- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04089683
Evaluation of Bacterial Flora Among Operation Theatre Staff at a Tertiary Care Hospital
Evaluation of Bacterial Flora Among Operation Theatre Staff at a Tertiary Care Hospital - An Observational Prospective Study
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
Inclusion Criteria: All Operation Theatre staff -
Exclusion Criteria: Patients in Operation Theatre, Operating room air & equipment
-
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Doctors
Swabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre
|
Swab sticks collected from Web Spaces, Scrub, Anterior Nares
|
|
Nurses
Swabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre
|
Swab sticks collected from Web Spaces, Scrub, Anterior Nares
|
|
OT Technicians
Swabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre
|
Swab sticks collected from Web Spaces, Scrub, Anterior Nares
|
|
House keeping staff and cleaners
Swabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre
|
Swab sticks collected from Web Spaces, Scrub, Anterior Nares
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Bacterial flora harboured at Web spaces among OT staff
Zeitfenster: 2 years
|
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
Zeitfenster: 2 years
|
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
Zeitfenster: 2 years
|
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
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KamineniAMSRC
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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