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Local Gentamicin Application to Reduce Postoperative Infection Rate

Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Surgical Wound Infection

Intervention: Collagen-gentamicin sponge (Device)

Phase: Phase 3

Status: Completed

Sponsored by: Oslo University Hospital

Official(s) and/or principal investigator(s):
Finnur Snorrason, Ph.D, Study Director

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.

Clinical Details

Official title: Local Gentamicin Application to Reduce Postoperative Infection Rate in Hemiarthroplasty After Fracture of the Proximal Femur: a Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Number of patients with postoperatively infection after hemiarthroplasty to evaluate locally administered collagen-gentamicin peroperatively

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Buskerud Hospital, Drammen, Drammen 3004, Norway

Elverum Hospital, Elverum 2408, Norway

Diakonhjemmets Hospital, Oslo 0784, Norway

Oslo University Hospital, Ullevål, Oslo 0407, Norway

Asker and Bærum Hospital, Bærum, Rud 1309, Norway

Additional Information

Starting date: January 2011
Last updated: August 15, 2013

Page last updated: August 23, 2015

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