Electrical burn is devastating injury in developing country that usually we loss the extremity and decrease the quality of life. Incidence in developed country is 2-3 % and in developing country is21-27%.in electrical burn the pathophysiology is different from other and is very complicated. We have some challenge such as necrosis; ischemia; infection; thrombosis; and so on. We must be careful to preserve the extremity. From 1986 early reconstruction reported but this procedure is new and need more study. This study performed to compare early and late upper extremity reconstruction in high voltage electrical burn. The type of study is clinical trial with intervention and control group. In intervention group, early reconstruction is performed while in control group, conventional treatment include wound debridement and excision and control until granulation formation and regular dressing. Inclusion criteria were electrical burn with more than 1000 volts that leads to vital organ injury included nerves, vessels, tendons, skeletal and articular structures like a open wound in upper and lower extremities and followed with skin, fascia, subcutaneous fat tissue and muscle loss. Exclusion criteria were inability to grafting or graft replacement on wound due to electrical injury, vital conditions instability and coagulopathy. The main outcome of study is organ function.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012112611576N1
Registration date:2013-09-03, 1392/06/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-03, 1392/06/12
Registrant information
Name
Ahmad Reza Dayani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 283 5743
Email address
drahmaddayan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Terhan University of Medical Sciencs
Expected recruitment start date
2012-12-22, 1391/10/02
Expected recruitment end date
2013-06-19, 1392/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of early and late upper extremity reconstruction in high voltage electrical burn
Public title
Comparison of early and late upper extemitty reconstruction in high voltage electrical burn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were electrical burn with more than 1000 volts that leads to vital organ injury included nerves, vessels, tendons, skeletal and articular structures like a open wound in upper and lower extermities and followed with skin, fascia, subcutaneous fat tissue and muscle loss.
Exclusion criteria were inability to grafting or graft replacement on wound due to electrical injury, vital conditions instability and coagulopathy.
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
6th floor; Central building of Tehran University of Medical Sciences, Ghods st., Keshavarze blv.
City
Tehran
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
67666
Health conditions studied
1
Description of health condition studied
Electrical injury, burn
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Early reconstruction
Timepoint
After 2 weeks; 3 & 6 mo
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Organ function
Timepoint
After 2weeks; 3& 6 mo
Method of measurement
Clinical examination
Intervention groups
1
Description
Early reconstruction of high voltage electrical burns of upper limbs
Category
Treatment - Surgery
2
Description
In control group: conventional treatment of electrical burn included wound debridment and excision and control until granulation formation and regular pancemant