Trial Outcomes & Findings for Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty (NCT NCT04075526)
NCT ID: NCT04075526
Last Updated: 2026-02-17
Results Overview
The definition of periprosthetic infection exists when the following criteria are met: * NEW MSIS criteria for PJI: 1 major criteria (2) or 6 minor criteria (6) 26-28 * Major Criteria: \[1\] sinus tract \[2\] + Cx from 2 separate aspirations * Minor Criteria: \[1\] ESR \>30 mm/hr (1 point), \[2\] D-dimer \>860 ng/mL or CRP \>1 mg/dL \[2\] increased synovial WBC (\>3000 cells/microliter) \[4\] alpha-defensin (signal-to-cutoff ratio\>1) \[5\] leukocyte esterase (++) \[6\] increased synovial PMNs of \>80% \[7\] synovial CRP \>6.9 mg/L
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
2129 participants
Primary outcome timeframe
90 Days
Results posted on
2026-02-17
Participant Flow
Participant milestones
| Measure |
Povidone Iodine and Vancomycin Powder
Povidone iodine: To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
Vancomycin powder: 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
|
Povidone Iodine Alone
Povidone iodine: To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
|
Vancomycin Powder Alone
Vancomycin powder: 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
|
Conventional
neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation
Conventional: No additional steps in management are required for the control arm of the study besides lavage with 1 L of isotonic sodium chloride solution without antibiotics. No vancomycin powder or dilute povidone iodine lavage would be utilized in this cohort
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
494
|
511
|
483
|
511
|
|
Overall Study
COMPLETED
|
474
|
488
|
455
|
484
|
|
Overall Study
NOT COMPLETED
|
20
|
23
|
28
|
27
|
Reasons for withdrawal
| Measure |
Povidone Iodine and Vancomycin Powder
Povidone iodine: To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
Vancomycin powder: 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
|
Povidone Iodine Alone
Povidone iodine: To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
|
Vancomycin Powder Alone
Vancomycin powder: 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
|
Conventional
neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation
Conventional: No additional steps in management are required for the control arm of the study besides lavage with 1 L of isotonic sodium chloride solution without antibiotics. No vancomycin powder or dilute povidone iodine lavage would be utilized in this cohort
|
|---|---|---|---|---|
|
Overall Study
Death
|
3
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
4
|
1
|
|
Overall Study
randomization arm could not be verified by medication log
|
10
|
17
|
17
|
19
|
Baseline Characteristics
Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty
Baseline characteristics by cohort
| Measure |
Povidone Iodine and Vancomycin Powder
n=474 Participants
Povidone iodine: To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
Vancomycin powder: 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
|
Povidone Iodine Alone
n=488 Participants
Povidone iodine: To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
|
Vancomycin Powder Alone
n=455 Participants
Vancomycin powder: 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
|
Conventional
n=484 Participants
neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation
Conventional: No additional steps in management are required for the control arm of the study besides lavage with 1 L of isotonic sodium chloride solution without antibiotics. No vancomycin powder or dilute povidone iodine lavage would be utilized in this cohort
|
Total
n=1901 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 11.5 • n=25 Participants
|
66.7 years
STANDARD_DEVIATION 11.8 • n=20 Participants
|
66.6 years
STANDARD_DEVIATION 11.6 • n=45 Participants
|
66.5 years
STANDARD_DEVIATION 11.5 • n=76 Participants
|
66.4 years
STANDARD_DEVIATION 11.6 • n=488 Participants
|
|
Sex: Female, Male
Female
|
267 Participants
n=25 Participants
|
197 Participants
n=20 Participants
|
294 Participants
n=45 Participants
|
309 Participants
n=76 Participants
|
1067 Participants
n=488 Participants
|
|
Sex: Female, Male
Male
|
207 Participants
n=25 Participants
|
291 Participants
n=20 Participants
|
161 Participants
n=45 Participants
|
175 Participants
n=76 Participants
|
834 Participants
n=488 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=488 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=488 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
474 Participants
n=25 Participants
|
488 Participants
n=20 Participants
|
455 Participants
n=45 Participants
|
484 Participants
n=76 Participants
|
1901 Participants
n=488 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=76 Participants
|
2 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=25 Participants
|
13 Participants
n=20 Participants
|
12 Participants
n=45 Participants
|
7 Participants
n=76 Participants
|
43 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=76 Participants
|
2 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Black or African American
|
105 Participants
n=25 Participants
|
94 Participants
n=20 Participants
|
100 Participants
n=45 Participants
|
97 Participants
n=76 Participants
|
396 Participants
n=488 Participants
|
|
Race (NIH/OMB)
White
|
282 Participants
n=25 Participants
|
307 Participants
n=20 Participants
|
268 Participants
n=45 Participants
|
315 Participants
n=76 Participants
|
1172 Participants
n=488 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=25 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=45 Participants
|
6 Participants
n=76 Participants
|
28 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
65 Participants
n=25 Participants
|
69 Participants
n=20 Participants
|
67 Participants
n=45 Participants
|
57 Participants
n=76 Participants
|
258 Participants
n=488 Participants
|
|
Region of Enrollment
United States
|
474 participants
n=25 Participants
|
488 participants
n=20 Participants
|
455 participants
n=45 Participants
|
484 participants
n=76 Participants
|
1901 participants
