Local Gentamicin Application to Reduce Postoperative Infection Rate

Surgical Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287780
• Other study ID #: 2010/18054
• Status: Completed
• Phase: Phase 3
• First received: January 25, 2011
• Last updated: August 15, 2013
• Start date: January 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway: Directorate of HealthNorway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Infection
• Surgical Wound Infection
• Wound Infection

Intervention

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.

Locations

Country	Name	City	State
Norway	Asker and Bærum Hospital	Bærum	Rud
Norway	Buskerud Hospital, Drammen	Drammen
Norway	Elverum Hospital	Elverum
Norway	Diakonhjemmets Hospital	Oslo
Norway	Oslo University Hospital, Ullevål	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No