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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04089683
Other study ID # KamineniAMSRC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2014
Est. completion date April 2016

Study information

Verified date September 2019
Source Kamineni Academy of Medical Sciences and Research Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Health care associated infection (HCAI) is a serious health hazard as it leads to increased morbidity and mortality of patients, length of hospital stay and costs associated with increased hospital stay.

A total of 361 subjects divided into four groups were included in this study. The first group comprised of 179 doctors, the second had 31 nurses, third group had 110 OT Technicians and the fourth group included 41 subjects which included housekeeping staff and cleaners. Swabs were collected from OT staff at the time of entry and at exit from the OT. Places of swabs taken were: A) Web space, B) OT dress and C) Anterior nares.


Description:

Introduction:

Health care associated infection (HCAI) is a serious health hazard as it leads to increased morbidity and mortality of patients, length of hospital stay and costs associated with increased hospital stay. Infections from OT is well known and is well established which are often referred to as "hot zones" for emergence & spread of microbial resistance. Contamination in an operation theatre is an important cause of HCAIs and is the third leading cause of HCAIs.

This was a prospective observational study conducted in the operation theatre of a tertiary hospital once a month randomly from April 2014 - April 2016. All Operation theatre (OT) staff were included in the study. All the patients in OT and samples from the OT air & equipment were excluded from the study. A total of 361 subjects divided into four groups were included in this study. The first group comprised of 179 doctors, the second had 31 nurses, third group had 110 OT Technicians and the fourth group included 41 subjects which included housekeeping staff and cleaners. Swabs were collected from OT staff at the time of entry and at exit from the OT. Places of swabs taken were: A) Web space, B) OT dress and C) Anterior nares.


Recruitment information / eligibility

Status Completed
Enrollment 361
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: All Operation Theatre staff -

Exclusion Criteria: Patients in Operation Theatre, Operating room air & equipment

-

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Swab stick
Swab sticks collected from Web Spaces, Scrub, Anterior Nares

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kamineni Academy of Medical Sciences and Research Centre

Outcome

Type Measure Description Time frame Safety issue
Primary Bacterial flora harboured at Web spaces among OT staff Swabs will be taken from web spaces before entering Operation Theatre and while going out of OT at the end of the day and cultured to look for growth of Bacteria 2 years
Primary Bacterial load on OT dress among OT staff Swabs will be taken from OT dress while donning them and before going out of OT at the end of the day and cultured to look for growth 2 years
Primary To identify the nasal carriers of organisms among OT staff Swabs will be taken from anterior nares while entering OT at the end of the day while leaving OT and cultured to look for growth 2 years
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