Local Gentamicin Application to Reduce Postoperative Infection Rate
This study is currently recruiting participants.
Verified January 2013 by Oslo University Hospital
Sponsor:
Oslo University Hospital
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01287780
First received: January 25, 2011
Last updated: January 7, 2013
Last verified: January 2013
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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
| Estimated Enrollment: | 800 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 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:
|
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287780
Contacts
| Contact: Marianne Westberg, M.D | +47 23070000 | marianne.westberg2@oslouniversitetssykehus.no |
| Contact: Finnur Snorrason, Ph.D | finnur.snorrason@lifi.no |
Locations
| Norway | |
| Asker and Bærum Hospital | Recruiting |
| Bærum, Rud, Norway, 1309 | |
| Contact: Wender Figved, Ph.D +47 900 888 30 wender@me.com | |
| Buskerud Hospital, Drammen | Recruiting |
| Drammen, Norway, 3004 | |
| Contact: Finnur Snorrason, Ph.D +47 32803000 finnur.snorrason@lifi.no | |
| Elverum Hospital | Recruiting |
| Elverum, Norway, 2408 | |
| Contact: Helge Wangen, M.D +47 06200 helge.wangen@sykehuset-innlandet.no | |
| Diakonhjemmets Hospital | Recruiting |
| Oslo, Norway, 0784 | |
| Contact: Tore Heier, M.D +4722451500 tore.heier@diakonsyk.no | |
| Oslo University Hospital, Ullevål | Recruiting |
| Oslo, Norway, 0407 | |
| Contact: Bjarne Grøgaard, Ph.D +47 22118080 bjarne.grogaard@oslouniversitetssykehus.no | |
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: | January 7, 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:
|
Surgical Wound Infection Wound Infection Infection Postoperative Complications Pathologic Processes Wounds and Injuries Gentamicins |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013