Comparison of Routine Method dressing , Hydrocolloid and Aliginats dressing with standard method and modified method in healing process of pilonidal sinus surgery
Today, various products containing various compounds are used in wound dressings. Here, we are aiming to compare the efficiency of alginate and hydrocolloidal wound dressing products with the efficiency of products used in the conventional, routine methods. To do so, 60 patients will be randomly divided in three groups of 20 (aged 18 to 40 who do not have diabetes, and do not suffer from paralysis or related problems) and will be randomly treated by a different dressing methods. The three dressing methods include routine method (using normal saline and wet sponge), standardized method recommended for alginate and hydrocolloidal compounds and the modified version of the previous method in which some changes have been made in the direction of use of the products. In the next step, for each patient in each group, the total number of dressing changes and duration of wound healing (in days)as well as the level of pain experienced by the patients during each dressing change will be recorded and compared. The level of pain during dressing change will be assessed by a Johnson’s pain assessment ruler in the scale of 1-10. Furthermore, the depth, width and length of the wound will be measured weekly and will be compared with its initial dimensions right after the surgery.Meanwhile, the patients who do not go on the dates specified for dressing change and the patients with surgical complications will be excluded from the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072118553N1
Registration date:2014-08-28, 1393/06/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-08-28, 1393/06/06
Registrant information
Name
Leila Sadati
Name of organization / entity
Alborz Universty of Medical Scincences
Country
Iran (Islamic Republic of)
Phone
+98 26 3253 4221
Email address
sadati@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University Of Medical Sciences
Expected recruitment start date
2014-09-01, 1393/06/10
Expected recruitment end date
2015-01-30, 1393/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Routine Method dressing , Hydrocolloid and Aliginats dressing with standard method and modified method in healing process of pilonidal sinus surgery
Public title
comparison of 3 methods in pilonidal wound dressing
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: between 18-40 year; surgery by one method and surgeons with similar experience; not obese with BMI<18.5;good diet; free of symptoms and a history of diabetes; no signs of paralysis or immobility; exclusion criteria: Patients who do not refer for dressing on determined date ; Patients who have complications after surgery such as bleeding and the need to have more attention.; Patients who volunteer and the treatment are subject to a special diet.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Alborz University of medical Sciences Ethics Committee
Street address
Research unit,Dara Department, Golshahr ST, karaj, Iran
City
Karj
Postal code
Approval date
2014-05-26, 1393/03/05
Ethics committee reference number
2375591
Health conditions studied
1
Description of health condition studied
PILONIDAL SINUS
ICD-10 code
Y70-Y82
ICD-10 code description
XII Diseases of the skin and subcutaneous tissue
Primary outcomes
1
Description
wound healing
Timepoint
weekly
Method of measurement
centimeter-junson ruller
Secondary outcomes
1
Description
pain
Timepoint
weekly
Method of measurement
jonson ruller
Intervention groups
1
Description
control group: dressing by normal saline and sponge as a routine method,
Category
Other
2
Description
first intervention group:dressing by hydroclloid and alginate compounds by standard method that recommended by company.
Category
Other
3
Description
second intervention group: dressing by alginate and hydrocolloidal compounds in the modified version that researcher will introduced it.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital (Karaj)
Full name of responsible person
Dr Ahmad Elahi
Street address
Shahid Bahonar Hospital (karaj)
City
karaj
2
Recruitment center
Name of recruitment center
professional clinic of alborz
Full name of responsible person
Dr ahmad Elahi
Street address
professional clinic of alborz, Shahid Beheshti ST, Karaj, Iran
City
karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Deputy of Research-Dr Gharavi
Street address
Deputy of Research, Dara department, Golshahr ST,
City
karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Leila-sadati
Position
Faculty member
Other areas of specialty/work
Street address
Paramedicine faculty, Golestan 6 Ave, Baghestan St.