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Intraoperative Hygiene Measures and Surgical Site Infections

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00555815
First received: November 8, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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
Surgery
Surgical Site Infection
Hygiene
Discipline
Colorectal Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intraoperative Hygiene Measures and Rates of Surgical Wound Infection in General Surgery

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Surgical site infection 30 days postoperative [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Adherence to rules of asepsis by members of the surgical team [ Time Frame: intraoperative ]

Enrollment: 1032
Study Start Date: July 2005
Study Completion Date: January 2007
Groups/Cohorts
1
Extended hygiene measures
2
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients undergoing general surgery in university hospital

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555815

Locations
Switzerland
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
  More Information

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00555815     History of Changes
Other Study ID Numbers: 1.05.01.30.-17
Study First Received: November 8, 2007
Last Updated: November 8, 2007
Health Authority: Switzerland: Federal Office of Public Health

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013