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The study of using medical honey compared to stapler(Advan disposable skin stapler) for skin graft fixation in burn wounds

Protocol summary

Study aim
Determining the effect of using medical honey compared to stapler(Advan disposable skin stapler ) in attaching skin grafts to burn wounds
Design
Clinical trial on 80 patients in addition of group control and in order to randomize the treatment between the groups, the 4 permutation blocks randomization.
Settings and conduct
The study population is all patients undergoing skin graft surgery admitted by the Velayat Burns Hospital. Skin graft surgery in 2 groups, using honey and using a stapler are included in the study. Comparison of honey group with stapler in terms of pain and itching, skin graft rejection, post-graft infection, graft skin displacement, creation hematoma, shrinkage of the skin and edema after transplantation
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with second-degree and third-degree of burn wounds need a graft and burns with less than 40% which are performed in one step. Exclusion criteria:Grafts that are performed in several stages and people with debilitating diseases and defected immune system, diabetes and Cortone users and head, face, neck injury and joints burned cases which are sensitive to honey and its derivatives.
Intervention groups
Two groups will be studied by honey and stapler used. In the first group, honey is used to attach the skin graft to the underlying tissue and in the second group, the stapler is used to attach the skin graft to the underlying tissue.
Main outcome variables
Evaluation and observation of the effectiveness of honey and stapler, Skin graft rejection, post-transplant infection, displacement of graft skin, hematoma, skin shrinkage, edema, pain and itching.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210524051384N2
Registration date: 2021-10-14, 1400/07/22
Registration timing: prospective

Last update: 2021-10-14, 1400/07/22
Update count: 0
Registration date
2021-10-14, 1400/07/22
Registrant information
Name
mohammadreza mobayen
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 8540
Email address
maziar.mobayen@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of using medical honey compared to stapler(Advan disposable skin stapler) for skin graft fixation in burn wounds
Public title
The effect of using medical honey on the attachment of skin grafts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with deep grade 2 and 3 of burn wounds who need a graft and burns with less than 40% which are performed in one- step.
Exclusion criteria:
Grafts that are performed late and in several stages and people with debilitating diseases and defected immune system, diabetes and Cortone users and burns injuries on the head, face, neck ,joints and allergies to honey and its products.
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the treatment between the groups, 4 permutation blocks method will be used. Group A is the intervention group and group B is the control group, and data randomization was performed with SAS software version 9.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethic Committees of Guilan University of Medical science
Street address
Guilan University of Medical science
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2021-09-29, 1400/07/07
Ethics committee reference number
IR.GUMS.REC.1400.304

Health conditions studied

1

Description of health condition studied
Burns
ICD-10 code
Z94.5
ICD-10 code description
Skin transplant status

Primary outcomes

1

Description
Efficiency of honey in attaching skin grafts
Timepoint
Duration of hospitalization
Method of measurement
By observing skin graft area and experienced burn specialist's opinion

Secondary outcomes

1

Description
Evaluating the degree of displacement of grafted skin
Timepoint
On fifth, seventh and fourteenth days after surgery
Method of measurement
Based on millimeters

2

Description
Infection after skin graft surgery
Timepoint
On seventh, fourteenth and one month after surgery
Method of measurement
Based on culture and Antibiogram

3

Description
Hematoma
Timepoint
On fifth, seventh and fourteenth days after surgery
Method of measurement
By observing the accumulation of blood outside the vessels around the skin graft

4

Description
The amount of pain
Timepoint
At 3, 6, 12 and 24 hours and by the third day after surgery
Method of measurement
Using the VAS criteria

5

Description
Itching
Timepoint
At 3, 6, 12 and 24 hours and by the third day after surgery
Method of measurement
Through the 5-D criterion based on the lenght, severity, recovery and disability degree caused by itching.

6

Description
Edema
Timepoint
On fifth, seventh and fourteenth days after surgery
Method of measurement
By observing the abnormal accumulation of interstitial fluid water under the skin graft and observing by professionals

7

Description
Shrinkage of the skin graft
Timepoint
On fifth, seventh and fourteenth days after surgery
Method of measurement
Based on millimeters (length and width)

8

Description
Follow-up of transplantation
Timepoint
On fifth, seventh and fourteenth days after surgery
Method of measurement
Based on discoloration of transplanted skin and photography and observing by burn specialist's opinion

9

Description
Duration of hospitalization
Timepoint
Duration of patients' hospitalization
Method of measurement
Day

Intervention groups

1

Description
Intervention group: Using honey instead of stapler to attach skin grafts.The medical honey used in this study is(Madi Hani) honey gel available in the market which is free from all the harms of ordinary honey to preserve all the properties of honey, including enzymes and diastases. Honey is refined at temperatures below 50 degrees. This honey has a low pH and high osmolarity with high antibacterial properties against the spectrum. A wide range of resistant strains along with maintaining the ideal moisture of the wound environment plays an effective role in healing. Patients with second and third deep grad of burn wounds require a graft, with burns less than 40% that are done in a single step that requires an autograft skin graft from the patient after the necessary and sufficient explanations about the study and the procedure for patients by an expert and physician and obtaining informed consent from 80 patients who are candidates for skin graft surgery using honey, which is removed from the patient with a skin dermatome device and placed in the appropriate area.
Category
Treatment - Drugs

2

Description
Control group: the use of stapler in attaching skin grafts. A stapler will be used to attach the skin graft to the underlying tissue. Using Advan disposable skin stapler which is disposable and is provided by Farab Surgeon Company, which is made and sterilized by the factory and is disposed of after use. Patients with second and third deep grad of burn wounds require a graft, with burns less than 40% that are done in a single step that requires an autograft skin graft from the patient after the necessary and sufficient explanations about the study and the procedure for patients by an expert and physician and obtaining informed consent from 80 patients who are candidates for skin graft surgery using honey, which is removed from the patient with a skin dermatome device and placed in the appropriate area
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Mohammadreza Mobayen
Street address
Parastar Street, Namjo Street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
maziar.mobayen@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Naghipour
Street address
Deputy of Research and Technology, in front of 17 Shahrivar Hospital, Namjo St.,
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Chancellor for Research, Guilan 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
Rasht University of Medical Sciences
Full name of responsible person
Dr.mohammadreza Mobayen
Position
Fellowship in Plastic Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Velayat Hospital, Namjo Street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
maziar.mobayen@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Mobayen
Position
Fellowship in Plastic Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Velayat Hospital, Namjo Street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
maziar.mobayen@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Alale Jarrahi
Position
Professional PhD student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Velayat Hospital, Namjo Street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
alalejarrahi.1995@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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