The aim of this study was the comparison between two EEG and DEG procedures in restoring the functionality of burn hands after 1 and 3 months by Michigan Hand Questionnaire (MHQ).
Design
A double blind, randomized parallel clinical trial
Settings and conduct
Hands are common sites for the burn. Early excision and grafting (EEG) and delayed excision and grafting (DEG) of burn wounds decreases the hospital stay, hospital costs, and septic complications. This study compares these 2 methods in restoring the functionality of hands after 1 and 3 months by Michigan Hand Questionnaire (MHQ).
This is the randomized double-blind clinical trial being performed from January 2013 to December 2015 on both hand burn who met inclusion criteria in Ghotbodin hospital, Shiraz University of Medical Sciences, Shiraz, Iran. The study participants and the observers will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
patients with deep second and third-degree burn covering less than 50% of total body surface area (TBSA) and both hand burn with deep second degree burn with an age limitation of 15-70 years.
Exclusion Criteria:
elderly patients with comorbidity diseases, scars from previous burn injuries and having connective tissue disorders or burn as a component of multiple trauma, significant inhalation injury or need to intensive care, Left handed patients and also less than 10 hand finger burn.
Intervention groups
The patients were assigned to two study groups; the early excision and grafting (EEG)group before 6 days and the delayed excision and grafting (DEG) group in the second week.
Main outcome variables
Hand Function; pain, activity daily limitation, overall satisfaction; cosmetics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141218020364N7
Registration date:2018-01-29, 1396/11/09
Registration timing:retrospective
Last update:2018-01-29, 1396/11/09
Update count:0
Registration date
2018-01-29, 1396/11/09
Registrant information
Name
Mohhammad Yasin Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3839 1385
Email address
karamiy@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
2013-01-11, 1391/10/22
Actual recruitment end date
2015-12-31, 1394/10/10
Trial completion date
empty
Scientific title
Effect of early excision and grafting versus delayed excision and grafting on restoring the functionality of deep burn-injured hands
Public title
Early Excision and Skin Grafting versus Delayed Skin Grafting effect on function in hand Deep Burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ِDeep second and third-degree burns
both hand burn with deep second degree burn
age limitation of 15-70 years
covering less than 50% of total body surface area (TBSA)
Exclusion criteria:
elderly patients with comorbidity diseases (diabetes Mellitus, chronic respiratory, cardiac and vascular diseases, hypertension)
scars from previous burn injuries
having connective tissue disorders
burn as a component of multiple trauma
significant inhalation injury or need to intensive care
Left handed patients
less than 10 hand finger burn
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
150
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
the random drawing of sealed envelopes (Computer-based table of randomization )
Blinding (investigator's opinion)
Double blinded
Blinding description
The study participants had know two types of common burn injuries treatment, But due to the dressing on the burn wound, they were not aware of the type of treatment we were used for them.
The observer who completed the questionnaire did not know the study groups.
The original researcher (burn surgeon) was aware of the study groups.
The data analyzer was not known from the study groups.
The safety committee and data monitoring were aware of 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 Shiraz University of Medical Sciences
Street address
Fakhrabad Street
City
Shiraz
Province
Fars
Postal code
987163854733
Approval date
2012-10-31, 1391/08/10
Ethics committee reference number
IR.SUMS.MED.REC.1394.90
Health conditions studied
1
Description of health condition studied
Deep Hand Burn
ICD-10 code
T23
ICD-10 code description
Burn and corrosion of wrist and hand
Primary outcomes
1
Description
Disabilities of hand
Timepoint
Patients were visited weekly in the first month and then every month for the next 3 months.
Method of measurement
Direct supervision by the surgeon and completed questionnaire (Michigan hand Q about the function of the hands, ADL, pain, daily activity limitation, scar formation and overall satisfaction in MHQ questionnaire).MHQ questionnaire filled at end of the first and third month.
Secondary outcomes
1
Description
Complication after surgery
Timepoint
3 month after surgery
Method of measurement
follow up by sergeon
Intervention groups
1
Description
Intervention Group 1 (Early Excision and Skin Grafting (EEG)): In the EEG group, the patients will be operating after being stabilized during the fifth or seventh day after the injury. In the operation room, under the sterile condition and after general anesthesia, upper extremity tourniquet will be used to decrease active bleeding. The dead tissue in deep burn hand skin will be debrided using Goulian knife; then, tissue viability will assess according to the amount of bleeding in the debrided tissues. The debrided area will then cover with a sheet of skin (0.3 mm thickness) and fixe with skin stapler. The dressing will be applied and all of the below mentioned postoperative steps for the DEG group will be used for the EED group. Short splitting will be applied on the hands until the first dressing change. Passive and active hand physiotherapy will start at the end of 7th day.
Category
Treatment - Surgery
2
Description
Intervention Group 2 (Delayed Excision Skin Grafting (DEG)): In the DEG group, the patients will operate after being stabilized (complete granulation tissue formation) after the first 14 days after injury. Daily dressing (twice a day) with topical antibiotics including silver sulfadiazine and mafenide acetate will use under a general surgeon supervision. The infected wound will be treated with intravenous antibiotics according to wound culture and antibiogram. In the operating room with an aseptic setting and under generalized anesthesia, the dead tissue (Scar) will be excised and debrided until reaching a proper bed for skin grafting (viable tissue). The debrided area will then cover with a partial thickness non-meshed (sheet) skin in use from the patient’s healthy skin of the thighs at the same stage. The dressing will then remove on the 5th postoperative day unless signs of infection (such as abnormal discharge, high-grade fever, changes in general condition, etc.) will observe; their dressings will change sooner.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghotb-eddin Burn Center
Full name of responsible person
Mehdi Ayaz
Street address
Fakhrabad Street
City
Shiraz
Province
Fars
Postal code
987163854733
Phone
+98 71 3821 9638
Fax
+98 71 3821 7090
Email
ayazmahdi@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hashemi Seyed Basir
Street address
Vice-chanceller of Research, Shiraz University of Medical Sciences Shiraz
City
Shiraz
Province
Fars
Postal code
98713451978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Ayaz
Position
Assistant Professor, General Surgeon
Latest degree
Specialist
Other areas of specialty/work
burn ُSurgery
Street address
Fakhrabad Street,
City
Shiraz
Province
Fars
Postal code
987163854733
Phone
+98 71 3821 9638
Fax
Email
ayazm@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
Mehdi Ayaz
Position
Assistant Professor, General Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Fakhrabad Street, Shiraz
City
Shiraz
Province
Fars
Postal code
987163854733
Phone
+98 71 3821 7090
Fax
Email
ayazm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Yasin Karami
Position
General Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Faghihi Hospital, Department of surgery
City
Shiraz
Province
Fars
Postal code
987163854733
Phone
+98 71 3233 1006
Fax
Email
karamiy@sums.ac.ir
Web page address
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
all collected deidentified IPD data could be shared.
When the data will become available and for how long
12 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
data analysis in the systematic review is provided.
From where data/document is obtainable
all applicant should call the following number:
Mehdi Ayaz; Burn and wound healing research center, Department of Surgery, Division of Burn and Reconstructive Surgery Shiraz University of Medical Sciences Shiraz, Iran. E-mail: ayazmahdi@yahoo.com Postal address: 71339-75121 Tel number: 00989121085896.
What processes are involved for a request to access data/document
After contacting the applicant and identifying the university identity and reviewing the application, the information will be e-mailed to him/her within a one-month period of time.