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

Sponsors and Collaborators:	University Hospital Orebro University Hospital, Linkoeping
Information provided by:	University Hospital Orebro
ClinicalTrials.gov Identifier:	NCT00484055

Purpose

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	Intervention
Drug Resistance, Bacterial Postoperative Wound Infection	Drug: Local application of collagen-gentamicin Procedure: Fixation of the sternotomy with more than six wires

MedlinePlus related topics: Antibiotics Heart Surgery Surgery

Drug Information available for: Gentamicins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
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

Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:

The incidences of methicillin- and gentamicin resistant microbiological agents in sternal wound infections that develop in study patients [ Time Frame: Within 2 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
The total incidence of SWI that requires surgical revision of the wound [ Time Frame: 2 months postoperatively ] [ Designated as safety issue: No ]

Enrollment:	1358
Study Start Date:	January 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484055

Locations

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

Sponsors and Collaborators

University Hospital Orebro

University Hospital, Linkoeping

Investigators

Principal Investigator:

Örjan Friberg, MD, PhD

Dept of Cardiothoracic Surgery and Anestesiology, University Hospital Orebro, Sweden

More Information

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.

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.

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.

Responsible Party:	Örebro University Hospital, Örebro, Sweden ( Dr Örjan Friberg )
Study ID Numbers:	OFR02
Study First Received:	June 6, 2007
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00484055 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by University Hospital Orebro:

Antibiotic Prophylaxis

Study placed in the following topic categories:

Anti-Bacterial Agents
Postoperative Complications
Gentamicins
Wounds and Injuries

Disorders of Environmental Origin
Surgical Wound Infection
Wound Infection

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Wounds and Injuries
Disorders of Environmental Origin
Enzyme Inhibitors
Surgical Wound Infection
Infection

Pharmacologic Actions
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Pathologic Processes
Postoperative Complications
Therapeutic Uses
Gentamicins
Wound Infection

ClinicalTrials.gov processed this record on May 07, 2009