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CompletedNCT00555815Updated Nov 9, 2007

Intraoperative Hygiene Measures and Surgical Site Infections

An observational study in Surgery, Surgical Site Infection and Hygiene, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2007-11-09.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,032
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Surgery
  • Surgical Site Infection
  • Hygiene
  • Discipline
  • Colorectal Surgery
03

In context

Surgical Wound Infection

687 studies on the registry are indexed under Surgical Wound Infection; 142 are open to participants now.

This study's enrollment of 1,032 is above the median of 240 across 133 observational studies indexed under Surgical Wound Infection.

Browse Surgical Wound Infection studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 737 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive patients undergoing general surgery in university hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous inclusion into study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,032 participants (actual)

Groups and cohorts

  • 1

    Extended hygiene measures

  • 2

    Standard hygiene measures

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What researchers measure

Primary outcomes

  1. Surgical site infection 30 days postoperative

    Time frame: 30 days

Secondary outcomes

  1. Adherence to rules of asepsis by members of the surgical team

    Time frame: intraoperative

07

Study locations

1 site
  • Department of Visceral and Transplant Surgery, University hospital, Inselspital
    Bern, 3010, Switzerland
08

References and documents

Publications

  • 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. PubMed 19285307 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00555815
First posted
Nov 9, 2007
Start date
Jul 2005
Completion
Jan 2007
Last update
Nov 9, 2007

Study contacts

Daniel Candinas, MD
study director · Department of Visceral and Transplant Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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