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Bacterial Growth in Vascular Surgery Wounds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanna Kouhia, North Karelia Central Hospital
ClinicalTrials.gov Identifier:
NCT01505738
First received: January 4, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Lower Limb Ischaemia
Aneurysm
 Other: bacterial samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Bacterial Growth in Vascular Surgery Wounds to the Incidence of Postoperative Wound Infections

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Further study details as provided by North Karelia Central Hospital:

Primary Outcome Measures:
  • wound infection [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    incidence of wound infection after lower limb vascular surgery


Enrollment: 100
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
bacterial samples taken

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • need for lower limb vascular by-pass surgery

Exclusion Criteria:

  • allergic to cefuroxime
  • patients refusal to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505738

Locations
Finland
North Karelia Central Hospital, Clinic of Surgery
Joensuu, Finland, FIN-80210
Sponsors and Collaborators
North Karelia Central Hospital
  More Information

No publications provided

Responsible Party: Sanna Kouhia, Principal investigator, North Karelia Central Hospital
ClinicalTrials.gov Identifier: NCT01505738     History of Changes
Other Study ID Numbers: NKCH-Surg-009
Study First Received: January 4, 2012
Last Updated: December 13, 2012
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

Additional relevant MeSH terms:
Aneurysm
Ischemia
Surgical Wound Infection
Vascular Diseases
Cardiovascular Diseases
 Pathologic Processes
Wound Infection
Infection
Postoperative Complications

ClinicalTrials.gov processed this record on May 22, 2013