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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01667874
• Other study ID #: 102635
• Status: Terminated
• Phase: Phase 3
• First received: August 15, 2012
• Last updated: February 14, 2017
• Start date: January 2013
• Est. completion date: September 1, 2016

Study information

• Verified date: February 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: September 1, 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

Drug:
• Collatamp G sponge
Collatamp G is an antibiotic impregnated sponge

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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