Local Gentamicin Application to Reduce Postoperative Infection Rate
Information source: Oslo University Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Surgical Wound Infection
Intervention: Collagen-gentamicin sponge (Device)
Phase: Phase 3
Status: Recruiting
Sponsored by: Oslo University Hospital Official(s) and/or principal investigator(s):
Finnur Snorrason, Ph.D, Study Director
Overall contact:
Marianne Westberg, M.D, Phone: +47 23070000, Email: marianne.westberg2@oslouniversitetssykehus.no
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
Marianne Westberg, M.D, Phone: +47 23070000, Email: marianne.westberg2@oslouniversitetssykehus.no
Buskerud Hospital, Drammen, Drammen 3004, Norway; Recruiting
Finnur Snorrason, Ph.D, Phone: +47 32803000, Email: finnur.snorrason@lifi.no
Elverum Hospital, Elverum 2408, Norway; Recruiting
Helge Wangen, M.D, Phone: +47 06200, Email: helge.wangen@sykehuset-innlandet.no
Diakonhjemmets Hospital, Oslo 0784, Norway; Recruiting
Tore Heier, M.D, Phone: +4722451500, Email: tore.heier@diakonsyk.no
Oslo University Hospital, Ullevål, Oslo 0407, Norway; Recruiting
Bjarne Grøgaard, Ph.D, Phone: +47 22118080, Email: bjarne.grogaard@oslouniversitetssykehus.no
Asker and Bærum Hospital, Bærum, Rud 1309, Norway; Recruiting
Wender Figved, Ph.D, Phone: +47 900 888 30, Email: wender@me.com
Additional Information
Starting date: January 2011
Last updated: January 7, 2013
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