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OpenTrials
Completed

NCT Number: NCT03432858

Preoperative Antibiotics for Carpal Tunnel Release Surgery

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

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

WellSpan Surgery and Rehab Hospital

York, Pennsylvania, 17404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin

Drug

Vancomycin - 1-gram dosing

Cefazolin

Drug

2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater

Saline Solution

Drug

Placebo

Primary outcomes

  1. Number of Participants With Surgical Site Infection

    Time frame: 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.

  2. Number of Participants With Surgical Site Infection

    Time frame: 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 outcomes

  1. Number of Participants With Diabetes Diagnosis and Surgical Site Infection

    Time frame: 2 weeks post-operative

    Number of patients with surgical site infection that have diabetes

  2. Number of Participants With Diabetes Diagnosis and Surgical Site Infection

    Time frame: 6 weeks post-operative

    Number of patients with surgical site infection that have diabetes

  3. Number of Participants With Surgical Site Infections That Use Tobacco

    Time frame: 2 weeks post-operative

    Number of patients with surgical site infections that use tobacco products

  4. Number of Participants With Surgical Site Infections That Use Tobacco

    Time frame: 6 weeks post-operative

    Number of patients with surgical site infections that use tobacco products

  5. Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection

    Time frame: 2 weeks post-operative

    Number of patients with surgical site infections that have chronic obstructive pulmonary disease

  6. Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection

    Time frame: 6 weeks post-operative

    Number of patients with surgical site infections that have chronic obstructive pulmonary disease

  7. Number of Participants With Anemia Diagnosis and Surgical Site Infection

    Time frame: 2 weeks post-operative

    Number of patients with surgical site infections that have anemia

  8. Number of Participants With Anemia Diagnosis and Surgical Site Infection

    Time frame: 6 weeks post-operative

    Number of patients with surgical site infections that have anemia

  9. Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection

    Time frame: 2 weeks post-operative

    Number of patients with surgical site infections that have peripheral artery disease

  10. Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection

    Time frame: 6 weeks post-operative

    Number of patients with surgical site infections that have peripheral artery disease

  11. Number of Participants With Surgical Site Infection and a History of Arthroplasty

    Time frame: 2 weeks post-operative

    Number of patients with surgical site infections with history of arthroplasty

  12. Number of Participants With Surgical Site Infection and History of Arthroplasty

    Time frame: 6 weeks post-operative

    Number of patients with surgical site infections with history of arthroplasty

  13. Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection

    Time frame: 2 weeks post-operative

    Number of patients with surgical site infections with valvular disease

  14. Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection

    Time frame: 6 weeks post-operative

    Number of patients with surgical site infections with valvular disease

  15. Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release

    Time frame: 2 weeks post-operative

    Number of patients with surgical site infections with single incision ECTR

  16. Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release

    Time frame: 6 weeks post-operative

    Number of patients with surgical site infections with single incision ECTR

  17. Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release

    Time frame: 2 weeks post-operative

    Number of patients with surgical site infections with double incision ECTR

  18. Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release

    Time frame: 6 weeks post-operative

    Number of patients with surgical site infections with double incision ECTR

  19. Time From Last Cortisone Injection

    Time frame: 2 weeks post-operative

    For patients sustaining surgical site infection, the time from their last cortisone injection

  20. Time From Last Cortisone Injection

    Time frame: 6 weeks post-operative

    For patients sustaining surgical site infection, the time from their last cortisone injection

  21. Acuity of Carpal Tunnel Syndrome

    Time frame: 2 weeks post-operative

    For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome

  22. Acuity of Carpal Tunnel Syndrome

    Time frame: 6 weeks post-operative

    For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome

Sponsors and collaborators

Lead sponsor

WellSpan Health

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 14, 2018
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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