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

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Linkoeping
Information provided by:
University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT00484055
First received: June 6, 2007
Last updated: October 3, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention
Drug Resistance, Bacterial
Postoperative Wound Infection
Drug: Local application of collagen-gentamicin
Procedure: Fixation of the sternotomy with more than six wires

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Local Application of Collagen-Gentamicin in Addition to Fixation of the Sternum With Extra Sternal Wires for Prevention of Sternal Wound Infection in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • The incidences of methicillin- and gentamicin resistant microbiological agents in sternal wound infections that develop in study patients [ Time Frame: Within 2 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The absolute incidence of all SWI and of superficial SWI within 2 months and the relative (the ratio) incidences of superficial vs deep SW [ Time Frame: 2 months postoperatively ] [ Designated as safety issue: No ]
  • The total incidence of SWI that requires surgical revision of the wound [ Time Frame: 2 months postoperatively ] [ Designated as safety issue: No ]

Enrollment: 1358
Study Start Date: January 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    Other Name: Collatamp-G
    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
Detailed Description:

A new technique for prevention of sternal wound infections after cardiac surgery is studied. Local application directly in the surgical wound of aminoglycoside antibiotics (gentamicin) bound to collagen reduced the incidence of wound infection with more than 50 % in a previous prospective randomised trial.

As the technique has been introduced in clinical practise two questions need to be monitored:

  • Are there signs of change in the bacteria that cause the wound infections with a shift over time towards more gentamicin resistant agents?
  • Is the effect of the prophylaxis still comparable to that which was seen in the previous study?

Furthermore, results from the previous study indicated that the effect of the local antibiotic was better when combined with an extra rigid sternal wound infection, defined as at least one extra steel wire for sternal fixation.

The study is conducted at those two Swedish cardiothoracic surgery centers where it was first studied. There are thus two objectives of the study: first to analyze the microbiologic findings of the sternal wound infections that occur, and secondly to monitor the incidence of sternal wound infection (especially deep infections) when the local collagen-gentamicin prophylaxis is used in daily routine in combination with a specific surgical technique for optimization of the strength of sternal fixation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All consecutive cardiac surgery patients operated via median sternotomy

Exclusion Criteria:

  • Existing inclusion of the patient in another study of treatment aimed at reducing postoperative SWI.
  • Known allergy or other contraindication to gentamicin or bovine collagen.
  • Pregnancy or breast feeding
  • Treatment with aminoglycosides during the last week
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484055

Locations
Sweden
University Hospital, Dept of Cardiothoracic Surgery
Linkoeping, Sweden, 58185
Dept of Cardiothoracic Surgery, University Hospital
Orebro, Sweden, 70185
Sponsors and Collaborators
University Hospital Orebro
University Hospital, Linkoeping
Investigators
Principal Investigator: Örjan Friberg, MD, PhD Dept of Cardiothoracic Surgery and Anestesiology, University Hospital Orebro, Sweden
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Örjan Friberg, Örebro University Hospital, Örebro, Sweden
ClinicalTrials.gov Identifier: NCT00484055     History of Changes
Other Study ID Numbers: OFR02
Study First Received: June 6, 2007
Last Updated: October 3, 2008
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital Orebro:
Antibiotic Prophylaxis

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014