Effect of Propolis Application on Burn Healing

Study Overview
=================
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.

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

Conditions
-----------------
Burns, Burn Wound

Intervention / Treatment
-----------------
* Biological: burn wound dressing


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>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<br>* 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.<br>|
| Active Comparator: 1% Silver Sulfadiazine<br>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<br>* 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.<br>|
| Active Comparator: %0.2 Nitrafurozon<br>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<br>* 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.<br>|
| Experimental: 10% Propolis<br>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<br>* 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.<br>|
| Experimental: 15% Propolis<br>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<br>* 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.<br>|
| Active Comparator: Propolis vehicle<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn, Burn wound, Propolis, Wound healing