Preoperative Antibiotics for Carpal Tunnel Release Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endoscopic Carpal Tunnel Release, Infection Incidence, and Prophylactic Antibiotics: Indicated or Kick the Habit?

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Drug: Vancomycin
* Drug: Cefazolin
* Drug: Saline Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vancomycin<br> | Drug: Vancomycin<br>* Vancomycin - 1-gram dosing<br>|
| Active Comparator: Cefazolin<br> | Drug: Cefazolin<br>* 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater<br>|
| Placebo Comparator: Saline<br> | Drug: Saline Solution<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks post-operative | 
| 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. | 6 weeks post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Diabetes Diagnosis and Surgical Site Infection | Number of patients with surgical site infection that have diabetes | 2 weeks post-operative | 
| Number of Participants With Diabetes Diagnosis and Surgical Site Infection | Number of patients with surgical site infection that have diabetes | 6 weeks post-operative | 
| Number of Participants With Surgical Site Infections That Use Tobacco | Number of patients with surgical site infections that use tobacco products | 2 weeks post-operative | 
| Number of Participants With Surgical Site Infections That Use Tobacco | Number of patients with surgical site infections that use tobacco products | 6 weeks post-operative | 
| 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 | 2 weeks post-operative | 
| 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 | 6 weeks post-operative | 
| Number of Participants With Anemia Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have anemia | 2 weeks post-operative | 
| Number of Participants With Anemia Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have anemia | 6 weeks post-operative | 
| Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have peripheral artery disease | 2 weeks post-operative | 
| Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have peripheral artery disease | 6 weeks post-operative | 
| Number of Participants With Surgical Site Infection and a History of Arthroplasty | Number of patients with surgical site infections with history of arthroplasty | 2 weeks post-operative | 
| Number of Participants With Surgical Site Infection and History of Arthroplasty | Number of patients with surgical site infections with history of arthroplasty | 6 weeks post-operative | 
| Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections with valvular disease | 2 weeks post-operative | 
| Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections with valvular disease | 6 weeks post-operative | 
| 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 | 2 weeks post-operative | 
| 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 | 6 weeks post-operative | 
| 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 | 2 weeks post-operative | 
| 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 | 6 weeks post-operative | 
| Time From Last Cortisone Injection | For patients sustaining surgical site infection, the time from their last cortisone injection | 2 weeks post-operative | 
| Time From Last Cortisone Injection | For patients sustaining surgical site infection, the time from their last cortisone injection | 6 weeks post-operative | 
| Acuity of Carpal Tunnel Syndrome | For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome | 2 weeks post-operative | 
| Acuity of Carpal Tunnel Syndrome | For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome | 6 weeks post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Carpal Tunnel Release, Prophylactic Antibiotics