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NCT00555815 Clinical Trial

Intraoperative Hygiene Measures and Surgical Site Infections

Surgery Clinical Trial

Official title:
Intraoperative Hygiene Measures and Rates of Surgical Wound Infection in General Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00555815
Other study ID # 1.05.01.30.-17
Secondary ID
Status Completed
Phase N/A
First received November 8, 2007
Last updated November 8, 2007
Start date July 2005
Est. completion date January 2007

Study information
Verified date November 2007
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Federal Office of Public Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1032
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patient undergoing surgical operation in one of two assigned operative theaters. Only initial operations are studied

Exclusion Criteria:

- Previous inclusion into study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Department of Visceral and Transplant Surgery, University hospital, Inselspital Bern

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surgical site infection 30 days postoperative 30 days
Secondary Adherence to rules of asepsis by members of the surgical team intraoperative
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