Surgical Wound Infection
Conditions
Keywords
Humans, Prostheses and Implants, Gentamicin administration and dosage, Surgical sponges, Treatment outcomes
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.
Interventions
DEVICECollagen-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.
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with postoperatively infection after hemiarthroplasty to evaluate locally administered collagen-gentamicin peroperatively | Within 4 weeks after prosthetic surgery | A randomized multicentre trial |
Countries
Norway
Outcome results
None listed