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Local Collagen-Gentamicin and Extra Fixation of the Sternum for Prevention of Sternal Wound Infection in Cardiac Surgery

NCT00484055 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1358

Last updated 2016-10-13

No results posted yet for this study

Summary

The aim of the present study is to evaluate a new technique for prevention of sternal wound infection consisting of local application of collagen-gentamicin in addition to routine i.v. antibiotic prophylaxis.

The technique has been evaluated in a previous randomised study. The aim of the present study is to evaluate the technique after it has been introduced in clinical practise to monitor the bacterial antibiotic susceptibility and to verify that the suggested reduction in sternal wound infection still exits.

Conditions

  • Drug Resistance, Bacterial
  • Postoperative Wound Infection

Interventions

DRUG

Local application of collagen-gentamicin

Application of 2 sponges (5 x 20 cm) of collagen-gentamicin between the sternal halves immediately before sternal closure

PROCEDURE

Fixation of the sternotomy with more than six wires

At least 7 (or more) sternal fixation wires (preferaby put as separate single wires) used for fixation of the sternum at wound closure

Sponsors & Collaborators

  • University Hospital, Linkoeping

    collaborator OTHER

  • Region Örebro County

    lead OTHER

Principal Investigators

  • Örjan Friberg, MD, PhD · Dept of Cardiothoracic Surgery and Anestesiology, University Hospital Orebro, Sweden

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00484055 on ClinicalTrials.gov