NCT00555815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,032

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
Last Updated

November 9, 2007

Status Verified

November 1, 2007

First QC Date

November 8, 2007

Last Update Submit

November 8, 2007

Conditions

SurgerySurgical Site InfectionHygieneDisciplineColorectal Surgery

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection 30 days postoperative

    30 days

Secondary Outcomes (1)

  • Adherence to rules of asepsis by members of the surgical team

    intraoperative

Study Arms (2)

1

Extended hygiene measures

2

Standard hygiene measures

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients undergoing general surgery in university hospital

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral and Transplant Surgery, University hospital, Inselspital

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 19285307DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Candinas, MD

    Department of Visceral and Transplant Surgery

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 9, 2007

Study Start

July 1, 2005

Study Completion

January 1, 2007

Last Updated

November 9, 2007

Record last verified: 2007-11

Locations

CH(1)