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Use of Collatamp G Antibiotic Impregnated Sponges in the Treatment of Peri-prosthetic Total Joint Infections

Primary Purpose

Infection

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Collatamp G sponge
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection focused on measuring Randomized controlled trial, early joint infection, gentamicin impregnated sponges

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with an acute total joint infection

Exclusion Criteria:

  • History of alcoholism
  • Unable to return for follow-up
  • Refuses to participate in the study
  • Does not speak English

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Collatamp sponge

Collatamp G sponge

Arm Description

Joint infection treated without the use of the Collatamp G sponge.

Use of Collatamp G Gentamicin impregnated sponge for the treatment of early total joint infections

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 15, 2012
Last Updated
February 14, 2017
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01667874
Brief Title
Use of Collatamp G Antibiotic Impregnated Sponges in the Treatment of Peri-prosthetic Total Joint Infections
Official Title
Use of Collatamp G Antibiotic Impregnated Sponges in the Treatment of Peri-prosthetic Total Joint Infections
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting patients for the study
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
While total hip and knee replacement surgery remains a highly successful treatment for arthritis of the hip and knee, infection following a joint replacement still remains an issue, occurring in approximately 1-2% of joint replacement patients. Treatment of infection remains very difficult with the successful elimination of the infection being quite variable, ranging from as low as 10% to approximately 85-90%, following a two stage revision. A two stage revision involves removing the joint replacement implant and replacing it with a cement spacer until the surgeon is comfortable that the infection has been eliminated. In the second part of a two stage revision the cement spacer is removed and a new joint replacement implant is inserted in the joint space. In particular, the treatment of an acute infection, that is, infection occurring in the early postoperative period or in a patient with less than two weeks duration of symptoms, is particularly problematic. As a first line of treatment, surgeons often perform an irrigation (washing out a wound with a stream of water) and debridement (the surgical removal of contaminated tissue) surrounding the joint in the hopes of preserving the joint replacement, although the success rate is highly variable. Most treatment routines involve irrigation of the joint with copious (large) amounts of fluid, removal of infected soft tissue, replacement of any removable parts (example plastic liners or femoral heads) and then intravenous antibiotics for a prolonged period of time (6-8 weeks). It is thought that part of the reason for failure with this form of treatment is the inability to adequately provide local antibiotics to the joint environment while the joint replacement components are in place. In particular, the formation of a bacterial slime by the infecting organism, which can attach itself to the metallic components, is thought to be a major hindrance to removing infection. In theory, the ability to infuse local antibiotics to the joint could prove advantageous to the treatment of joint replacement infections. Collatamp® is a like a small flat sponge soaked with antibiotics that delivers a consistent dose of fast-release antibiotics called Gentamicin Sulphate (2.0 mg/cm2). The antibiotic is concentrated locally in the tissue around the joint replacement. The sponge is reabsorbed by the body and therefore does not need to be surgically removed. Collatamp® sponges have been utilized in the clinical setting for over 20 yrs. This material has been used in treatment of other orthopaedic, general surgery, and cardiac infections, but has not been studied in the setting of infected total joint replacements. The purpose of this study is to examine the use of CollatampTM sponges as an addition to the treatment of acute joint infections after a total joint replacement surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Randomized controlled trial, early joint infection, gentamicin impregnated sponges

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Collatamp sponge
Arm Type
No Intervention
Arm Description
Joint infection treated without the use of the Collatamp G sponge.
Arm Title
Collatamp G sponge
Arm Type
Experimental
Arm Description
Use of Collatamp G Gentamicin impregnated sponge for the treatment of early total joint infections
Intervention Type
Drug
Intervention Name(s)
Collatamp G sponge
Other Intervention Name(s)
Gentamicin Sulphate 2.0 mg/cm2
Intervention Description
Collatamp G is an antibiotic impregnated sponge
Primary Outcome Measure Information:
Title
Eradication of infection
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with an acute total joint infection Exclusion Criteria: History of alcoholism Unable to return for follow-up Refuses to participate in the study Does not speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard McCalden, MD, MPhil(Edin), F.R.C.S.(C)
Organizational Affiliation
London Health Sciences Centre - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9167145
Citation
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.
Results Reference
background

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Use of Collatamp G Antibiotic Impregnated Sponges in the Treatment of Peri-prosthetic Total Joint Infections

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