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Efficacy of absorbable dressing foam on prevention of tracheostomy site infections

Protocol summary

Summary
This study is semi experimental clinical trial. In this trail, eighty ICU patients that they have 18-60 Y/O and low GCSS (Glascow Coma Scale Score) because of head injury are enrolled. The level of consciousness of these patients, according to clinical information, diagnostic CT scan and Counseling with Neurologist, will not rise up to 21 days. Therefore, they are undergoing tracheostomy surgery at the first 3 days after ICU admission. Then the eligible patients randomly allocated into one of two groups. In the intervention group, the absorbable foams are used for dressing of theracheostomy site for 7 days and in the control group the normal gas are used for dressing of theracheostomy site for 7 days. These absorbable dressing foams or normal gas are put on in the theracheostomy site immediately after theracheostomy surgery. Then the culture samples from the tracheostomy site are prepared in 24, 72, 168 hours after tracheostomy surgery and sent to the laboratory as blind. These Patients should receive the same antibiotics in ICU. The patients with Diabetes, Pneumonia, Renal failure, Hepatic failure, Chronic cardiopulmonary disorders, history of antibiotic therapy from last, clear infection signs in anterior neck, anterior neck burning and foam sensitivity are excluded from the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205215426N5
Registration date: 2012-07-17, 1391/04/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-17, 1391/04/27
Registrant information
Name
Mehdi Ahmadinejad
Name of organization / entity
Anesthesiology department, Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 0223 5011
Email address
m.ahmadinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences Research Center
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of absorbable dressing foam on prevention of tracheostomy site infections
Public title
Efficacy of absorbable dressing foam on prevention of tracheostomy site infections
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Eighteen to sixty Y/O patients; the patients with low GCSS (Glascow Coma Scale Score) because of head injury that this score, will not increase in up to 21 days, according to clinical information, diagnostic CT scan and Counseling with Neurologist; the Patients that undergoing tracheostomy at the first 3 days after ICU admission and all the Patients should receive the same antibiotics in ICU. Exclusion Criteria: the patients with Diabetes; Pneumonia; Renal failure; Hepatic failure; Chronic cardiopulmonary disorders; history of antibiotic therapy from last; clear infection signs in anterior neck; anterior neck burning and foam sensitivity.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kerman University of Medical Sciences Research Center Ethics Committee
Street address
Jahad street, Kerman University of Medical Sciences Research Center
City
kerman
Postal code
Approval date
2012-06-17, 1391/03/28
Ethics committee reference number
ka/91/63

Health conditions studied

1

Description of health condition studied
Tracheostomy site infections
ICD-10 code
J95.0
ICD-10 code description
Tracheostomy malfunction

Primary outcomes

1

Description
Tracheostomy site infections
Timepoint
The culture samples from the tracheostomy site are prepared in 24, 72, 168 hours after tarcheostomy surgery
Method of measurement
The prepared culture samples from the tracheostomy site, sent to the laboratory as blind and followed up for result.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The absorbable foams are used for dressing of theracheostomy site for 7 days.
Category
Prevention

2

Description
Control Group: The normal gas are used for dressing of theracheostomy site for 7 days.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
ICU ward, Shahid Bahonar hospital
Full name of responsible person
Mehdi Ahmadinejad
Street address
Shahid Bahonar hospital of Kerman
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences Research Center
Full name of responsible person
Dr. Malekpour Afshar
Street address
Kerman University of Medical Sciences Research Center
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences Research Center
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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi nejad
Position
Assistant professor - Fellowship in critical care
Other areas of specialty/work
Street address
ICU ward, Shahid Bahonar hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
mehdia50@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi nejad
Position
Assistant professor - Fellowship in Critical care
Other areas of specialty/work
Street address
ICU ward, Shahid Bahonar hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
mehdia50@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi nejad
Position
Assistant professor - Fellowship in Critical care
Other areas of specialty/work
Street address
Kerman University of Medical Sciences
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
mehdia50@ 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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