Clinical trial NCT00484055: Local Collagen-Gentamicin and Extra Fixation of the Sternum for Prevention of Sternal Wound Infection in Cardiac Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Resistance, Bacterial
Postoperative Wound Infection
Keywords: Antibiotic Prophylaxis
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: University Hospital, Linkoeping
First posted: 2007-06-08
Enrollment: 1358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: The incidences of methicillin- and gentamicin resistant microbiological agents in sternal wound infections that develop in study patients
timeFrame: Within 2 months postoperatively
Secondary outcomes:
measure: The absolute incidence of all SWI and of superficial SWI within 2 months and the relative (the ratio) incidences of superficial vs deep SW
timeFrame: 2 months postoperatively
measure: The total incidence of SWI that requires surgical revision of the wound
timeFrame: 2 months postoperatively
Other outcomes:
Locations:
city: Linkoeping
country: Sweden
facility: University Hospital, Dept of Cardiothoracic Surgery
city: Orebro
country: Sweden
facility: Dept of Cardiothoracic Surgery, University Hospital
Study officials:
affiliation: Dept of Cardiothoracic Surgery and Anestesiology, University Hospital Orebro, Sweden
name: Örjan Friberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friberg O, Svedjeholm R, Kallman J, Soderquist B. Incidence, microbiological findings, and clinical presentation of sternal wound infections after cardiac surgery with and without local gentamicin prophylaxis. Eur J Clin Microbiol Infect Dis. 2007 Feb;26(2):91-7. doi: 10.1007/s10096-006-0252-6.
citation: Friberg O, Dahlin LG, Soderquist B, Kallman J, Svedjeholm R. Influence of more than six sternal fixation wires on the incidence of deep sternal wound infection. Thorac Cardiovasc Surg. 2006 Oct;54(7):468-73. doi: 10.1055/s-2006-924437.
citation: Friberg O, Svedjeholm R, Soderquist B, Granfeldt H, Vikerfors T, Kallman J. Local gentamicin reduces sternal wound infections after cardiac surgery: a randomized controlled trial. Ann Thorac Surg. 2005 Jan;79(1):153-61; discussion 161-2. doi: 10.1016/j.athoracsur.2004.06.043.
citation: Friberg O, Dahlin LG, Kallman J, Kihlstrom E, Soderquist B, Svedjeholm R. Collagen-gentamicin implant for prevention of sternal wound infection; long-term follow-up of effectiveness. Interact Cardiovasc Thorac Surg. 2009 Sep;9(3):454-8. doi: 10.1510/icvts.2009.207514. Epub 2009 Jun 18.