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Effect of Propolis Application on Burn Healing

Primary Purpose

Burns, Burn Wound

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
burn wound dressing
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Burn, Burn wound, Propolis, Wound healing

Eligibility Criteria

8 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

Control group

1% Silver Sulfadiazine

%0.2 Nitrafurozon

10% Propolis

15% Propolis

Propolis vehicle

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

wound size
photos will be taken every day to determine the wound size
bulla
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
bulla
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
bulla
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
bulla
examination of the skin at the light microscopic level. Erythemawill be considered as present or absent.
edema
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
edema
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
edema
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
edema
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
inflammatory cell infiltration
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
inflammatory cell infiltration
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
inflammatory cell infiltration
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
inflammatory cell infiltration
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
necrosis
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
necrosis
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
necrosis
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
necrosis
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
ulceration
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
ulceration
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
ulceration
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
ulceration
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
angiogenesis
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
angiogenesis
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
angiogenesis
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
angiogenesis
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
fibroblast proliferation
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
fibroblast proliferation
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
fibroblast proliferation
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
fibroblast proliferation
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
epithelization
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
epithelization
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
epithelization
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
epithelization
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
collagenization
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
collagenization
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
collagenization
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
collagenization
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
microorganism colonization
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
microorganism colonization
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
microorganism colonization
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
microorganism colonization
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2020
Last Updated
August 2, 2022
Sponsor
Izmir Katip Celebi University
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1. Study Identification

Unique Protocol Identification Number
NCT04277182
Brief Title
Effect of Propolis Application on Burn Healing
Official Title
Effect of Topical Turkish Propolis Application on Burn Healing in Experimental Burn Model
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 28, 2020 (Actual)
Study Completion Date
September 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Burn Wound
Keywords
Burn, Burn wound, Propolis, Wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1st. group: It will be considered as a control group and rats will not be treated. 2nd. group: Vehicle group, Propolis vehicle will be applied to rats for 21 days. 3rd. group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days. 4th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days. 5th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days. 6th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.
Masking
Outcomes Assessor
Masking Description
the researcher who will analyze the primary outcome of the study will not know which group of animals the samples were taken from.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
1% Silver Sulfadiazine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
%0.2 Nitrafurozon
Arm Type
Active Comparator
Arm Description
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.
Arm Title
10% Propolis
Arm Type
Experimental
Arm Description
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.
Arm Title
15% Propolis
Arm Type
Experimental
Arm Description
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.
Arm Title
Propolis vehicle
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
burn wound dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
wound size
Description
photos will be taken every day to determine the wound size
Time Frame
21 days
Title
bulla
Description
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
Time Frame
3rd day of the research
Title
bulla
Description
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
Time Frame
7th day of the research
Title
bulla
Description
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
Time Frame
14th day of the research
Title
bulla
Description
examination of the skin at the light microscopic level. Erythemawill be considered as present or absent.
Time Frame
21st day day of the research
Title
edema
Description
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
Time Frame
3rd day of the research
Title
edema
Description
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
Time Frame
7th day of the research
Title
edema
Description
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
Time Frame
14th day of the research
Title
edema
Description
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
Time Frame
21st day of the research
Title
inflammatory cell infiltration
Description
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
Time Frame
3rd day of the research
Title
inflammatory cell infiltration
Description
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
Time Frame
7th day of the research
Title
inflammatory cell infiltration
Description
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
Time Frame
14th day of the research
Title
inflammatory cell infiltration
Description
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
Time Frame
21st day of the research
Title
necrosis
Description
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
Time Frame
3rd day of the research
Title
necrosis
Description
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
Time Frame
7th day of the research
Title
necrosis
Description
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
Time Frame
14th day of the research
Title
necrosis
Description
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
Time Frame
21st day of the research
Title
ulceration
Description
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
Time Frame
3rd day of the research
Title
ulceration
Description
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
Time Frame
7th day of the research
Title
ulceration
Description
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
Time Frame
14th day of the research
Title
ulceration
Description
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
Time Frame
21st day of the research
Title
angiogenesis
Description
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
Time Frame
3rd day of the research
Title
angiogenesis
Description
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
Time Frame
7th day of the research
Title
angiogenesis
Description
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
Time Frame
14th day of the research
Title
angiogenesis
Description
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
Time Frame
21st day of the research
Title
fibroblast proliferation
Description
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
Time Frame
3rd day of the research
Title
fibroblast proliferation
Description
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
Time Frame
7th day of the research
Title
fibroblast proliferation
Description
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
Time Frame
14th day of the research
Title
fibroblast proliferation
Description
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
Time Frame
21st day of the research
Title
epithelization
Description
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
Time Frame
3rd day of the research
Title
epithelization
Description
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
Time Frame
7th day of the research
Title
epithelization
Description
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
Time Frame
14th day of the research
Title
epithelization
Description
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
Time Frame
21st day of the research
Title
collagenization
Description
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
Time Frame
3rd day of the research
Title
collagenization
Description
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
Time Frame
7th day of the research
Title
collagenization
Description
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
Time Frame
14th day of the research
Title
collagenization
Description
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
Time Frame
21st day of the research
Title
microorganism colonization
Description
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
Time Frame
3rd day of the research
Title
microorganism colonization
Description
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
Time Frame
7th day of the research
Title
microorganism colonization
Description
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
Time Frame
14th day of the research
Title
microorganism colonization
Description
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
Time Frame
21st day of the research

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Figen Yardımcı
Organizational Affiliation
Ege University
Official's Role
Study Director
Facility Information:
Facility Name
Ege University
City
İ̇zmi̇r
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
the study's data is planned to be published and shared in a scientific paper

Learn more about this trial

Effect of Propolis Application on Burn Healing

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