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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Wound Infection; Drug Resistance, Bacterial
• Intervention / Treatment: Drug: Local application of collagen-gentamicin; Procedure: Fixation of the sternotomy with more than six wires

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
• Enrollment (Actual): 1358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linkoeping, Sweden, 58185
    • University Hospital, Dept of Cardiothoracic Surgery
  • Orebro, Sweden, 70185
    • Dept of Cardiothoracic Surgery, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidences of methicillin- and gentamicin resistant microbiological agents in sternal wound infections that develop in study patients	Within 2 months postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
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
The total incidence of SWI that requires surgical revision of the wound	2 months postoperatively

Collaborators and Investigators

• Sponsor: Region Örebro County
• Collaborators: University Hospital, Linkoeping
• Investigators: Principal Investigator: Örjan Friberg, MD, PhD, Dept of Cardiothoracic Surgery and Anestesiology, University Hospital Orebro, Sweden

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): August 1, 2008
• Study Completion (ACTUAL): August 1, 2008

Study Registration Dates

• First Submitted: June 6, 2007
• First Submitted That Met QC Criteria: June 6, 2007
• First Posted (ESTIMATE): June 8, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Antibiotic Prophylaxis
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound Infection; Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: OFR02