Protocol summary

Summary
General Purpose: Determining the effect of topical vitamin C solution on healing process second-degree burns. Vitamin C is a drug that has been used orally and intravenously to healing burn wound from the past, but the effects of its topical application remain unclear. In this study, after permission of Medical Ethics Committee at Sabzevar University of Medical Sciences, the researcher referred to the Vasee Hospital. After the explanations required for obtaining a letter of satisfaction of patients the Project began. In accordance with the sample size has been determined, 30 patients, who have been suffered burns (grade 2) and admitted in Vasee Hospital, were selected. According to the multiple factors involved in the restoration or wound infection, two research groups, were choosed parallel, so that the routine use of ointments (sulfadiazine) and the Vitamin C along with Silver sulfadiazine will be done on the same patient, but in the two symmetric or two separate parts of body. The Physician reviewers wounds has been blind. After washing and cleaning the wounds, dressing will replace daily. The wounds were examined on the days of first, third, seventh and fourteenth using the parameters of Bates-Jensen Wound Assessment Tool. The data was analyzed by SPSS version 20, using the ANOVA and repeated measurements tests. Inclusion criteria: 1. patients with second- degree burns range from 1% to 40 % of the body surface 2. Patient age 18-60 years old 3. Burn originated from hot fluids or heating source 4. Patient admitted to the hospital during the first 6 hours after burning Exclusion criteria: 1- Reluctance of patients to participate in this study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015101224487N1
Registration date: 2016-05-19, 1395/02/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-19, 1395/02/30
Registrant information
Name
Hamid Robat Sarpooshi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4421 7146
Email address
robatsarpushih1@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2015-08-20, 1394/05/29
Expected recruitment end date
2015-12-20, 1394/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mixture of topical vitamin C solution to silver sulfadiazine ointment 1% in contrast only apply sulfadiazine ointment 1% on process of Burn wound changes in patients referring to Vasee hospital of Sabzevar
Public title
The effect of topical vitamin C solution on burns wound healing
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 1. patients with second- degree burns range from 1% to 40 % of the body surface 2. Patient age 18-60 years old 3. Burn originated from hot fluids or heating source 4. Patient admitted to the hospital during the first 6 hours after burning Exclusion criteria: 1. Reluctance of patients to participate in this study
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not 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
Ethics committee of sabzevar University of Medical Sciences
Street address
Building number two, Vice Chancellor for Education, Sabzevar University of Medical Sciences and Health Services
City
Sabzevar
Postal code
9613873136
Approval date
2015-07-15, 1394/04/24
Ethics committee reference number
IR.MEDSAB.REC.1394.60

Health conditions studied

1

Description of health condition studied
Burned patients
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified

Primary outcomes

1

Description
Score of burn wounds
Timepoint
one, three, seven and Fourteen day after the burning.
Method of measurement
Bates-Jensen wound assessment tool

Secondary outcomes

empty

Intervention groups

1

Description
In the control group: Before the study, wounds were assessed based on the checklist and examined by a doctor. After washing with water and normal saline solution, the limb or a section of the burned wound dried with sterile gauze. Then silver sulfadiazine ointment 1% was laid by sterile gloves and burned wound was dressed. The maximum level of a limb which was compared with other organ or part of an organ was considered 20%. The depth of each of the areas that were compared were also quite similar. In this study wound healing was assessed on days 1, 3, 7 and 14 after burning. The checklists were completed and improvement of the two organs were compared with each other.
Category
Treatment - Drugs

2

Description
In the intervention group: Before the study, wounds were assessed based on the checklist and examined by a doctor. On the other limb or another part of the body that was under study, after washing and drying like the previous step, Vitamin C 10% solution was applied on the surface of the wound. Then silver sulfadiazine 1% ointment was laid by sterile gloves and burned wound was dressed. The maximum level of a limb which was compared with other organ or part of an organ was considered 20%. The depth of each of the areas that were compared were also quite similar. In this study wound healing was assessed on days 1, 3, 7 and 14 after burning. The checklists were completed and improvement of the two organs were compared with each other.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sabzevars Vasee Hospital
Full name of responsible person
Hamid Robat Sarpooshi
Street address
Next to health Park of Sabzevar
City
Sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President of Research, Sabzevar University of Medical Sciences
Full name of responsible person
Mr. Musa al-Reza Tadayonfar
Street address
Building Number two,Vice Chancellor for Education,Sabzevar University of Medical Sciences and Health services
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research, Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Hamid Robat Sarpooshi
Position
Master of Nursing
Other areas of specialty/work
Street address
Building Number two,Vice Chancellor for Education,Sabzevar University of Medical Sciences and Health services
City
Sabzevar
Postal code
9613846776
Phone
+98 44419569
Fax
Email
sarpooshi92@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar university of medical sciences
Full name of responsible person
Forough Mortazavi
Position
ph.d, Maternal health
Other areas of specialty/work
Street address
Building Number two,Vice Chancellor for Education,Sabzevar University of Medical Sciences and Health services
City
Sabzevar
Postal code
9613846776
Phone
+98 51 4441 9569
Fax
Email
frmortazavi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Hamid Robat Sarpooshi
Position
Master of Nursing
Other areas of specialty/work
Street address
Building Number two,Vice Chancellor for Education,Sabzevar University of Medical Sciences and Health services
City
Sabzevar
Postal code
9613846776
Phone
+98 51 4441 9569
Fax
Email
sarpooshi92@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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