Local Gentamicin Application to Reduce Postoperative Infection Rate
1 other identifier
interventional
800
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2011
Typical duration for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 25, 2011
CompletedFirst Posted
Study publicly available on registry
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedAugust 16, 2013
August 1, 2013
2.5 years
January 25, 2011
August 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with postoperatively infection after hemiarthroplasty to evaluate locally administered collagen-gentamicin peroperatively
A randomized multicentre trial
Within 4 weeks after prosthetic surgery
Study Arms (2)
Collagen-gentamicin sponges
ACTIVE COMPARATORTwo 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.
No intervention
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of proximal femoral fracture
- Must be planned operated with a prosthesis of the hip
You may not qualify if:
- Known allergy to gentamicin
- Ongoing treatment with aminoglycosides
- Reduced renal function
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Buskerud Hospital, Drammen
Drammen, Drammen, 3004, Norway
Elverum Hospital
Elverum, Elverum, 2408, Norway
Oslo University Hospital, Ullevål
Oslo, Oslo County, 0407, Norway
Asker and Bærum Hospital
Bærum, Rud, 1309, Norway
Diakonhjemmets Hospital
Oslo, 0784, Norway
Related Publications (1)
Westberg M, Frihagen F, Brun OC, Figved W, Grogaard B, Valland H, Wangen H, Snorrason F. Effectiveness of gentamicin-containing collagen sponges for prevention of surgical site infection after hip arthroplasty: a multicenter randomized trial. Clin Infect Dis. 2015 Jun 15;60(12):1752-9. doi: 10.1093/cid/civ162. Epub 2015 Mar 3.
PMID: 25737375DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Finnur Snorrason, Ph.D
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2011
First Posted
February 1, 2011
Study Start
January 1, 2011
Primary Completion
July 1, 2013
Study Completion
August 1, 2013
Last Updated
August 16, 2013
Record last verified: 2013-08