Investigating the Effect of Fibrin Glue Enriched with Platelets Compared to Stapler on the Faster Clinching of Skin Autografts Lesions in Burn Patients
Improvement of the patient's skin at the first, third and fourth month.
Design
Two arm parallel, individual randomised, single-blinded controlled trial.
Settings and conduct
This project will be conducted in the burn department of Imam Reza Hospital (p) in Mashhad. The data analyzer will be unaware of the group to which patients are assigned.
Participants/Inclusion and exclusion criteria
Patients with burns that need autograft will be included in the study. Patients with diabetes, collagen vascular disorders, taking anticoagulant drugs or corticosteroids or being allergic to local anaesthesia will be excluded.
Intervention groups
The fibrin glue, a biological surgical glue and a mixture of gelatin and ReCverin, will be evaluated in comparison to the stapler.
Main outcome variables
Percentage of improvement of lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130819014404N3
Registration date:2019-04-28, 1398/02/08
Registration timing:prospective
Last update:2019-04-28, 1398/02/08
Update count:0
Registration date
2019-04-28, 1398/02/08
Registrant information
Name
Majid Khadem-Rezaiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9262
Email address
khademrm831@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Fibrin Glue Enriched with Platelets Compared to Stapler on the Faster Clinching of Skin Autografts Lesions in Burn Patients
Public title
Effect of fibrin glue enriched with platelets and stapler in burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who had burn injuries.
Burn lesions that need graft.
Exclusion criteria:
Diabetes.
Collagen vascular disease or hemorrhagic disorders.
Consuming anticoagulants or steroids drugs.
Being allergic to local anesthesia or Bacitracin.
Patient dissatisfaction.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization using the table of random numbers which are palced in sealed opaque envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyser will be blinded to the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Before Golestan Crossroad, Daneshgah Ave., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2018-04-11, 1397/01/22
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.009
Health conditions studied
1
Description of health condition studied
Burns of head, face, and neck
ICD-10 code
T20
ICD-10 code description
Burn and corrosion of head, face, and neck
2
Description of health condition studied
Burns of trunk
ICD-10 code
T21
ICD-10 code description
Burn and corrosion of trunk
3
Description of health condition studied
Burns of shoulder and upper limb
ICD-10 code
T22
ICD-10 code description
Burn and corrosion of shoulder and upper limb, except wrist and hand
4
Description of health condition studied
Burns of wrist and hand
ICD-10 code
T23
ICD-10 code description
Burn and corrosion of wrist and hand
5
Description of health condition studied
Burns of lower limb
ICD-10 code
T24
ICD-10 code description
Burn and corrosion of lower limb, except ankle and foot
6
Description of health condition studied
Burns of ankle and foot
ICD-10 code
T25
ICD-10 code description
Burn and corrosion of ankle and foot
7
Description of health condition studied
Burns of multiple body regions
ICD-10 code
T29
ICD-10 code description
Burns and corrosions of multiple body regions
Primary outcomes
1
Description
The improvement of patients' skin
Timepoint
One, three and four weeks after surgery.
Method of measurement
Clinical evaluation
Secondary outcomes
1
Description
Condition of skin infection
Timepoint
One, three and four weeks after surgery
Method of measurement
Clinical evaluation and wound culture
2
Description
The condition of skin graft
Timepoint
At 8th week after surgery (followup)
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Intervention group: Surgical biological adhesive; Fibrin glue which is produced by the Microwave Company of France and the Tisceon brand
Category
Treatment - Devices
2
Description
Control group: Stapler
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza (p) Hospital
Full name of responsible person
ِDr. Seyed Hasan Tavoosi
Street address
Ibn Sina street, Imam Reza Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91379-13316
Phone
+98 51 3854 3031
Email
TavoosiH@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreishi Building, Before Golestan Crossroad, Daneshgah Ave., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Email
TafaghodiM@mums.ac.ir
Grant name
Dr. Seyed Hassan Tavoosi
Grant code / Reference number
950681
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Hasan Tavousi
Position
Specialist of General surgery, fellowship of burn
Latest degree
Specialist
Other areas of specialty/work
Burn
Street address
Imam Reza Hospital, Imam Reza Sq., Ibn Sina Ave.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
TavoosiH@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Hasan Tavousi
Position
Specialist of General surgery, fellowship of burn
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Reza Hospital, Imam Reza Sq., Ibn Sina Ave.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
TavoosiH@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Hasan Tavousi
Position
Specialist of General surgery, fellowship of burn
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Reza Hospital, Imam Reza Sq., Ibn Sina Ave.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
TavoosiH@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Clinical Study Report
When the data will become available and for how long
After finishing the study and publication of findings
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Acquiring permission and coordination with primary researchers
From where data/document is obtainable
Dr. Daryoush Hamidi Alamdari (Email: HamidiAD@mums.ac.ir)
What processes are involved for a request to access data/document
A written agreement from the Vice-Chancellor of Research of Mashhad University of Medical Sciences