Intraoperative Hygiene Measures and Surgical Site Infections - Full Text View

Sponsored by:	University Hospital Inselspital, Berne
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00555815

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

MedlinePlus related topics: Germs and Hygiene

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Study placed in the following topic categories:

Postoperative Complications
Surgical Wound Infection
Wound Infection

Additional relevant MeSH terms:

Communicable Diseases
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 15, 2009