Preoperative Antibiotics for Carpal Tunnel Release Surgery

W

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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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