NCT01971138

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

1 month

First QC Date

August 28, 2013

Last Update Submit

October 23, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (4)

  • Which method is used for routine registration of SSI´s in Sweden.

    spring 2013

  • How is the SSI classified in different hospitals in Sweden.

    spring 2013

  • How is the variation of SSI at the surgical clinic in Halmstad County Hospital, Sweden, the last 10 years.

    for 10 years

  • How large the difference have to be between in registered SSI frequency to surely detect a deviation in SSI presence

    for 10 years

Study Arms (1)

Surgical site infection registration

Is there a routine for SSI registration

Other: this is a survey

Interventions

Surgical site infection registration

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical clinics in Sweden.

You may qualify if:

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

You may not qualify if:

  • Clinics that dosen´t report.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halmstad County Hospital

Halmstad, Halland County, 30232, Sweden

Location

Related Publications (6)

  • 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.

    PMID: 10580621BACKGROUND
  • Smyth ET, Emmerson AM. Surgical site infection surveillance. J Hosp Infect. 2000 Jul;45(3):173-84. doi: 10.1053/jhin.2000.0736.

    PMID: 10896795BACKGROUND
  • 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.

    PMID: 20922541BACKGROUND
  • 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.

    PMID: 11855922BACKGROUND
  • 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.

    PMID: 10196487BACKGROUND
  • 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.

    PMID: 1332552BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claes Hjalmarsson, MD, PhD

    Halmstad County Hospital, Halmstad, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 28, 2013

First Posted

October 29, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2013

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations