Effect of Propolis Application on Burn Healing

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277182
• Other study ID #: 2019-048
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 28, 2020

Study information

• Verified date: August 2022
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 28, 2020
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Weeks to 12 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Burn Wound
• Burns

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ege University	I?zmi?r

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound size	photos will be taken every day to determine the wound size	21 days
Primary	bulla	examination of the skin at the light microscopic level. Bulla will be considered as present or absent.	3rd day of the research
Primary	bulla	examination of the skin at the light microscopic level. Bulla will be considered as present or absent.	7th day of the research
Primary	bulla	examination of the skin at the light microscopic level. Bulla will be considered as present or absent.	14th day of the research
Primary	bulla	examination of the skin at the light microscopic level. Erythemawill be considered as present or absent.	21st day day of the research
Primary	edema	examination of the skin at the light microscopic level. Edema will be considered as present or absent.	3rd day of the research
Primary	edema	examination of the skin at the light microscopic level. Edema will be considered as present or absent.	7th day of the research
Primary	edema	examination of the skin at the light microscopic level. Edema will be considered as present or absent.	14th day of the research
Primary	edema	examination of the skin at the light microscopic level. Edema will be considered as present or absent.	21st day of the research
Primary	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
Primary	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
Primary	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
Primary	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
Primary	necrosis	examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.	3rd day of the research
Primary	necrosis	examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.	7th day of the research
Primary	necrosis	examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.	14th day of the research
Primary	necrosis	examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.	21st day of the research
Primary	ulceration	examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.	3rd day of the research
Primary	ulceration	examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.	7th day of the research
Primary	ulceration	examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.	14th day of the research
Primary	ulceration	examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.	21st day of the research
Primary	angiogenesis	examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.	3rd day of the research
Primary	angiogenesis	examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.	7th day of the research
Primary	angiogenesis	examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.	14th day of the research
Primary	angiogenesis	examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.	21st day of the research
Primary	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
Primary	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
Primary	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
Primary	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
Primary	epithelization	examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.	3rd day of the research
Primary	epithelization	examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.	7th day of the research
Primary	epithelization	examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.	14th day of the research
Primary	epithelization	examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.	21st day of the research
Primary	collagenization	examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.	3rd day of the research
Primary	collagenization	examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.	7th day of the research
Primary	collagenization	examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.	14th day of the research
Primary	collagenization	examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.	21st day of the research
Primary	microorganism colonization	examination of the skin at the light microscopic level. Colonization will be considered as present or absent.	3rd day of the research
Primary	microorganism colonization	examination of the skin at the light microscopic level. Colonization will be considered as present or absent.	7th day of the research
Primary	microorganism colonization	examination of the skin at the light microscopic level. Colonization will be considered as present or absent.	14th day of the research
Primary	microorganism colonization	examination of the skin at the light microscopic level. Colonization will be considered as present or absent.	21st day of the research