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Preoperative Antibiotics for Carpal Tunnel Release Surgery

NCT ID: NCT03432858

Last Updated: 2021-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-17

Study Completion Date

2020-12-14

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome

Keywords

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Endoscopic Carpal Tunnel Release Prophylactic Antibiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Principal investigator, co-investigators, and participants are blinded to study intervention

Study Groups

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Vancomycin

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Vancomycin - 1-gram dosing

Cefazolin

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

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

Saline

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type DRUG

Placebo

Interventions

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Vancomycin

Vancomycin - 1-gram dosing

Intervention Type DRUG

Cefazolin

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

Intervention Type DRUG

Saline Solution

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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WellSpan Health

OTHER

Sponsor Role lead

Responsible Party

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Richard C Trevino, MD

Orthopedic Surgeon -WellSpan Orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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WellSpan Surgery and Rehab Hospital

York, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Prophylactic Antibiotics: ESCR

Identifier Type: -

Identifier Source: org_study_id