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

Postoperative Wound Infection Clinical Trial

— LOGIX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484055
• Other study ID #: OFR02
• Status: Completed
• Phase: N/A
• First received: June 6, 2007
• Last updated: October 12, 2016
• Start date: January 2007
• Est. completion date: August 2008

Study information

• Verified date: October 2016
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1358
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Drug Resistance, Bacterial
• Infection
• Postoperative Wound Infection
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Sweden	University Hospital, Dept of Cardiothoracic Surgery	Linkoeping
Sweden	Dept of Cardiothoracic Surgery, University Hospital	Orebro

Sponsors (2)

Lead Sponsor	Collaborator
Region Örebro County	University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Friberg O, Dahlin LG, Söderquist B, Källman 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. — View Citation

Friberg O, Svedjeholm R, Källman J, Söderquist 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. — View Citation

Friberg O, Svedjeholm R, Söderquist B, Granfeldt H, Vikerfors T, Källman 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidences of methicillin- and gentamicin resistant microbiological agents in sternal wound infections that develop in study patients		Within 2 months postoperatively	No
Secondary	The absolute incidence of all SWI and of superficial SWI within 2 months and the relative (the ratio) incidences of superficial vs deep SW		2 months postoperatively	No
Secondary	The total incidence of SWI that requires surgical revision of the wound		2 months postoperatively	No