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Local Gentamicin Application to Reduce Postoperative Infection Rate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01287780
First received: January 25, 2011
Last updated: August 15, 2013
Last verified: August 2013
History of Changes

January 25, 2011
August 15, 2013
January 2011
July 2013   (final data collection date for primary outcome measure)
Number of patients with postoperatively infection after hemiarthroplasty to evaluate locally administered collagen-gentamicin peroperatively [ Time Frame: Within 4 weeks after prosthetic surgery ] [ Designated as safety issue: No ]
A randomized multicentre trial
Same as current
Complete list of historical versions of study NCT01287780 on ClinicalTrials.gov Archive Site
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Local Gentamicin Application to Reduce Postoperative Infection Rate
Local Gentamicin Application to Reduce Postoperative Infection Rate in Hemiarthroplasty After Fracture of the Proximal Femur: a Randomized Controlled Trial

The majority of elderly patients with a displaced fracture of the proximal femur are now treated with a hemiarthroplasty. Prosthetic joint infection is a devastating complication, and the infection rate is high in this group of elderly patients. Local application of gentamicin produces high antibiotic concentrations in the wound. The aim of this study is to determine whether locally administered collagen-gentamicin in the joint perioperatively in addition to routine IV prophylaxis with beta-lactam antibiotics can reduce the early postoperative infection rate (< 4 weeks postoperative)after hemiarthroplasty in proximal femoral fractures.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Surgical Wound Infection
Device: 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 Names:
  • Gentamicin-collagen sponge
  • Infection prophylaxis in orthopaedic surgery
  • Active Comparator: 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.
    Intervention: Device: Collagen-gentamicin sponge
  • No Intervention: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
August 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of proximal femoral fracture
  • Must be planned operated with a prosthesis of the hip

Exclusion Criteria:

  • Known allergy to gentamicin
  • Ongoing treatment with aminoglycosides
  • Reduced renal function
  • Pregnancy
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01287780
2010/18054
Yes
Oslo University Hospital
Oslo University Hospital
Not Provided
Study Director: Finnur Snorrason, Ph.D
Oslo University Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP