Local Gentamicin Application to Reduce Postoperative Infection Rate
NCT ID: NCT01287780
Last Updated: 2013-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
800 participants
INTERVENTIONAL
2011-01-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Collagen-gentamicin sponges
Two sponges of collagen-gentamicin will be inserted into the hip immediately before closure of the wound. Each sponge (10 by 10 cm) contains 280 mg of collagen and 130 mg of gentamicin.
Collagen-gentamicin sponge
A 10 by 10 cm sponge consisting of 280 mg collagen and 130 mg gentamicin.Two sponges are inserted during hemiarthroplasty surgery, one in the joint and one underneath the fascia at the time of surgical closure.
No intervention
No interventions assigned to this group
Interventions
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Collagen-gentamicin sponge
A 10 by 10 cm sponge consisting of 280 mg collagen and 130 mg gentamicin.Two sponges are inserted during hemiarthroplasty surgery, one in the joint and one underneath the fascia at the time of surgical closure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be planned operated with a prosthesis of the hip
Exclusion Criteria
* Ongoing treatment with aminoglycosides
* Reduced renal function
* Pregnancy
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Principal Investigators
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Finnur Snorrason, Ph.D
Role: STUDY_DIRECTOR
Locations
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Buskerud Hospital, Drammen
Drammen, Drammen, Norway
Elverum Hospital
Elverum, Elverum, Norway
Oslo University Hospital, Ullevål
Oslo, Oslo County, Norway
Asker and Bærum Hospital
Bærum, Rud, Norway
Diakonhjemmets Hospital
Oslo, , Norway
Countries
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References
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Westberg M, Frihagen F, Brun OC, Figved W, Grogaard B, Valland H, Wangen H, Snorrason F. Effectiveness of gentamicin-containing collagen sponges for prevention of surgical site infection after hip arthroplasty: a multicenter randomized trial. Clin Infect Dis. 2015 Jun 15;60(12):1752-9. doi: 10.1093/cid/civ162. Epub 2015 Mar 3.
Other Identifiers
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2010/18054
Identifier Type: -
Identifier Source: org_study_id