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Effect of Propolis Application on Burn Healing

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04277182
Enrollment
36
Registered
2020-02-20
Start date
2020-09-01
Completion date
2020-09-28
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Burn Wound

Keywords

Burn, Burn wound, Propolis, Wound healing

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.

Interventions

BIOLOGICALburn wound dressing

1. st. group: It will be considered as a control group and rats will not be treated. 2. nd. group: Vehicle group, Propolis vehicle will be applied topically to rats for 21 days. 3. rd group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days. 4. th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days. 5. th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days. 6. th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.

Sponsors

Izmir Katip Celebi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
8 Weeks to 12 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
necrosis3rd day of the researchexamination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
wound size21 daysphotos will be taken every day to determine the wound size
bulla3rd day of the researchexamination of the skin at the light microscopic level. Bulla will be considered as present or absent.
edema3rd day of the researchexamination of the skin at the light microscopic level. Edema will be considered as present or absent.
inflammatory cell infiltration3rd day of the researchexamination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
ulceration3rd day of the researchexamination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
angiogenesis3rd day of the researchexamination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
fibroblast proliferation3rd day of the researchexamination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
epithelization3rd day of the researchexamination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
collagenization3rd day of the researchexamination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
microorganism colonization3rd day of the researchexamination of the skin at the light microscopic level. Colonization will be considered as present or absent.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026