Arthroplasty, Knee ReplacementPhase 4NCT01184196
ChloraPrep Versus Betadine for Elective Knee Replacement Surgery
A Phase 4 study testing Swab area with Betadine and Swab area with ChloraPrep in people with Arthroplasty, Knee Replacement and Replacement, Total Knee, run by Central DuPage Hospital at 1 site in United States.
Trial summary
This study will enroll patients who will be receiving primary total knee replacements. Subjects will be randomized into two groups: Betadine surgical scrub preparation and ChloraPrep preparation prior to total knee replacements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Knee Replacement, Replacement, Total Knee, Total Knee Replacement
- What is being tested?
- Swab area with Betadine and Swab area with ChloraPrep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2012
- Phase
- Phase 4
- 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
- Scheduled to undergo primary total knee arthroplasty
- Age 18 or over
Who cannot join
- Inability to provide informed consent or to comply with study assessments due to cognitive impairment or geographic distance
- Age 17 or younger
- Allergies to chlorhexadine gluconate or povidone iodine
- Topical antimicrobial use within 14 days of surgery
- Any active dermatoses or open wounds over the operative site
- Any condition requiring antibiotics 14 days prior to arriving for surgery
- Patients with chronic immunosuppression (such as HIV/AIDS)
- Unable to adhere to follow up schedule and treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Chlorhexadine Gluconate Versus Povidone Iodine Surgical Preparation in Skin Bacterial Colony Counts for Elective Knee Replacement Surgery
This study will enroll patients who will be receiving primary total knee replacements. Subjects will be randomized into two groups: Betadine surgical scrub preparation and ChloraPrep preparation prior to total knee replacements.
Study hypothesis: When used as a surgical scrub preparation prior to primary total knee arthroplasties, ChloraPrep (2% chlorhexadine gluconate and 70% isopropyl alcohol) is superior to Betadine (10% povidone iodine) in reducing incision site bacterial colony counts.
Read the detailed description
Swabs will be taken over the operative knee by study personnel for a bacterial colony count immediately before surgical site preparation is started, after the surgery prep is complete, and 24 hours post surgery prep. Swabs will be sent to the lab for quantitative colony counts and all 3 measurements will be compared and analyzed.
- Being tested
- Swab area with Betadine, Swab area with ChloraPrep
- Keywords
- knee replacement, knee arthroplasty, total knee replacement, arthroplasty, knee replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swab area with BetadineDrug
Also called Povidone Iodine
A swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery.
Swab area with ChloraPrepDrug
Also called Chlorhexadine Gluconate
A swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Subjects randomized to Arm 1 will receive Betadine surgical scrub at the time of primary total knee arthroplasty. Receives: Drug: Swab area with Betadine |
| Arm 2 | Active comparator | Subjects in Arm 2 will receive ChloraPrep surgical scrub prior to elective primary total knee arthroplasty. Receives: Drug: Swab area with ChloraPrep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative bacterial colony counts for aerobic and anaerobic culture swabs will be taken at 3 timeperiods to determine if ChloraPrep is superior to Betadine in reducing incision site bacterial colony counts.
Subjects scheduled to undergo primary total knee arthroplasty will be randomized to receive either a Betadine surgical scrub or ChloraPrep surgical scrub at the time of surgery. Subjects will be enrolled until swab #3 is obtained, 24 hours post-surgery.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: ChloroPrep Wipes no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Knee ReplacementStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central DuPage Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Sporer, MD, Principal investigator, Midwest Orthopaedics at Rush
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184196
- Sponsor's protocol ID
- 10-008
- Status last verified
- Apr 2013
- First submitted
- 16 Aug 2010
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.
PubMed 15866959Edwards PS, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2004;(3):CD003949. doi: 10.1002/14651858.CD003949.pub2.
PubMed 15266508Aly R, Maibach HI. Comparative antibacterial efficacy of a 2-minute surgical scrub with chlorhexidine gluconate, povidone-iodine, and chloroxylenol sponge-brushes. Am J Infect Control. 1988 Aug;16(4):173-7. doi: 10.1016/0196-6553(88)90029-6.
PubMed 3189943Kaul AF, Jewett JF. Agents and techniques for disinfection of the skin. Surg Gynecol Obstet. 1981 May;152(5):677-85. No abstract available.
PubMed 7013126Grabsch EA, Mitchell DJ, Hooper J, Turnidge JD. In-use efficacy of a chlorhexidine in alcohol surgical rub: a comparative study. ANZ J Surg. 2004 Sep;74(9):769-72. doi: 10.1111/j.1445-1433.2004.03154.x.
PubMed 15379808Nishimura C. Comparison of the antimicrobial efficacy of povidone-iodine, povidone-iodine-ethanol and chlorhexidine gluconate-ethanol surgical scrubs. Dermatology. 2006;212 Suppl 1:21-5. doi: 10.1159/000089195.
PubMed 16490971Geelhoed GW, Sharpe K, Simon GL. A comparative study of surgical skin preparation methods. Surg Gynecol Obstet. 1983 Sep;157(3):265-8.
PubMed 6612574Keblish DJ, Zurakowski D, Wilson MG, Chiodo CP. Preoperative skin preparation of the foot and ankle: bristles and alcohol are better. J Bone Joint Surg Am. 2005 May;87(5):986-92. doi: 10.2106/JBJS.D.02695.
