Preoperative Antibiotics for Carpal Tunnel Release Surgery
Study Details
Study Description
Brief Summary
This is a clinical trial to determine how effective antibiotics administered prior to endoscopic carpal tunnel release surgery are in preventing surgical site infections.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
Study participants will be randomized to a prophylactic IV antibiotic treatment arm (Vancomycin or Cefazolin) or a placebo IV saline solution. Subjects will be monitored following surgery for surgical site infections.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Vancomycin
|
Drug: Vancomycin
Vancomycin - 1-gram dosing
|
Active Comparator: Cefazolin
|
Drug: Cefazolin
2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater
|
Placebo Comparator: Saline
|
Drug: Saline Solution
Placebo
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Surgical Site Infection [2 weeks post-operative]
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.
- Number of Participants With Surgical Site Infection [6 weeks post-operative]
Definitive 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.
Secondary Outcome Measures
- Number of Participants With Diabetes Diagnosis and Surgical Site Infection [2 weeks post-operative]
Number of patients with surgical site infection that have diabetes
- Number of Participants With Diabetes Diagnosis and Surgical Site Infection [6 weeks post-operative]
Number of patients with surgical site infection that have diabetes
- Number of Participants With Surgical Site Infections That Use Tobacco [2 weeks post-operative]
Number of patients with surgical site infections that use tobacco products
- Number of Participants With Surgical Site Infections That Use Tobacco [6 weeks post-operative]
Number of patients with surgical site infections that use tobacco products
- Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection [2 weeks post-operative]
Number of patients with surgical site infections that have chronic obstructive pulmonary disease
- Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection [6 weeks post-operative]
Number of patients with surgical site infections that have chronic obstructive pulmonary disease
- Number of Participants With Anemia Diagnosis and Surgical Site Infection [2 weeks post-operative]
Number of patients with surgical site infections that have anemia
- Number of Participants With Anemia Diagnosis and Surgical Site Infection [6 weeks post-operative]
Number of patients with surgical site infections that have anemia
- Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection [2 weeks post-operative]
Number of patients with surgical site infections that have peripheral artery disease
- Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection [6 weeks post-operative]
Number of patients with surgical site infections that have peripheral artery disease
- Number of Participants With Surgical Site Infection and a History of Arthroplasty [2 weeks post-operative]
Number of patients with surgical site infections with history of arthroplasty
- Number of Participants With Surgical Site Infection and History of Arthroplasty [6 weeks post-operative]
Number of patients with surgical site infections with history of arthroplasty
- Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection [2 weeks post-operative]
Number of patients with surgical site infections with valvular disease
- Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection [6 weeks post-operative]
Number of patients with surgical site infections with valvular disease
- Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release [2 weeks post-operative]
Number of patients with surgical site infections with single incision ECTR
- Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release [6 weeks post-operative]
Number of patients with surgical site infections with single incision ECTR
- Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release [2 weeks post-operative]
Number of patients with surgical site infections with double incision ECTR
- Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release [6 weeks post-operative]
Number of patients with surgical site infections with double incision ECTR
- Time From Last Cortisone Injection [2 weeks post-operative]
For patients sustaining surgical site infection, the time from their last cortisone injection
- Time From Last Cortisone Injection [6 weeks post-operative]
For patients sustaining surgical site infection, the time from their last cortisone injection
- Acuity of Carpal Tunnel Syndrome [2 weeks post-operative]
For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
- Acuity of Carpal Tunnel Syndrome [6 weeks post-operative]
For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
Eligibility Criteria
Criteria
Inclusion Criteria:
-
High probability (>12 points) on the Carpal Tunnel-6 diagnostic aide
-
Recommendation for carpal tunnel release
-
Capable of providing informed consent/LAR to act on subject's behalf
Exclusion Criteria:
-
Patients allergic to both penicillin/cephalosporins and vancomycin
-
Patient immobilized with splint or cast
-
Unwilling unable to provide informed consent
-
Children under the age of 18
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | WellSpan Surgery and Rehab Hospital | York | Pennsylvania | United States | 17404 |
Sponsors and Collaborators
- WellSpan Health
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- Prophylactic Antibiotics: ESCR
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Period Title: Overall Study | |||
STARTED | 12 | 83 | 89 |
COMPLETED | 10 | 72 | 72 |
NOT COMPLETED | 2 | 11 | 17 |
Baseline Characteristics
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo | Total |
---|---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo | Total of all reporting groups |
Overall Participants | 10 | 72 | 72 | 154 |
Age (Count of Participants) | ||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
5
50%
|
47
65.3%
|
51
70.8%
|
103
66.9%
|
>=65 years |
5
50%
|
25
34.7%
|
21
29.2%
|
51
33.1%
|
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
68.6
(14.10)
|
59.0
(15.37)
|
55.8
(16.36)
|
57.5
(15.70)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
7
70%
|
46
63.9%
|
47
65.3%
|
100
64.9%
|
Male |
3
30%
|
26
36.1%
|
25
34.7%
|
54
35.1%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
0
0%
|
5
6.9%
|
10
13.9%
|
15
9.7%
|
Not Hispanic or Latino |
10
100%
|
66
91.7%
|
62
86.1%
|
138
89.6%
|
Unknown or Not Reported |
0
0%
|
1
1.4%
|
0
0%
|
1
0.6%
|
Race (NIH/OMB) (Count of Participants) | ||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
2
20%
|
2
2.8%
|
3
4.2%
|
7
4.5%
|
White |
8
80%
|
66
91.7%
|
59
81.9%
|
133
86.4%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
4
5.6%
|
10
13.9%
|
14
9.1%
|
Region of Enrollment (participants) [Number] | ||||
United States |
10
100%
|
72
100%
|
72
100%
|
154
