Efficacy of the Nanosized Composition of Propolis in Repairing the Donor Graft Site
Design
The clinical Trial has a Control Group and parallel Groups. Double-blind. Randomized. On 30 Patients. Based on the Block of Four Numbers prepared by Excel Software.
Settings and conduct
Patients in the plastic surgery,enter the study.
In order to blind the patient and not know which cream was used in which area, the blinding will be done in a (double-blind) way, so that the patient will be given two gels in the same tubes. It is given and asked from the patient that it is the supervisor who knows which lesion of the patient with which code, which gel will be prescribed with which code, and the researcher and the patient do not know about the codes related to the lesions and the content of the gels.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
patients with spilit-thickness graft candidate
Exit criteria:
• History of collection from Donor place
• History of keloid and hypertrophic scar
• smoking
• history of hypersensitivity reaction to honey and its derivatives
• Those who do not want to participate in the study
history of impaired wound healing or diseases that interfere with the wound healing process
• Elderly people (over 60 years old)/ Immunodeficiency
• Pregnant
Intervention groups
The skin graft harvesting site is disinfected with 10% betadine and from two adjacent areas (one centimeter apart) with the same dimensions as the transplanted tissue. All skin grafts with a thickness of 0.4 mm from the antero-lateral area of the thigh.
Main outcome variables
wound healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220908055916N1
Registration date:2023-01-19, 1401/10/29
Registration timing:prospective
Last update:2023-01-19, 1401/10/29
Update count:0
Registration date
2023-01-19, 1401/10/29
Registrant information
Name
Hamed Shahdadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119
Email address
hamedshahdadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination and Comparision the Effectiveness of Nano Propolis in Wound healing of the donor site Skin Graft in Patients
Public title
Effect of Nano Propolis in Donor Site Graft Healing
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Schaduled for partial Thickness Skin Graft with informed Consent
Exclusion criteria:
history of graft harvest from donor site
history of kelloid and HTS
Cigarette smoking
allergy history to honey
history of wound healing impairment disorder
old age patient(>60 years old)
immune deficient patient
pregnant patient
with out informed consent
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Patients who meet the necessary conditions to enter the study, undergo surgery after complete anesthesia. The skin graft harvesting site is disinfected with 10% betadine solution and from two adjacent areas (one centimeter apart) with the same dimensions as the transplanted tissue. All skin grafts with a thickness of 0.4 mm from the antero-lateral area of the thigh are prepared by an electric dermatome. The areas that are selected as donors are randomly placed in one of the following two groups to receive panmesan with nano propolis medicinal composition and traditional treatment method.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is not done to select People because the Case and Control are done on One Person, but Randomization is done for the Type of Cream in the Wound Healing Site. The Lesions on the Patient's Body will be randomly selected based on the Block Classification of Four Numbers prepared by Excel Software, and will be placed in One of the Two relevant Groups to receive the Panemsan Type
Blinding (investigator's opinion)
Double blinded
Blinding description
In Order to blind the Patient and not know which Cream was used in which Area, the Blinding will be done in a (double-blind) way, so that the Patient will be given Two Gels in the same Tubes. It is given and asked from the Patient that It is the Supervisor Who knows which Lesion of the Patient with which Code, which Gel will be prescribed with which Code, and the Researcher and the Patient do not know about the Codes related to the Lesions and the Content of the Gels.
Randomly, in One of the Two Skin Graft harvesting Sites, Treatment with Nano Propolis gel (Group A) and Placebo Treatment (base Gel without Propolis - Group B) will be used in the Other Place. Nanopropolis Gel and Placebo Gel are similar in Appearance, Weight, Color and Consistency and can only be recognized by a Special Code that was prepared by the harmaceutical Company in cooperation with Sharif University and with the Formulation that is available in the Attachment, and the Researcher and the Patient They do not know about the Codes related to the Content of the Gels.
The Random Selection Sequence of Groups A and B will be calculated by a Statistician and Methodology Expert and maintained by a Person Who has no Other Interest or Participation in the Project. The Researchers and Subjects and the Statistical Analyst will be blind to the Content of the Gels throughout the Study and during the statistical Analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Imam Khomeini Hospital Tehran University of Medical Sciences
Street address
tehran, keshavarz blvd,imam khumeini hospital
City
تهران
Province
Tehran
Postal code
1444863841
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
ir.tums.ikhc.rec.1401.245
Health conditions studied
1
Description of health condition studied
patients need skin graft
ICD-10 code
t14.0
ICD-10 code description
Superficial injury of unspecified body region
Primary outcomes
1
Description
wound healing according to bates-jensen criteria
Timepoint
1-3-7-14-21-28 day
Method of measurement
bates-jensen scoring
Secondary outcomes
1
Description
wound infection rate
Timepoint
1-3-7-14-21-28 day
Method of measurement
examination or culture
2
Description
pain
Timepoint
1-3-7-14-21-28 day
Method of measurement
visual analogue score
3
Description
scar
Timepoint
1-3-7-14-21-28 day
Method of measurement
physical exam
Intervention groups
1
Description
patients with skin defects candidated healing with partial thicknes skin grafts after harvesting the grafted skin at the donor site, which are divided into two equal parts with a distance, and each of these parts are selected as intervention and control subjects: intervention group: in the part that is randomly assigned to The place of intervention is selected, honey nano propolis ointment is prescribed, and after training, daily dressing is done, and on days 1-3-7-14-21-28, the condition of wound healing is checked using Bates-Jensen criteria.
Category
Treatment - Drugs
2
Description
Control group: Control group: Vaseline ointment is prescribed in the part that is randomly selected as the control area, and after training, dressing is done daily and on days 1-3-7-14-21-28 using criteria bates-jensen tests and wound healing status are examined.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khumeini Hospital Complex
Full name of responsible person
Ahmad Reza Taheri
Street address
Tehran,Keshavarz blvd,Valiasrhospital,Plastic department
City
Tehran
Province
Tehran
Postal code
1444863841
Phone
+98 913 503 1653
Email
hamedshahdadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Futuhi
Street address
Tehran, Keshavarz blvd, Imam Khumeini Hospital
City
Tehran
Province
Tehran
Postal code
1444863841
Phone
+98 913 503 1653
Email
hamedshahdadi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Shahdadi
Position
Fellow
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Tehran,Keshavarz blvd, Imam Hospital,Plastic department
City
Tehran
Province
Tehran
Postal code
1444863841
Phone
+98 21 6119 2472
Email
hamedshahdadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Shahdadi
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Tehran,Keshavarz blvd,Imam Hospital, Plastic department