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NCT03432858 Clinical Trial

Preoperative Antibiotics for Carpal Tunnel Release Surgery

Carpal Tunnel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03432858
Other study ID # Prophylactic Antibiotics: ESCR
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 17, 2018
Est. completion date December 14, 2020

Study information
Verified date October 2021
Source WellSpan Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 184
Est. completion date December 14, 2020
Est. primary completion date December 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Vancomycin
Vancomycin - 1-gram dosing
• Cefazolin
2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater
• Saline Solution
Placebo

Locations
Country Name City State
United States WellSpan Surgery and Rehab Hospital York Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
WellSpan Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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. 2 weeks post-operative
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. 6 weeks post-operative
Secondary Number of Participants With Diabetes Diagnosis and Surgical Site Infection Number of patients with surgical site infection that have diabetes 2 weeks post-operative
Secondary Number of Participants With Diabetes Diagnosis and Surgical Site Infection Number of patients with surgical site infection that have diabetes 6 weeks post-operative
Secondary 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
Secondary 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
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 2 weeks post-operative
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 6 weeks post-operative
Secondary Number of Participants With Anemia Diagnosis and Surgical Site Infection Number of patients with surgical site infections that have anemia 2 weeks post-operative
Secondary Number of Participants With Anemia Diagnosis and Surgical Site Infection Number of patients with surgical site infections that have anemia 6 weeks post-operative
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 2 weeks post-operative
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 6 weeks post-operative
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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 2 weeks post-operative
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 6 weeks post-operative
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 2 weeks post-operative
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 6 weeks post-operative
Secondary Time From Last Cortisone Injection For patients sustaining surgical site infection, the time from their last cortisone injection 2 weeks post-operative
Secondary Time From Last Cortisone Injection For patients sustaining surgical site infection, the time from their last cortisone injection 6 weeks post-operative
Secondary Acuity of Carpal Tunnel Syndrome For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome 2 weeks post-operative
Secondary Acuity of Carpal Tunnel Syndrome For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome 6 weeks post-operative
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