ChloraPrep Versus Betadine for Elective Knee Replacement Surgery
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | November 2009 |
| End Date: | December 2012 |
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.
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.
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.
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.
Inclusion Criteria:
- Scheduled to undergo primary total knee arthroplasty
- Age 18 or over
Exclusion Criteria:
- 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
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