Preoperative Antibiotics for Carpal Tunnel Release Surgery

Phase 4

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: Cefazolin; Drug: Saline Solution; Drug: Vancomycin

• Registration Number: NCT03432858
• Lead Sponsor: WellSpan Health

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.

Study Timeline

• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-14
• Study Start: 2018-05-17
• Primary Completion: 2020-12-14
• Study Completion: 2020-12-14
• Results First Submitted: 2021-01-26
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-12
• Last Update Submitted: 2021-10-12
• Results First Posted: 2021-11-10
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefazolin	Cefazolin	-
Saline	Saline Solution	-
Vancomycin	Vancomycin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 Anemia Diagnosis and Surgical Site Infection	6 weeks post-operative	Number of patients with surgical site infections that have anemia
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	6 weeks post-operative	Number of patients with surgical site infections that have chronic obstructive pulmonary 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	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	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	6 weeks post-operative	Number of patients with surgical site infections with double incision ECTR
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	6 weeks post-operative	For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome

Trial Locations

Locations (1)

WellSpan Surgery and Rehab Hospital; 🇺🇸 York, Pennsylvania, United States