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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484055
Recruitment Status : Completed
First Posted : June 8, 2007
Last Update Posted : October 13, 2016
University Hospital, Linkoeping
Information provided by (Responsible Party):
Orjan Friberg, Region Örebro County

Brief 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.

Condition or disease Intervention/treatment Phase
Drug Resistance, Bacterial Postoperative Wound Infection Drug: Local application of collagen-gentamicin Procedure: Fixation of the sternotomy with more than six wires Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1358 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: treatment

Use of local CollagenGentamicin and enhanced sternal fixation according to the Clinical routine introduced 4 years earlier as a result of a previous RCT on 2000 patients. In that sense these patients did not receive any intervention but just the standard treatment introduced 4 years earlier.

The aim of the study was to PROSPECTIVELY include a defined number of patients to compare their complication rate with that from aControl Group of patients från a previous RCT to verify that the effect of the treatment was stable over time.

As the study did not include any intervention compared to the present standard treatment at that time ethical approval was Exempt.

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

Primary Outcome Measures :
  1. The incidences of methicillin- and gentamicin resistant microbiological agents in sternal wound infections that develop in study patients [ Time Frame: Within 2 months postoperatively ]

Secondary Outcome Measures :
  1. 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 ]
  2. The total incidence of SWI that requires surgical revision of the wound [ Time Frame: 2 months postoperatively ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00484055

University Hospital, Dept of Cardiothoracic Surgery
Linkoeping, Sweden, 58185
Dept of Cardiothoracic Surgery, University Hospital
Orebro, Sweden, 70185
Sponsors and Collaborators
Region Örebro County
University Hospital, Linkoeping
Principal Investigator: Örjan Friberg, MD, PhD Dept of Cardiothoracic Surgery and Anestesiology, University Hospital Orebro, Sweden

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Orjan Friberg, MD, PhD, Region Örebro County Identifier: NCT00484055     History of Changes
Other Study ID Numbers: OFR02
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Orjan Friberg, Region Örebro County:
Antibiotic Prophylaxis

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