Local Gentamicin Application to Reduce Postoperative Infection Rate

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.

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Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buskerud Hospital, Drammen, Drammen, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collagen-gentamicin sponge

Device

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: Gentamicin-collagen sponge, Infection prophylaxis in orthopaedic surgery

Primary outcomes

Number of patients with postoperatively infection after hemiarthroplasty to evaluate locally administered collagen-gentamicin peroperatively

Time frame: Within 4 weeks after prosthetic surgery

A randomized multicentre trial

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Feb 1, 2011
Registry last updated: Aug 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed