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Evaluating Family Presence Influencing Nosocomial Infections in Burn Intensive Care Unit

Protocol summary

Summary
The aim of this randomized clinical trial is evaluating family presence influencing nosocomial infections in Burn Intensive Care Unitburn intensive care unit is Zareh hospital in Sari.Inclusion Criteria: all alert patients over 18 yrs, with their hospitalization passing 48 h and about the patient's attendant, being over 18 yrs and the attendant not suffering from communicable diseases through Eireborn (measles, chicken pox and etc.). Exclusion Criteria: the incidence of cases such as addiction, respiratory distress, intubation, the wound changing color toward getting infected, the patient's discharge or death and for the attendants ,not cooperating about the ward regulations and infection control precautions and afflicted with any communicable disease during the project implementation (especially via Eireborn). Sample: 360 patients being randomly selected and put in one of the test and control groups (each with 180 subjects). In the 3rd reception day, some training is presented by the researcher encompassing the ward regulations, infection control standard precautions in particular washing hands, as the most critical method to control nosocomial infection and preventing the spread of antimicrobial resistance .In the test group, the patient's desired attendant's 1 h presence is implemented in clinic for 5 consecutive days observing the trained cases from the 4th to the 8th days .In the control group , no presence of the attendant (the ward routine )is implemented .Nosocomial infection level in the patients is recorded from the 5th to the 15th ICU hospitalization days and in case of the patient being transferred to another ward from the ICU ,it is recorded for 7 days. The data on nosocomial infection symptoms and signs are collected using Nosocomial National Infection System (NNIS) designed questionnaire for the major nosocomial infections diagnosis (pneumonia, UTI, intravenous catheters, surgical site infection and burn) from the 4th to the 15th days and if the patient is eligible for one of the standard criteria for each of the main infections, the related diagnostic code is extracted from NNIS table and recorded. All drugs (albumin and crystalloid), antibiotics, tests, cultures result (blood, urine, sputum, central catheters) and their antibiograms and surgery times during the project are recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201606297494N19
Registration date: 2016-09-12, 1395/06/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-12, 1395/06/22
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2016-07-15, 1395/04/25
Expected recruitment end date
2017-07-16, 1396/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating Family Presence Influencing Nosocomial Infections in Burn Intensive Care Unit
Public title
Evaluating Family Presence Influencing Nosocomial Infections in Burn Intensive Care Unit
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion Criteria: all alert patients over 18 yrs, with their hospitalization passing 48 h and about the patient's attendant, being over 18 yrs and the attendant not suffering from communicable diseases through Eireborn (measles, chicken pox and etc.). Exclusion Criteria: the incidence of cases such as addiction, respiratory distress, intubation, the wound changing color toward getting infected, the patient's discharge or death and for the attendants ,not cooperating about the ward regulations and infection control precautions and afflicted with any communicable disease during the project implementation (especially via Eireborn).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 360
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Start of valiye asr highway, Imam Square, Sari, Mazandaran
City
Sari
Postal code
4736131167
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MAZUMS.REC.95.2368

Health conditions studied

1

Description of health condition studied
Burns and corrosions
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases

Primary outcomes

1

Description
Ponumony
Timepoint
At the 4th and 15th day of admission
Method of measurement
by using a questionnaire designed by the national system of hospital infection surveillance

2

Description
Burn wound infection
Timepoint
At the 4th and 15th day of admission
Method of measurement
by using a questionnaire designed by the national system of hospital infection surveillance

3

Description
Sepsis
Timepoint
At the 4th and 15th day of admission
Method of measurement
by using a questionnaire designed by the national system of hospital infection surveillance

4

Description
Catheter Related Blood stream Infections
Timepoint
At the 4th and 15th day of admission
Method of measurement
by using a questionnaire designed by the national system of hospital infection surveillance

Secondary outcomes

empty

Intervention groups

1

Description
the fourth day of hospitalization, one of a family member (patient preference) for five days in one-hour sessions before dressing change will be present at the bedside
Category
Other

2

Description
Control group (without family) are treated routine
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Zare hospital
Full name of responsible person
Masoomeh Koohi
Street address
Zare Hospital,sari
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Mazandaran University of Medical Sciences.
Full name of responsible person
Dr.Ahmadali Enayati
Street address
Moallem Square-sari
City
Sari
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 Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Masoomeh Koohi
Position
MSC in Critical Care Nursing
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, , Sari
City
Sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
m.koohi61@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Masoumeh Bagheri Nesami-Dr mohamad sadegh rezaii
Position
PHD in nursing/ faculty member-Professor of Pediatric Infectious (Associate Professor) Associate
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences
City
Sari
Postal code
48197-53171
Phone
+98 11 3336 7342
Fax
Email
anna30432003@yahoo.com
Web page address

Person responsible for updating data

Contact

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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