Protocol summary

Study aim
Determining the effect of a combination of aloevera/olive oil cream in healing of open wound of pilonidal cyst surgery
Design
Clinical trial with control group double-blind, systemic randomized sampling with 60 people in four phases.
Settings and conduct
Patients with pilonidal sinus surgery in Baqiyatallah hospital were randomly assigned (double-blinded) into intervention and placebo groups during pylonidal ulcer healing.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pilonidal sinus, open surgery Exclusion criteria: Diabetes mellitus; immune deficiency; pregnancy; Lactation
Intervention groups
The effect of a combination of olive oil and aloe vera cream on wound healing pilonidal sinus surgery and compared with the placebo group.
Main outcome variables
Improve the time of surgical wound healing of pilonidal sinus; Postoperative pain and patient satisfaction after surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161209031306N2
Registration date: 2018-07-24, 1397/05/02
Registration timing: retrospective

Last update: 2018-07-24, 1397/05/02
Update count: 0
Registration date
2018-07-24, 1397/05/02
Registrant information
Name
ali hajihashemi
Name of organization / entity
agiattallah U.
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 3591
Email address
stu.hajihashemi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative trial of Aloe vera/olive oil combination cream versus placebo in repair of Surgical wounds of pilonidal disease in open surgical technique.
Public title
Comparative trial of Aloe vera/olive oil combination cream versus placebo in repair of surgical wounds of pilonidal disease in open surgical technique.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age Patients under 60 years old with Pylonidal sinus Candidate for Open Sinus Pillonidal Surgery Referring to Baqiyatallah Hospital
Exclusion criteria:
Diabetes mellitus immune deficiency pregnancy Lactation
Age
From 18 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
A systematic approach (alternative: active and placebo)
Blinding (investigator's opinion)
Double blinded
Blinding description
The medication and placebo (A and B) are available to the therapist and the patient, where medications or placebo are differentiated.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of the University of Medical Sciences of baghiatalah
Street address
Molasadra
City
Tehran
Province
Tehran
Postal code
1698741195
Approval date
2017-05-23, 1396/03/02
Ethics committee reference number
IR.BMSU.REC.1396.32

Health conditions studied

1

Description of health condition studied
Pilonidal disease
ICD-10 code
L05
ICD-10 code description
Pilonidal cyst and sinus

Primary outcomes

1

Description
Wound healing time after pilonidal sinus surgery
Timepoint
The beginning of the study and days 7; 30; 60; 90
Method of measurement
Clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Patients after the sinus surgery are divided in 1 groups of 30, who take the medication twice daily for 3 weeks.
Category
Treatment - Drugs

2

Description
Patients after the sinus surgery are divided in 1 groups of 30, who take the placebo twice daily for 3 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Ghafoorimanesh saeed
Street address
Mullasadra Street, Baqiyatallah Hospital
City
Tehran
Province
Tehran
Postal code
1465793811
Phone
+98 21 8126 3591
Email
ghafour_manesh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Jalali Mohamad
Street address
Molasadra
City
Tehran
Province
Tehran
Postal code
1465793811
Phone
+98 21 8126
Email
jalali@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ghafoorimanesh Saeed
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Molasadra
City
Tehran
Province
Tehran
Postal code
1465793811
Phone
+98 81263591
Email
ghafour_manesh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ghafoorimanesh Saeed
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Molasadra
City
Tehran
Province
Tehran
Postal code
1465793811
Phone
+98 81263591
Email
ghafour_manesh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ghafoorimanesh Saeed
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Molasadra
City
Tehran
Province
Tehran
Postal code
1465793811
Phone
+98 81263591
Email
ghafour_manesh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A part of the information, such as information on the main outcome, can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Email:ghafour_manesh@yahoo.com
What processes are involved for a request to access data/document
After the request is sent
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