PubMed 15866960
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Chlorhexadine Gluconate Versus Povidone Iodine Surgical Preparation in Skin Bacterial Colony Counts for Elective Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT01184196
- Acronym / sponsor ID
- 10-008
- Keywords
- knee replacement, knee arthroplasty, total knee replacement, arthroplasty, knee replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: ChloroPrep Wipes no longer available
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Central DuPage HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Aug 2010 (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.
This study will enroll patients who will be receiving primary total knee replacements. Subjects will be randomized into two groups: Betadine surgical scrub preparation and ChloraPrep preparation prior to total knee replacements.
Study hypothesis: When used as a surgical scrub preparation prior to primary total knee arthroplasties, ChloraPrep (2% chlorhexadine gluconate and 70% isopropyl alcohol) is superior to Betadine (10% povidone iodine) in reducing incision site bacterial colony counts.
Detailed description
Swabs will be taken over the operative knee by study personnel for a bacterial colony count immediately before surgical site preparation is started, after the surgery prep is complete, and 24 hours post surgery prep. Swabs will be sent to the lab for quantitative colony counts and all 3 measurements will be compared and analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Swab area with BetadineSubjects randomized to Arm 1 will receive Betadine surgical scrub at the time of primary total knee arthroplasty. |
| Arm 2 | Active comparator | Drug: Swab area with ChloraPrepSubjects in Arm 2 will receive ChloraPrep surgical scrub prior to elective primary total knee arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled to undergo primary total knee arthroplasty
- Age 18 or over
Key exclusion criteria (8 listed)
- Inability to provide informed consent or to comply with study assessments due to cognitive impairment or geographic distance
- Age 17 or younger
- Allergies to chlorhexadine gluconate or povidone iodine
- Topical antimicrobial use within 14 days of surgery
- Any active dermatoses or open wounds over the operative site
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 |
|---|---|---|
| Swab area with BetadineAlso: Povidone IodineA swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery. | Drug | Arm 1 |
| Swab area with ChloraPrepAlso: Chlorhexadine GluconateA swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery. | Drug | Arm 2 |
Primary outcome
Quantitative bacterial colony counts for aerobic and anaerobic culture swabs will be taken at 3 timeperiods to determine if ChloraPrep is superior to Betadine in reducing incision site bacterial colony counts.
Time frame: 24 hours
Subjects scheduled to undergo primary total knee arthroplasty will be randomized to receive either a Betadine surgical scrub or ChloraPrep surgical scrub at the time of surgery. Subjects will be enrolled until swab #3 is obtained, 24 hours post-surgery.
Results and safety
The study was stopped early (reason given: ChloroPrep Wipes no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
- Background: PubMed 15866959Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.
- Background: PubMed 15266508Edwards PS, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2004;(3):CD003949. doi: 10.1002/14651858.CD003949.pub2.
- Background: PubMed 3189943Aly R, Maibach HI. Comparative antibacterial efficacy of a 2-minute surgical scrub with chlorhexidine gluconate, povidone-iodine, and chloroxylenol sponge-brushes. Am J Infect Control. 1988 Aug;16(4):173-7. doi: 10.1016/0196-6553(88)90029-6.
- Background: PubMed 7013126Kaul AF, Jewett JF. Agents and techniques for disinfection of the skin. Surg Gynecol Obstet. 1981 May;152(5):677-85. No abstract available.
- Background: PubMed 15379808Grabsch EA, Mitchell DJ, Hooper J, Turnidge JD. In-use efficacy of a chlorhexidine in alcohol surgical rub: a comparative study. ANZ J Surg. 2004 Sep;74(9):769-72. doi: 10.1111/j.1445-1433.2004.03154.x.
- Background: PubMed 16490971Nishimura C. Comparison of the antimicrobial efficacy of povidone-iodine, povidone-iodine-ethanol and chlorhexidine gluconate-ethanol surgical scrubs. Dermatology. 2006;212 Suppl 1:21-5. doi: 10.1159/000089195.
- Background: PubMed 6612574Geelhoed GW, Sharpe K, Simon GL. A comparative study of surgical skin preparation methods. Surg Gynecol Obstet. 1983 Sep;157(3):265-8.
- Background: PubMed 15866960Keblish DJ, Zurakowski D, Wilson MG, Chiodo CP. Preoperative skin preparation of the foot and ankle: bristles and alcohol are better. J Bone Joint Surg Am. 2005 May;87(5):986-92. doi: 10.2106/JBJS.D.02695.
- Midwest Ortho at RUSHLink provided by the sponsor.
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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.
Scott Sporer, MD principal investigator
Midwest Orthopaedics at Rush
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Swab area with Betadine and Swab area with ChloraPrep in people with Arthroplasty, Knee Replacement and Replacement, Total Knee, run by Central DuPage Hospital at 1 site 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 8 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 16 Apr 2013. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: ChloroPrep Wipes no longer available). 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?
Quantitative bacterial colony counts for aerobic and anaerobic culture swabs will be taken at 3 timeperiods to determine if ChloraPrep is superior to Betadine in reducing incision site bacterial colony counts. (time frame: 24 hours). 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 NCT01184196, which also lists 8 linked publications.
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 16 Apr 2013.