Surgical Site InfectionSurveyOICNCT04310878
Gaps Between Evidence and Practice in Prevention of Surgical Site Infection in Spain
An observational study of Surgical Site Infection, run by Hospital de Granollers at 1 site in Spain.
Trial summary
Web-based survey to members of 10 Spanish Associations of surgical nurses and surgeons of different specialities to know the application of preventative measures for surgical site infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Survey among perioperative nurses and surgeons
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2019to 1 Jul 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Perioperative nurses and surgeons of 11 invited Spanish societies
Who may be able to join
- Nurses and surgeons pertaining to invited societies
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Privada Hospital Asil de Granollers
Granollers, Barcelona, 08402
About this study
Official title: Gaps Between Evidence and Practice in Prevention of Surgical Site Infection in Spain: A Survey of the Observatory of Infection in Surgery
Web-based survey to members of 10 Spanish Associations of surgical nurses and surgeons of different specialities to know the application of preventative measures for surgical site infection.
Read the detailed description
A web-based survey to the members of the Colorectal Chapter of 10 Spanish Associations of surgical nurses and surgeons of different specialities. A link to the web page containing the survey will be disseminated via email, newsletter and Twitter.
A board from the Surgical Infection Section did a review of evidence and previous guidelines to be used in the evaluation of the results. The most recent clinical practice guidelines have been analysed. According to the review, the preventive measures analysed in the survey have been distributed into two groups: high or low level of evidence.
The survey aim to assess knowledge, beliefs, and practices of attending nurses and surgeons on preventative measures. Furthermore, the questions address the level of accordance between their beliefs and the protocols or the usual practice of their units. The agreement rate between the beliefs and usual practice of all respondents will be calculated on a scale from 0 to 100. For discussion, the responses on the implementation of major surgical site infection (SSI) prevention measures will be compared with the recommendations of the expert group.
The results will be expressed in percentages on the total answers obtained. Responses will be entered into a computerized database that will be analysed using an specific program. The results will be analysed using the chi-square test with statistical significance defined as p <0.05.
- Conditions
- Surgical Site Infection
- Being tested
- Survey among perioperative nurses and surgeons
- Keywords
- Surgical site infection, Preventative measures
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey among perioperative nurses and surgeonsOther
Online survey
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness of practice
Percentage of responders who use each preventive measures for surgical site infection
Measured: 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Apr 2019
- Primary completion29 Jun 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josep Badia-Perez, MD, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310878
- Sponsor's protocol ID
- OIC Survey3
- Acronym
- SurveyOIC
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaps Between Evidence and Practice in Prevention of Surgical Site Infection in Spain: A Survey of the Observatory of Infection in Surgery
- ClinicalTrials.gov ID
- NCT04310878
- Acronym / sponsor ID
- SurveyOIC / OIC Survey3
- Conditions
- Surgical Site Infection
- Keywords
- Surgical site infection, Preventative measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 17 Mar 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.
Web-based survey to members of 10 Spanish Associations of surgical nurses and surgeons of different specialities to know the application of preventative measures for surgical site infection.
Detailed description
A web-based survey to the members of the Colorectal Chapter of 10 Spanish Associations of surgical nurses and surgeons of different specialities. A link to the web page containing the survey will be disseminated via email, newsletter and Twitter.
A board from the Surgical Infection Section did a review of evidence and previous guidelines to be used in the evaluation of the results. The most recent clinical practice guidelines have been analysed. According to the review, the preventive measures analysed in the survey have been distributed into two groups: high or low level of evidence.
The survey aim to assess knowledge, beliefs, and practices of attending nurses and surgeons on preventative measures. Furthermore, the questions address the level of accordance between their beliefs and the protocols or the usual practice of their units. The agreement rate between the beliefs and usual practice of all respondents will be calculated on a scale from 0 to 100. For discussion, the responses on the implementation of major surgical site infection (SSI) prevention measures will be compared with the recommendations of the expert group.
The results will be expressed in percentages on the total answers obtained. Responses will be entered into a computerized database that will be analysed using an specific program. The results will be analysed using the chi-square test with statistical significance defined as p <0.05.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Perioperative nurses and surgeons of 11 invited Spanish societies
Key inclusion criteria (1 listed)
- Nurses and surgeons pertaining to invited societies
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Survey among perioperative nurses and surgeonsOnline survey | Other | – |
Primary outcome
Awareness of practice
Time frame: 2020
Percentage of responders who use each preventive measures for surgical site infection
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 15 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Josep Badia-Perez, MD study director
Universitat Internacional de Catalunya
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 Surgical Site Infection, run by Hospital de Granollers at 1 site in Spain.
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: finished, as of the sponsor's last update on 15 Jul 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 Spain. 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?
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?
Awareness of practice (time frame: 2020). 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 15 Jul 2020.