Clinical Evaluation of Bedside Pulse Lavage Irrigation Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Lavage group

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

Group Type EXPERIMENTAL

Pulsed lavage (Stryker Pulsavac Plus)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Stryker Pulsavac Plus

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes