Carpal Tunnel Syndrome
Conditions
Keywords
Endoscopic Carpal Tunnel Release, Prophylactic Antibiotics
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.
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.
Interventions
DRUGVancomycin
Vancomycin - 1-gram dosing
DRUGCefazolin
2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater
DRUGSaline Solution
Placebo
Sponsors
WellSpan Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Principal investigator, co-investigators, and participants are blinded to study intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 Anemia Diagnosis and Surgical Site Infection | 2 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 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 Diabetes Diagnosis and Surgical Site Infection | 2 weeks post-operative | Number of patients with surgical site infection that have diabetes |
| 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 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 Double Incision Endoscopic Carpal Tunnel Release | 2 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 |
| Acuity of Carpal Tunnel Syndrome | 2 weeks post-operative | For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Comparator 1 Vancomycin: 1-gram dosing | 10 |
| Active Comparator 2 Cefazolin: 2-gram dosing for patients \<120 kg 3-gram dosing for patients 120 kg or greater | 72 |
| Placebo Saline Solution: Placebo | 72 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Procedure canceled/rescheduled | 0 | 9 | 6 |
| Overall Study | Protocol Violation | 2 | 1 | 9 |
| Overall Study | Required postop mobilization with splinting | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Active Comparator 1 | Active Comparator 2 | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 25 Participants | 21 Participants | 51 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 47 Participants | 51 Participants | 103 Participants |
| Age, Continuous | 68.6 years STANDARD_DEVIATION 14.1 | 59.0 years STANDARD_DEVIATION 15.37 | 55.8 years STANDARD_DEVIATION 16.36 | 57.5 years STANDARD_DEVIATION 15.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 5 Participants | 10 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 66 Participants | 62 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 10 Participants | 14 Participants |
| Race (NIH/OMB) White | 8 Participants | 66 Participants | 59 Participants | 133 Participants |
| Region of Enrollment United States | 10 participants | 72 participants | 72 participants | 154 participants |
| Sex: Female, Male Female | 7 Participants | 46 Participants | 47 Participants | 100 Participants |
| Sex: Female, Male Male | 3 Participants | 26 Participants | 25 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 72 | 0 / 72 |
| other Total, other adverse events | 0 / 10 | 0 / 72 | 2 / 72 |
| serious Total, serious adverse events | 0 / 10 | 0 / 72 | 0 / 72 |
Outcome results
Primary
Number of Participants With Surgical Site Infection
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Surgical Site Infection | 0 Participants |
| Active Comparator 2 | Number of Participants With Surgical Site Infection | 0 Participants |
| Placebo | Number of Participants With Surgical Site Infection | 0 Participants |
Primary
Number of Participants With Surgical Site Infection
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Surgical Site Infection | 0 Participants |
| Active Comparator 2 | Number of Participants With Surgical Site Infection | 0 Participants |
| Placebo | Number of Participants With Surgical Site Infection | 0 Participants |
Secondary
Acuity of Carpal Tunnel Syndrome
For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
Time frame: 2 weeks post-operative
Population: No patients sustained surgical site infections and data were not collected for this Outcome Measure.
Secondary
Acuity of Carpal Tunnel Syndrome
For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
Time frame: 6 weeks post-operative
Population: No patients sustained surgical site infections and data were not collected for this Outcome Measure
Secondary
Number of Participants With Anemia Diagnosis and Surgical Site Infection
Number of patients with surgical site infections that have anemia
Time frame: 6 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Anemia Diagnosis and Surgical Site Infection | 0 Participants |
| Active Comparator 2 | Number of Participants With Anemia Diagnosis and Surgical Site Infection | 0 Participants |
| Placebo | Number of Participants With Anemia Diagnosis and Surgical Site Infection | 0 Participants |
Secondary
Number of Participants With Anemia Diagnosis and Surgical Site Infection
Number of patients with surgical site infections that have anemia
Time frame: 2 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Anemia Diagnosis and Surgical Site Infection | 0 Participants |
| Active Comparator 2 | Number of Participants With Anemia Diagnosis and Surgical Site Infection | 0 Participants |
| Placebo | Number of Participants With Anemia Diagnosis and Surgical Site Infection | 0 Participants |
Secondary
Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection
Number of patients with surgical site infections that have chronic obstructive pulmonary disease
Time frame: 6 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection | 0 Participants |
| Active Comparator 2 | Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection | 0 Participants |
| Placebo | Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection | 0 Participants |
Secondary
Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection
Number of patients with surgical site infections that have chronic obstructive pulmonary disease
Time frame: 2 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection | 0 Participants |
| Active Comparator 2 | Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection | 0 Participants |
| Placebo | Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection | 0 Participants |
Secondary
Number of Participants With Diabetes Diagnosis and Surgical Site Infection
Number of patients with surgical site infection that have diabetes
Time frame: 2 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Diabetes Diagnosis and Surgical Site Infection | 0 Participants |
| Active Comparator 2 | Number of Participants With Diabetes Diagnosis and Surgical Site Infection | 0 Participants |
| Placebo | Number of Participants With Diabetes Diagnosis and Surgical Site Infection | 0 Participants |
Secondary
Number of Participants With Diabetes Diagnosis and Surgical Site Infection
