In this study we investigated the topical effect of grape seed extract on skin wound healing in humans. This double blind clinical trial conducted on two groups of treatment and placebo. Surgery was performed on skin lesions such as skin tags and moles which were found on the neck, trunk and limbs (except for face). After enrollment and obtaining informed consent from participants, they were randomized into two groups of treatment and placebo. Excision of the lesions was done by surgical scissors. The lesions got restored by secondary intention method. After the first day of treatment, the patients were visited on the 3rd, 7th, 10th, 14th, and 21st day. Grape seed extract cream 2% was produced and coded by the Faculty of Pharmacy, Ahvaz University of Medical Sciences. In order to compare the two groups, T-test was used. For time assessing, analysis of variance with repeated measures was employed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110314190N6
Registration date:2015-05-11, 1394/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-11, 1394/02/21
Registrant information
Name
Mohammad Bahadoram
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3011
Email address
bahadoram.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Development, Ahvaz Jondishapur University of Medical Sci
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Topical Effect of Grape Seed Extract 2% Cream on Surgery Wound Healing
Public title
The Topical Effect of Grape Seed Extract Cream on Wound Healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: comprised skin lesions such as skin tag and mole on the neck, trunk and limbs (except for face); age between 14 and 50 years; clinical benignity of the lesion; size of the lesion larger than 3mm and smaller than1cm.
Exclusion Criteria: having any underlying diseases, immunosuppressant or other certain medications; pregnancy or lactation; smoking or any long-term drug use; and having concurrent malignancy.
Age
From 14 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Ahvaz
City
Ahvaz
Postal code
Approval date
2012-09-16, 1391/06/26
Ethics committee reference number
ajums.REC.1393.436
Health conditions studied
1
Description of health condition studied
Surgical Site Infection and Wound Healing
ICD-10 code
L08.9
ICD-10 code description
Local infection of skin and subcutaneous tissue, unspecified
Primary outcomes
1
Description
surface area of the skin
Timepoint
Then the patients were visited on the 3rd, 7th, 10th, 14th, and 21st day.
Method of measurement
In all the patients, transparent sheet was used to measure the surface area of the sample and the shape of the lesion was graphed. Furthermore, in every visit the patients’ wounds were photographed with an 8 MP Cannon camera. On the first day, wound level was considered 100% and improvement 0%, the next days, wound level and the rate of improvement were assessed and registered.
Secondary outcomes
1
Description
wound infection
Timepoint
At the end of the study
Method of measurement
clinical findings and wound culture
Intervention groups
1
Description
Intervention group: patients treated Grape Seed Extract 2% Cream and were followed for 3 weeks.
Category
Treatment - Drugs
2
Description
Control group: patients treated with placebo and were followed for 3 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Dr. Ali Asghar Hemmati
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Development, Ahvaz Jondishapur University of Medical Sci
Full name of responsible person
Dr.Nader Saki
Street address
Ground Floor, Faculty of Rehabilitation Sciences ,Ahvaz Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
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 and Technology Development, Ahvaz Jondishapur University of Medical Sci
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Maryam foroozan
Position
Dermatology Resident
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Ahvaz Ahvaz
City
Ahvaz
Postal code
Phone
+98 613336754
Fax
Email
foroozan.m@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Zahra Beigom Moosavi
Position
Associate Professor Department of Dermatology
Other areas of specialty/work
Street address
Emmam Khomeini Hospital, Department of Dermatology, Azadegan St
City
Ahvaz
Postal code
Phone
+98 61 3338 7481
Fax
Email
Moosavi-zb@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Bahadoram
Position
Medical Student
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Ahvaz
City
Ahvaz
Postal code
Phone
+98 613336754
Fax
Email
mohammadbahadoram@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)