Local Gentamicin Application to Reduce Postoperative Infection Rate

University of Oslo (UIO)

Status and phase: Completed; Phase 3

Conditions: Surgical Wound Infection

Treatments: Device: Collagen-gentamicin sponge

Study type: Interventional

Funder types: Other

Identifiers

NCT01287780

2010/18054

Details and patient eligibility

About

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.

Enrollment: 800 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 2 patient groups

Collagen-gentamicin sponges

Active Comparator group

Description:

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.

Treatment:

Device: Collagen-gentamicin sponge

No intervention

No Intervention group