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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

27 days study duration

First Submitted

Initial submission to the registry

February 17, 2020

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed

6 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed

27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2020

Completed

Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

27 days

First QC Date

February 17, 2020

Last Update Submit

August 2, 2022

Conditions

Burns Burn Wound

Keywords

BurnBurn woundPropolisWound healing

Outcome Measures

Primary Outcomes (41)

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

Study Arms (6)

Control group

PLACEBO COMPARATOR

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.