Intraoperative Hygiene Measures and Surgical Site Infections | NCT00555815

Studies
Intraoperative Hygiene Measures and Surgical Site Infections

NCT00555815

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Nov 9, 2007Estimated

Enrollment

1,032Actual

Phase

Not provided

Conditions

Surgery
Surgical Site Infection
Hygiene
Discipline
Colorectal Surgery

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

Jan 2007Actual

First Submitted Date

Nov 8, 2007

First Submission Date that Met QC Criteria

Nov 8, 2007

First Posted Date

Nov 9, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2007

Last Update Posted Date

Nov 9, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,032Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Extended hygiene measures
2		Standard hygiene measures

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical site infection 30 days postoperative		30 days

Secondary Outcomes

Measure	Description	Time Frame
Adherence to rules of asepsis by members of the surgical team		intraoperative

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Consecutive patients undergoing general surgery in university hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Candinas, MD	Department of Visceral and Transplant Surgery	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Visceral and Transplant Surgery, University hospital, Inselspital		Bern		3010	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19285307	Derived	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.

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes