To determine the impact of topical effects of grape seed 5% extract ointment on appendectomy wound healing
Design
In this randomized, controlled clinical trial study, a total of 78 patients with inclusion criteria were randomly selected and allocated into one of the three groups of control, intervention and placebo using permutation blocking.
Settings and conduct
The study will be conducted in the surgical ward of Imam Reza Hospital in Birjand in 2018. The intervention group is treated with 5% grape seed extract and the placebo group is treated by vaseline. No intervention is performed in the control group. Moreover, the study is not blinded.
Participants/Inclusion and exclusion criteria
Major inclusion criteria consist of age between 10 and 30 years; patients having undergone appendectomy; body mass index between 18.5 and 25; and
McBurney’s incision with maximum length of 10 centimeters.
Major exclusion criteria comprise of: Appendicitis accompanied by perforation and gangrene; unwillingness to participate in the study or discontinued cooperation; sensitivity to grape seed ointment and the inability to follow-up the patient; and peritonitis.
Intervention groups
There are three groups in this study. In the intervention group, the grape seed 5% extract ointment will be applied in 1 centimeter width and one millimeter thickness onto the sutured region using sterilized, graded paper. This is performed twice a day (12 ± 2 hours) from the second to the sixteenth post-operative day. In the placebo group, vaseline ointment will be applied in 1 centimeter width and one millimeter thickness onto the sutured region using sterilized, graded paper. This is performed twice a day (12 ± 2 hours) from the second to the sixteenth post-operative day. In the control group, no ointment is used.
Main outcome variables
appendectomy wound healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140519017756N38
Registration date:2018-02-19, 1396/11/30
Registration timing:registered_while_recruiting
Last update:2018-02-19, 1396/11/30
Update count:0
Registration date
2018-02-19, 1396/11/30
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing topical effects of grape seed 5% extract ointment, placebo, and no intervention on appendectomy wound healing
Public title
Effect of grape seed extract 5% ointment on appendectomy wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 10 and 30 years
Patient having undergone appendectomy
Body mass index between 18.5 and 25
McBurney’s incision with maximum length of 10 centimeters
Exclusion criteria:
Appendicitis accompanied by perforation and gangrene
Unwillingness to participate in the study or discontinued cooperation
Sensitivity to grape seed ointment and the inability to follow-up the patient
Peritonitis
Suffering from immune system threatening diseases such as diabetes mellitus, uremia, cancer, malnutrition, hypertension and heart disease
Use of immunosuppressive drugs
Age
From 10 years old to 30 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be selected based on the inclusion criteria via purposive sampling method. Nonetheless, they will be assigned into study groups randomly via permutation blocking randomization. There are three cards, a, b and c, indicative of the study groups. Each participants will select one and will be allocated into the associated group.
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
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2018-01-16, 1396/10/26
Ethics committee reference number
Ir.bums.1394.359
Health conditions studied
1
Description of health condition studied
appendectomy wound healing
ICD-10 code
K38
ICD-10 code description
Other diseases of appendix
Primary outcomes
1
Description
appendectomy wound healing
Timepoint
second postoperative day (i.e., before intervention), eighth postoperative day (six days after intervention), and 16th postoperative day (14 days after intervention)
Intervention group 1 (grape seed ointment): Grape seed 5% extract ointment will be applied in 1 centimeter width and one millimeter thickness onto the sutured region using sterilized, graded paper. This is performed twice a day (12 ± 2 hours) from the second to the sixteenth post-operative day.
Category
Treatment - Other
2
Description
Control group (placebo): Vaseline ointment will be applied in 1 centimeter width and one millimeter thickness onto the sutured region using sterilized, graded paper. This is performed twice a day (12 ± 2 hours) from the second to the sixteenth post-operative day.
Category
Placebo
3
Description
Control group (No intervention): In the control group, no ointment is used.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Reza Hospital
Full name of responsible person
Hosain Abbasi
Street address
Taleghani St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5003
Email
abbasi.hosain@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5001
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hosain Abbasi
Position
MSc. Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5001
Email
abbasi.hosain@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hosain Abbasi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5001
Email
abbasi.hosain@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Email
hadirooz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Upon the participants' request, no information can be shared.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Study Protocol
When the data will become available and for how long
In future in the paper extracted from the research project, and as long as the paper is accessible.
To whom data/document is available
all readers
Under which criteria data/document could be used
No certain criteria
From where data/document is obtainable
the extracted paper
What processes are involved for a request to access data/document
access to the journal wherein the paper is published