Bacterial Growth in Vascular Surgery Wounds | NCT01505738

Studies
Bacterial Growth in Vascular Surgery Wounds

NCT01505738

Sponsor

North Karelia Central Hospital

Status

Completed

Last Update Posted

Dec 17, 2012Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Lower Limb Ischaemia
Aneurysm

Interventions

bacterial samples

Countries

Finland

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

Dec 2012

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

Jan 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Jan 4, 2012

First Submission Date that Met QC Criteria

Jan 5, 2012

First Posted Date

Jan 6, 2012Estimated

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

Dec 13, 2012

Last Update Posted Date

Dec 17, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sanna Kouhia, Principal investigator, North Karelia Central HospitalPrincipal Investigator

Lead Sponsor

North Karelia Central HospitalOTHER

Collaborators

Not provided

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

The amount and species of bacteria have been shown to have an effect in wound infections in several fields of surgery (such as gastrointestinal and orthopaedic surgery and the surgery of facial area). In vascular surgery, wound infections are a common and expensive complication. The aim of the present study is to investigate the prevalence of bacteria in vascular surgery wounds perioperatively, and determine whether is correlates with the incidence of wound infections postoperatively.

Detailed Description

Not provided

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bacterial cultures		Bacterial samples are collected preoperatively from urine, nose and possible lower limb ischaemic wounds, perioperatively from inguinal area and wound edges, and twice postoperatively. In addition, in case of a wound infection, bacterial samples are taken for diagnosis as usual.	Other: bacterial samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bacterial samples	Other	bacterial samples taken	bacterial cultures

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
wound infection	incidence of wound infection after lower limb vascular surgery	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

need for lower limb vascular by-pass surgery

Exclusion Criteria:

allergic to cefuroxime
patients refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

100 patients requiring lower limb vascular surgery due to ischaemic changes and/or lower limb aneurysms.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Karelia Central Hospital, Clinic of Surgery		Joensuu		FIN-80210	Finland

Condition Browse Module

MeSH Terms

ID	Term
D000783	Aneurysm

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided