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Clinical Evaluation of Bedside Pulse Lavage Irrigation Device

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT01457183
Collaborator
Baxter Healthcare Corporation (Industry)
5
Enrollment
1
Location
1
Arm
12
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates how subjects with intact skin tolerate a water jet (psi 10-12) and how well the water stream is contained by a new containment device.

Condition or Disease Intervention/Treatment Phase
  • Device: Pulsed lavage (Stryker Pulsavac Plus)
 N/A

Detailed Description

Pulse lavage irrigation is an effective method of cleaning both acute and chronic wounds. The major drawback to pulse irrigation is that it is extremely messy and can easily contaminate the patient's surroundings, putting other patients and the person operating the device at risk. In order to obtain the benefits of pulse lavage, we have created a device that will contain the water spray from the lavage and protect both the patient and their surroundings. This study evaluates how well the device contains the spray from pulse lavage and how well subjects with intact skin tolerate pulse lavage when awake.

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Bedside Pulse Lavage Irrigation Project
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lavage group

Healthy subjects with intact skin will be lavaged within the device in 3 locations on their bodies.

Device: Pulsed lavage (Stryker Pulsavac Plus)
Healthy subjects with intact skin will be lavaged through the device for 1 minute on 3 different sites. The stryker pulsavac plus will be used for the lavage.
Other Names:
  • Stryker Pulsavac Plus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Leak [up to 1 day]

      After each lavage treatment, leak will be assessed by the presence of moisture outside of the lavage chamber. The time period of evaluation will take place immediately after the lavage. The subject will not be followed after their visit is complete.

    Secondary Outcome Measures

    1. Seals [up to 1 day]

      After each lavage treatment, the ability of the device to maintain appropriate seals between components will be assessed. The time period of evaluation will take place immediately after the lavage. The subject will not be followed after their visit is complete.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Subjects must be healthy and willing to complete the study procedures.
    Exclusion Criteria:
    • Subjects must not have any chronic pain conditions or take any pain medications on a regular basis. Must not have any chronic wounds. Must not have any medical conditions that interfere with pain sensation. Must not have an allergy to skin adhesives. Patients must not be taking any immunosuppressive medications. Patients must not have any chronic infections.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern Memorial Hospital Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University
    • Baxter Healthcare Corporation

    Investigators

    • Principal Investigator: Robert D Galiano, MD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Galiano, Assistant Professor of Surgery, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT01457183
    Other Study ID Numbers:
    • STU00037071
    • SP0003917
    First Posted:
    Oct 21, 2011
    Last Update Posted:
    Dec 28, 2012
    Last Verified:
    Dec 1, 2012
    Keywords provided by Robert Galiano, Assistant Professor of Surgery, Northwestern University
    pulsed lavage
    evaluate containment
    evaluate tolerability

    Study Results

    No Results Posted as of Dec 28, 2012