Comparison of the antibacterial effect of Silver sulfadiazine ointment and spray of silver nanoparticles on Pseudomonas aeruginosa and Staphylococcus aureus bacteria in burn wounds in patients with burn grade 2 and 3 and burn area below 20% due to heat
Design
Clinical trial with two intervention groups, with parallel, two-way blind, randomized groups
Settings and conduct
This study is being performed at Imam Reza (AS) Hospital in Birjand, South Khorasan Province. Sixty-six patients were randomly assigned to two groups of nanosilver sprays or sulfur sulfaziazine ointment. Then, the presence of infection in 3 and 6 days after hospitalization and the size of the burn wound on 0 and 7 days after hospitalization will be examined.
Participants/Inclusion and exclusion criteria
The study population of patients admitted to the burn ward of Imam Reza (AS) Hospital in Birjand with burn grade 2 and 3 and burn area below 20% will be in 1399.
Criteria for entering the study include: having conscious consent of the patient or his close companion to enter the study, at least 12 mg / dl hemoglobin, degree of burns 2 and 3 and percentage of thermal burns below 20%, no intervention to wash and burn the burn before visiting The hospital and the ability to answer questions should be the patient himself or his companion.
And the criteria for leaving the study include: patients taking corticosteroids for more than a month, suppressing the immune system and chemotherapy, not having diabetes, AIDS, hypertension, skin allergies, dissatisfaction to continue studying.
Intervention groups
Burnt patients who will be treated with nanosilver spray or Silver Sulfudiazine ointment when dressing.
Main outcome variables
Wound size
Wound site infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043934N4
Registration date:2020-06-19, 1399/03/30
Registration timing:registered_while_recruiting
Last update:2020-06-19, 1399/03/30
Update count:0
Registration date
2020-06-19, 1399/03/30
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-19, 1399/03/30
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Comparison of the Antibacterial Effect of Nanosilver Spray with Silversolfadiazin Ointment on Burnt Patients
Public title
Comparison of nanosilver spray with silorsulfadiazine ointment in burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having conscious consent of the patient or his close companion to enter the study
Minimum hemoglobin mg / dl 12
Grade 2 and 3 burns
Percentage of thermal burns below 20%
Failure to perform surgery to wash and burn the burn before visiting the hospital
Ability to answer questions
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
66
More than 1 sample in each individual
Number of samples in each individual:
2
If there is fuel in two different locations, sampling will be performed from two different locations.
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking method of Simple random sampling
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants
Consequence Assessor
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2020-06-10, 1399/03/21
Ethics committee reference number
IR.BUMS.REC.1399.089
Health conditions studied
1
Description of health condition studied
Burning
ICD-10 code
M61.3
ICD-10 code description
Calcification and ossification of muscles associated with burns
Primary outcomes
1
Description
Wound size
Timepoint
Zero day (hospitalization) and day 7 after hospitalization
Method of measurement
The size of the patient's wound will be measured based on the Betsy Jensen checklist
Secondary outcomes
1
Description
Wound infection
Timepoint
3 and 6 days after hospitalization
Method of measurement
Sampling of the wound by a sterile swab using the Levine technique
Intervention groups
1
Description
Intervention group: Use a nanosilver spray when replacing a burn wound dressing (spray on the wound site to wet the entire burn wound).
Category
Treatment - Drugs
2
Description
Intervention group: Use of Silver Sulfadiazine ointment when replacing burn wound dressings (the burn site will be covered with a topical ointment of Silver Sulfadiazine 1.5 mm thick that is routinely used to treat burn wounds).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital-Birjand
Full name of responsible person
Dr. AbdolVahhab Javaheri
Street address
Moallem BLV
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr, Tooba Kazemi
Street address
Ghaffari Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
oabstudent@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Moallem BLV
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohsen Najmaddini
Position
Member of the Faculty
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Taleghani Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Moallem St
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available