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

Information source: University Hospital Orebro
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug Resistance, Bacterial; Postoperative Wound Infection

Intervention: Local application of collagen-gentamicin (Drug); Fixation of the sternotomy with more than six wires (Procedure)

Phase: N/A

Status: Completed

Sponsored by: University Hospital Orebro

Official(s) and/or principal investigator(s):
Örjan Friberg, MD, PhD, Principal Investigator, Affiliation: Dept of Cardiothoracic Surgery and Anestesiology, University Hospital Orebro, Sweden

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.

Clinical Details

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

Primary outcome: The incidences of methicillin- and gentamicin resistant microbiological agents in sternal wound infections that develop in study patients

Secondary outcome:

The absolute incidence of all SWI and of superficial SWI within 2 months and the relative (the ratio) incidences of superficial vs deep SW

The total incidence of SWI that requires surgical revision of the wound

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

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

Additional Information

Related publications:

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.

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.

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.

Starting date: January 2007
Last updated: October 3, 2008

Page last updated: August 23, 2015

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