Local Collagen-Gentamicin and Extra Fixation of the Sternum for Prevention of Sternal Wound Infection in Cardiac Surgery (LOGIX)
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
- 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 ]
- 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) |
-
Drug: Local application of collagen-gentamicin
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 |
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| Sweden | |
| University Hospital, Dept of Cardiothoracic Surgery | |
| Linkoeping, Sweden, 58185 | |
| Dept of Cardiothoracic Surgery, University Hospital | |
| Orebro, Sweden, 70185 | |
| Principal Investigator: | Örjan Friberg, MD, PhD | Dept of Cardiothoracic Surgery and Anestesiology, University Hospital Orebro, Sweden |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Örjan Friberg, Örebro University Hospital, Örebro, Sweden |
| ClinicalTrials.gov Identifier: | NCT00484055 History of Changes |
| Other Study ID Numbers: | OFR02 |
| Study First Received: | June 6, 2007 |
| Last Updated: | October 3, 2008 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by University Hospital Orebro:
|
Antibiotic Prophylaxis |
Additional relevant MeSH terms:
|
Surgical Wound Infection Wound Infection Infection Postoperative Complications Pathologic Processes Wounds and Injuries Gentamicins |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013