Protocol summary

Summary
Study purpose : comparison of the healing of pilonidal sinus wound(Created after open surgery) after dressing with honey, olive oil, normal saline, combination of olive oil and honey. The size of the skin defect after pilonidal sinus open surgery between 5 and 10 cm, is an inclusion criteria. Autoimmune and chronic diseases, infectious abscess, long-term use of corticosteroids and history of chemotherapy are the exclusion criteria. Study population is all patients under pilonidal sinus open surgery referred to Khorramabad Shohada Ashayer Hospital. The sample size is 168 patients; that will be allocated to the intervention group (according to the title of study) and a control group (receiving normal saline alone). Double-blind study for researcher and analyser will be conducted. After the surgery in the operating room, in each of the four groups on the surgical site wound, washing with wet sterile gas and normal saline, will be performed. Then daily washing with normal saline will be done for a week. And then daily desired dressing (honey, olive oil, or both) in a uniform layer on the wound will be performed. In the control group, the same process as a month, daily washing with normal saline alone will continue. All groups after four weeks, see a doctor and wound healing, new tissue formation at the surgical site and local infection will be observed and recorded. Next visit and check for recurrence, three months later will be done.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012020734N1
Registration date: 2015-07-06, 1394/04/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-06, 1394/04/15
Registrant information
Name
Younes Azizpourfard
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 919 038 3060
Email address
dr.azizpourfard@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Lorestan University of Medical Sciences.
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of open pilonidal sinus surgical wound healing following dressing by honey, olive oil, normal saline and honey-olive oil mixture
Public title
Comparison of open pilonidal sinus surgical wound healing following dressing by honey, olive oil, normal saline and honey-olive oil mixture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 15-40 years old; the size of the skin defect after pilonidal sinus open surgery between 5 and 10 cm. Exclusion criteria: Diabetes, heart disease, renal, infectious abscess, an autoimmune disease, a history of chemotherapy, long-term use of corticosteroids.
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 168
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
samples will randomly placed in each of the four groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
3th km to khgoramabad-Boroujerd road
City
khgoramabad
Postal code
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
LUMS.REC.1394.12

Health conditions studied

1

Description of health condition studied
Pilonidal cyst
ICD-10 code
L05
ICD-10 code description
fistula sinus coccygeal or pilonidal

Primary outcomes

1

Description
Healing of pilonidal sinus wound (after open surgery)
Timepoint
One month and three months after intervention
Method of measurement
Assessed by the surgeon

2

Description
Infection of pilonidal sinus wound (after open surgery)
Timepoint
One month and three months after intervention
Method of measurement
Assessed by the surgeon

Secondary outcomes

1

Description
Adverse reactions (allergy)
Timepoint
In all phases of the project
Method of measurement
By examination and regular visits and patient complaints

2

Description
Recurrence of pilonidal sinus
Timepoint
In all phases of the project
Method of measurement
By examination and regular visits and patient complaints

Intervention groups

1

Description
The first intervention group: dressing with honey.
Category
Treatment - Drugs

2

Description
The second intervention group: dressing with olive oil.
Category
Treatment - Drugs

3

Description
The third intervention group: dressing with a combination of honey and olive oil.
Category
Treatment - Drugs

4

Description
Control: washing with normal saline.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Ashayer Hospital of Khorramabad
Full name of responsible person
Hormoz Mahmoudvand
Street address
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Lorestan University of Medical Sciences
Full name of responsible person
Dr. varzi
Street address
3th km to Khorramabad-Boroujerd road
City
Khorramabad
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 of Lorestan 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
Lorestan University of Medical Science
Full name of responsible person
Younes AzizpourFard
Position
Medical student
Other areas of specialty/work
Street address
22 Bahman street, Shohada Ashayer Hospital
City
Khorramabad
Postal code
Phone
+98 66 3323 6404
Fax
Email
Dr.azizpourfard@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Hormoz Mahmoudvand
Position
Assistant proffessor
Other areas of specialty/work
Street address
22 Bahman street, Shohada Ashayer Hospital
City
Khorramabad
Postal code
Phone
+98 66 3323 6404
Fax
Email
Dr.mahmoudvand@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Younes Azizpourfard
Position
Medical student
Other areas of specialty/work
Street address
22 Bahman street, Shohada Ashayer Hospital
City
Khorramabad
Postal code
Phone
Fax
Email
Dr.azizpourfard@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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