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Intraoperative Hygiene Measures and Surgical Site Infections

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT00555815
Collaborator
(none)
1,032
Enrollment
1
Location
18
Duration (Months)
57.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    1032 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Intraoperative Hygiene Measures and Rates of Surgical Wound Infection in General Surgery
    Study Start Date :
    Jul 1, 2005
    Actual Study Completion Date :
    Jan 1, 2007

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Extended hygiene measures
    2

    Standard hygiene measures

    Outcome Measures

    Primary Outcome Measures

    1. Surgical site infection 30 days postoperative [30 days]

    Secondary Outcome Measures

    1. Adherence to rules of asepsis by members of the surgical team [intraoperative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient undergoing surgical operation in one of two assigned operative theaters. Only initial operations are studied
    Exclusion Criteria:
    • Previous inclusion into study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Visceral and Transplant Surgery, University hospital, Inselspital Bern Switzerland 3010

    Sponsors and Collaborators

    • University Hospital Inselspital, Berne

    Investigators

    • Study Director: Daniel Candinas, MD, Department of Visceral and Transplant Surgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00555815
    Other Study ID Numbers:
    • 1.05.01.30.-17
    First Posted:
    Nov 9, 2007
    Last Update Posted:
    Nov 9, 2007
    Last Verified:
    Nov 1, 2007
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Surgical Wound Infection

    Study Results

    No Results Posted as of Nov 9, 2007