Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04277182
Other study ID # 2019-048
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Completed NCT05276869 - Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Not yet recruiting NCT06076031 - Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing N/A
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT03113253 - TRANexamic Acid to Reduce Bleeding in BURN Surgery Phase 4
Recruiting NCT04090424 - Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT03159182 - Study of Silicone Material Inserts To Treat Burn Scars N/A
Recruiting NCT02904941 - Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns N/A
Completed NCT02681757 - Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT01437852 - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns Phase 1
Completed NCT01214811 - Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing Phase 3
Completed NCT01061502 - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds Phase 1/Phase 2
Terminated NCT00822796 - Thermogard™ Efficacy Trial N/A
Terminated NCT00634166 - Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group Phase 4
Terminated NCT00824681 - Effect of Music Therapy on Families of Burn Patients Phase 1
Terminated NCT00464386 - Continuous Glucose Monitoring (POC) in the ICU N/A
Withdrawn NCT00216983 - Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding N/A