OsteoarthritisPhase 2SAGENCT02469311
Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths.
A Phase 2 study testing chlorhexidine impregnated cloths in people with Osteoarthritis and Infection, run by LifeBridge Health.
Trial summary
Subjects in the study were randomized to a treatment group using Chlorhexidine cloths or a standard-of-care group who only had a bath with antibacterial soap and water. Both groups received standard infection control practices during admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Infection
- What is being tested?
- chlorhexidine impregnated cloths
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 539 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Apr 2014
- Phase
- Phase 2
- 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
- Joint replacement surgery for any reason
- 18 years or older
Who cannot join
- unable to comply with study requirements
- were pregnant
- were under the age of 18 years
- medical history of immunosuppression or systemic disease e.g. human immunodeficiency virus, status-post organ transplantation
- received greater than 10 milligrams of prednisone equivalent for more than 10 days within 90 days prior to enrollment;
- chronic hepatitis B or C infection
- had an infection in or around the joint requiring surgery.
About this study
Official title: Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths in Reducing Surgical Site Infections for Total Hip and Knee Arthroplasty.
Subjects in the study were randomized to a treatment group using Chlorhexidine cloths or a standard-of-care group who only had a bath with antibacterial soap and water. Both groups received standard infection control practices during admission.
Read the detailed description
Between March 2012 and November 2012, patients scheduled for total hip arthroplasty (THA) or total knee arthroplasty (TKA) were randomized (539 patients; 554 arthroplasties) at the time of their preoperative clinic visit. Patients in the chlorhexidine protocol group (275 arthroplasties) applied 2% chlorhexidine gluconate-impregnated cloths to their skin the night before and the morning of surgical admission. Patients in the standard of care group (279 arthroplasties) took a bath with soap and water the night before surgical admission. Both groups were subject to standard infection control practices during admission. The primary outcome was periprosthetic infection incidence within one year of surgery, and secondary outcomes included the potential influence of risk factors for periprosthetic infection and incidence of adverse events.
- Conditions
- Osteoarthritis, Infection
- Being tested
- chlorhexidine impregnated cloths, Standard of care bathing with antibacterial soap and water
- Keywords
- infection; arthroplasty; chlorhexidine; hip; knee
- Medical subject headings
- Osteoarthritis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidine impregnated clothsOther
Pre-operative use of Chlorhexidine cloths night before and morning of surgery
Standard of care bathing with antibacterial soap and waterOther
Patients had standard pre-operative bathing with antibacterial soap and water the night before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Primary Control TKA | Sham comparator | Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water. Receives: Other: Standard of care bathing with antibacterial soap and water |
| Primary Treatment TKA | Active comparator | Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths. Receives: Other: chlorhexidine impregnated cloths |
| Revision Treatment TKA | Active comparator | Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of a chlorhexidine impregnated cloths. Receives: Other: chlorhexidine impregnated cloths |
| Revision Control TKA | Sham comparator | Patients undergoing a second or revision total knee arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water. Receives: Other: Standard of care bathing with antibacterial soap and water |
| Primary Control THA | Sham comparator | Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water. Receives: Other: Standard of care bathing with antibacterial soap and water |
| Primary Treatment THA | Active comparator | Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths. Receives: Other: chlorhexidine impregnated cloths |
| Revision Control THA | Sham comparator | Patients undergoing a second or revision total hip arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water. Receives: Other: Standard of care bathing with antibacterial soap and water |
| Revision Treatment THA | Active comparator | Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths. Receives: Other: chlorhexidine impregnated cloths |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of periprosthetic infection.
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 posted11 Jun 2015 (estimated)
- Study startMar 2012
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Preliminary results showed that the use of the cloths helped prevent infections.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A Mont, MD, Principal investigator, Director, Rubin Instituted for Advanced Orthopedics and Joint Preservation and Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469311
- Sponsor's protocol ID
- LifeBridgeH
- Acronym
- SAGE
- Status last verified
- Mar 2018
- First submitted
- 9 Jun 2015
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths in Reducing Surgical Site Infections for Total Hip and Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT02469311
- Acronym / sponsor ID
- SAGE / LifeBridgeH
- Conditions
- Osteoarthritis, Infection
- Keywords
- infection; arthroplasty; chlorhexidine; hip; knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary results showed that the use of the cloths helped prevent infections.
- Enrolment
- 539 participants (actual)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Jun 2015 (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.
Subjects in the study were randomized to a treatment group using Chlorhexidine cloths or a standard-of-care group who only had a bath with antibacterial soap and water. Both groups received standard infection control practices during admission.
Detailed description
Between March 2012 and November 2012, patients scheduled for total hip arthroplasty (THA) or total knee arthroplasty (TKA) were randomized (539 patients; 554 arthroplasties) at the time of their preoperative clinic visit. Patients in the chlorhexidine protocol group (275 arthroplasties) applied 2% chlorhexidine gluconate-impregnated cloths to their skin the night before and the morning of surgical admission. Patients in the standard of care group (279 arthroplasties) took a bath with soap and water the night before surgical admission. Both groups were subject to standard infection control practices during admission. The primary outcome was periprosthetic infection incidence within one year of surgery, and secondary outcomes included the potential influence of risk factors for periprosthetic infection and incidence of adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Primary Control TKA | Sham comparator | Other: Standard of care bathing with antibacterial soap and waterPatients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water. |
| Primary Treatment TKA | Active comparator | Other: chlorhexidine impregnated clothsPatients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths. |
| Revision Treatment TKA | Active comparator | Other: chlorhexidine impregnated clothsPatients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of a chlorhexidine impregnated cloths. |
| Revision Control TKA | Sham comparator | Other: Standard of care bathing with antibacterial soap and waterPatients undergoing a second or revision total knee arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water. |
| Primary Control THA | Sham comparator | Other: Standard of care bathing with antibacterial soap and waterPatients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water. |
| Primary Treatment THA | Active comparator | Other: chlorhexidine impregnated clothsPatients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths. |
| Revision Control THA | Sham comparator | Other: Standard of care bathing with antibacterial soap and waterPatients undergoing a second or revision total hip arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water. |
| Revision Treatment THA | Active comparator | Other: chlorhexidine impregnated clothsPatients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Joint replacement surgery for any reason
- 18 years or older
Key exclusion criteria (7 listed)
- unable to comply with study requirements
- were pregnant
- were under the age of 18 years
- medical history of immunosuppression or systemic disease e.g. human immunodeficiency virus, status-post organ transplantation
- received greater than 10 milligrams of prednisone equivalent for more than 10 days within 90 days prior to enrollment;
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 |
|---|---|---|
| chlorhexidine impregnated clothsPre-operative use of Chlorhexidine cloths night before and morning of surgery | Other | Primary Treatment THA, Primary Treatment TKA, Revision Treatment THA, Revision Treatment TKA |
| Standard of care bathing with antibacterial soap and waterPatients had standard pre-operative bathing with antibacterial soap and water the night before surgery. | Other | Primary Control THA, Primary Control TKA, Revision Control THA, Revision Control TKA |
Primary outcome
The incidence of periprosthetic infection.
Time frame: One year
Results and safety
The study was stopped early (reason given: Preliminary results showed that the use of the cloths helped prevent infections.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
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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.
Michael A Mont, MD principal investigator
Director, Rubin Instituted for Advanced Orthopedics and Joint Preservation and Replacement
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chlorhexidine impregnated cloths in people with Osteoarthritis and Infection, run by LifeBridge Health.
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 2 inclusion and 7 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Preliminary results showed that the use of the cloths helped prevent infections.). 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?
The incidence of periprosthetic 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?
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 14 Mar 2018.