Back to resultsLocal Gentamicin Application to Reduce Postoperative Infection Rate
Primary Purpose
Surgical Wound Infection
Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Collagen-gentamicin sponge
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection focused on measuring Humans, Prostheses and Implants, Gentamicin administration and dosage, Surgical sponges, Treatment outcomes
Eligibility Criteria
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
Sites / Locations
- Asker and Bærum Hospital
- Buskerud Hospital, Drammen
- Elverum Hospital
- Oslo University Hospital, Ullevål
- Diakonhjemmets Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Collagen-gentamicin sponges
No intervention
Arm 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.
Outcomes
Primary Outcome Measures
Number of patients with postoperatively infection after hemiarthroplasty to evaluate locally administered collagen-gentamicin peroperatively
A randomized multicentre trial
Secondary Outcome Measures
Full Information
NCT ID
NCT01287780
First Posted
January 25, 2011
Last Updated
August 15, 2013
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01287780
Brief Title
Local Gentamicin Application to Reduce Postoperative Infection Rate
Official Title
Local Gentamicin Application to Reduce Postoperative Infection Rate in Hemiarthroplasty After Fracture of the Proximal Femur: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Humans, Prostheses and Implants, Gentamicin administration and dosage, Surgical sponges, Treatment outcomes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Collagen-gentamicin sponges
Arm Type
Active Comparator
Arm 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.
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Collagen-gentamicin sponge
Other Intervention Name(s)
Gentamicin-collagen sponge, Infection prophylaxis in orthopaedic surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with postoperatively infection after hemiarthroplasty to evaluate locally administered collagen-gentamicin peroperatively
Description
A randomized multicentre trial
Time Frame
Within 4 weeks after prosthetic surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finnur Snorrason, Ph.D
Official's Role
Study Director
Facility Information:
Facility Name
Asker and Bærum Hospital
City
Bærum
State/Province
Rud
ZIP/Postal Code
1309
Country
Norway
Facility Name
Buskerud Hospital, Drammen
City
Drammen
ZIP/Postal Code
3004
Country
Norway
Facility Name
Elverum Hospital
City
Elverum
ZIP/Postal Code
2408
Country
Norway
Facility Name
Oslo University Hospital, Ullevål
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Diakonhjemmets Hospital
City
Oslo
ZIP/Postal Code
0784
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
25737375
Citation
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.
Results Reference
derived
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Local Gentamicin Application to Reduce Postoperative Infection Rate
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