Drug Resistance, BacterialLOGIXNCT00484055
Local Collagen-Gentamicin and Extra Fixation of the Sternum for Prevention of Sternal Wound Infection in Cardiac Surgery
A study testing Local application of collagen-gentamicin and Fixation of the sternotomy with more than six wires in people with Drug Resistance, Bacterial and Postoperative Wound Infection, run by Region Örebro County at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Resistance, Bacterial, Postoperative Wound Infection
- What is being tested?
- Local application of collagen-gentamicin and Fixation of the sternotomy with more than six wires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,358 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive cardiac surgery patients operated via median sternotomy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
University Hospital, Dept of Cardiothoracic Surgery
Linköping, 58185
Dept of Cardiothoracic Surgery, University Hospital
Örebro, 70185
About this 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
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.
Read the 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.
- Being tested
- Local application of collagen-gentamicin, Fixation of the sternotomy with more than six wires
- Keywords
- Antibiotic Prophylaxis
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local application of collagen-gentamicinDrug
Also called Collatamp-G
Application of 2 sponges (5 x 20 cm) of collagen-gentamicin between the sternal halves immediately before sternal closure
Fixation of the sternotomy with more than six wiresProcedure or surgery
At least 7 (or more) sternal fixation wires (preferaby put as separate single wires) used for fixation of the sternum at wound closure
| Study group | Role | What they receive |
|---|---|---|
| treatment | Active comparator | 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. Receives: Drug: Local application of collagen-gentamicin; Procedure: Fixation of the sternotomy with more than six wires |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidences of methicillin- and gentamicin resistant microbiological agents in sternal wound infections that develop in study patients
Measured: Within 2 months postoperatively
Secondary outcomes (2)
The absolute incidence of all SWI and of superficial SWI within 2 months and the relative (the ratio) incidences of superficial vs deep SW
Measured: 2 months postoperatively
The total incidence of SWI that requires surgical revision of the wound
Measured: 2 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Drug Resistance, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping
- Responsible party
- Principal investigator, Orjan Friberg, Region Örebro County
- Investigators
- Örjan Friberg, MD, PhD, Principal investigator, Dept of Cardiothoracic Surgery and Anestesiology, University Hospital Orebro, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484055
- Sponsor's protocol ID
- OFR02
- Acronym
- LOGIX
- Status last verified
- Oct 2016
- First submitted
- 6 Jun 2007
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17211605Friberg 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.
PubMed 17089314Friberg 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.
PubMed 15620935Friberg 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.
PubMed 19541691
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00484055
- Acronym / sponsor ID
- LOGIX / OFR02
- Keywords
- Antibiotic Prophylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,358 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping
- Study start
- Jan 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 8 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Active comparator | Drug: Local application of collagen-gentamicin, Procedure: Fixation of the sternotomy with more than six wiresUse 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive cardiac surgery patients operated via median sternotomy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local application of collagen-gentamicinAlso: Collatamp-GApplication of 2 sponges (5 x 20 cm) of collagen-gentamicin between the sternal halves immediately before sternal closure | Drug | treatment |
| Fixation of the sternotomy with more than six wiresAt least 7 (or more) sternal fixation wires (preferaby put as separate single wires) used for fixation of the sternum at wound closure | Procedure or surgery | treatment |
Primary outcome
The incidences of methicillin- and gentamicin resistant microbiological agents in sternal wound infections that develop in study patients
Time frame: Within 2 months postoperatively
2 secondary outcomes
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
The total incidence of SWI that requires surgical revision of the wound
Time frame: 2 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Background: PubMed 17211605Friberg 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.
- Background: PubMed 17089314Friberg 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.
- Background: PubMed 15620935Friberg 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.
- Derived from this study: PubMed 19541691Friberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Örjan Friberg, MD, PhD principal investigator
Dept of Cardiothoracic Surgery and Anestesiology, University Hospital Orebro, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local application of collagen-gentamicin and Fixation of the sternotomy with more than six wires in people with Drug Resistance, Bacterial and Postoperative Wound Infection, run by Region Örebro County at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidences of methicillin- and gentamicin resistant microbiological agents in sternal wound infections that develop in study patients (time frame: Within 2 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00484055, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.