Evaluation of the effect of skin grafts on the platelet level of patients after surgery in Imam Khomeini Hospital of Urmia in the first 6 months of 2019
The present study was conducted to evaluate the effect of skin grafts on patients' platelet counts after surgery in Imam Khomeini Teaching Hospital.
Design
This study was a quasi-experimental study with a single arm, non-randomized, own control and before and after design.
Settings and conduct
The eligible patients were selected from the burn surgical ward in Imam Khomeini Teaching Hospital in Iran. Related demographic and clinical information were collected and recorded using a checklist. Blood samples were taken from patients during surgery and on the third and fifth days after transplantation to determine the patient's platelet count. Finally, the patient's conditions were recorded regarding wound healing, vital signs, lack of sepsis criteria, platelet level, and transplant success at discharge.
Participants/Inclusion and exclusion criteria
Inclusion criteria included the consent of the patient or the patient's parents to participate in the study and patients who needed skin graft surgery. The exclusion criteria were no history of smoking, no history of diabetes, no skin infections, and not using the drugs affecting platelet factors.
Intervention groups
Eligible patients were selected and underwent skin grafting by a burn surgeon after taking blood and completing the checklist.
There was no control group in this study.
Main outcome variables
The patient's platelet count was the main outcome of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131112015390N8
Registration date:2024-01-06, 1402/10/16
Registration timing:retrospective
Last update:2024-01-06, 1402/10/16
Update count:0
Registration date
2024-01-06, 1402/10/16
Registrant information
Name
Naser Parizad
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1348 7649
Email address
parizad.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-01, 1399/10/12
Expected recruitment end date
2021-06-30, 1400/04/09
Actual recruitment start date
2021-01-01, 1399/10/12
Actual recruitment end date
2021-06-30, 1400/04/09
Trial completion date
2021-12-29, 1400/10/08
Scientific title
Evaluation of the effect of skin grafts on the platelet level of patients after surgery in Imam Khomeini Hospital of Urmia in the first 6 months of 2019
Public title
The effect of skin grafts on the platelet level of burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Burn patients who needed skin graft surgery.
Patients who were willing to participate in the study.
Parents who consented to the participation of their minor patient.
Exclusion criteria:
Patients who had no history of smoking.
Patients who had no history of diabetes.
Patients who did not have skin infections.
Patients who did not use drugs affecting platelet factors.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
220
Actual sample size reached:
200
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
Urmia University of Medical Sciences ethics committee
Street address
Emergency alley, Resalat Blvd., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-11-22, 1399/09/02
Ethics committee reference number
IR.UMSU.REC.1399.388
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The mean platelet counts
Timepoint
Blood samples were taken from patients during surgery and on the third and fifth days after transplantation to determine the patient's platelet count (Primary outcome).
Method of measurement
Sysmex KX-21N Hematology Analyzer
Secondary outcomes
empty
Intervention groups
1
Description
In patients with relatively deep or deep burns that penetrate the reticular dermis layer, blood vessels, and skin appendages, surgical debridement, and skin graft were performed to repair the burn site. For this purpose, excision and skin graft were performed in one session after the patient's initial resuscitation. In this surgical procedure, the ischemic and necrotic burnt tissue was removed layer by layer by a dermatome. Until the wound bed began to bleed, which indicated that there was blood supply from this layer and that it was not involved in a burn. After the hemostasis of bleeding, skin grafts were taken from healthy body parts that had not suffered burns. The skin grafts were taken around the thighs, and in case of the thigh's involvement, the grafts were taken from the legs, arms, forearms, and trunk. The depth of the skin removal was adjusted on the Dermatome, based on the patient’s’ need; the skin was removed on the required area, which was debrided, placed, and sutured with a stapler. At the end of the operation, the grafted area was dressed with sterile vaseline gases, and it was not opened for five days to one week. The skin that was left in place guaranteed the graft's success. The place that suffered a deep burn was repaired by replacing the person's healthy skin (autograft).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Teaching Hospital
Full name of responsible person
Jafar Kazemzadeh
Street address
Ayat Allah Madras Blvd., Ershad Blvd., Imam Khomeini Teaching Hospital, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Phone
+98 44 3345 9538
Email
jafarkazemzade48@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Saber Gholizadeh
Street address
Jahad Ave., Resalat Blvd., Headquarters of Urmia University of Medical Sciences, Urmia.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
sabergholizadeh@yahoo.com
Grant name
Urmia University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Jafar Kazemzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
General Surgery
Street address
Ayat Allah Madras Blvd., Ershad Blvd., Imam Khomeini Teaching Hospital, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Phone
+98 44 3345 9538
Email
jafarkazemzade48@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Jafar Kazemzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
General Surgery
Street address
Ayat Allah Madras Blvd., Ershad Blvd., Imam Khomeini Teaching Hospital, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Phone
+98 44 3345 9538
Email
jafarkazemzade48@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Jafar Kazemzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
General Surgery
Street address
Ayat Allah Madras Blvd., Ershad Blvd., Imam Khomeini Teaching Hospital, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Phone
+98 44 3345 9538
Email
jafarkazemzade48@gmail.com
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
Yes - There is 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
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
Six months after the results are published
To whom data/document is available
All researchers who need data.
Under which criteria data/document could be used
All researchers who use the data for research can apply.
From where data/document is obtainable
The data will be accessible via the following email. jafarkazemzade48@gmail.com
What processes are involved for a request to access data/document
The ethics code of the current study will be sufficient for data delivery.