Clinical trial NCT04089683: Evaluation of Bacterial Flora Among Operation Theatre Staff at a Tertiary Care Hospital
Official title: Evaluation of Bacterial Flora Among Operation Theatre Staff at a Tertiary Care Hospital - An Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbial Colonization
Keywords: Operation Theatre
Bacterial Contamination
Web-space
OT Dress
Anterior Nares
Lead sponsor: Kamineni Academy of Medical Sciences and Research Centre
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 361
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All OT staff viz. Surgeons, Anesthetists, Residents, OT matron/Nurse, OT Technicians, Housekeeping and Cleaning staff were include in the study. All the patients in OT and samples from the OT air \& equipment were excluded from the study. All subjects were screened as per inclusion and exclusion criteria and selected without any gender bias.

The study population contained 361 subjects among which were divided into four groups. Doctors, Nurses, OT technicians and others. Swabs were collected from OT staff at the time of entry in to OT and at the time of exit from OT. Places of swabs taken are: A) Web space, B) OT dress, C) Anterior nares (distal 1cm in a circular motion). Swabs were inoculated on 5% sheep blood agar/ Mueller-Hinton agar/ Mannitol salted agar/ MacConkey agar and were incubated at 35-37 degree centigrade under aerobic conditions for 48hrs with observation once in 24hrs. The age, gender and rank of the OT staff were collected as a part of demographic data.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria: All Operation Theatre staff -

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

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Primary outcomes:
measure: Bacterial flora harboured at Web spaces among OT staff
timeFrame: 2 years
measure: Bacterial load on OT dress among OT staff
timeFrame: 2 years
measure: To identify the nasal carriers of organisms among OT staff
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: