Preoperative Antibiotics for Carpal Tunnel Release Surgery

Sponsor
WellSpan Health (Other)
Overall Status
Completed
CT.gov ID
NCT03432858
Collaborator
(none)
184
1
3
30.9
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
184 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Principal investigator, co-investigators, and participants are blinded to study intervention
Primary Purpose:
Prevention
Official Title:
Endoscopic Carpal Tunnel Release, Infection Incidence, and Prophylactic Antibiotics: Indicated or Kick the Habit?
Actual Study Start Date :
May 17, 2018
Actual Primary Completion Date :
Dec 14, 2020
Actual Study Completion Date :
Dec 14, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Vancomycin

Drug: Vancomycin
Vancomycin - 1-gram dosing

Active Comparator: Cefazolin

Drug: Cefazolin
2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater

Placebo Comparator: Saline

Drug: Saline Solution
Placebo

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Surgical Site Infection [2 weeks post-operative]

    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. Number of Participants With Surgical Site Infection [6 weeks post-operative]

    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.

Secondary Outcome Measures

  1. Number of Participants With Diabetes Diagnosis and Surgical Site Infection [2 weeks post-operative]

    Number of patients with surgical site infection that have diabetes

  2. Number of Participants With Diabetes Diagnosis and Surgical Site Infection [6 weeks post-operative]

    Number of patients with surgical site infection that have diabetes

  3. Number of Participants With Surgical Site Infections That Use Tobacco [2 weeks post-operative]

    Number of patients with surgical site infections that use tobacco products

  4. Number of Participants With Surgical Site Infections That Use Tobacco [6 weeks post-operative]

    Number of patients with surgical site infections that use tobacco products

  5. Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection [2 weeks post-operative]

    Number of patients with surgical site infections that have chronic obstructive pulmonary disease

  6. Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection [6 weeks post-operative]

    Number of patients with surgical site infections that have chronic obstructive pulmonary disease

  7. Number of Participants With Anemia Diagnosis and Surgical Site Infection [2 weeks post-operative]

    Number of patients with surgical site infections that have anemia

  8. Number of Participants With Anemia Diagnosis and Surgical Site Infection [6 weeks post-operative]

    Number of patients with surgical site infections that have anemia

  9. Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection [2 weeks post-operative]

    Number of patients with surgical site infections that have peripheral artery disease

  10. Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection [6 weeks post-operative]

    Number of patients with surgical site infections that have peripheral artery disease

  11. Number of Participants With Surgical Site Infection and a History of Arthroplasty [2 weeks post-operative]

    Number of patients with surgical site infections with history of arthroplasty

  12. Number of Participants With Surgical Site Infection and History of Arthroplasty [6 weeks post-operative]

    Number of patients with surgical site infections with history of arthroplasty

  13. Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection [2 weeks post-operative]

    Number of patients with surgical site infections with valvular disease

  14. Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection [6 weeks post-operative]

    Number of patients with surgical site infections with valvular disease

  15. Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release [2 weeks post-operative]

    Number of patients with surgical site infections with single incision ECTR

  16. Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release [6 weeks post-operative]

    Number of patients with surgical site infections with single incision ECTR

  17. Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release [2 weeks post-operative]

    Number of patients with surgical site infections with double incision ECTR

  18. Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release [6 weeks post-operative]

    Number of patients with surgical site infections with double incision ECTR

  19. Time From Last Cortisone Injection [2 weeks post-operative]

    For patients sustaining surgical site infection, the time from their last cortisone injection

  20. Time From Last Cortisone Injection [6 weeks post-operative]

    For patients sustaining surgical site infection, the time from their last cortisone injection

  21. Acuity of Carpal Tunnel Syndrome [2 weeks post-operative]

    For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome

  22. Acuity of Carpal Tunnel Syndrome [6 weeks post-operative]

    For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 WellSpan Surgery and Rehab Hospital York Pennsylvania United States 17404

Sponsors and Collaborators

  • WellSpan Health

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Richard C Trevino, MD, Orthopedic Surgeon -WellSpan Orthopedics, WellSpan Health
ClinicalTrials.gov Identifier:
NCT03432858
Other Study ID Numbers:
  • Prophylactic Antibiotics: ESCR
First Posted:
Feb 14, 2018
Last Update Posted:
Nov 10, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Richard C Trevino, MD, Orthopedic Surgeon -WellSpan Orthopedics, WellSpan Health
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Period Title: Overall Study
STARTED 12 83 89
COMPLETED 10 72 72
NOT COMPLETED 2 11 17

Baseline Characteristics

Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo Total
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo Total of all reporting groups
Overall Participants 10 72 72 154
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
5
50%
47
65.3%
51
70.8%
103
66.9%
>=65 years
5
50%
25
34.7%
21
29.2%
51
33.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
68.6
(14.10)
59.0
(15.37)
55.8
(16.36)
57.5
(15.70)
Sex: Female, Male (Count of Participants)
Female
7
70%
46
63.9%
47
65.3%
100
64.9%
Male
3
30%
26
36.1%
25
34.7%
54
35.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
5
6.9%
10
13.9%
15
9.7%
Not Hispanic or Latino
10
100%
66
91.7%
62
86.1%
138
89.6%
Unknown or Not Reported
0
0%
1
1.4%
0
0%
1
0.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
Black or African American
2
20%
2
2.8%
3
4.2%
7
4.5%
White
8
80%
66
91.7%
59
81.9%
133
86.4%
More than one race
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
4
5.6%
10
13.9%
14
9.1%
Region of Enrollment (participants) [Number]
United States
10
100%
72
100%
72
100%
154
100%

