In this study early excision and skin grafting was compared with delay skin grafting in deep hand burns. During 16 months, fifty patients with hand burn with burn size less than 30% TBSA (total body surface area) of deep second and third degree which at least one of the hands also involved with 3 degree burn were randomly allocated into early excision and grafting group (Group I) and delayed grafting group (Group II). We prepared a questionnaire based on DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire to evaluate final functional outcome of hand movements. Also hypertrophic scar formation, contracture and deformities were measured accordingly.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711091605N1
Registration date:2009-05-08, 1388/02/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-05-08, 1388/02/18
Registrant information
Name
Ali Akbar Mohammadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1621 6097
Email address
mohamadiaa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, Vice chancellor for Research
Expected recruitment start date
2006-09-01, 1385/06/10
Expected recruitment end date
2008-01-01, 1386/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Early Excision and Skin Grafting versus Delayed Skin Grafting in Deep hand Burns
Public title
Early Excision and Skin Grafting versus Delayed Skin Grafting in Deep hand Burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hand burn with size less than 30% TBSA (total body surface area) of deep second and third degree which at least one of the hands also involved with 3 degree burn
Exclusion criteria: burn as a component of multiple Trauma, elderly patients with comorbidity, significant inhalation injury or need to intensive care.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences, Ghotb-eddin Burn Center
Street address
Fakhrabad Street, Shiraz
City
Shiraz
Postal code
71638-54733
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
CT-86-3774
Health conditions studied
1
Description of health condition studied
Deep hand Burns
ICD-10 code
T23
ICD-10 code description
Burn and corrosion of wrist and hand
Primary outcomes
1
Description
Disabilities of hand
Timepoint
weekly for first month and then monthly for the following 3 months
Method of measurement
Direct supervision by the surgeon and completed questionnaire(disability scores of five daily activities of hand including combing, opening a can, typing or writing, moving objects)
2
Description
Hypertrophic scar formation after operation
Timepoint
weekly for first month and then monthly for following 3 months.
Method of measurement
by specific ruller
Secondary outcomes
1
Description
Complication after surgery
Timepoint
6-8 mounths after surgery
Method of measurement
follow up by sergeon
Intervention groups
1
Description
Early Excision and Skin Grafting
Category
Treatment - Drugs
2
Description
Delayed Skin Grafting
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghotb-eddin Burn Center
Full name of responsible person
Street address
City
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research
Full name of responsible person
Mohammad Hossein Dabbaghmanesh
Street address
Vice-chanceller of Research, Shiraz University of Medical Sciences
City
Shiraz
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Ali akbar Mohammadi
Position
Assistant Professor, General Surgeon
Other areas of specialty/work
Street address
Fakhrabad Street, Shiraz
City
Shiraz
Postal code
71638-54733
Phone
+98 71 1821 9638
Fax
+98 71 1821 7090
Email
mohamadiaa@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Akbar Mohammadi
Position
Assistant Professor, General Surgeon
Other areas of specialty/work
Street address
Fakhrabad Street, Shiraz
City
Shiraz
Postal code
71638-54733
Phone
Fax
Email
mohamadiaa@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)