n=488 Participants
|
PRIMARY outcome
Timeframe: 90 DaysThe definition of periprosthetic infection exists when the following criteria are met: * NEW MSIS criteria for PJI: 1 major criteria (2) or 6 minor criteria (6) 26-28 * Major Criteria: \[1\] sinus tract \[2\] + Cx from 2 separate aspirations * Minor Criteria: \[1\] ESR \>30 mm/hr (1 point), \[2\] D-dimer \>860 ng/mL or CRP \>1 mg/dL \[2\] increased synovial WBC (\>3000 cells/microliter) \[4\] alpha-defensin (signal-to-cutoff ratio\>1) \[5\] leukocyte esterase (++) \[6\] increased synovial PMNs of \>80% \[7\] synovial CRP \>6.9 mg/L
Outcome measures
| Measure |
Povidone Iodine and Vancomycin Powder
n=474 Participants
Povidone iodine: To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
Vancomycin powder: 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
|
Povidone Iodine Alone
n=488 Participants
Povidone iodine: To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
|
Vancomycin Powder Alone
n=455 Participants
Vancomycin powder: 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
|
Conventional
n=484 Participants
neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation
Conventional: No additional steps in management are required for the control arm of the study besides lavage with 1 L of isotonic sodium chloride solution without antibiotics. No vancomycin powder or dilute povidone iodine lavage would be utilized in this cohort
|
|---|---|---|---|---|
|
Rate of Periprosthetic Infection (PJI) After Elective Total Joint Arthroplasty.
|
7 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Povidone Iodine and Vancomycin Powder
Serious events: 12 serious events
Other events: 24 other events
Deaths: 3 deaths
Povidone Iodine Alone
Serious events: 10 serious events
Other events: 25 other events
Deaths: 1 deaths
Vancomycin Powder Alone
Serious events: 15 serious events
Other events: 20 other events
Deaths: 1 deaths
Conventional
Serious events: 12 serious events
Other events: 22 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Povidone Iodine and Vancomycin Powder
n=511 participants at risk
Povidone iodine: To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
Vancomycin powder: 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
|
Povidone Iodine Alone
n=524 participants at risk
Povidone iodine: To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
|
Vancomycin Powder Alone
n=489 participants at risk
Vancomycin powder: 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
|
Conventional
n=531 participants at risk
neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation
Conventional: No additional steps in management are required for the control arm of the study besides lavage with 1 L of isotonic sodium chloride solution without antibiotics. No vancomycin powder or dilute povidone iodine lavage would be utilized in this cohort
|
|---|---|---|---|---|
|
Infections and infestations
PJI Requiring Septic Revision
|
1.4%
7/511 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.00%
0/524 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.61%
3/489 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.38%
2/531 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
|
Surgical and medical procedures
Aseptic revision/reoperation
|
0.20%
1/511 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.95%
5/524 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
1.6%
8/489 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.75%
4/531 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
|
Musculoskeletal and connective tissue disorders
Other MSK- or fall-related readmission
|
0.59%
3/511 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.95%
5/524 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.41%
2/489 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.56%
3/531 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
|
Vascular disorders
Readmission for PE/DVT
|
0.20%
1/511 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.00%
0/524 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.41%
2/489 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.56%
3/531 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
Other adverse events
| Measure |
Povidone Iodine and Vancomycin Powder
n=511 participants at risk
Povidone iodine: To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
Vancomycin powder: 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
|
Povidone Iodine Alone
n=524 participants at risk
Povidone iodine: To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
|
Vancomycin Powder Alone
n=489 participants at risk
Vancomycin powder: 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
|
Conventional
n=531 participants at risk
neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation
Conventional: No additional steps in management are required for the control arm of the study besides lavage with 1 L of isotonic sodium chloride solution without antibiotics. No vancomycin powder or dilute povidone iodine lavage would be utilized in this cohort
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Persistent Wound Drainage or Dehiscence
|
2.7%
14/511 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
2.5%
13/524 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
2.2%
11/489 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
2.1%
11/531 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
|
Skin and subcutaneous tissue disorders
Cellulitis or Abscess
|
0.59%
3/511 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.57%
3/524 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.00%
0/489 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
0.38%
2/531 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
|
Musculoskeletal and connective tissue disorders
Other MSK-related ED visit not requiring readmission
|
1.4%
7/511 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
1.7%
9/524 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
1.8%
9/489 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
1.7%
9/531 • 90 days
Regular investigator assessment at postoperative follow-up visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place