InfectionNCT00896402
Chlorhexidine Versus Betadine in Preventing Colonization of Femoral Nerve Catheters After Total Joint Arthroplasty (TJA)
A study testing Skin antisepsis with chlorhexidine and povidone-iodine in people with Infection, run by Northwell Health at 2 sites in United States.
Trial summary
Continuous femoral nerve block (CFNB) techniques continue to be increasingly used in the management of postoperative pain after total knee arthroplasty. Although the risk of full blown infection with CFNB has been poorly defined, the rate of catheter colonization after antisepsis with povidone-iodine has been… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- Skin antisepsis with chlorhexidine and povidone-iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Jun 2015
- Phase
- Interventional
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1-3,
- Undergoing primary total knee arthroplasty.
Who cannot join
- Hypersensitivity/allergy to antiseptics,
- Recent opioid/alcohol abuse,
- Presence of contraindications to regional anesthesia,
- Coagulation disorder,
- Diabetic/femoral neuropathy,
- Prior surgery to inguinal area,
- Patient refusal.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Syosset Hospital
Syosset, New York, 11791
Franklin Hospital
Valley Stream, New York, 11580
About this study
Official title: Chlorhexidine vs. Betadine in Preventing Colonization of Continuous Femoral Catheters After Total Joint Arthroplasty
Continuous femoral nerve block (CFNB) techniques continue to be increasingly used in the management of postoperative pain after total knee arthroplasty. Although the risk of full blown infection with CFNB has been poorly defined, the rate of catheter colonization after antisepsis with povidone-iodine has been demonstrated to be high (Cuivillion et al. showed the rate of colonization to be 57% after 48 hours). Recently, several anecdotal case reports have demonstrated severe infectious complications including psoas abscess and necrotizing fasciitis associated with continuous nerve block techniques. As the use of CFNB techniques increase in popularity, infectious complications will undoubtedly become more common.
The American Society of Regional Anesthesia and Pain Medicine recommends the routine use of antiseptic solutions with an alcohol base for skin disinfection before peripheral regional techniques due to their penetration of the stratum corneum and their rapid and prolonged effect. Chlorhexidine(chloraprep) has been proven to be better than povidone iodine solution for skin preparation before epidural catheter and intravascular device insertion (Kinirons et al., Ostrander et al., Mimoz et al.,). The goal of this prospective trial therefore is to determine if an alcoholic solution of 0.5% chlorhexidine is more effective than an aqueous solution of 10% povidone-iodine in reducing catheter colonization and reducing skin flora associated with short term ( 48 hours) postoperative continuous femoral nerve catheter placement. The investigators will also compare the ability of chloraprep and betadine disinfection at the time of catheter placement to prevent bacterial contamination of the continuous femoral catheter.
Read the detailed description
After antisepsis four different cultures will be analyzed:
- The femoral nerve catheter will be removed after 48 hours and a culture of the distal tip of the femoral nerve catheter will be performed between the 2 arms.
- immediately before skin antisepsis, a culture of the the skin will be performed to identify baseline skin flora.
- immediately after antisepsis with both betadine and chlorhexidine, a culture of the skin will be performed to assess antiseptic efficacy.
- just prior to removal of the femoral nerve catheter, a culture of the skin/catheter interface will be performed between the 2 arms.
- Conditions
- Infection
- Being tested
- Skin antisepsis with chlorhexidine, povidone-iodine
- Keywords
- chloraprep, betadine, colonization, femoral catheter
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin antisepsis with chlorhexidineDrug
Also called Chlora-prep: 2% w/v chlorhexidine and 70% v/v isopropyl alcohol
Chlorhexidine swabs will be used to antiseptically clean the skin, then cultures of the skin and femoral nerve block catheters will be analyzed via standard microbiological techniques
povidone-iodineDrug
Also called Povidone-Iodine, USP 10% topical solution
Povidone-iodine swabs will be used to antiseptically clean the skin; then cultures of the skin and femoral nerve catheters will be performed by standard microbiologic techniques
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Active comparator | skin antisepsis with chlorhexidine Receives: Drug: Skin antisepsis with chlorhexidine |
| Povidone-iodine | Active comparator | skin antisepsis with povidone-iodine Receives: Drug: povidone-iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of bacterial colonization of the distal femoral catheter tip 48 hours after antiseptic application
Measured: July 2013
Secondary outcomes (1)
Incidences of bacterial colonization of skin before/after skin antisepsis and skin/catheter interface
Measured: July 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startJul 2014
- Primary completionJan 2015
- Study completionJun 2015
Why it stopped: Funding inadequate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Marino M.D., Northwell Health
- Investigators
- Joseph Marino, M.D., Principal investigator, Franklin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896402
- Sponsor's protocol ID
- 1989mdmd
- Status last verified
- Aug 2015
- First submitted
- 7 May 2009
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine vs. Betadine in Preventing Colonization of Continuous Femoral Catheters After Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT00896402
- Acronym / sponsor ID
- 1989mdmd
- Conditions
- Infection
- Keywords
- chloraprep, betadine, colonization, femoral catheter
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding inadequate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 May 2009 (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.
