NCT03432858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 17, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 10, 2021

Completed
Last Updated

November 10, 2021

Status Verified

October 1, 2021

Enrollment Period

2.6 years

First QC Date

February 6, 2018

Results QC Date

January 26, 2021

Last Update Submit

October 12, 2021

Conditions

Carpal Tunnel Syndrome

Keywords

Endoscopic Carpal Tunnel ReleaseProphylactic Antibiotics

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (22)

  • Number of Participants With Diabetes Diagnosis and Surgical Site Infection

    2 weeks post-operative

  • Number of Participants With Diabetes Diagnosis and Surgical Site Infection

    6 weeks post-operative

  • Number of Participants With Surgical Site Infections That Use Tobacco

    2 weeks post-operative

  • Number of Participants With Surgical Site Infections That Use Tobacco

    6 weeks post-operative

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

    2 weeks post-operative

  • +17 more secondary outcomes

Study Arms (3)

Vancomycin

ACTIVE COMPARATOR
Drug: Vancomycin

Cefazolin

ACTIVE COMPARATOR
Drug: Cefazolin

Saline

PLACEBO COMPARATOR
Drug: Saline Solution

Interventions

VancomycinDRUG

Vancomycin - 1-gram dosing

Vancomycin
CefazolinDRUG

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

Cefazolin
Saline SolutionDRUG

Placebo

Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WellSpan Surgery and Rehab Hospital

York, Pennsylvania, 17404, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

VancomycinCefazolinSaline Solution

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Clinical Research Associate
Organization
WellSpan Health
cbush@wellspan.org
(717) 851-7634

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Principal investigator, co-investigators, and participants are blinded to study intervention
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon -WellSpan Orthopedics

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 14, 2018

Study Start

May 17, 2018

Primary Completion

December 14, 2020

Study Completion

December 14, 2020

Last Updated

November 10, 2021

Results First Posted

November 10, 2021

Record last verified: 2021-10

Locations

US(1)