Suspended

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

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What is being tested

Collatamp G sponge

Drug
Who is being recruted

Infections

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Last updated: February 15, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Last updated: February 15, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

17 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Infections

Criteria

1 inclusion criteria required to participate
Patients with an acute total joint infection

4 exclusion criteria prevent from participating
Does not speak English

History of alcoholism

Refuses to participate in the study

Unable to return for follow-up

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
Joint infection treated without the use of the Collatamp G sponge.

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

London Health Sciences Centre

London, CanadaOpen London Health Sciences Centre in Google Maps
SuspendedOne Study Center