Trial Outcomes & Findings for Preoperative Antibiotics for Carpal Tunnel Release Surgery (NCT NCT03432858)
NCT ID: NCT03432858
Last Updated: 2021-11-10
Results Overview
Definitive diagnosis of infection of surgical site -wounds determined to be infected will be divided into superficial or deep infections and treated according to the standard of care at WellSpan health.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
184 participants
Primary outcome timeframe
2 weeks post-operative
Results posted on
2021-11-10
Participant Flow
Participant milestones
| Measure |
Active Comparator 1
Vancomycin: 1-gram dosing
|
Active Comparator 2
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
Saline Solution: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
83
|
89
|
|
Overall Study
COMPLETED
|
10
|
72
|
72
|
|
Overall Study
NOT COMPLETED
|
2
|
11
|
17
|
Reasons for withdrawal
| Measure |
Active Comparator 1
Vancomycin: 1-gram dosing
|
Active Comparator 2
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
Saline Solution: Placebo
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
9
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Procedure canceled/rescheduled
|
0
|
9
|
6
|
|
Overall Study
Required postop mobilization with splinting
|
0
|
0
|
1
|
Baseline Characteristics
Preoperative Antibiotics for Carpal Tunnel Release Surgery
Baseline characteristics by cohort
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 14.10 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 15.37 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 16.36 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 15.70 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
72 participants
n=7 Participants
|
72 participants
n=5 Participants
|
154 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 weeks post-operativeDefinitive diagnosis of infection of surgical site -wounds determined to be infected will be divided into superficial or deep infections and treated according to the standard of care at WellSpan health.
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Surgical Site Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post-operativeDefinitive diagnosis of infection of surgical site -Definitive diagnosis of infection of surgical site -wounds determined to be infected will be divided into superficial or deep infections and treated according to the standard of care at WellSpan health.
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Surgical Site Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post-operativeNumber of patients with surgical site infection that have diabetes
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Diabetes Diagnosis and Surgical Site Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post-operativeNumber of patients with surgical site infection that have diabetes
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Diabetes Diagnosis and Surgical Site Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post-operativeNumber of patients with surgical site infections that use tobacco products
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Surgical Site Infections That Use Tobacco
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post-operativeNumber of patients with surgical site infections that use tobacco products
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Surgical Site Infections That Use Tobacco
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post-operativeNumber of patients with surgical site infections that have chronic obstructive pulmonary disease
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post-operativeNumber of patients with surgical site infections that have chronic obstructive pulmonary disease
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post-operativeNumber of patients with surgical site infections that have anemia
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Anemia Diagnosis and Surgical Site Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post-operativeNumber of patients with surgical site infections that have anemia
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Anemia Diagnosis and Surgical Site Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post-operativeNumber of patients with surgical site infections that have peripheral artery disease
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post-operativeNumber of patients with surgical site infections that have peripheral artery disease
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post-operativeNumber of patients with surgical site infections with history of arthroplasty
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Surgical Site Infection and a History of Arthroplasty
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post-operativeNumber of patients with surgical site infections with history of arthroplasty
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Surgical Site Infection and History of Arthroplasty
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post-operativeNumber of patients with surgical site infections with valvular disease
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post-operativeNumber of patients with surgical site infections with valvular disease
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post-operativeNumber of patients with surgical site infections with single incision ECTR
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post-operativeNumber of patients with surgical site infections with single incision ECTR
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post-operativeNumber of patients with surgical site infections with double incision ECTR
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post-operativeNumber of patients with surgical site infections with double incision ECTR
Outcome measures
| Measure |
Active Comparator 1
n=10 Participants
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 Participants
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 Participants
Saline Solution: Placebo
|
|---|---|---|---|
|
Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post-operativePopulation: No patients sustained surgical site infections and data were not collected for this Outcome Measure.
For patients sustaining surgical site infection, the time from their last cortisone injection
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks post-operativePopulation: No patients sustained surgical site infections and data were not collected for this Outcome Measure.
For patients sustaining surgical site infection, the time from their last cortisone injection
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeks post-operativePopulation: No patients sustained surgical site infections and data were not collected for this Outcome Measure.
For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks post-operativePopulation: No patients sustained surgical site infections and data were not collected for this Outcome Measure
For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
Outcome measures
Outcome data not reported
Adverse Events
Active Comparator 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Comparator 1
n=10 participants at risk
Vancomycin: 1-gram dosing
|
Active Comparator 2
n=72 participants at risk
Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo
n=72 participants at risk
Saline Solution: Placebo
|
|---|---|---|---|
|
Vascular disorders
Pyogenic granuloma
|
0.00%
0/10 • 6 weeks post procedure
|
0.00%
0/72 • 6 weeks post procedure
|
1.4%
1/72 • Number of events 1 • 6 weeks post procedure
|
|
Musculoskeletal and connective tissue disorders
Postoperative splinting
|
0.00%
0/10 • 6 weeks post procedure
|
0.00%
0/72 • 6 weeks post procedure
|
1.4%
1/72 • Number of events 1 • 6 weeks post procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place