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Investigating the healing effects of a natural oint based on herbal oil, honey and egg yolk on 1st and 2nd degree burn wounds

Protocol summary

Study aim
Determining the healing effects of natural oint based on herbal oil, honey and egg yolk on first and second degree burn wounds
Design
Clinical trial with control group, single, double blind, randomized, phase 1-2, on 70 patients. The rand function of Excel software is used for randomization
Settings and conduct
The wounds of patients referred to Kausar Sanandaj Hospital are divided into two equal parts in terms of the largest dimension. Burn ointment based on vegetable oil is applied on one side and usual treatment is done on the other side. Simple masking gas is used for the control level and gauze impregnated with burn ointment is used for the intervention level. Care is similar.At the beginning of the study and also after two days and 5 days of using the effective substance, the two criteria of the level of disinfection and the level of healing of the wound are evaluated by an expert.
Participants/Inclusion and exclusion criteria
Exclusion criteria:3rd degree burns, patients' dissatisfaction in participating in the plan ,death of patients, stopping treatment in patients whose wound healing process is problematic; Inclusion criteria:1st and 2nd degree burn patients referred to Kausar Sanandaj Hospital
Intervention groups
Intervention group:Treatment with burn ointment (based on natural oils, honey and eggs), which is performed on the left side in horizontal wounds, upper side in vertical wounds, and right side in oblique wounds.Gauze impregnated with burn ointment is used at the intervention site.Control group: usual clinical procedures are performed on the right side in horizontal wounds, the bottom in vertical wounds and the left side in oblique wounds. A simple masking gas is used for the control surface.
Main outcome variables
Surgical Site Infection; Early Healing Score which includes clinical signs of re-epithelization, clinical signs of haemostasis, clinical signs of inflammation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141208020249N8
Registration date: 2024-09-23, 1403/07/02
Registration timing: registered_while_recruiting

Last update: 2024-09-23, 1403/07/02
Update count: 0
Registration date
2024-09-23, 1403/07/02
Registrant information
Name
Behzad Khalafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3344 9697
Email address
khalafi.behzad70@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-08-23, 1404/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the healing effects of a natural oint based on herbal oil, honey and egg yolk on 1st and 2nd degree burn wounds
Public title
Investigating the healing effects of a natural oint based on herbal oil, honey and egg yolk on 1st and 2nd degree burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1st and 2nd degree burn patients referred to Kowsar Sanandaj Hospital who consent to participate in the research project.
Exclusion criteria:
Dissatisfaction of patients in participating in the study Death of patients Stopping treatment in patients who have problems with wound healing
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
More than 1 sample in each individual
Number of samples in each individual: 2
In order to randomly assign the type of treatment, wounds are divided into two equal parts, and A, which is a burn ointment based on vegetable oils, honey and eggs, is divided into the left parts in horizontal wounds, the top in vertical wounds and The right side is allocated in oblique wounds and the other side is treated B.) usual clinical procedures are performed.
Randomization (investigator's opinion)
Randomized
Randomization description
We divide the burn site into two parts (half medial) A and (half lateral) B and use the drug under study as follows. The part of the burn that does not receive the study drug will be partially controlled. 0001: A 0007: B 0013: B 0019: A 0025: A 0031: B 0002: B 0008: A 0014: A 0020: B 0026: B 0032: B 0003: A 0009: B 0015: B 0021: B 0027: B 0033: B 0004: A 0010: B 0016: A 0022: B 0028: B 0034: A 0005: A 0011: A 0017: A 0023: B 0029: A 0035: B 0006: A 0012: A 0018: A 0024: A 0030: A
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blind, so that the doctor responsible for measuring the outcome/intervention and the patient will be blind to the type of intervention received.
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Abider Street
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Approval date
2024-06-19, 1403/03/30
Ethics committee reference number
IR.MUK.REC.1403.070

Health conditions studied

1

Description of health condition studied
1st and 2nd degree burns
ICD-10 code
T30
ICD-10 code description
Burn and corrosion, body region unspecified

Primary outcomes

1

Description
Surgical Site Infection score
Timepoint
Before starting the study and 2 and 5 days after the intervention
Method of measurement
In this measure, Surgical Site Infection (SSI) indicators based on CDC guidelines are used to evaluate the risk of wound infection.

2

Description
Early Healing Score
Timepoint
Before starting the study and 2 and 5 days after the intervention
Method of measurement
EHS evaluation consists of clinical signs of re-epithelization (CSR), clinical signs of haemostasis (CSH) and clinical signs of inflammation (CSI).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Treatment with burn ointment (based on natural oils, honey and eggs), which is performed on the left side in horizontal wounds, upper side in vertical wounds, and right side in oblique wounds.Gauze impregnated with burn ointment is used at the intervention site
Category
Treatment - Drugs

2

Description
Control group: The usual clinical procedures (mefenaid ointment) are performed on the right side in horizontal wounds, the bottom in vertical wounds and the left side in oblique wounds. (The wound is divided into two equal parts in terms of the largest dimension). It is used for the control surface.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Sanandaj Hospital
Full name of responsible person
Behzad Khalafi
Street address
Kawsar Hospital, Shohadaye Salamat Blvd, Pasdaran St.,
City
Sanandaj
Province
Kurdistan
Postal code
6617784817
Phone
+98 87 3377 7925
Email
khalafi.behzad70@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Abider Street, Sanandaj, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3324 4990
Email
info@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Kawsar Hospital, Shohadaye Salamat Blvd, Pasdaran St.,
City
Sanandaj
Province
Kurdistan
Postal code
6617784817
Phone
+98 87 3377 7925
Email
khalafi.behzad70@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Research Associate
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Pasdaran St.,
City
Sanandaj
Province
Kurdistan
Postal code
6617784817
Phone
+98 45 3344 9697
Fax
Email
khalafi.behzad70@muk.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Research Associate / Researcher Soldier - General Physician of Kurdistan University of Medical Scien
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Pasdaran Boulevard
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 45 3344 9697
Fax
+98 87 3366 4645
Email
khalafi.behzad70@muk.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the original data will be published in the form of an article, and supplementary data can be obtained from the responsible author upon reasonable request.
When the data will become available and for how long
2025 spring
To whom data/document is available
Official academic researchers or working in commercial research and development units
Under which criteria data/document could be used
Scientific research uses
From where data/document is obtainable
Researchers can request documents or data files by sending an email to the person responsible for the scientific responsibility of the study. The exact response time is not known. The email address and details of the person responsible for responding are as follows: The full name of the responsible person: Behzad Khalafi Email: khalafi.behzad70@gmail.com Phone +98 87 3377 7925 Address: Pasdaran Street, Shahada Salamat Blvd., Kawsar Hospital Postal code 6617784817
What processes are involved for a request to access data/document
First, the researchers send an e-mail to the person responsible for the scientific response(The full name of the responsible person: Behzad Khalafi Email: khalafi.behzad70@gmail.com) and specify which of the data they want. The information (except for the personal information of the participants) will be available to the said person after reviewing the request through e-mail.
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