Comparison of the effect of wound dressing with chamomile cream 10% and silver sulfadiazine 1% cream on healing time and complications of two degree burn wounds
Determination and comparison of second degree burn time and burn injuries in two methods of dressing with chamomile cream and silver sulfadiazine cream
Design
Samples will be randomly assigned to two groups of 30, and each group was dressed daily with a type of cream (chamomile or silver sulfadiazine 1%) until complete wound healing. The duration of recovery and burn complications in the two groups will be measured and compared
Settings and conduct
Outpatients referring to Imam Mousa Kazem Medical Center Clinic in Isfahan will be studied if they have entry criteria.
Participants/Inclusion and exclusion criteria
The age range from 18 to 60 years old, has a second degree burn with an area of 10-1% and no underlying disease
Intervention groups
Chamomile group: Chamomile cream dressing up to full recovery and silver group: Silver sulfadiazine cream dressing until complete recovery.
Main outcome variables
Duration of restoration, complications of burn wound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180424039406N1
Registration date:2018-09-19, 1397/06/28
Registration timing:retrospective
Last update:2018-09-19, 1397/06/28
Update count:0
Registration date
2018-09-19, 1397/06/28
Registrant information
Name
Mahdi Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3732 0393
Email address
daryabeigi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-22, 1397/01/02
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-03-22, 1397/01/02
Trial completion date
2018-03-22, 1397/01/02
Scientific title
Comparison of the effect of wound dressing with chamomile cream 10% and silver sulfadiazine 1% cream on healing time and complications of two degree burn wounds
Public title
Comparison of the effect of wound dressing with chamomile cream 10% and silver sulfadiazine 1% cream on healing time and complications of two degree burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. One person is between 18 and 60 years old
2. Individuals are only exposed to hot liquids or heat sources.
3. Persons with grade 2 burns according to the criteria
Class 2 burns with a wound burn of between 1% and 10%
The ulcer of the patients is not infected and has not been injured.
People did not use any substance other than drinking water for wound healing before going to the clinic.
The burn wounds are not located in the head and face areas of the genital area, and only in the trunk and limbs (hands and feet).
Substance Abuse (Alcohol, Drugs)
The body mass index is between 18.5 and 30.
People without underlying illness
Women not included in the study are pregnant.
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Actual sample size reached:
67
Randomization (investigator's opinion)
Randomized
Randomization description
After making the cards A and B (with the same size), they were placed inside a non-transparent envelope and the sample group is determined based on the card removed from the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Use the cream with a uniform and uniform A or B package
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Assistant Professor of Research and Technology, University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-12-22, 1396/10/01
Ethics committee reference number
IR.MUI.REC.1396.3.701
Health conditions studied
1
Description of health condition studied
Burn of second degree
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
Primary outcomes
1
Description
The duration of wound healing
Timepoint
Daily wound examination until definite symptoms of complete recovery
Method of measurement
See symptoms of complete wound healing by a researcher
Secondary outcomes
1
Description
Side effects when taking any of the ointments, such as sensitivity, burning and infections
Timepoint
Every day when changing dressings
Method of measurement
By observing the wound by the researcher and verifying it by a specialist physician
2
Description
pain
Timepoint
daily
Method of measurement
Using the VAS ruler
Intervention groups
1
Description
Intervention group: Dressing with chamomile cream 10% (made at Isfahan Pharmaceutical Faculty), which is changed daily until wound healing is approved by the checklist.(The base of the cream is similar to the other group).
Category
Treatment - Drugs
2
Description
Control group: Daily dressing with 1% silver sulfadiazine cream (Produced by Sobhan Darou), which is changed daily until wound healing is approved by the checklist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Musa Kazem (AS) burn injury center in Isfahan
Full name of responsible person
Mahdi Ebrahimi
Street address
Isfahan, Kaveh St. - Imam Musa Kazem (AS) burn injury center in Isfahan
City
Efahan
Province
Isfehan
Postal code
8174673461
Phone
+98 51 3732 0393
Email
medk45v@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian
Street address
Hezaerjerib av. medical university of Esfahan
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahdi Ebrahimi
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 51 3732 0393
Email
medk45v@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Daryabigi
Position
Faculty Member of Faculty of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7551
Email
daryabeigi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahdi Ebrahimi
Position
master student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 51 3732 0393
Email
MEDK45V@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