Intraoperative Hygiene Measures and Surgical Site Infections

NCT ID: NCT00555815

Last Updated: 2007-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1032 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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Surgery Surgical Site Infection Hygiene Discipline Colorectal Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Extended hygiene measures

No interventions assigned to this group

2

Standard hygiene measures

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previous inclusion into study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Principal Investigators

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Daniel Candinas, MD

Role: STUDY_DIRECTOR

Department of Visceral and Transplant Surgery

Locations

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Department of Visceral and Transplant Surgery, University hospital, Inselspital

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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Beldi G, Bisch-Knaden S, Banz V, Muhlemann K, Candinas D. Impact of intraoperative behavior on surgical site infections. Am J Surg. 2009 Aug;198(2):157-62. doi: 10.1016/j.amjsurg.2008.09.023. Epub 2009 Mar 12.

Reference Type DERIVED
PMID: 19285307 (View on PubMed)

Other Identifiers

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1.05.01.30.-17

Identifier Type: -

Identifier Source: org_study_id