Carpal Tunnel SyndromePhase 4NCT03432858

Preoperative Antibiotics for Carpal Tunnel Release Surgery

A Phase 4 study testing Vancomycin, Cefazolin and Saline Solution in people with Carpal Tunnel Syndrome, run by WellSpan Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carpal Tunnel Syndrome
What is being tested?: Vancomycin, Cefazolin and Saline Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 184 participants
Where: 1 siteUnited States
Study dates: 17 May 2018to 14 Dec 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

WellSpan Surgery and Rehab Hospital
York, Pennsylvania, 17404

Other trials in United States

About this study

Official title: Endoscopic Carpal Tunnel Release, Infection Incidence, and Prophylactic Antibiotics: Indicated or Kick the Habit?

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

Read the 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.

Conditions: Carpal Tunnel Syndrome
Being tested: Vancomycin, Cefazolin, Saline Solution
Keywords: Endoscopic Carpal Tunnel Release, Prophylactic Antibiotics
Medical subject headings: Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VancomycinDrug
Vancomycin - 1-gram dosing
CefazolinDrug
2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater
Saline SolutionDrug
Placebo

Study groups in NCT03432858
Study group	Role	What they receive
Vancomycin	Active comparator	Not described Receives: Drug: Vancomycin
Cefazolin	Active comparator	Not described Receives: Drug: Cefazolin
Saline	Placebo comparator	Not described Receives: Drug: Saline Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 6 weeks post-operative

Secondary outcomes (22)

Number of Participants With Diabetes Diagnosis and Surgical Site Infection
Number of patients with surgical site infection that have diabetes
Measured: 2 weeks post-operative
Number of Participants With Diabetes Diagnosis and Surgical Site Infection
Number of patients with surgical site infection that have diabetes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 weeks post-operative
Number of Participants With Anemia Diagnosis and Surgical Site Infection
Number of patients with surgical site infections that have anemia
Measured: 2 weeks post-operative
Number of Participants With Anemia Diagnosis and Surgical Site Infection
Number of patients with surgical site infections that have anemia
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 weeks post-operative
Time From Last Cortisone Injection
For patients sustaining surgical site infection, the time from their last cortisone injection
Measured: 2 weeks post-operative
Time From Last Cortisone Injection
For patients sustaining surgical site infection, the time from their last cortisone injection
Measured: 6 weeks post-operative
Acuity of Carpal Tunnel Syndrome
For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
Measured: 2 weeks post-operative
Acuity of Carpal Tunnel Syndrome
For patients sustaining surgical site infection, the acuity of their carpal tunnel syndrome
Measured: 6 weeks post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 201814 Dec 2020

First posted14 Feb 2018
Study start17 May 2018
Primary completion14 Dec 2020
Study completion14 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03432858
Sponsor's protocol ID: Prophylactic Antibiotics: ESCR
Status last verified: Oct 2021
First submitted: 6 Feb 2018
Last updated: 10 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery

All Carpal Tunnel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Endoscopic Carpal Tunnel Release, Infection Incidence, and Prophylactic Antibiotics: Indicated or Kick the Habit?
ClinicalTrials.gov ID: NCT03432858
Acronym / sponsor ID: Prophylactic Antibiotics: ESCR
Conditions: Carpal Tunnel Syndrome
Keywords: Endoscopic Carpal Tunnel Release, Prophylactic Antibiotics
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: WellSpan HealthUniversity, hospital or other
Study start: 17 May 2018 (actual)
Primary completion: 14 Dec 2020 (actual)
Study completion: 14 Dec 2020 (actual)
First posted: 14 Feb 2018 (actual)
Results: Posted 10 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Vancomycin	Active comparator	Drug: Vancomycin
Cefazolin	Active comparator	Drug: Cefazolin
Saline	Placebo comparator	Drug: Saline Solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VancomycinVancomycin - 1-gram dosing	Drug	Vancomycin
Cefazolin2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater	Drug	Cefazolin
Saline SolutionPlacebo	Drug	Saline

Primary outcome

Number of Participants With Surgical Site Infection
Time frame: 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.
Number of Participants With Surgical Site Infection
Time frame: 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.

22 secondary outcomes

Number of Participants With Diabetes Diagnosis and Surgical Site Infection
Time frame: 2 weeks post-operative
Number of Participants With Diabetes Diagnosis and Surgical Site Infection
Time frame: 6 weeks post-operative
Number of Participants With Surgical Site Infections That Use Tobacco
Time frame: 2 weeks post-operative
Number of Participants With Surgical Site Infections That Use Tobacco
Time frame: 6 weeks post-operative
Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection
Time frame: 2 weeks post-operative
Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection
Time frame: 6 weeks post-operative
Number of Participants With Anemia Diagnosis and Surgical Site Infection
Time frame: 2 weeks post-operative
Number of Participants With Anemia Diagnosis and Surgical Site Infection
Time frame: 6 weeks post-operative
Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
Time frame: 2 weeks post-operative
Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection
Time frame: 6 weeks post-operative
Number of Participants With Surgical Site Infection and a History of Arthroplasty
Time frame: 2 weeks post-operative
Number of Participants With Surgical Site Infection and History of Arthroplasty
Time frame: 6 weeks post-operative
Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
Time frame: 2 weeks post-operative
Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection
Time frame: 6 weeks post-operative
Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release
Time frame: 2 weeks post-operative
Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release
Time frame: 6 weeks post-operative
Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release
Time frame: 2 weeks post-operative
Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release
Time frame: 6 weeks post-operative
Time From Last Cortisone Injection
Time frame: 2 weeks post-operative
Time From Last Cortisone Injection
Time frame: 6 weeks post-operative
Acuity of Carpal Tunnel Syndrome
Time frame: 2 weeks post-operative
Acuity of Carpal Tunnel Syndrome
Time frame: 6 weeks post-operative

Results and safety

Results posted to the registry on 10 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Comparator 1	12	10
Active Comparator 2	83	72
Placebo	89	72

Primary outcome: Number of Participants With Surgical Site Infection

Time frame: 2 weeks post-operative. Count of participants. Unit: Participants

Measure	Active Comparator 1 n = 10	Active Comparator 2 n = 72	Placebo n = 72
Value	0	0	0

Primary outcome: Number of Participants With Surgical Site Infection

Time frame: 6 weeks post-operative. Count of participants. Unit: Participants

Measure	Active Comparator 1 n = 10	Active Comparator 2 n = 72	Placebo n = 72
Value	0	0	0

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks post procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Comparator 1	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Active Comparator 2	0 of 72 (0%)	0 of 72 (0%)	0 of 72
Placebo	0 of 72 (0%)	2 of 72 (2.8%)	0 of 72

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Carpal Tunnel Syndrome

Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vancomycin, Cefazolin and Saline Solution in people with Carpal Tunnel Syndrome, run by WellSpan Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Surgical Site Infection (time frame: 2 weeks post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03432858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.