Preoperative Antibiotics for Carpal Tunnel Release Surgery

WellSpan Health

Status and phase: Completed; Phase 4

Conditions: Carpal Tunnel Syndrome

Treatments: Drug: Vancomycin; Drug: Cefazolin; Drug: Saline Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03432858

Prophylactic Antibiotics: ESCR

Details and patient eligibility

About

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

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 3 patient groups, including a placebo group

Vancomycin

Active Comparator group

Treatment:

Drug: Vancomycin

Cefazolin

Active Comparator group

Treatment:

Drug: Cefazolin

Saline

Placebo Comparator group

Treatment:

Drug: Saline Solution