Operation Wound; InfectionNCT04609384
Nudging Effect of Timer on Surgical Rub
An observational study of Operation Wound; Infection and Bacterial Infections, run by Sygehus Lillebaelt at 1 site in Denmark.
Trial summary
To study whether a device has a nudging effect on the time spend on surgical rub. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Operation Wound; Infection, Bacterial Infections, Surgical Procedure, Unspecified
- What is being tested?
- Alcohol rub timer device
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2020to 1 Jan 2023
- 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
- Child, Adult, Older adult
Study population: All health care workers who perform alcohol rub.
Who may be able to join
- All professional health care workers, who perform surgical ru
Who cannot join
- Students and other persons at a hospital, who are not paid to be working at the hospital.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Sygehus Lillebaelt
Kolding, 6000
per h gundtoft, 4526195112, per.hviid.gundtoft@rsyd.dk
per h gundtoft, md
About this study
Official title: The Effect on a Timer-device on the Time Spend on Surgical Rub
To study whether a device has a nudging effect on the time spend on surgical rub.
Read the detailed description
The investigators observed the time spend on surgical rub prior to an operation. The investigators do not record names, age, sex or orther features about the health care workers who perform the surgical rub.
After 200 observations a device will be attach to the dispenser that might help increase the time spend on the surgical rub in the operathing theather. The investigatos will then make another 200 observations to see if the device cause an increase in the time spend on surgical rub.
- Being tested
- Alcohol rub timer device
- Medical subject headings
- Surgical Wound Infection, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol rub timer deviceDevice
A device that should help the surgeon to increase the time spend on surgical rub. Further detail cannot be described due to confidence
| Study group | Role | What they receive |
|---|---|---|
| Prior to installation of device | Health care workers who perform the surgical rub prior to installation of the device that should increase the time spend on surgical rub. Receives: Device: Alcohol rub timer device | |
| Post device installation | Health care workers who perform the surgical rub following installation of the device that should increase the time spend on surgical rub. Receives: Device: Alcohol rub timer device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
time used on surgical rub
Measured: Seconds used on surgical rub at least 300 seconds. Observation begin from start of surgical rub (defined as the time when the dispenser is activated) to the end of surgical rub (defined as the time when the surgeon pick up the surgical gown)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Jan 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Operation Wound; InfectionStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sygehus Lillebaelt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, per hviid gundtoft, Sygehus Lillebaelt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609384
- Sponsor's protocol ID
- PHG_1_timer
- Status last verified
- Oct 2020
- First submitted
- 30 Jun 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not keep indivicual participants data but treat all data anonymous.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on a Timer-device on the Time Spend on Surgical Rub
- ClinicalTrials.gov ID
- NCT04609384
- Acronym / sponsor ID
- PHG_1_timer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sygehus LillebaeltUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 30 Oct 2020 (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.
To study whether a device has a nudging effect on the time spend on surgical rub.
Detailed description
The investigators observed the time spend on surgical rub prior to an operation. The investigators do not record names, age, sex or orther features about the health care workers who perform the surgical rub.
After 200 observations a device will be attach to the dispenser that might help increase the time spend on the surgical rub in the operathing theather. The investigatos will then make another 200 observations to see if the device cause an increase in the time spend on surgical rub.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prior to installation of device | – | Device: Alcohol rub timer deviceHealth care workers who perform the surgical rub prior to installation of the device that should increase the time spend on surgical rub. |
| Post device installation | – | Device: Alcohol rub timer deviceHealth care workers who perform the surgical rub following installation of the device that should increase the time spend on surgical rub. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All health care workers who perform alcohol rub.
Key inclusion criteria (1 listed)
- All professional health care workers, who perform surgical ru
Key exclusion criteria (1 listed)
- Students and other persons at a hospital, who are not paid to be working at the hospital.
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 |
|---|---|---|
| Alcohol rub timer deviceA device that should help the surgeon to increase the time spend on surgical rub. Further detail cannot be described due to confidence | Device | Post device installation, Prior to installation of device |
Primary outcome
Time
Time frame: Seconds used on surgical rub at least 300 seconds. Observation begin from start of surgical rub (defined as the time when the dispenser is activated) to the end of surgical rub (defined as the time when the surgeon pick up the surgical gown)
time used on surgical rub
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No. We do not keep indivicual participants data but treat all data anonymous.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Operation Wound; Infection and Bacterial Infections, run by Sygehus Lillebaelt at 1 site in Denmark.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (time frame: Seconds used on surgical rub at least 300 seconds. Observation begin from start of surgical rub (defined as the time when the dispenser is activated) to the end of surgical rub (defined as the time when the surgeon pick up the surgical gown)). 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 30 Oct 2020.