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
  Purpose

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 Intervention Phase
Surgical Wound Infection
Device: Collagen-gentamicin sponge
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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


Enrollment: 800
Study Start Date: January 2011
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287780

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

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01287780     History of Changes
Other Study ID Numbers: 2010/18054
Study First Received: January 25, 2011
Last Updated: August 15, 2013
Health Authority: Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Regional Ethics Commitee

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

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

ClinicalTrials.gov processed this record on October 23, 2014