Local Gentamicin Application to Reduce Postoperative Infection Rate

NCT ID: NCT01287780

Last Updated: 2013-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Wound Infection

Keywords

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Humans Prostheses and Implants Gentamicin administration and dosage Surgical sponges Treatment outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Collagen-gentamicin sponges

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.

Group Type ACTIVE_COMPARATOR

Collagen-gentamicin sponge

Intervention Type 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.

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Gentamicin-collagen sponge Infection prophylaxis in orthopaedic surgery

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Finnur Snorrason, Ph.D

Role: STUDY_DIRECTOR

Locations

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Buskerud Hospital, Drammen

Drammen, Drammen, Norway

Site Status

Elverum Hospital

Elverum, Elverum, Norway

Site Status

Oslo University Hospital, Ullevål

Oslo, Oslo County, Norway

Site Status

Asker and Bærum Hospital

Bærum, Rud, Norway

Site Status

Diakonhjemmets Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 25737375 (View on PubMed)

Other Identifiers

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2010/18054

Identifier Type: -

Identifier Source: org_study_id