressing with 15% Propolis will be done on the back of the rats every day for 21 days.	Biological: burn wound dressing; st. group: It will be considered as a control group and rats will not be treated.; nd. group: Vehicle group, Propolis vehicle will be applied topically to rats for 21 days.; rd group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days.; th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days.; th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days.; th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.
Active Comparator: Propolis vehicle; 4 experimental burn wounds will be created on the back of the rats in the group and dressing with Propolis vehicle will be done on the back of the rats every day for 21 days.	Biological: burn wound dressing; st. group: It will be considered as a control group and rats will not be treated.; nd. group: Vehicle group, Propolis vehicle will be applied topically to rats for 21 days.; rd group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days.; th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days.; th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days.; th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound size	photos will be taken every day to determine the wound size	21 days
bulla	examination of the skin at the light microscopic level. Bulla will be considered as present or absent.	3rd day of the research
bulla	examination of the skin at the light microscopic level. Bulla will be considered as present or absent.	7th day of the research
bulla	examination of the skin at the light microscopic level. Bulla will be considered as present or absent.	14th day of the research
bulla	examination of the skin at the light microscopic level. Erythemawill be considered as present or absent.	21st day day of the research
edema	examination of the skin at the light microscopic level. Edema will be considered as present or absent.	3rd day of the research
edema	examination of the skin at the light microscopic level. Edema will be considered as present or absent.	7th day of the research
edema	examination of the skin at the light microscopic level. Edema will be considered as present or absent.	14th day of the research
edema	examination of the skin at the light microscopic level. Edema will be considered as present or absent.	21st day of the research
inflammatory cell infiltration	examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.	3rd day of the research
inflammatory cell infiltration	examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.	7th day of the research
inflammatory cell infiltration	examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.	14th day of the research
inflammatory cell infiltration	examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.	21st day of the research
necrosis	examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.	3rd day of the research
necrosis	examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.	7th day of the research
necrosis	examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.	14th day of the research
necrosis	examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.	21st day of the research
ulceration	examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.	3rd day of the research
ulceration	examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.	7th day of the research
ulceration	examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.	14th day of the research
ulceration	examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.	21st day of the research
angiogenesis	examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.	3rd day of the research
angiogenesis	examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.	7th day of the research
angiogenesis	examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.	14th day of the research
angiogenesis	examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.	21st day of the research
fibroblast proliferation	examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.	3rd day of the research
fibroblast proliferation	examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.	7th day of the research
fibroblast proliferation	examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.	14th day of the research
fibroblast proliferation	examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.	21st day of the research
epithelization	examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.	3rd day of the research
epithelization	examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.	7th day of the research
epithelization	examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.	14th day of the research
epithelization	examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.	21st day of the research
collagenization	examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.	3rd day of the research
collagenization	examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.	7th day of the research
collagenization	examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.	14th day of the research
collagenization	examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.	21st day of the research
microorganism colonization	examination of the skin at the light microscopic level. Colonization will be considered as present or absent.	3rd day of the research
microorganism colonization	examination of the skin at the light microscopic level. Colonization will be considered as present or absent.	7th day of the research
microorganism colonization	examination of the skin at the light microscopic level. Colonization will be considered as present or absent.	14th day of the research
microorganism colonization	examination of the skin at the light microscopic level. Colonization will be considered as present or absent.	21st day of the research

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University
• Investigators: Study Director: Figen Yardımcı, Ege University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 28, 2020
• Study Completion (Actual): September 28, 2020

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Wound healing; Propolis; Burn; Burn wound
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 2019-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: the study's data is planned to be published and shared in a scientific paper

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No