Clinical Evaluation of Bedside Pulse Lavage Irrigation Device

Study Overview
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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.

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.

Official Title
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Bedside Pulse Lavage Irrigation Project

Conditions
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Healthy

Intervention / Treatment
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* Device: Pulsed lavage (Stryker Pulsavac Plus)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lavage group<br>Healthy subjects with intact skin will be lavaged within the device in 3 locations on their bodies. | Device: Pulsed lavage (Stryker Pulsavac Plus)<br>* 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.<br>* Other names: Stryker Pulsavac Plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leak | 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. | up to 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seals | 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. | up to 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulsed lavage, evaluate containment, evaluate tolerability