- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
Inclusion Criteria: All Operation Theatre staff -
Exclusion Criteria: Patients in Operation Theatre, Operating room air & equipment
-
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Bacterial flora harboured at Web spaces among OT staff
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KamineniAMSRC
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Swab stick
-
Rose Research Center, LLCFoundation for a Smoke Free World INCConcluídoParar de fumarEstados Unidos
-
Butantan InstituteConcluído
-
Guangzhou University of Chinese MedicineDesconhecidoSíndrome da fadiga crônicaChina
-
Medical University InnsbruckDesconhecido
-
Rigshospitalet, DenmarkRecrutamentoCOVID-19 | Gripe | Infecção por RSVDinamarca
-
University of CalgaryHealth CanadaAtivo, não recrutando
-
Assistance Publique Hopitaux De MarseilleConcluído
-
Assistance Publique Hopitaux De MarseilleConcluídoFebre do viajanteFrança
-
Universitaire Ziekenhuizen KU LeuvenAtivo, não recrutandoMicrobioma da Superfície OcularBélgica
-
Seoul National University HospitalConcluídoInfecção por Helicobacter PyloriRepublica da Coréia