- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01971138
Review of Surgical Site Infection Registration Routine at Surgery Departments in Sweden and Validation of One of the Used Routines
October 23, 2013 updated by: Claes Hjalmarsson, Halmstad County Hospital
This study explores the routines of registration of surgical site infections (SSI) at different surgical centers in Sweden.
It explores the sensitivity and specificity of the registration routines of SSI are at Halmstad County Hospital, Sweden.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Halland
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Halmstad, Halland, Sweden, 30232
- Halmstad County Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Surgical clinics in Sweden.
Description
Inclusion Criteria:
- Surgical Clinics in Sweden that report tho the Swedish national register for Colorectal Cancer.
Exclusion Criteria:
- Clinics that dosen´t report.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Surgical site infection registration
Is there a routine for SSI registration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In which proportion do surgical clinics in Sweden register Surgical Site Infections
Time Frame: spring 2013
|
A questionnaire will be sent to every surgical clinic in Sweden.
This study will then summarize in what way the surgical clinics in Sweden perform their SSI surveillance.
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spring 2013
|
In which proportion does the routine SSI registration at Halmstad County Hospital register the actual number of SSI´s.
Time Frame: up to four years
|
Aiming to validate the SSI surveillance at Halmstad County Hospital.
Patients who underwent elective colorectal resection between 2007-2008 were identified for inclusion in the study.
A total of 66 patient were included.
They were followed prospectively for four weeks and were controlled daily regarded SSI as a part of the study.
After these four weeks the patients also filled a form regarding SSI.
This group where then used as a control group.
The results from the SSI registration routine at Halmstad County Hospital were then compared with the control group regarded SSI.
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up to four years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Which method is used for routine registration of SSI´s in Sweden.
Time Frame: spring 2013
|
A questionnaire will be sent to every surgical clinic in Sweden.
This study will then summarize in what way the surgical clinics in Sweden perform their SSI surveillance.
|
spring 2013
|
How is the SSI classified in different hospitals in Sweden.
Time Frame: spring 2013
|
A questionnaire will be sent to every surgical clinic in Sweden.
This study will then summarize in what way the surgical clinics in Sweden perform their SSI surveillance.
|
spring 2013
|
How is the variation of SSI at the surgical clinic in Halmstad County Hospital, Sweden, the last 10 years.
Time Frame: for 10 years
|
The study aims to do a statistical Analysis of the SSI surveillance material collected at the Halmstad County Hospital between 2002-2012.
We want to know how big the variation is between years regarding SSI and if the statistics i good enough to draw conclusions from.
|
for 10 years
|
How large the difference have to be between in registered SSI frequency to surely detect a deviation in SSI presence
Time Frame: for 10 years
|
The study aims to do a statistical Analysis of the SSI surveillance material collected at the Halmstad County Hospital between 2002-2012.
We want to know how big the variation is between years regarding SSI and if the statistics i good enough to draw conclusions from.
|
for 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Claes Hjalmarsson, MD, PhD, Halmstad County Hospital, Halmstad, Sweden
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.
- Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572.
- Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Am J Infect Control. 1992 Oct;20(5):271-4. doi: 10.1016/s0196-6553(05)80201-9. No abstract available.
- Smyth ET, Emmerson AM. Surgical site infection surveillance. J Hosp Infect. 2000 Jul;45(3):173-84. doi: 10.1053/jhin.2000.0736.
- Degrate L, Garancini M, Misani M, Poli S, Nobili C, Romano F, Giordano L, Motta V, Uggeri F. Right colon, left colon, and rectal surgeries are not similar for surgical site infection development. Analysis of 277 elective and urgent colorectal resections. Int J Colorectal Dis. 2011 Jan;26(1):61-9. doi: 10.1007/s00384-010-1057-8. Epub 2010 Oct 5.
- Malone DL, Genuit T, Tracy JK, Gannon C, Napolitano LM. Surgical site infections: reanalysis of risk factors. J Surg Res. 2002 Mar;103(1):89-95. doi: 10.1006/jsre.2001.6343.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
August 28, 2013
First Submitted That Met QC Criteria
October 23, 2013
First Posted (Estimate)
October 29, 2013
Study Record Updates
Last Update Posted (Estimate)
October 29, 2013
Last Update Submitted That Met QC Criteria
October 23, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 121020-V02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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