Clinical trial NCT03432858: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Keywords: Endoscopic Carpal Tunnel Release
Prophylactic Antibiotics
Lead sponsor: WellSpan Health
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants With Surgical Site Infection
timeFrame: 2 weeks post-operative
measure: Number of Participants With Surgical Site Infection
timeFrame: 6 weeks post-operative
Secondary outcomes:
measure: Number of Participants With Diabetes Diagnosis and Surgical Site Infection
timeFrame: 2 weeks post-operative
measure: Number of Participants With Diabetes Diagnosis and Surgical Site Infection
timeFrame: 6 weeks post-operative
measure: Number of Participants With Surgical Site Infections That Use Tobacco
timeFrame: 2 weeks post-operative
measure: Number of Participants With Surgical Site Infections That Use Tobacco
timeFrame: 6 weeks post-operative
measure: Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection
timeFrame: 2 weeks post-operative
measure: Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection
timeFrame: 6 weeks post-operative
measure: Number of Participants With Anemia Diagnosis and Surgical Site Infection
timeFrame: 2 weeks post-operative
measure: Number of Participants With Anemia Diagnosis and Surgical Site Infection
timeFrame: 6 weeks post-operative
measure: Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
timeFrame: 2 weeks post-operative
measure: Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
timeFrame: 6 weeks post-operative
measure: Number of Participants With Surgical Site Infection and a History of Arthroplasty
timeFrame: 2 weeks post-operative
measure: Number of Participants With Surgical Site Infection and History of Arthroplasty
timeFrame: 6 weeks post-operative
measure: Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
timeFrame: 2 weeks post-operative
measure: Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
timeFrame: 6 weeks post-operative
measure: Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release
timeFrame: 2 weeks post-operative
measure: Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release
timeFrame: 6 weeks post-operative
measure: Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release
timeFrame: 2 weeks post-operative
measure: Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release
timeFrame: 6 weeks post-operative
measure: Time From Last Cortisone Injection
timeFrame: 2 weeks post-operative
measure: Time From Last Cortisone Injection
timeFrame: 6 weeks post-operative
measure: Acuity of Carpal Tunnel Syndrome
timeFrame: 2 weeks post-operative
measure: Acuity of Carpal Tunnel Syndrome
timeFrame: 6 weeks post-operative
Other outcomes:
Locations:
city: York
country: United States
facility: WellSpan Surgery and Rehab Hospital
state: Pennsylvania
Study officials:
References: