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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin | Active Comparator |
| |
| Cefazolin | Active Comparator |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | Vancomycin - 1-gram dosing |
| |
| Cefazolin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Diabetes Diagnosis and Surgical Site Infection | Number of patients with surgical site infection that have diabetes | 2 weeks post-operative |
| Number of Participants With Diabetes Diagnosis and Surgical Site Infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WellSpan Surgery and Rehab Hospital | York | Pennsylvania | 17404 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator 1 | Vancomycin: 1-gram dosing |
| FG001 | Active Comparator 2 | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater |
| FG002 | Placebo | Saline Solution: Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator 1 | Vancomycin: 1-gram dosing |
| BG001 | Active Comparator 2 | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 2 weeks post-operative |
|
6 weeks post procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Comparator 1 | Vancomycin: 1-gram dosing | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyogenic granuloma | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Associate | WellSpan Health | (717) 851-7634 | cbush@wellspan.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2018 | Jan 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| D002437 | Cefazolin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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Principal investigator, co-investigators, and participants are blinded to study intervention
| Drug |
2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater |
|
| Saline Solution | Drug | Placebo |
|
Number of patients with surgical site infection that have diabetes
| 6 weeks post-operative |
| Number of Participants With Surgical Site Infections That Use Tobacco | Number of patients with surgical site infections that use tobacco products | 2 weeks post-operative |
| Number of Participants With Surgical Site Infections That Use Tobacco | Number of patients with surgical site infections that use tobacco products | 6 weeks post-operative |
| Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have chronic obstructive pulmonary disease | 2 weeks post-operative |
| Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have chronic obstructive pulmonary disease | 6 weeks post-operative |
| Number of Participants With Anemia Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have anemia | 2 weeks post-operative |
| Number of Participants With Anemia Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have anemia | 6 weeks post-operative |
| Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have peripheral artery disease | 2 weeks post-operative |
| Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have peripheral artery disease | 6 weeks post-operative |
| Number of Participants With Surgical Site Infection and a History of Arthroplasty | Number of patients with surgical site infections with history of arthroplasty | 2 weeks post-operative |
| Number of Participants With Surgical Site Infection and History of Arthroplasty | Number of patients with surgical site infections with history of arthroplasty | 6 weeks post-operative |
| Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections with valvular disease | 2 weeks post-operative |
| Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections with valvular disease | 6 weeks post-operative |
| Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release | Number of patients with surgical site infections with single incision ECTR | 2 weeks post-operative |
| Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release | Number of patients with surgical site infections with single incision ECTR | 6 weeks post-operative |
| Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release | Number of patients with surgical site infections with double incision ECTR | 2 weeks post-operative |
| Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release | Number of patients with surgical site infections with double incision ECTR | 6 weeks post-operative |
| Time From Last Cortisone Injection | For patients sustaining surgical site infection, the time from their last cortisone injection | 2 weeks post-operative |
| Time From Last Cortisone Injection | For patients sustaining surgical site infection, the time from their last cortisone injection | 6 weeks post-operative |
| Acuity of Carpal Tunnel Syndrome | For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome | 2 weeks post-operative |
| Acuity of Carpal Tunnel Syndrome | For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome | 6 weeks post-operative |
| Procedure canceled/rescheduled |
|
| Required postop mobilization with splinting |
|
| BG002 | Placebo | Saline Solution: Placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Saline Solution: Placebo |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 6 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Diabetes Diagnosis and Surgical Site Infection | Number of patients with surgical site infection that have diabetes | Posted | Count of Participants | Participants | 2 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Diabetes Diagnosis and Surgical Site Infection | Number of patients with surgical site infection that have diabetes | Posted | Count of Participants | Participants | 6 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Surgical Site Infections That Use Tobacco | Number of patients with surgical site infections that use tobacco products | Posted | Count of Participants | Participants | 2 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Surgical Site Infections That Use Tobacco | Number of patients with surgical site infections that use tobacco products | Posted | Count of Participants | Participants | 6 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have chronic obstructive pulmonary disease | Posted | Count of Participants | Participants | 2 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have chronic obstructive pulmonary disease | Posted | Count of Participants | Participants | 6 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Anemia Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have anemia | Posted | Count of Participants | Participants | 2 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Anemia Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have anemia | Posted | Count of Participants | Participants | 6 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have peripheral artery disease | Posted | Count of Participants | Participants | 2 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections that have peripheral artery disease | Posted | Count of Participants | Participants | 6 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Surgical Site Infection and a History of Arthroplasty | Number of patients with surgical site infections with history of arthroplasty | Posted | Count of Participants | Participants | 2 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Surgical Site Infection and History of Arthroplasty | Number of patients with surgical site infections with history of arthroplasty | Posted | Count of Participants | Participants | 6 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections with valvular disease | Posted | Count of Participants | Participants | 2 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection | Number of patients with surgical site infections with valvular disease | Posted | Count of Participants | Participants | 6 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release | Number of patients with surgical site infections with single incision ECTR | Posted | Count of Participants | Participants | 2 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release | Number of patients with surgical site infections with single incision ECTR | Posted | Count of Participants | Participants | 6 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release | Number of patients with surgical site infections with double incision ECTR | Posted | Count of Participants | Participants | 2 weeks post-operative |
|
|
|
| Secondary | Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release | Number of patients with surgical site infections with double incision ECTR | Posted | Count of Participants | Participants | 6 weeks post-operative |
|
|
|
| Secondary | Time From Last Cortisone Injection | For patients sustaining surgical site infection, the time from their last cortisone injection | No patients sustained surgical site infections and data were not collected for this Outcome Measure. | Posted | 2 weeks post-operative |
|
|
| Secondary | Time From Last Cortisone Injection | For patients sustaining surgical site infection, the time from their last cortisone injection | No patients sustained surgical site infections and data were not collected for this Outcome Measure. | Posted | 6 weeks post-operative |
|
|
| Secondary | Acuity of Carpal Tunnel Syndrome | For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome | No patients sustained surgical site infections and data were not collected for this Outcome Measure. | Posted | 2 weeks post-operative |
|
|
| Secondary | Acuity of Carpal Tunnel Syndrome | For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome | No patients sustained surgical site infections and data were not collected for this Outcome Measure | Posted | 6 weeks post-operative |
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Active Comparator 2 | Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater | 0 | 72 | 0 | 72 | 0 | 72 |
| EG002 | Placebo | Saline Solution: Placebo | 0 | 72 | 0 | 72 | 2 | 72 |
| Postoperative splinting | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject experienced wrist pain unrelated to wound or procedure. |
|
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |