The purpose of this study was to evaluate the effect of consumption of oral olive oil on clinical outcomes and wound healing of thermally injured patients with hospital stays. One hundred patients with 10% to 20% Total Body Surface Area, deep second-degree and more burn wounds were randomized to receive either oral olive oil or sunflower oil as the oil in their diet. Inclusion criteria were being on oral diet and aged between13 to 59 years. Patients had to be enrolled within 12 hours of developing these criteria. Patients were evaluated daily for occurrence of wound infection, sepsis and healing of the grafted skin. Also the duration of hospitalization and admission to the intensive care unit were compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010414901N2
Registration date:2014-01-11, 1392/10/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-11, 1392/10/21
Registrant information
Name
Zahra Vahdat Shariatpanahi
Name of organization / entity
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7484
Email address
z.shariatpanahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Velayat Subspecialist Burn and Plastic Surgery Hospital
Expected recruitment start date
2013-09-01, 1392/06/10
Expected recruitment end date
2013-12-01, 1392/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral olive oil on healing of 10% to 20 %Total Body Surface Area, deep second degree and more burn wounds in hospitalized patients
Public title
Burn and Olive Oil
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being on oral diet; Aged between13 to 59 years; Deep second degree wounds and more with 10% to 20% TBSA
Exclusion criteria: Intolerance to Olive oil
Age
From 13 years old to 59 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Science, International Branch
Street address
Tavanir st.
City
Tehran
Postal code
Approval date
2013-10-07, 1392/07/15
Ethics committee reference number
116/2878
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T29.4
ICD-10 code description
Corrosions of multiple regions, unspecified degree
Primary outcomes
1
Description
مدت زمان ترميم زخم
Timepoint
روزانه
Method of measurement
معاينه فيزيکي
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
Daily
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention Group: Oral Olive oil, 15% total calorie, during hospitalization
Category
Treatment - Other
2
Description
Control Group: Oral Sunflower oil, 15% total calorie, during hospitalization
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Subspecialist Burn and Plastic Surgery Hospital
Full name of responsible person
Dr Mohammad Tolouei
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Velayat Subspecialist Burn and Plastic Surgery Hospital.
Full name of responsible person
Dr Mohammad Tolouei
Street address
Valiasr Street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Velayat Subspecialist Burn and Plastic Surgery Hospital.
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
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Vahdat Shariatpanahi
Position
MD, PhD in nutrition
Other areas of specialty/work
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods,Tehran, I.R. Iran
City
Tehran
Postal code
Phone
+98 21223574843
Fax
Email
nutritiondata@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Vahdat Shariatpanahi
Position
MD, PhD in nutritionدانشکده تغذيه و صنايع غذايي، دانشگاه علوم پزشکي شهيد بهشتي
Other areas of specialty/work
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods,Tehran, I.R. Iran