Protocol summary

Summary
1) Objectives: This research will be accomplished with the purpose of the effect of Adibderm herbal ointment on treatment of grade II dermal burning injuries in Emergency department 2) Design: 60 patients with grade II dermal burning injury will be divided two groups [Adibderm (group 1), Silver sulfadiazine (group 2)] with use Random Allocation Software. 3) Setting and conduct: After obtain the informed consent, severity, location and cause of burning and demographic information of patients will be registered. Then patient will be treated based on group number (1 or 2). 4) Participants including major eligibility criteria: inclusion criteria: All grade II, and 1-10% dermal burning injury 18-65 years old patients, burning with hot fluid or fire, time interval between injury and admission to the emergency room less than 6 hours. Exclusion criteria: Grade I, III, and IV burning injury, admission required to hospital ward, pregnant patients, chemical burning, face and neck and perineal burning, any underlying disease causing impaired healing (e.g. immunodeficiency, diabetes, anemia, cancer, cytotoxic drugs and allergic skin disease), dissatisfaction to participate to study. 5) Intervention: Type of treatment used in two groups are different. In group one Adibderm herbal ointment, and in group two silver sulfadiazine ointment will be used. 6) Main outcome measures variables: Healing time will be compared in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062912592N2
Registration date: 2015-09-11, 1394/06/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-11, 1394/06/20
Registrant information
Name
Farzad Rahmani
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 2078
Email address
rahmanif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effects of Silver Sulfadiazine Ointment and Adibderm Herbal Ointment in Treatment of Patients with Grade II Dermal burns admitted to the Emergency Department
Public title
Effect of Adibderm Herbal Ointment on Dermal Burning Injury Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: All grade II, and 1-10% dermal burning injury 18-65 years old patients; burning with hot fluid or fire; time interval between injury and admission to the emergency room less than 6 hours. Exclusion criteria: Grade I, III, and IV burning injury; admission required to hospital ward; pregnant patients; chemical burning; face and neck and perineal burning; any underlying disease causing impaired healing (e.g. immunodeficiency, diabetes, anemia, cancer, cytotoxic drugs and allergic skin disease); dissatisfaction to participate to study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethic Committee of Tabriz University of Medical Sciences
Street address
Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
TBZMED.REC.1394.491

Health conditions studied

1

Description of health condition studied
Burning
ICD-10 code
X00, X01,
ICD-10 code description
Exposure to smoke, fire and flames

Primary outcomes

1

Description
Wound healing
Timepoint
Daily
Method of measurement
Eemergency medicine specialist opinion

2

Description
Patient satisfaction
Timepoint
After the end of treatment, we will ask from patient about satisfaction of treatment
Method of measurement
Visual Analog Scale. This scale contains 1-10 scores that score 1 shows dissatisfaction and score 10 show excellent satisfaction

Secondary outcomes

1

Description
Treatment complication
Timepoint
Daily
Method of measurement
Emergency medicine specialist opinion

Intervention groups

1

Description
Intervention group 1: In this group, adibderm herbal ointment ( Danakasian company, Adib Eksir Pharmaceutical company, Khorramabad, IR Iran) based on instruction, will be used for burning injury dressing.
Category
Treatment - Drugs

2

Description
Intervention group 1: In this group, silver sulfadiazine ointment ( Flamexin, Sina daru pharmaceutical company, Tehran, IR Iran) based on instruction, will be used for burning injury dressing.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital, Tabriz
Full name of responsible person
Farzad Rahmani
Street address
Azadi Avenue, Sina Hospital, Emergency Department
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Rahmani
Position
Assistant Professor / Emergency Medicine Specialist
Other areas of specialty/work
Street address
Azadi Avenue, Sina Hospital, Emergency Department
City
Tabriz
Postal code
Phone
+98 41 3549 8144
Fax
Email
farzadrhn88@gmail.com, farzadrhn@yahoo.com, rahmanif@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Rahmani
Position
Assistant Professor / Emergency Medicine Specialist
Other areas of specialty/work
Street address
Azadi Avenue, Sina Hospital, Emergency Department
City
Tabriz
Postal code
Phone
+98 41 3549 8144
Fax
Email
farzadrhn88@gmail.com, farzadrhn@yahoo.com, rahmanif@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Rahmani
Position
Assistant Professor / Emergency Medicine Specialist
Other areas of specialty/work
Street address
Azadi Avenue, Sina Hospital, Emergency Department
City
Tabriz
Postal code
Phone
+98 41 3549 8144
Fax
Email
farzadrhn88@gmail.com, farzadrhn@yahoo.com, rahmanif@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...