Microbial ColonizationNCT04089683
Evaluation of Bacterial Flora Among Operation Theatre Staff at a Tertiary Care Hospital
An observational study of Microbial Colonization, run by Kamineni Academy of Medical Sciences and Research Centre.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Swab stick
- How many people
- 361 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Exclusion Criteria: Patients in Operation Theatre, Operating room air \& equipment
- -
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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.
- Conditions
- Microbial Colonization
- Being tested
- Swab stick
- Keywords
- Operation Theatre, Bacterial Contamination, Web-space, OT Dress, Anterior Nares
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swab stickOther
Swab sticks collected from Web Spaces, Scrub, Anterior Nares
| Study group | Role | What they receive |
|---|---|---|
| Doctors | Swabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre Receives: Other: Swab stick | |
| Nurses | Swabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre Receives: Other: Swab stick | |
| OT Technicians | Swabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre Receives: 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 Receives: Other: Swab stick |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study startApr 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamineni Academy of Medical Sciences and Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Metta Jayachandra Reddy, Kamineni Academy of Medical Sciences and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089683
- Sponsor's protocol ID
- KamineniAMSRC
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study Protocol
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bacterial Flora Among Operation Theatre Staff at a Tertiary Care Hospital - An Observational Prospective Study
- ClinicalTrials.gov ID
- NCT04089683
- Acronym / sponsor ID
- KamineniAMSRC
- Conditions
- Microbial Colonization
- Keywords
- Operation Theatre, Bacterial Contamination, Web-space, OT Dress, Anterior Nares
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Kamineni Academy of Medical Sciences and Research CentreUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Doctors | – | Other: Swab stickSwabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre |
| Nurses | – | Other: Swab stickSwabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre |
| OT Technicians | – | Other: Swab stickSwabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre |
| House keeping staff and cleaners | – | Other: Swab stickSwabs collected from Web space, Scrub, Anterior nares before entering Operation theatre and while exit from operation theatre |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Exclusion Criteria: Patients in Operation Theatre, Operating room air \& equipment
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swab stickSwab sticks collected from Web Spaces, Scrub, Anterior Nares | Other | Doctors, House keeping staff and cleaners, Nurses, OT Technicians |
Primary outcome
Bacterial flora harboured at Web spaces among OT staff
Time frame: 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
Bacterial load on OT dress among OT staff
Time frame: 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
To identify the nasal carriers of organisms among OT staff
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Individual participant dataSharing planned: Undecided. Study Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization, run by Kamineni Academy of Medical Sciences and Research Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial flora harboured at Web spaces among OT staff (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.