Review of Surgical Site Infection Registration Routine at Surgery Departments in Sweden and Validation of One of the Used Routines

Surgical Site Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971138
• Other study ID #: 121020-V02
• Status: Completed
• Phase: N/A
• First received: August 28, 2013
• Last updated: October 23, 2013
• Start date: March 2013

Study information

• Verified date: October 2013
• Source: Halmstad County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish Data Inspection BoardSweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Surgical Clinics in Sweden that report tho the Swedish national register for Colorectal Cancer.

Exclusion Criteria:

• Clinics that dosen´t report.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Surgical Site Infections
• Surgical Wound Infection

Intervention

Other:
• this is a survey

Locations

Country	Name	City	State
Sweden	Halmstad County Hospital	Halmstad	Halland

Sponsors (1)

Lead Sponsor	Collaborator
Halmstad County Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Smyth ET, Emmerson AM. Surgical site infection surveillance. J Hosp Infect. 2000 Jul;45(3):173-84. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In which proportion do surgical clinics in Sweden register Surgical Site Infections	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	No
Primary	In which proportion does the routine SSI registration at Halmstad County Hospital register the actual number of SSI´s.	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.	up to four years	No
Secondary	Which method is used for routine registration of SSI´s in Sweden.	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	No
Secondary	How is the SSI classified in different hospitals in Sweden.	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	No
Secondary	How is the variation of SSI at the surgical clinic in Halmstad County Hospital, Sweden, the last 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	No
Secondary	How large the difference have to be between in registered SSI frequency to surely detect a deviation in SSI presence	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	No