Number of patients with surgical site infection that have diabetes
Time frame: 6 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Diabetes Diagnosis and Surgical Site Infection | 0 Participants |
| Active Comparator 2 | Number of Participants With Diabetes Diagnosis and Surgical Site Infection | 0 Participants |
| Placebo | Number of Participants With Diabetes Diagnosis and Surgical Site Infection | 0 Participants |
Secondary
Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
Number of patients with surgical site infections that have peripheral artery disease
Time frame: 6 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection | 0 Participants |
| Active Comparator 2 | Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection | 0 Participants |
| Placebo | Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection | 0 Participants |
Secondary
Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
Number of patients with surgical site infections that have peripheral artery disease
Time frame: 2 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection | 0 Participants |
| Active Comparator 2 | Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection | 0 Participants |
| Placebo | Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection | 0 Participants |
Secondary
Number of Participants With Surgical Site Infection and a History of Arthroplasty
Number of patients with surgical site infections with history of arthroplasty
Time frame: 2 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Surgical Site Infection and a History of Arthroplasty | 0 Participants |
| Active Comparator 2 | Number of Participants With Surgical Site Infection and a History of Arthroplasty | 0 Participants |
| Placebo | Number of Participants With Surgical Site Infection and a History of Arthroplasty | 0 Participants |
Secondary
Number of Participants With Surgical Site Infection and History of Arthroplasty
Number of patients with surgical site infections with history of arthroplasty
Time frame: 6 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Surgical Site Infection and History of Arthroplasty | 0 Participants |
| Active Comparator 2 | Number of Participants With Surgical Site Infection and History of Arthroplasty | 0 Participants |
| Placebo | Number of Participants With Surgical Site Infection and History of Arthroplasty | 0 Participants |
Secondary
Number of Participants With Surgical Site Infections That Use Tobacco
Number of patients with surgical site infections that use tobacco products
Time frame: 6 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Surgical Site Infections That Use Tobacco | 0 Participants |
| Active Comparator 2 | Number of Participants With Surgical Site Infections That Use Tobacco | 0 Participants |
| Placebo | Number of Participants With Surgical Site Infections That Use Tobacco | 0 Participants |
Secondary
Number of Participants With Surgical Site Infections That Use Tobacco
Number of patients with surgical site infections that use tobacco products
Time frame: 2 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Surgical Site Infections That Use Tobacco | 0 Participants |
| Active Comparator 2 | Number of Participants With Surgical Site Infections That Use Tobacco | 0 Participants |
| Placebo | Number of Participants With Surgical Site Infections That Use Tobacco | 0 Participants |
Secondary
Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release
Number of patients with surgical site infections with double incision ECTR
Time frame: 2 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release | 0 Participants |
| Active Comparator 2 | Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release | 0 Participants |
| Placebo | Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release | 0 Participants |
Secondary
Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release
Number of patients with surgical site infections with double incision ECTR
Time frame: 6 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release | 0 Participants |
| Active Comparator 2 | Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release | 0 Participants |
| Placebo | Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release | 0 Participants |
Secondary
Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release
Number of patients with surgical site infections with single incision ECTR
Time frame: 2 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release | 0 Participants |
| Active Comparator 2 | Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release | 0 Participants |
| Placebo | Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release | 0 Participants |
Secondary
Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release
Number of patients with surgical site infections with single incision ECTR
Time frame: 6 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release | 0 Participants |
| Active Comparator 2 | Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release | 0 Participants |
| Placebo | Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release | 0 Participants |
Secondary
Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
Number of patients with surgical site infections with valvular disease
Time frame: 2 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection | 0 Participants |
| Active Comparator 2 | Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection | 0 Participants |
| Placebo | Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection | 0 Participants |
Secondary
Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
Number of patients with surgical site infections with valvular disease
Time frame: 6 weeks post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator 1 | Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection | 0 Participants |
| Active Comparator 2 | Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection | 0 Participants |
| Placebo | Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection | 0 Participants |
Secondary
Time From Last Cortisone Injection
For patients sustaining surgical site infection, the time from their last cortisone injection
Time frame: 6 weeks post-operative
Population: No patients sustained surgical site infections and data were not collected for this Outcome Measure.
Secondary
Time From Last Cortisone Injection
For patients sustaining surgical site infection, the time from their last cortisone injection
Time frame: 2 weeks post-operative
Population: No patients sustained surgical site infections and data were not collected for this Outcome Measure.