Determination of effect of silver nanocrystal dressing (Agicoat) in second degree burn patients of Motahhari hospital and camparision it with Acticoat and silver sulfadiazine
This study is designed for comparison between effects of Agicoat , Acticoat and silver sulfadiazine in second degree burn between 15-40% referred to Motahhari hospital that are not candidate for surgical intervention. Total number of 120 patients are devided into three groups of treatment.The dressing will do upon related protocol. Primary outcome measures includ scar of burn wound,epithelialization time, total days of admission,pain severity and narcotic usage, infection rate and total cost of each group. Exclusion criterias : 1- Unresidency of patients in Tehran
2- Underlying medical diseases
3- Sensitivity to Ag
4- Young and old ages: under 5 and over 65 years old
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206237913N2
Registration date:2012-10-08, 1391/07/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-10-08, 1391/07/17
Registrant information
Name
Mohammadreza Akhoondinasab Meibodi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 4275
Email address
m-akhoondinasab@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Emad pharmacy company
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of effect of silver nanocrystal dressing (Agicoat) in second degree burn patients of Motahhari hospital and camparision it with Acticoat and silver sulfadiazine
Public title
Effect of Agicoat(silver nanocrystal dressing) in burn wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterias : 1- 2nd degree burn between 15- 40%
Exclusion criterias : 1- Unresidency of patients in Tehran
2- Underlying medical diseases
3- Sensitivity to Ag
4- Young and old ages: under 5 and over 65 years old
Age
From 5 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
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
Iranian Registry of Clinical Trial
Street address
Second floor, No. 7, Poorsina ave., Ghods st., Enghelab square
City
Tehran
Postal code
Approval date
2012-08-01, 1391/05/11
Ethics committee reference number
90-03-129-14757-57675
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T29.6
ICD-10 code description
Corrosions of multiple regions, no more than second-degree corrosions mentioned
Primary outcomes
1
Description
Scar
Timepoint
1 mo and 3mo and 6mo after discharge
Method of measurement
Vancover scar scale scor
2
Description
Wound epithelialization
Timepoint
1wk after intervention and every 3days till 6wk
Method of measurement
Day
3
Description
Admission duration
Timepoint
Discharge date
Method of measurement
Discharge date minus admission date
4
Description
Infection
Timepoint
From time of admission till 1 mo after discharge
Method of measurement
Culture- biopsy
5
Description
Pain severity
Timepoint
Every 3 days till discharge date
Method of measurement
Visual analogue scale
6
Description
Expenditure
Timepoint
At discharge date
Method of measurement
Rial
Secondary outcomes
1
Description
Ethiology
Timepoint
Admission time
Method of measurement
Scald, Fire
2
Description
Burn percentage
Timepoint
Admission time
Method of measurement
Tatal body surface burned
3
Description
Age
Timepoint
Admission time
Method of measurement
Year of entrance to study minus birth day
Intervention groups
1
Description
Dressing with silver sulfadiazine daily (closed dressing): the ointment will apply daily and with sterile gauze will close
Category
Treatment - Drugs
2
Description
Acticoat dressing apply after wetting it by distilled water and fixing it to bed by tape and melonin and moistuering it by distilled water every 6 hours.The dressing will change every 4 days till wound healing
Category
Treatment - Drugs
3
Description
Agicoat dressing will undertake after wetting it by distilled water and applying itver wound. The first dressing change will take place after 72 hours or when there is discharge from wound.If there is no discharge the dressing can be left for 7 to 10 days over wound .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari hosp.
Full name of responsible person
Mohammadreza Akhoondinasab
Street address
Motahhari hospital,Yasami alley, Valiasr st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Emad pharmacy co.
Full name of responsible person
Amuee dr.
Street address
Emad pharmacy co., No.18.1, Sepahsalar, Sajjad st.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Emad pharmacy co.
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
Tehran University of Medical Sciences
Full name of responsible person
Mohammadrza Akhoondinasab
Position
Postgraduate of plastic surgery
Other areas of specialty/work
Street address
Motahhari hosp.
City
Tehran
Postal code
Phone
+98 21 8877 0031
Fax
Email
burncenter_89@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Akhoondinasab
Position
Assistant professor of plastic surgery
Other areas of specialty/work
Street address
Motahhari hosp.
City
Tehran
Postal code
Phone
+98 21 8888 4275
Fax
Email
akhoondinasab@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Mobaiien
Position
Burn fellowship
Other areas of specialty/work
Street address
Motahhari hosp.
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)