Outcome Measures

1. Primary Outcome
Title Number of Participants With Surgical Site Infection
Description 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.
Time Frame 2 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
2. Primary Outcome
Title Number of Participants With Surgical Site Infection
Description 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.
Time Frame 6 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
3. Secondary Outcome
Title Number of Participants With Diabetes Diagnosis and Surgical Site Infection
Description Number of patients with surgical site infection that have diabetes
Time Frame 2 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
4. Secondary Outcome
Title Number of Participants With Diabetes Diagnosis and Surgical Site Infection
Description Number of patients with surgical site infection that have diabetes
Time Frame 6 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
5. Secondary Outcome
Title Number of Participants With Surgical Site Infections That Use Tobacco
Description Number of patients with surgical site infections that use tobacco products
Time Frame 2 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
6. Secondary Outcome
Title Number of Participants With Surgical Site Infections That Use Tobacco
Description Number of patients with surgical site infections that use tobacco products
Time Frame 6 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
7. Secondary Outcome
Title Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection
Description Number of patients with surgical site infections that have chronic obstructive pulmonary disease
Time Frame 2 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
8. Secondary Outcome
Title Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection
Description Number of patients with surgical site infections that have chronic obstructive pulmonary disease
Time Frame 6 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
9. Secondary Outcome
Title Number of Participants With Anemia Diagnosis and Surgical Site Infection
Description Number of patients with surgical site infections that have anemia
Time Frame 2 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
10. Secondary Outcome
Title Number of Participants With Anemia Diagnosis and Surgical Site Infection
Description Number of patients with surgical site infections that have anemia
Time Frame 6 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
11. Secondary Outcome
Title Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
Description Number of patients with surgical site infections that have peripheral artery disease
Time Frame 2 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
12. Secondary Outcome
Title Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
Description Number of patients with surgical site infections that have peripheral artery disease
Time Frame 6 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
13. Secondary Outcome
Title Number of Participants With Surgical Site Infection and a History of Arthroplasty
Description Number of patients with surgical site infections with history of arthroplasty
Time Frame 2 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
14. Secondary Outcome
Title Number of Participants With Surgical Site Infection and History of Arthroplasty
Description Number of patients with surgical site infections with history of arthroplasty
Time Frame 6 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
15. Secondary Outcome
Title Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
Description Number of patients with surgical site infections with valvular disease
Time Frame 2 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
16. Secondary Outcome
Title Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
Description Number of patients with surgical site infections with valvular disease
Time Frame 6 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
17. Secondary Outcome
Title Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release
Description Number of patients with surgical site infections with single incision ECTR
Time Frame 2 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
18. Secondary Outcome
Title Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release
Description Number of patients with surgical site infections with single incision ECTR
Time Frame 6 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
19. Secondary Outcome
Title Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release
Description Number of patients with surgical site infections with double incision ECTR
Time Frame 2 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
20. Secondary Outcome
Title Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release
Description Number of patients with surgical site infections with double incision ECTR
Time Frame 6 weeks post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 10 72 72
Count of Participants [Participants]
0
0%
0
0%
0
0%
21. Secondary Outcome
Title Time From Last Cortisone Injection
Description For patients sustaining surgical site infection, the time from their last cortisone injection
Time Frame 2 weeks post-operative

Outcome Measure Data

Analysis Population Description
No patients sustained surgical site infections and data were not collected for this Outcome Measure.
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 0 0 0
22. Secondary Outcome
Title Time From Last Cortisone Injection
Description For patients sustaining surgical site infection, the time from their last cortisone injection
Time Frame 6 weeks post-operative

Outcome Measure Data

Analysis Population Description
No patients sustained surgical site infections and data were not collected for this Outcome Measure.
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 0 0 0
23. Secondary Outcome
Title Acuity of Carpal Tunnel Syndrome
Description For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
Time Frame 2 weeks post-operative

Outcome Measure Data

Analysis Population Description
No patients sustained surgical site infections and data were not collected for this Outcome Measure.
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 0 0 0
24. Secondary Outcome
Title Acuity of Carpal Tunnel Syndrome
Description For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
Time Frame 6 weeks post-operative

Outcome Measure Data

Analysis Population Description
No patients sustained surgical site infections and data were not collected for this Outcome Measure
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
Measure Participants 0 0 0

Adverse Events

Time Frame 6 weeks post procedure
Adverse Event Reporting Description
Arm/Group Title Active Comparator 1 Active Comparator 2 Placebo
Arm/Group Description Vancomycin: 1-gram dosing Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater Saline Solution: Placebo
All Cause Mortality
Active Comparator 1 Active Comparator 2 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/10 (0%) 0/72 (0%) 0/72 (0%)
Serious Adverse Events
Active Comparator 1 Active Comparator 2 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/10 (0%) 0/72 (0%) 0/72 (0%)
Other (Not Including Serious) Adverse Events
Active Comparator 1 Active Comparator 2 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/10 (0%) 0/72 (0%) 2/72 (2.8%)
Musculoskeletal and connective tissue disorders
Postoperative splinting 0/10 (0%) 0/72 (0%) 1/72 (1.4%) 1
Vascular disorders
Pyogenic granuloma 0/10 (0%) 0/72 (0%) 1/72 (1.4%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Clinical Research Associate
Organization WellSpan Health
Phone (717) 851-7634
Email cbush@wellspan.org
Responsible Party:
Richard C Trevino, MD, Orthopedic Surgeon -WellSpan Orthopedics, WellSpan Health
ClinicalTrials.gov Identifier:
NCT03432858
Other Study ID Numbers:
  • Prophylactic Antibiotics: ESCR
First Posted:
Feb 14, 2018
Last Update Posted:
Nov 10, 2021
Last Verified:
Oct 1, 2021