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Preoperative Antibiotics for Carpal Tunnel Release Surgery

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ClinicalTrials.gov Identifier: NCT03432858
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Richard Trevino, 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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: Vancomycin Drug: Cefazolin Drug: Saline Solution Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Principal investigator, co-investigators, and participants are blinded to study intervention
Primary Purpose: Prevention
Official Title: Endoscopic Carpal Tunnel Release, Infection Incidence, and Prophylactic Antibiotics: Indicated or Kick the Habit?
Actual Study Start Date : May 17, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Active Comparator: Vancomycin Drug: Vancomycin
Vancomycin - 1-gram dosing

Active Comparator: Cefazolin Drug: Cefazolin
2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater

Placebo Comparator: Saline Drug: Saline Solution
Placebo




Primary Outcome Measures :
  1. 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. 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 Outcome Measures :
  1. Diabetes diagnosis [ Time Frame: 2 weeks post-operative ]
    Proportion of patients with surgical site infection that have diabetes

  2. Diabetes diagnosis [ Time Frame: 6 weeks post-operative ]
    Proportion of patients with surgical site infection that have diabetes

  3. Tobacco use [ Time Frame: 2 weeks post-operative ]
    Proportion of patients with surgical site infections that use tobacco products

  4. Tobacco use [ Time Frame: 6 weeks post-operative ]
    Proportion of patients with surgical site infections that use tobacco products

  5. COPD [ Time Frame: 2 weeks post-operative ]
    Proportion of patients with surgical site infections that have COPD

  6. COPD [ Time Frame: 6 weeks post-operative ]
    Proportion of patients with surgical site infections that have COPD

  7. Anemia [ Time Frame: 2 weeks post-operative ]
    Proportion of patients with surgical site infections that have anemia

  8. Anemia [ Time Frame: 6 weeks post-operative ]
    Proportion of patients with surgical site infections that have anemia

  9. Peripheral artery disease [ Time Frame: 2 weeks post-operative ]
    Proportion of patients with surgical site infections that have peripheral artery disease

  10. Peripheral artery disease [ Time Frame: 6 weeks post-operative ]
    Proportion of patients with surgical site infections that have peripheral artery disease

  11. History of arthroplasty [ Time Frame: 2 weeks post-operative ]
    Proportion of patients with surgical site infections with history of arthroplasty

  12. History of arthroplasty [ Time Frame: 6 weeks post-operative ]
    Proportion of patients with surgical site infections with history of arthroplasty

  13. Valvular Disease [ Time Frame: 2 weeks post-operative ]
    Proportion of patients with surgical site infections with valvular disease

  14. Valvular Disease [ Time Frame: 6 weeks post-operative ]
    Proportion of patients with surgical site infections with valvular disease

  15. Single Incision ECTR [ Time Frame: 2 weeks post-operative ]
    Proportion of patients with surgical site infections with single incision ECTR

  16. Single Incision ECTR [ Time Frame: 6 weeks post-operative ]
    Proportion of patients with surgical site infections with single incision ECTR

  17. Double Incision ECTR [ Time Frame: 2 weeks post-operative ]
    Proportion of patients with surgical site infections with double incision ECTR

  18. Double Incision ECTR [ Time Frame: 6 weeks post-operative ]
    Proportion 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 SSI, the time from their last cortisone injection

  20. Time from last cortisone injection [ Time Frame: 6 weeks post-operative ]
    For patients sustaining SSI, the time from their last cortisone injection

  21. Acuity of CTS [ Time Frame: 2 weeks post-operative ]
    For patients sustaining SSI, the acuity of their CTS

  22. Acuity of CTS [ Time Frame: 6 weeks post-operative ]
    For patients sustaining SSI, the acuity of their CTS



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432858


Contacts
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Contact: Richard Trevino, MD (717) 812-4090 rtrevino2@wellspan.org

Locations
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United States, Pennsylvania
WellSpan Surgery and Rehab Hospital Recruiting
York, Pennsylvania, United States, 17404
Contact: Richard Trevino, MD    717-812-4090    rtrevino2@wellspan.org   
Sponsors and Collaborators
WellSpan Health

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Responsible Party: Richard Trevino, Orthopedic Surgeon -WellSpan Orthopedics, WellSpan Health
ClinicalTrials.gov Identifier: NCT03432858     History of Changes
Other Study ID Numbers: Prophylactic Antibiotics: ESCR
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Trevino, WellSpan Health:
Endoscopic Carpal Tunnel Release
Prophylactic Antibiotics
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Anti-Bacterial Agents
Vancomycin
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents