Protocol summary

Summary
Objectives: This study aimed to investigate the effect of Olea ointment (topical honey ointment) in preventing infection and speeding up the formation of granulation tissue in the second degree burn. Design: 30 patients who had second degree burns (burn depth of 0.2 to 5.0 mm) were investigated as the study population. Setting and conduct: This was a randomized controlled trial which was conducted in the burn ward in Tohid hospital in Sanandaj. The patients were divided into two groups using simple randomized method (using computer); the chance of entering the control group was twice as that of the intervention group. Thus 20 patients were allocated in the control group and 10 patients were allocated in the intervention group. Participants and inclusion and exclusion criteria: According to inclusion criteria people with second degree burns and with burns equal or less than 40% of body surface area were enrolled in the study. Patients with underlying conditions such as diabetes, chronic renal or hepatic diseases, and patients with burns and concomitant trauma, and with concomitant skin tears were excluded. Interventions: One of the groups was treated on a daily basis using topical Olea ointment (FaraTeb Co, Iran) and the other group using Acetate Mafenide ointment (8.5%, Sina Daru, Iran). Main outcome variables: Wound infection and granulation tissue formation were considered as the main outcomes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014020516490N1
Registration date: 2014-04-11, 1393/01/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-11, 1393/01/22
Registrant information
Name
Ebrahim Ghaderi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1613 1366
Email address
ebrahimghaderi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2005-10-23, 1384/08/01
Expected recruitment end date
2006-12-22, 1385/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of Olea ointment (a compound of honey, olive, and sesame) on infection and granulation tissue formation in second degree burn wounds - A randomized clinical trial
Public title
Effect of Olea ointment on burn wounds
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients who had second degree burns (burn depth of 0.2 to 5.0 mm); burns covered 40% or less of their body surface area; were aged between 15 to 40 years; consented to participate in the study; referred at the first 24 hours of injury; and had negative ulcer culture on admission. Exclusion criteria: patients with underlying conditions such as diabetes; chronic renal or hepatic diseases, and patients with simultaneous burns, trauma, and skin lacerations.
Age
From 15 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
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 Kurdistan University of Medical Sciences
Street address
Vice chancellor for research, Medicine School, Pasdaran Ave
City
Sanandaj
Postal code
6617713446
Approval date
2005-09-23, 1384/07/01
Ethics committee reference number
1384/پ/42

Health conditions studied

1

Description of health condition studied
Burn
ICD-10 code
T22.2
ICD-10 code description
Burn of second degree of shoulder and upper limb, except wrist and hand

Primary outcomes

1

Description
Wound infection
Timepoint
A week after intervention
Method of measurement
Culture

Secondary outcomes

1

Description
Situation of granulation tissues formation
Timepoint
A week after intervention
Method of measurement
Pathology

Intervention groups

1

Description
Intervention group 1 was consisted of 10 patients who were treated using Olea ointment (manufactured in Farateb Co. Iran). Olea ointment contains 33.4% honey, 33.3% olive oil and 33.3% Sesame oil. After washing the wound with normal saline solution, 3-5 mm of Olea ointment was applied over the wound and closed dressing was performed every day.
Category
Treatment - Drugs

2

Description
The intervention group 2 was consisted of 20 patients; they were treated using 1-2 mm thick of Acetate Mafenide ointment (8.5%, manufactured by Sina Daro pharmaceutical company, Iran) over the wound.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Ronak Babashahabi
Street address
Burn Unit, Tohid Hospital, Geryashan Ave
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kurdistan University of Medical Sciences
Full name of responsible person
Dr Ataollah Heidari
Street address
Vice chancellor for research, Medicine School, Pasdaran Ave
City
Sanandaj
Grant name
طرح پژوهشی غیر HSR
Grant code / Reference number
1384/42
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kurdistan 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
Tohid Hospital, Kurdistan University of Medical Sciences
Full name of responsible person
Ronak Babashahabi
Position
MSc in Nursing
Other areas of specialty/work
Street address
Burn Unit, Tohid Hospital, Geryashan Ave
City
Sanandaj
Postal code
6618634683
Phone
+98 87 1666 0092
Fax
+98 87 1322 7118
Email
roonak_sh@hotmail.com
Web page address
http://muk.ac.ir/Muk/Hospitals/tawhid.aspx

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tohid Hospital, Kurdistan University of Medical Sciences
Full name of responsible person
Mohsen Zahmatkesh
Position
General Practitioner
Other areas of specialty/work
Street address
Burn Unit, Tohid Hospital, Geryashan Ave
City
Sanandaj
Postal code
6618634683
Phone
+98 87 1666 0092
Fax
+98 87 1322 7118
Email
dr.zahmatkash@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tohid Hospital
Full name of responsible person
Ronak Babashahabi
Position
MSc
Other areas of specialty/work
Street address
Burn Unit, Tohid Hospital, Geryashan Ave
City
Sanandaj
Postal code
6618634683
Phone
+98 87 1666 0092
Fax
+98 87 1322 7118
Email
roonak_sh@hotmail.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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