Intraoperative Hygiene Measures and Surgical Site Infections - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Intraoperative Hygiene Measures and Surgical Site Infections

Official Title ^†

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

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.

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 Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Primary Outcome Measure ^†

Surgical site infection 30 days postoperative [ Time Frame: 30 days ]

Secondary Outcome Measure ^†

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

Condition ^†

Surgery
Surgical Site Infection
Hygiene
Discipline
Colorectal Surgery

Intervention ^†

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

1032

Start Date ^†

July 2005

Completion Date

January 2007

Primary Completion Date

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Switzerland

Administrative Information Fields

NCT ID ^†

NCT00555815

Organization ID

1.05.01.30.-17

Secondary IDs ^††

Study Sponsor ^†

University Hospital Inselspital, Berne

Collaborators ^††

Investigators ^†

Study Director:

Daniel Candinas, MD

Department of Visceral and Transplant Surgery

Information Provided By

University Hospital Inselspital, Berne

Verification Date

November 2007

First Received Date ^†

November 8, 2007

Last Updated Date

November 8, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.