Local Gentamicin Application to Reduce Postoperative Infection Rate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01287780
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : August 16, 2013
Information provided by (Responsible Party):
Oslo University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Device: Collagen-gentamicin sponge Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Local Gentamicin Application to Reduce Postoperative Infection Rate in Hemiarthroplasty After Fracture of the Proximal Femur: a Randomized Controlled Trial
Study Start Date : January 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
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
No Intervention: No intervention

Primary Outcome Measures :
  1. Number of patients with postoperatively infection after hemiarthroplasty to evaluate locally administered collagen-gentamicin peroperatively [ Time Frame: Within 4 weeks after prosthetic surgery ]
    A randomized multicentre trial

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01287780

Asker and Bærum Hospital
Bærum, Rud, Norway, 1309
Buskerud Hospital, Drammen
Drammen, Norway, 3004
Elverum Hospital
Elverum, Norway, 2408
Oslo University Hospital, Ullevål
Oslo, Norway, 0407
Diakonhjemmets Hospital
Oslo, Norway, 0784
Sponsors and Collaborators
Oslo University Hospital
Study Director: Finnur Snorrason, Ph.D

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Oslo University Hospital Identifier: NCT01287780     History of Changes
Other Study ID Numbers: 2010/18054
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: August 16, 2013
Last Verified: August 2013

Keywords provided by Oslo University Hospital:
Prostheses and Implants
Gentamicin administration and dosage
Surgical sponges
Treatment outcomes

Additional relevant MeSH terms:
Communicable Diseases
Wound Infection
Surgical Wound
Surgical Wound Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action