Protocol summary

Summary
In this study, after permission of Medical Ethics Committee at Iran University, the researcher referred to the Shahid Motahari Hospital. After the explanations required for obtaining a letter of satisfaction of patients or his legal (in patients who cannot make their own satisfaction) the Project will plan to start. In accordance with the sample size has been determined, 64 patients, who have been suffered burns (grade 2 and 3) and admitted in Shahid Motahari Hospital, were selected. According to the multiple factors involved in the restoration or wound infection, two research groups, will be chosen parallel, so that the routine use of ointments (sulfadiazine) and the Hyaluronic acid will be done on the same patient, but in the two symmetric or two separate parts of body. The research will be conducted as a blind. After washing and cleaning the wounds, dressing will replace daily. The questionnaire will fill in both groups and the image will be taken as well. Numerical measure (10-0) will use for pain and itching. Wound healing will be measured by taking pictures of each group. Infection will be examined by getting wound culture over two turns from both groups. In this study, the people over 12 years, and patients who have no underlying diseases (because of the delay in wound healing) will be selected.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201311278177N10
Registration date: 2014-06-13, 1393/03/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-13, 1393/03/23
Registrant information
Name
Mohammad Javad Fatemi
Name of organization / entity
Burn Research Center of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 4275
Email address
mj-fatemi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Science
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Hyaluronic Acid and Silver Sulfadiazine cream in burn wound healing
Public title
The effect of Hyaluronic Acid and Silver Sulfadiazine cream in burn wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients over 12 years; patients who have been suffered burns Grade 2 and 3; hospitalized patients. Exclusion criteria: Patients who withdrew from the study in any way; patients with underlying disease.
Age
From 12 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemmat High Way
City
Tehran
Postal code
Approval date
2014-04-30, 1393/02/10
Ethics committee reference number
100993

Health conditions studied

1

Description of health condition studied
Burn wound
ICD-10 code
T20-T32
ICD-10 code description
Burns and Corrosions

Primary outcomes

1

Description
Wound Healing( Epitelialization)
Timepoint
Daily
Method of measurement
Picture

2

Description
Itching
Timepoint
Daily
Method of measurement
Questionare

3

Description
Pain
Timepoint
Daily
Method of measurement
Pain Scale

4

Description
Infection
Timepoint
Towice
Method of measurement
Wond Culture

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: Hyaluronic Acid ointment
Category
Treatment - Drugs

2

Description
Control: common ointment (Silver sulfadiazine)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Teaching Hospital
Full name of responsible person
Parviz Namazi
Street address
Motahari Teaching Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Burn Reaserch Center of Iran University
Full name of responsible person
Dr Fatemi
Street address
Burn Reaserch Center
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Burn Reaserch Center of Iran University
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
Motahri Teaching Hospital
Full name of responsible person
Parviz Namazi
Position
Nurse Director
Other areas of specialty/work
Street address
Valiasr St. Rashid Yasemi st.
City
Tehran
Postal code
Iran
Phone
+98 21 8877 0046
Fax
Email
namaziparviz@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Burn Research Center
Full name of responsible person
Parviz Namazi
Position
MSc
Other areas of specialty/work
Street address
Valiasr St, Rashid Yasemi
City
Tehran
Postal code
Iran
Phone
+98 21 8877 0046
Fax
Email
namaziparviz@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Burn Research Center
Full name of responsible person
Parviz Namazi
Position
Nurse Director
Other areas of specialty/work
Street address
Valiasr St. Rashid Yasemi St.
City
Tehran
Postal code
Iran
Phone
+98 21 8877 0046
Fax
Email
namaziparviz@gmail.com
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
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