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Comparison of Split thickness skin graft fixation with pressure dressing and stapler fixation in burn

Protocol summary

Study aim
Determining and comparing the status of healing quality in two methods of pressure dressing and stapler
Design
This study will be conducted as a clinical trial on 30 samples. Free skin graft surgery will be performed in two burn areas by pressure dressing and stapler method and after five days, the dressings are opened and will be studied. ​
Settings and conduct
The present study will be conducted in the burn department and operating room of Imam Khomeini (RA) hospital in Ardabil. People will be included in the study according to the inclusion criteria, and free skin grafting surgery will be performed in two burn areas using pressure dressing and stapler method, and after five days, the dressings will be opened and grips of the two The area in terms of necrosis, infection, displacement, and finally got the appropriate quality (based on the examination and judgment of the surgeon) will be recorded in two areas of the studied burn.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patients with 2nd and 3rd degree burns 2. Patients in the age range of 30-60 years 3. Not taking immunosuppressive drugs 4. Not suffering from underlying diseases (diabetes, chronic Renal failure, etc.) 5. Absence of addiction and heavy consumption of tobacco 6. Taking informed consent Non-entry criteria: 1.A burn with an extent of more than 50% that it is not possible to remove the healthy skin as a scar
Intervention groups
Free skin grafting surgery will be performed in two burn areas using pressure dressing and stapler method, and after five days, the dressings will be opened and the grafts in the two areas will be moved in terms of necrosis, infection, and finally it will be of good quality (according to the examination). and the surgeon's judgment (will be studied in two areas of burn).
Main outcome variables
Necrosis, infection, displacement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100628004256N9
Registration date: 2023-05-15, 1402/02/25
Registration timing: prospective

Last update: 2023-05-15, 1402/02/25
Update count: 0
Registration date
2023-05-15, 1402/02/25
Registrant information
Name
Nasrin Samadi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 3057
Email address
na.samadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Split thickness skin graft fixation with pressure dressing and stapler fixation in burn
Public title
Comparison of pressure dressing and stapler in skin graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with 2nd and 3rd degree burns Patients in the age range of 30-60 years Not taking immunosuppressive drugs No underlying diseases (diabetes, chronic Renal failure, etc.) No addiction and heavy smoking obtaining informed consent
Exclusion criteria:
A burn with an extent of more than 50% that it is not possible to remove the healthy skin as a scar
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethic Committees of Ardabil University of Medical Sciences
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.ARUMS.REC.1401.216

Health conditions studied

1

Description of health condition studied
Burn
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Skin graft in terms of necrosis
Timepoint
ِDuring surgery, 5 and 7 days after graft
Method of measurement
The grafts of two areas will be studied in terms of necrosis, and finally the quality of scars (based on the examination and judgment of the surgeon) in the two areas of the burn.

2

Description
Skin graft in terms of infection
Timepoint
ِDuring surgery, 5 and 7 days after graft
Method of measurement
The grafts of two areas will be studied in terms of infection, and finally the quality of scars (based on the examination and judgment of the surgeon) in the two areas of the burn.

3

Description
Skin graft in terms of necrosis
Timepoint
ِDuring surgery, 5 and 7 days after graft
Method of measurement
The grafts of two areas will be studied in terms of displacement and finally the quality of the grips (based on the examination and judgment of the surgeon) in the two regions of the burn.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Free skin grafting surgery will be performed in two burn areas using pressure dressing and stapler method, and after five days, the dressings will be opened and according to the regulatory questionnaire, the two areas will be affected in terms of necrosis, infection, and displacement. It was taken and finally the quality was taken (based on the surgeon's examination and judgment) in two areas of the studied burn.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ardabil
Full name of responsible person
Dr Hamed Mohammadi
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 914 682 9709
Email
na.samadi@arums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Hamed Mohammadi
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 914 682 9709
Email
na.samadi@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Hamed Mohammadi
Position
surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 914 682 9709
Email
na.samadi@arums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Hamed Mohammadi
Position
Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 914 682 9709
Email
na.samadi@arums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Hamed Mohammadi
Position
Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 914 682 9709
Email
na.samadi@arums.ac.ir

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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