Effect of Propolis Application on Burn Healing

Not Applicable

Completed

• Conditions: Burn Wound; Burns
• Interventions: Biological: burn wound dressing

• Registration Number: NCT04277182
• Lead Sponsor: Izmir Katip Celebi University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Study Start: 2020-09-01
• Primary Completion: 2020-09-28
• Study Completion: 2020-09-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% Silver Sulfadiazine	burn wound dressing	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.
Propolis vehicle	burn wound dressing	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.
Control group	burn wound dressing	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.
%0.2 Nitrafurozon	burn wound dressing	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.
15% Propolis	burn wound dressing	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.
10% Propolis	burn wound dressing	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ege University; 🇹🇷 İ̇zmi̇r, Turkey