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Intraoperative Hygiene Measures and Surgical Site Infections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555815
First Posted: November 9, 2007
Last Update Posted: November 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Inselspital, Berne
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 8, 2007
First Posted: November 9, 2007
Last Update Posted: November 9, 2007
Last Verified: November 2007

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