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NCT Number: NCT00484055

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Dept of Cardiothoracic Surgery, Linköping, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local application of collagen-gentamicin

Drug

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

Other names: Collatamp-G

Fixation of the sternotomy with more than six wires

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • University Hospital, Linkoeping

Registry information

Official study 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

Acronym: LOGIX

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 8, 2007
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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