Effect of turmeric extract versus topical phenytoin and placebo on healing of open wound after pilonidal sinus surgery: a double blind randomized clinical trial
Objectives: To assess the effect of turmeric extract versus topical phenytoin and placebo on healing of open wound after pilonidal sinus surgery.
Design: A double blind randomized clinical trial.
Setting and conduct: The eligible patients with pilonidal sinus who will undergo surgery in Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 65 years; pilonidal sinus candidate for surgery.
Exclusion criteria: Diabetes; Immunodeficiency; local abscess.
Intervention group 1: Topical cream including turmeric extract on surgical wound twice a day for 2 weeks.
Intervention group 2: Topical cream including phenytoin on surgical wound twice a day for 2 weeks.
Control group: Topical placebo cream on surgical wound twice a day for 2 weeks
Primary outcome: Healing of surgical wound one and two week and also one month after surgery via physical examination.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201711129014N200
Registration date:2017-11-14, 1396/08/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-14, 1396/08/23
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-11-21, 1396/08/30
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of turmeric extract versus topical phenytoin and placebo on healing of open wound after pilonidal sinus surgery: a double blind randomized clinical trial
Public title
Effect of turmeric extract versus topical phenytoin and placebo on healing of open wound after pilonidal sinus surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; pilonidal sinus candidate for surgery.
Exclusion criteria: Diabetes; Immunodeficiency; local abscess.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-10-14, 1396/07/22
Ethics committee reference number
IR.UMSHA.REC.1396.495
Health conditions studied
1
Description of health condition studied
Pilonidal sinus
ICD-10 code
L05
ICD-10 code description
Pilonidal cyst
Primary outcomes
1
Description
Healing of surgical wound
Timepoint
one and two week and also one month after surgery
Method of measurement
Via physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Topical cream including turmeric extract on surgical wound twice a day for 2 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: Topical cream including phenytoin on surgical wound twice a day for 2 weeks.
Category
Treatment - Drugs
3
Description
Control group: Topical placebo cream on surgical wound twice a day for 2 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Nayereh Erfani Moghaddam
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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, Hamadan 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
Besat Hospital
Full name of responsible person
Dr Nayereh Erfani Moghaddam
Position
Resident of Surgery
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
n85erf@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Seyyed Mohammad Reza Javadi
Position
Surgeon
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
mohamadreza.javadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)