Local Gentamicin Application to Reduce Postoperative Infection Rate

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT01287780

First received: January 25, 2011

Last updated: August 15, 2013

Last verified: August 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 25, 2011

Last Updated Date

August 15, 2013

Start Date ^ICMJE

January 2011

Primary Completion Date

July 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01287780 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Local Gentamicin Application to Reduce Postoperative Infection Rate

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Surgical Wound Infection

Intervention ^ICMJE

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.

Other Names:

Gentamicin-collagen sponge
Infection prophylaxis in orthopaedic surgery

Study Arms

Active Comparator: 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.

Intervention: Device: Collagen-gentamicin sponge
No Intervention: No intervention

Publications *

Westberg M, Frihagen F, Brun OC, Figved W, Grøgaard 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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

800

Completion Date

August 2013

Primary Completion Date

July 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Norway

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01287780

Other Study ID Numbers ^ICMJE

2010/18054

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Oslo University Hospital

Study Sponsor ^ICMJE

Oslo University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Finnur Snorrason, Ph.D

PRS Account

Oslo University Hospital

Verification Date

August 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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