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NCT01411891 · ClinicalTrials.gov registry record · Phase 4

Post-Operative Colonization Rates of Femoral Nerve Catheters Treated With Chlorhexidine-Impregnated Patch

A Phase 4 study, sponsored by University of Wisconsin, Madison.

Completed
Registry status
Phase 4
Development phase
100
Enrollment target

NCT01411891: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.

NCT01411891 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01411891, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Phase 4
Development phase
100 participants
Enrollment target

Study Summary

Joint replacement is becoming an increasingly common procedure. In 2005, 534,000 total knee arthroplasties (TKA) were performed in the United States which is at a rate of 18.1 per 10,000 individuals, and the demand for primary TKA is projected to grow by 673% by 2030. Effective post-operative analgesia is an important component with regards to patient satisfaction and hospital stay. Regional anesthesia has been shown to decrease duration of surgery, need for transfusion, post-operative nausea and vomiting, and the incidence of thromboembolic disease in patients undergoing total knee or total hip replacement when compared with general anesthesia. Post-operatively, regional anesthesia has been shown to reduce pain scores and/or morphine consumption as well as opioid-related adverse effects. Epidural catheter or spinal anesthesia has become the standard of care at the University of Wisconsin-Madison for intraoperative management of TKA patients. General anesthesia is still occasionally used for patients that would strongly prefer a general anesthetic, those that are taking anticoagulation medications or with a coagulopathy, those with previous back surgery, and those with certain neurologic conditions such as multiple sclerosis or spina bifida. Comparison studies between lumbar epidural analgesia and femoral nerve catheters (FNC) for postoperative analgesia following TKA show no significant difference in pain scores, morphine consumption, or post-operative nausea and vomiting. However, epidural analgesia has been associated with higher incidence of hypotension and urinary retention. FNC's placed for postoperative pain allow patients to ambulate more effectively as there should not be much of a lower extremity motor block. Patients with a FNC for postoperative analgesia also do not require a urinary catheter which eliminates a common source of infection in postoperative patients. FNCs have also demonstrated improved rehabilitation times and decreased hospital stays whi

Primary Outcome

Three cm of the for research purposes only, a 3 cm distal portion will be cut using sterile scissors into a sterile container, and sent to the lab for culture in a sterile container. The catheter segments will be rolled onto blood agar plates at 35°C under aerobic and anaerobic conditions. Number of colonies will be counted at 1 week. The peripheral nerve catheter tip will be considered colonized if the culture yields 15 or greater colony forming units.

Interventions

  • DEVICE Chlorhexidine impregnated patch (Biopatch)

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2011-08
Est. Completion 2012-04
Phase Phase 4
University of Wisconsin, Madison

1,039 total trials

What the finished NCT01411891 record still lists

NCT01411891 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 1 intervention - of which Chlorhexidine impregnated patch (Biopatch) is the first listed.

NCT01411891 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01411891 about?

NCT01411891 is a clinical study titled "Post-Operative Colonization Rates of Femoral Nerve Catheters Treated With Chlorhexidine-Impregnated Patch". Joint replacement is becoming an increasingly common procedure. In 2005, 534,000 total knee arthroplasties (TKA) were performed in the United States which is at a rate of 18.1 per 10,000 individuals, and the demand for primary TKA is projected to grow by 673% by 2030. Effective post-operative analge...

What is the current status of trial NCT01411891?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2011-08. Estimated completion is 2012-04.

What interventions are being tested in trial NCT01411891?

The interventions under investigation include: Chlorhexidine impregnated patch (Biopatch) (DEVICE).

Who is sponsoring clinical trial NCT01411891?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01411891's enrollment target sits among peer trials

100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01411891, the US trial registry maintained by the National Library of Medicine. NCT01411891 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.