InfectionPhase 3NCT01667874
Use of Collatamp G Antibiotic Impregnated Sponges in the Treatment of Peri-prosthetic Total Joint Infections
A Phase 3 study testing Collatamp G sponge in people with Infection, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Collatamp G sponge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to 1 Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an acute total joint infection
Who cannot join
- History of alcoholism
- Unable to return for follow-up
- Refuses to participate in the study
- Does not speak English
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Infection
- Being tested
- Collatamp G sponge
- Keywords
- Randomized controlled trial, early joint infection, gentamicin impregnated sponges
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collatamp G spongeDrug
Also called Gentamicin Sulphate 2.0 mg/cm2
Collatamp G is an antibiotic impregnated sponge
| Study group | Role | What they receive |
|---|---|---|
| No Collatamp sponge | No intervention | Joint infection treated without the use of the Collatamp G sponge. |
| Collatamp G sponge | Experimental | Use of Collatamp G Gentamicin impregnated sponge for the treatment of early total joint infections Receives: Drug: Collatamp G sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startJan 2013
- Primary completionSep 2016
- Study completion1 Sep 2016
Why it stopped: Difficulty in recruiting patients for the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard McCalden, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Richard McCalden, MD, MPhil(Edin), F.R.C.S.(C), Principal investigator, London Health Sciences Centre - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667874
- Sponsor's protocol ID
- 102635
- Status last verified
- Feb 2017
- First submitted
- 15 Aug 2012
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 9167145
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Collatamp G Antibiotic Impregnated Sponges in the Treatment of Peri-prosthetic Total Joint Infections
- ClinicalTrials.gov ID
- NCT01667874
- Acronym / sponsor ID
- 102635
- Conditions
- Infection
- Keywords
- Randomized controlled trial, early joint infection, gentamicin impregnated sponges
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting patients for the study
- Enrolment
- 17 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Collatamp sponge | No intervention | –Joint infection treated without the use of the Collatamp G sponge. |
| Collatamp G sponge | Experimental | Drug: Collatamp G spongeUse of Collatamp G Gentamicin impregnated sponge for the treatment of early total joint infections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with an acute total joint infection
Key exclusion criteria (4 listed)
- History of alcoholism
- Unable to return for follow-up
- Refuses to participate in the study
- Does not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collatamp G spongeAlso: Gentamicin Sulphate 2.0 mg/cm2Collatamp G is an antibiotic impregnated sponge | Drug | Collatamp G sponge |
Primary outcome
Eradication of infection
Time frame: One year
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.
Results and safety
The study was stopped early (reason given: Difficulty in recruiting patients for the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Background: PubMed 9167145Stemberger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard McCalden, MD, MPhil(Edin), F.R.C.S.(C) principal investigator
London Health Sciences Centre - University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Collatamp G sponge in people with Infection, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruiting patients for the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication of infection (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01667874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.