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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Richard McCalden, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01667874
First received: August 15, 2012
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Infection
Drug: Collatamp G sponge
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Use of Collatamp G Antibiotic Impregnated Sponges in the Treatment of Peri-prosthetic Total Joint Infections

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Eradication of infection [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Collatamp sponge
Joint infection treated without the use of the Collatamp G sponge.
Experimental: Collatamp G sponge
Use of Collatamp G Gentamicin impregnated sponge for the treatment of early total joint infections
Drug: Collatamp G sponge
Collatamp G is an antibiotic impregnated sponge
Other Name: Gentamicin Sulphate 2.0 mg/cm2

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667874

Contacts
Contact: Abigail E Korczak, BScN (519) 685-8300 ext 32789 Abigail.Korczak@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Abigail Korczak, BScN    5196858300 ext 32789    abigail.korczak@lhsc.on.ca   
Sub-Investigator: Steven J MacDonald, MD, FRCSC         
Sub-Investigator: James Howard, MD, FRCSC         
Sub-Investigator: Douglas Naudie, MD, FRCSC         
Sub-Investigator: James McAuley, MD, FRCSC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Richard McCalden, MD, MPhil(Edin), F.R.C.S.(C) London Health Sciences Centre - University Hospital
  More Information

Publications:
Responsible Party: Richard McCalden, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01667874     History of Changes
Other Study ID Numbers: 102635
Study First Received: August 15, 2012
Last Updated: April 30, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Randomized controlled trial
early joint infection
gentamicin impregnated sponges

Additional relevant MeSH terms:
Arthritis, Infectious
Infection
Arthritis
Joint Diseases
Musculoskeletal Diseases
Anti-Bacterial Agents
Gentamicins
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014