Study Stopped
Difficulty in recruiting patients for the study
Use of Collatamp G Antibiotic Impregnated Sponges in the Treatment of Peri-prosthetic Total Joint Infections
1 other identifier
interventional
17
1 country
1
Brief Summary
The purpose of this study is to determine if Collatamp, a small flat sponge soaked with antibiotics will help to improve the success rate of the treatment of acute joint infections after a joint replacement surgery. Our hypothesis is that those patients receiving the Collatamp sponges will have an improved success with respect to the eradication of infection at one year following treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2013
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedFebruary 15, 2017
February 1, 2017
3.7 years
August 15, 2012
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Eradication of infection
Success will be defined as those patients whose implant is still in place at one year and demonstrate no clinical signs or symptoms of infection. Eradication of infection will be defined as those patients whose inflammatory markers (ESR and CRP)have returned to normal values following one year treatment.
One year
Study Arms (2)
No Collatamp sponge
NO INTERVENTIONJoint infection treated without the use of the Collatamp G sponge.
Collatamp G sponge
EXPERIMENTALUse of Collatamp G Gentamicin impregnated sponge for the treatment of early total joint infections
Interventions
Collatamp G is an antibiotic impregnated sponge
Eligibility Criteria
You may qualify if:
- Patients with an acute total joint infection
You may not qualify if:
- History of alcoholism
- Unable to return for follow-up
- Refuses to participate in the study
- Does not speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Related Publications (1)
Stemberger A, Grimm H, Bader F, Rahn HD, Ascherl R. Local treatment of bone and soft tissue infections with the collagen-gentamicin sponge. Eur J Surg Suppl. 1997;(578):17-26. No abstract available.
PMID: 9167145BACKGROUND
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard McCalden, MD, MPhil(Edin), F.R.C.S.(C)
London Health Sciences Centre - University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 15, 2012
First Posted
August 17, 2012
Study Start
January 1, 2013
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
February 15, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share