100%
|
Outcome Measures
Title | Number of Participants With Surgical Site Infection |
---|---|
Description | 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. |
Time Frame | 2 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Surgical Site Infection |
---|---|
Description | Definitive 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. |
Time Frame | 6 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Diabetes Diagnosis and Surgical Site Infection |
---|---|
Description | Number of patients with surgical site infection that have diabetes |
Time Frame | 2 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Diabetes Diagnosis and Surgical Site Infection |
---|---|
Description | Number of patients with surgical site infection that have diabetes |
Time Frame | 6 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Surgical Site Infections That Use Tobacco |
---|---|
Description | Number of patients with surgical site infections that use tobacco products |
Time Frame | 2 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Surgical Site Infections That Use Tobacco |
---|---|
Description | Number of patients with surgical site infections that use tobacco products |
Time Frame | 6 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection |
---|---|
Description | Number of patients with surgical site infections that have chronic obstructive pulmonary disease |
Time Frame | 2 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection |
---|---|
Description | Number of patients with surgical site infections that have chronic obstructive pulmonary disease |
Time Frame | 6 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Anemia Diagnosis and Surgical Site Infection |
---|---|
Description | Number of patients with surgical site infections that have anemia |
Time Frame | 2 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Anemia Diagnosis and Surgical Site Infection |
---|---|
Description | Number of patients with surgical site infections that have anemia |
Time Frame | 6 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection |
---|---|
Description | Number of patients with surgical site infections that have peripheral artery disease |
Time Frame | 2 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection |
---|---|
Description | Number of patients with surgical site infections that have peripheral artery disease |
Time Frame | 6 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Surgical Site Infection and a History of Arthroplasty |
---|---|
Description | Number of patients with surgical site infections with history of arthroplasty |
Time Frame | 2 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Surgical Site Infection and History of Arthroplasty |
---|---|
Description | Number of patients with surgical site infections with history of arthroplasty |
Time Frame | 6 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection |
---|---|
Description | Number of patients with surgical site infections with valvular disease |
Time Frame | 2 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection |
---|---|
Description | Number of patients with surgical site infections with valvular disease |
Time Frame | 6 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release |
---|---|
Description | Number of patients with surgical site infections with single incision ECTR |
Time Frame | 2 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release |
---|---|
Description | Number of patients with surgical site infections with single incision ECTR |
Time Frame | 6 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release |
---|---|
Description | Number of patients with surgical site infections with double incision ECTR |
Time Frame | 2 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release |
---|---|
Description | Number of patients with surgical site infections with double incision ECTR |
Time Frame | 6 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 10 | 72 | 72 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Time From Last Cortisone Injection |
---|---|
Description | For patients sustaining surgical site infection, the time from their last cortisone injection |
Time Frame | 2 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
No patients sustained surgical site infections and data were not collected for this Outcome Measure. |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 0 | 0 | 0 |
Title | Time From Last Cortisone Injection |
---|---|
Description | For patients sustaining surgical site infection, the time from their last cortisone injection |
Time Frame | 6 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
No patients sustained surgical site infections and data were not collected for this Outcome Measure. |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 0 | 0 | 0 |
Title | Acuity of Carpal Tunnel Syndrome |
---|---|
Description | For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome |
Time Frame | 2 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
No patients sustained surgical site infections and data were not collected for this Outcome Measure. |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 0 | 0 | 0 |
Title | Acuity of Carpal Tunnel Syndrome |
---|---|
Description | For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome |
Time Frame | 6 weeks post-operative |
Outcome Measure Data
Analysis Population Description |
---|
No patients sustained surgical site infections and data were not collected for this Outcome Measure |
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo |
---|---|---|---|
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo |
Measure Participants | 0 | 0 | 0 |
Adverse Events
Time Frame | 6 weeks post procedure | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Active Comparator 1 | Active Comparator 2 | Placebo | |||
Arm/Group Description | Vancomycin: 1-gram dosing | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | Saline Solution: Placebo | |||
All Cause Mortality |
||||||
Active Comparator 1 | Active Comparator 2 | Placebo | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | 0/72 (0%) | 0/72 (0%) | |||
Serious Adverse Events |
||||||
Active Comparator 1 | Active Comparator 2 | Placebo | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | 0/72 (0%) | 0/72 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Active Comparator 1 | Active Comparator 2 | Placebo | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | 0/72 (0%) | 2/72 (2.8%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Postoperative splinting | 0/10 (0%) | 0/72 (0%) | 1/72 (1.4%) | 1 | ||
Vascular disorders | ||||||
Pyogenic granuloma | 0/10 (0%) | 0/72 (0%) | 1/72 (1.4%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Clinical Research Associate |
---|---|
Organization | WellSpan Health |
Phone | (717) 851-7634 |
cbush@wellspan.org |
- Prophylactic Antibiotics: ESCR