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Preoperative Antibiotics for Carpal Tunnel Release Surgery

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Cefazolin
Saline Solution
Sponsored by
WellSpan Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carpal Tunnel Syndrome focused on measuring Endoscopic Carpal Tunnel Release, Prophylactic Antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • WellSpan Surgery and Rehab Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Vancomycin

Cefazolin

Saline

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Number of Participants With Diabetes Diagnosis and Surgical Site Infection
Number of patients with surgical site infection that have diabetes
Number of Participants With Diabetes Diagnosis and Surgical Site Infection
Number of patients with surgical site infection that have diabetes
Number of Participants With Surgical Site Infections That Use Tobacco
Number of patients with surgical site infections that use tobacco products
Number of Participants With Surgical Site Infections That Use Tobacco
Number of patients with surgical site infections that use tobacco products
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
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
Number of Participants With Anemia Diagnosis and Surgical Site Infection
Number of patients with surgical site infections that have anemia
Number of Participants With Anemia Diagnosis and Surgical Site Infection
Number of patients with surgical site infections that have anemia
Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
Number of patients with surgical site infections that have peripheral artery disease
Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
Number of patients with surgical site infections that have peripheral artery disease
Number of Participants With Surgical Site Infection and a History of Arthroplasty
Number of patients with surgical site infections with history of arthroplasty
Number of Participants With Surgical Site Infection and History of Arthroplasty
Number of patients with surgical site infections with history of arthroplasty
Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
Number of patients with surgical site infections with valvular disease
Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
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
Number of patients with surgical site infections with single incision ECTR
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
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
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
Time From Last Cortisone Injection
For patients sustaining surgical site infection, the time from their last cortisone injection
Time From Last Cortisone Injection
For patients sustaining surgical site infection, the time from their last cortisone injection
Acuity of Carpal Tunnel Syndrome
For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
Acuity of Carpal Tunnel Syndrome
For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome

Full Information

First Posted
February 6, 2018
Last Updated
October 12, 2021
Sponsor
WellSpan Health
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1. Study Identification

Unique Protocol Identification Number
NCT03432858
Brief Title
Preoperative Antibiotics for Carpal Tunnel Release Surgery
Official Title
Endoscopic Carpal Tunnel Release, Infection Incidence, and Prophylactic Antibiotics: Indicated or Kick the Habit?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
December 14, 2020 (Actual)
Study Completion Date
December 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
WellSpan Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Endoscopic Carpal Tunnel Release, Prophylactic Antibiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Principal investigator, co-investigators, and participants are blinded to study intervention
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin
Arm Type
Active Comparator
Arm Title
Cefazolin
Arm Type
Active Comparator
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Vancomycin - 1-gram dosing
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Description
2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With Surgical Site Infection
Description
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.
Time Frame
2 weeks post-operative
Title
Number of Participants With Surgical Site Infection
Description
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.
Time Frame
6 weeks post-operative
Secondary Outcome Measure Information:
Title
Number of Participants With Diabetes Diagnosis and Surgical Site Infection
Description
Number of patients with surgical site infection that have diabetes
Time Frame
2 weeks post-operative
Title
Number of Participants With Diabetes Diagnosis and Surgical Site Infection
Description
Number of patients with surgical site infection that have diabetes
Time Frame
6 weeks post-operative
Title
Number of Participants With Surgical Site Infections That Use Tobacco
Description
Number of patients with surgical site infections that use tobacco products
Time Frame
2 weeks post-operative
Title
Number of Participants With Surgical Site Infections That Use Tobacco
Description
Number of patients with surgical site infections that use tobacco products
Time Frame
6 weeks post-operative
Title
Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection
Description
Number of patients with surgical site infections that have chronic obstructive pulmonary disease
Time Frame
2 weeks post-operative
Title
Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection
Description
Number of patients with surgical site infections that have chronic obstructive pulmonary disease
Time Frame
6 weeks post-operative
Title
Number of Participants With Anemia Diagnosis and Surgical Site Infection
Description
Number of patients with surgical site infections that have anemia
Time Frame
2 weeks post-operative
Title
Number of Participants With Anemia Diagnosis and Surgical Site Infection
Description
Number of patients with surgical site infections that have anemia
Time Frame
6 weeks post-operative
Title
Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
Description
Number of patients with surgical site infections that have peripheral artery disease
Time Frame
2 weeks post-operative
Title
Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
Description
Number of patients with surgical site infections that have peripheral artery disease
Time Frame
6 weeks post-operative
Title
Number of Participants With Surgical Site Infection and a History of Arthroplasty
Description
Number of patients with surgical site infections with history of arthroplasty
Time Frame
2 weeks post-operative
Title
Number of Participants With Surgical Site Infection and History of Arthroplasty
Description
Number of patients with surgical site infections with history of arthroplasty
Time Frame
6 weeks post-operative
Title
Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
Description
Number of patients with surgical site infections with valvular disease
Time Frame
2 weeks post-operative
Title
Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
Description
Number of patients with surgical site infections with valvular disease
Time Frame
6 weeks post-operative
Title
Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release
Description
Number of patients with surgical site infections with single incision ECTR
Time Frame
2 weeks post-operative
Title
Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release
Description
Number of patients with surgical site infections with single incision ECTR
Time Frame
6 weeks post-operative
Title
Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release
Description
Number of patients with surgical site infections with double incision ECTR
Time Frame
2 weeks post-operative
Title
Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release
Description
Number of patients with surgical site infections with double incision ECTR
Time Frame
6 weeks post-operative
Title
Time From Last Cortisone Injection
Description
For patients sustaining surgical site infection, the time from their last cortisone injection
Time Frame
2 weeks post-operative
Title
Time From Last Cortisone Injection
Description
For patients sustaining surgical site infection, the time from their last cortisone injection
Time Frame
6 weeks post-operative
Title
Acuity of Carpal Tunnel Syndrome
Description
For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
Time Frame
2 weeks post-operative
Title
Acuity of Carpal Tunnel Syndrome
Description
For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
Time Frame
6 weeks post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
WellSpan Surgery and Rehab Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Preoperative Antibiotics for Carpal Tunnel Release Surgery

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