Preoperative Antibiotics for Carpal Tunnel Release Surgery

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

This is a clinical trial to determine how effective antibiotics administered prior to endoscopic carpal tunnel release surgery are in preventing surgical site infections.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: Saline Solution; Drug: Vancomycin; Drug: Cefazolin

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 Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • York, Pennsylvania, United States, 17404
      • WellSpan Surgery and Rehab Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: WellSpan Health

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2018
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): December 14, 2020

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Prophylactic Antibiotics; Endoscopic Carpal Tunnel Release
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin; Cefazolin
• Other Study ID Numbers: Prophylactic Antibiotics: ESCR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No