Objectives: To assess the result of dermal graft without suture fixation in burn patients.
Design: a clinical trial.
Setting and conduct: The eligible burn patients who will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: burn patients who are candidate for dermal graft.
Exclusion criteria: Sensitivity to anesthesia medications; contraindication of general or spinal anesthesia.
Intervention group: Dermal graft without suture fixation
Control group: Nothing.
Primary outcome: Assessing the result of dermal graft without suture fixation through physical examination 5 days after surgery.
Secondary outcome: Assessing local hematoma or bleeding at surgical location through physical examination 5 days after surgery.
Randomization: Single group without randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610029014N118
Registration date:2016-10-03, 1395/07/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-03, 1395/07/12
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the result of dermal graft without suture fixation in burn patients: a clinical trial
Public title
Assessing the result of dermal graft without suture fixation in burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: burn patients who are candidate for dermal graft.
Exclusion criteria: Sensitivity to anesthesia medications; contraindication of general or spinal anesthesia.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: Single group without randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-05-13, 1395/02/24
Ethics committee reference number
IR.UMSHA.REC.1395.96
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T20
ICD-10 code description
Burn and corrosion of head and neck
2
Description of health condition studied
Burn
ICD-10 code
T21
ICD-10 code description
Burn and corrosion of trunk
3
Description of health condition studied
Burn
ICD-10 code
T22
ICD-10 code description
Burn and corrosion of shoulder and upper limb, except wrist and hand
Primary outcomes
1
Description
Assessing the result of dermal graft without suture fixation
Timepoint
5 days after surgery
Method of measurement
through physical examination
Secondary outcomes
1
Description
Assessing local hematoma or bleeding at surgical location
Timepoint
5 days after surgery
Method of measurement
through physical examination
Intervention groups
1
Description
Dermal graft without suture fixation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Abbas Ali Eskandarion
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Abbas Ali Eskandarion
Position
Resident of sugery
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
pjsk625@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Mahdi Eskandarloo
Position
Surgeon
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
Dr Mahdi Eskandarloo
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)