NCT04089683

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

September 6, 2019

Last Update Submit

September 12, 2019

Conditions

Keywords

Operation TheatreBacterial ContaminationWeb-spaceOT DressAnterior Nares

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (4)

Doctors

Swabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre

Other: Swab stick

Nurses

Swabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre

Other: Swab stick

OT Technicians

Swabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre

Other: Swab stick

House keeping staff and cleaners

Swabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre

Other: Swab stick

Interventions

Swab sticks collected from Web Spaces, Scrub, Anterior Nares

DoctorsHouse keeping staff and cleanersNursesOT Technicians

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Dept of Surgery, KAMSRC, Hyderabad, India

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 13, 2019

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 13, 2019

Record last verified: 2019-09