Protocol summary

Summary
This study is designed to evaluate effect of organic honey on second degree burn wound healing. It is a randomized clinical trial, performed on 60 patients. Inclusion criteria are: 18-60 years old patients; burning extent with less than 10% of body surface; patients referring to the hospital in the first 24 h after burning and filling out the informed consent. Exclusion criteria include: co-morbidity; burn wound on face, fingers, perinea; electrical, chemical and respiratory burns. The patients are divided into intervention and control groups based on random number table. In the intervention group, patient wounds are covered with a thin layer of organic honey, expecting to lead to qualitative and quantitative results of 92 national standard and make microbial tests negative. Wounds of the patients in the control group are covered with a thin layer of Nitrofurazone (usual dressing). Daily wound dressing will continue until the sites are completely healed in both groups. Microbial culture samples are taken from the wounds on 1st, 7th and 14th days of treatment and sent to the pathology laboratory on day 14th. Wound healings are daily detected by photography and the infection signs and pain rates will be evaluated during dressing treatment. Patients’ wound scar will be inspected 6 months after the first day of their reference. Speed of wound healing, pain, infection, scar, cost dressing and pathologic criteria will be compared in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205158177N3
Registration date: 2013-07-22, 1392/04/31
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-07-22, 1392/04/31
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
Tehran University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of organic honey and Nitrofurazone on second degree burn wound healing
Public title
The effect of organic honey on second degree burn wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Both sexes 2 - Age 18-60 year old 3- Referral in 24 hours after burn injury 4- Burn with of less than 10% TBSA 5- Filling informed consent Exclusion criteria: 1- Co-morbidity 2-Electrical, chemical, inhalation burn injury 3- Facial, fingers, perinea burn injury
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
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
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran
City
Tehran
Postal code
1417653761
Approval date
2013-05-08, 1392/02/18
Ethics committee reference number
91-03-129-19146-82523

Health conditions studied

1

Description of health condition studied
Burn
ICD-10 code
T20, T21,
ICD-10 code description
Burns and corrosions of external body surface, specified by site

Primary outcomes

1

Description
Epithelization
Timepoint
Daily after beginning of intervention and 14th day after beginning of intervention with biopsy
Method of measurement
Clinical assessment, Photography, Biopsy

2

Description
Cost
Timepoint
After ending intervention
Method of measurement
Calculation of dressing costs per group

Secondary outcomes

1

Description
Scar
Timepoint
Six months after beginning of intervention
Method of measurement
Vancouver Scar Scale

2

Description
Pain
Timepoint
Daily after beginning of intervention
Method of measurement
Visual Analogue Scale

3

Description
Infection
Timepoint
Days 1, 3, 7 after beginning of intervention
Method of measurement
Wound Culture

Intervention groups

1

Description
Intervention: In the intervention group, patient wounds are covered with a thin layer of organic honey, expecting to lead to qualitative and quantitative results of 92 national standard and make microbial tests negative. Dressing will be continues daily till complete healing of the wound.
Category
Treatment - Other

2

Description
Control group: Dressing burn wound with a thin layer of silver sulfadyazine ointment (usual dressing). Dressing will be continues daily till complete healing of the wound.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Burn Hospital
Full name of responsible person
Mohammad Javad Fatemi
Street address
Shahid Motahari Burn Hospital, Rashid Yasami Ave, Vali Asr Ave, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Tehran university of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central Department of Tehran University of Medical Sciences, Keshavarz Bvld, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran 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
Burn Research Center
Full name of responsible person
Tooran Bagheri
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
Burn Research Center, Shahid Motahari Burn Hospital, Rashid Yasami Ave, Vali Asr Ave, Tehran
City
Tehran
Postal code
1196714353
Phone
+98 21 8888 4275
Fax
Email
tooran_bagheri@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Burn Research Center
Full name of responsible person
Mohammad Javad Fatemi
Position
Associate Professor of Plastic and Reconstructive Surgery
Other areas of specialty/work
Street address
Burn Research Center, Shahid Motahari Burn Hospital, Rashid Yasami Ave, Vali Asr Ave, Tehran
City
Tehran
Postal code
1196714353
Phone
+98 21 8888 4275
Fax
Email
mj-fatemi@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Burn Research Center
Full name of responsible person
Tooran Bagheri
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
Burn Research Center, Shahid Motahari Burn Hospital, Rashid Yasami Ave, Vali Asr Ave, Tehran
City
Tehran
Postal code
1196714353
Phone
+98 21 8888 4572
Fax
Email
tooran_bagheri@yahoo.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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