Comparison of therapeutic effect of dressing with skin allograft and silver sulfadiazine in deep second degree burn wounds in Zanjan Ayatollah Mousavi hospital, 2016-2017
The main goal of this RCT is to verifying the therapeutic effects of skin allograf in compare with silver sulfadiazine ointment in deep second degree burn injuries of trunk and limbs. Fifty patients randomly divided in 2 groups(each one 25 patients)with inclusion criteria which were: deep second degree burn injuries in trunk and limbs, BSA between 10 to 20 percent, age above 18 and less than 65 years old without any comorbidities. We excluded patient with old burning, infected wounds, other medical conditions and candidates for autograft skin grafts.
In intervention group we applied skin allografts produced by ITP company(Iranian tissue products) as a biological bandage; in control group we used silver sulfadiazine ointment. The rate of infection was measured by culture from wounds if the patients had symptoms like fever or leucocytosis.The pain was measured with the scale called VAS and also the amount of IV pain killer consumption mentioned in questionare.and the scar and epitelialisation evaluated in days 7,14 and 30.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112431074N1
Registration date:2017-02-13, 1395/11/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-13, 1395/11/25
Registrant information
Name
Ali Farahanchi Baradaran
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9134
Email address
dr-ali-farahanchi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of dressing with skin allograft and silver sulfadiazine in deep second degree burn wounds in Zanjan Ayatollah Mousavi hospital, 2016-2017
Public title
Therapeutic effect of skin allograft in deep second degree burn wounds
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: patients with thermal deep second degree burn wound who are admitted in our ward, age above 18,with out respiratory burning, with out any comorbidities like addiction. History of DM, renal disease, malignancies, psychiatric problems and non- pregnant patients.
Exclusion criteria: head and neck burn wounds; genitalia burn wounds; pregnant patients; third and forth degree burn wounds; unstable patients; patients with burn wounds BSA>20% or BSA<10%; psychiatric patients; addict and smoker patients; patients with other comorbidities like renal and hepatic problem, DM, malnutrition and immunocompromised patients, respiratory burning, old wounds; infected wounds and age below 18.
Age
From 18 years old to 65 years old
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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Postal code
Approval date
2016-11-23, 1395/09/03
Ethics committee reference number
IR.ZUMS.REC.1395.204
Health conditions studied
1
Description of health condition studied
Deep second degree burn wounds of limbs and trunk
ICD-10 code
T21.2
ICD-10 code description
Burn of second degree of trunk
Primary outcomes
1
Description
Pain
Timepoint
Daily during admission
Method of measurement
VAS scale
2
Description
Epitelialisation duration
Timepoint
days: 7, 14 and 30
Method of measurement
Physical examination
3
Description
Amount of IV pain killer
Timepoint
Daily during admission
Method of measurement
Nursing report
4
Description
Finall remaining scar
Timepoint
Day 30 after intervention
Method of measurement
Physical examination and questionare
Secondary outcomes
1
Description
Addmision days
Timepoint
Time of discharge
Method of measurement
Discharge ward
2
Description
Number of bandage refreshment
Timepoint
Daily during admission
Method of measurement
Nursing report and direct checking
3
Description
Treatment cost
Timepoint
At the time of discharge
Method of measurement
Finall bill
4
Description
Infection
Timepoint
During admission
Method of measurement
Culture from wound
Intervention groups
1
Description
In control group we used silver sulfadiazine ointment daily after washing the wounds.we consume 20 gram of ointment for each percent of burn wound(each tube is consist of 50 gram of ointment).
Category
Treatment - Drugs
2
Description
In intervention group we applied skin allografts produced by ITP company(Iranian tissue products) as a biological bandage.first we sutured the allograft with few simple stiches then with we badage with wet gauze (under anestesia in OR)the day after procidure we remove the bandage and dry it by heat lamp and do not bandage any more.