Continuous femoral nerve block (CFNB) techniques continue to be increasingly used in the management of postoperative pain after total knee arthroplasty. Although the risk of full blown infection with CFNB has been poorly defined, the rate of catheter colonization after antisepsis with povidone-iodine has been demonstrated to be high (Cuivillion et al. showed the rate of colonization to be 57% after 48 hours). Recently, several anecdotal case reports have demonstrated severe infectious complications including psoas abscess and necrotizing fasciitis associated with continuous nerve block techniques. As the use of CFNB techniques increase in popularity, infectious complications will undoubtedly become more common.
The American Society of Regional Anesthesia and Pain Medicine recommends the routine use of antiseptic solutions with an alcohol base for skin disinfection before peripheral regional techniques due to their penetration of the stratum corneum and their rapid and prolonged effect. Chlorhexidine(chloraprep) has been proven to be better than povidone iodine solution for skin preparation before epidural catheter and intravascular device insertion (Kinirons et al., Ostrander et al., Mimoz et al.,). The goal of this prospective trial therefore is to determine if an alcoholic solution of 0.5% chlorhexidine is more effective than an aqueous solution of 10% povidone-iodine in reducing catheter colonization and reducing skin flora associated with short term ( 48 hours) postoperative continuous femoral nerve catheter placement. The investigators will also compare the ability of chloraprep and betadine disinfection at the time of catheter placement to prevent bacterial contamination of the continuous femoral catheter.
Detailed description
After antisepsis four different cultures will be analyzed:
- The femoral nerve catheter will be removed after 48 hours and a culture of the distal tip of the femoral nerve catheter will be performed between the 2 arms.
- immediately before skin antisepsis, a culture of the the skin will be performed to identify baseline skin flora.
- immediately after antisepsis with both betadine and chlorhexidine, a culture of the skin will be performed to assess antiseptic efficacy.
- just prior to removal of the femoral nerve catheter, a culture of the skin/catheter interface will be performed between the 2 arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Active comparator | Drug: Skin antisepsis with chlorhexidineskin antisepsis with chlorhexidine |
| Povidone-iodine | Active comparator | Drug: povidone-iodineskin antisepsis with povidone-iodine |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1-3,
- Undergoing primary total knee arthroplasty.
Key exclusion criteria (7 listed)
- Hypersensitivity/allergy to antiseptics,
- Recent opioid/alcohol abuse,
- Presence of contraindications to regional anesthesia,
- Coagulation disorder,
- Diabetic/femoral neuropathy,
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 |
|---|---|---|
| Skin antisepsis with chlorhexidineAlso: Chlora-prep: 2% w/v chlorhexidine and 70% v/v isopropyl alcoholChlorhexidine swabs will be used to antiseptically clean the skin, then cultures of the skin and femoral nerve block catheters will be analyzed via standard microbiological techniques | Drug | Chlorhexidine |
| povidone-iodineAlso: Povidone-Iodine, USP 10% topical solutionPovidone-iodine swabs will be used to antiseptically clean the skin; then cultures of the skin and femoral nerve catheters will be performed by standard microbiologic techniques | Drug | Povidone-iodine |
Primary outcome
Presence or absence of bacterial colonization of the distal femoral catheter tip 48 hours after antiseptic application
Time frame: July 2013
1 secondary outcome
Incidences of bacterial colonization of skin before/after skin antisepsis and skin/catheter interface
Time frame: July 2013
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
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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.
Joseph Marino, M.D. principal investigator
Franklin Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin antisepsis with chlorhexidine and povidone-iodine in people with Infection, run by Northwell Health at 2 sites in United States.
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: withdrawn, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Presence or absence of bacterial colonization of the distal femoral catheter tip 48 hours after antiseptic application (time frame: July 2013). 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 27 Aug 2015.