SurgeryNCT00555815
Intraoperative Hygiene Measures and Surgical Site Infections
An observational study of Surgery and Surgical Site Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Surgical site infections are associated with high morbidity and cost Hypothesis: Extended intraoperative hygiene measures decrease surgical site infections in general surgery compared to standard hygiene measures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Surgical Site Infection, Hygiene
- How many people
- 1,032 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2005to Jan 2007
- 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: Consecutive patients undergoing general surgery in university hospital
Who may be able to join
- Patient undergoing surgical operation in one of two assigned operative theaters. Only initial operations are studied
Who cannot join
- Previous inclusion into study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral and Transplant Surgery, University hospital, Inselspital
Bern, 3010
About this study
Official title: Intraoperative Hygiene Measures and Rates of Surgical Wound Infection in General Surgery
Surgical site infections are associated with high morbidity and cost Hypothesis: Extended intraoperative hygiene measures decrease surgical site infections in general surgery compared to standard hygiene measures.
Read the detailed description
Intraoperatively two types of hygiene measures were performed randomly: standard and extensive. Standard hygiene measures included empiric accepted measures (e.g. gloves, masks, disinfection). Extensive hygiene measures included among others: double gloving, astro caps, extensive disinfection, extensive intraoperative rinsing. In addition, intraoperative adherence to the rules of asepsis were registered by an independent observer.
Patients were followed for 30 days.
- Conditions
- Surgery, Surgical Site Infection, Hygiene, Discipline, Colorectal Surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Extended hygiene measures | |
| 2 | Standard hygiene measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection 30 days postoperative
Measured: 30 days
Secondary outcomes (1)
Adherence to rules of asepsis by members of the surgical team
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startJul 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 1,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Candinas, MD, Study director, Department of Visceral and Transplant Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555815
- Sponsor's protocol ID
- 1.05.01.30.-17
- Status last verified
- Nov 2007
- First submitted
- 8 Nov 2007
- Last updated
- 9 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Beldi G, Bisch-Knaden S, Banz V, Muhlemann K, Candinas D. Impact of intraoperative behavior on surgical site infections. Am J Surg. 2009 Aug;198(2):157-62. doi: 10.1016/j.amjsurg.2008.09.023. Epub 2009 Mar 12.
PubMed 19285307
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Hygiene Measures and Rates of Surgical Wound Infection in General Surgery
- ClinicalTrials.gov ID
- NCT00555815
- Acronym / sponsor ID
- 1.05.01.30.-17
- Conditions
- Surgery, Surgical Site Infection, Hygiene, Discipline, Colorectal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,032 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 9 Nov 2007 (estimated)
- 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.
Surgical site infections are associated with high morbidity and cost Hypothesis: Extended intraoperative hygiene measures decrease surgical site infections in general surgery compared to standard hygiene measures.
Detailed description
Intraoperatively two types of hygiene measures were performed randomly: standard and extensive. Standard hygiene measures included empiric accepted measures (e.g. gloves, masks, disinfection). Extensive hygiene measures included among others: double gloving, astro caps, extensive disinfection, extensive intraoperative rinsing. In addition, intraoperative adherence to the rules of asepsis were registered by an independent observer.
Patients were followed for 30 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Extended hygiene measures |
| 2 | – | –Standard hygiene measures |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients undergoing general surgery in university hospital
Key inclusion criteria (1 listed)
- Patient undergoing surgical operation in one of two assigned operative theaters. Only initial operations are studied
Key exclusion criteria (1 listed)
- Previous inclusion into study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical site infection 30 days postoperative
Time frame: 30 days
1 secondary outcome
Adherence to rules of asepsis by members of the surgical team
Time frame: intraoperative
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 9 Nov 2007.
- Derived from this study: PubMed 19285307Beldi G, Bisch-Knaden S, Banz V, Muhlemann K, Candinas D. Impact of intraoperative behavior on surgical site infections. Am J Surg. 2009 Aug;198(2):157-62. doi: 10.1016/j.amjsurg.2008.09.023. Epub 2009 Mar 12.
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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.
Daniel Candinas, MD study director
Department of Visceral and Transplant Surgery
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 Surgery and Surgical Site Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 9 Nov 2007. 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 Switzerland. 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?
Surgical site infection 30 days postoperative (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00555815, which also lists 1 linked publication.
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 9 Nov 2007.