Healthy
Conditions
Keywords
pulsed lavage, evaluate containment, evaluate tolerability
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.
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.
Interventions
DEVICEPulsed 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.
Sponsors
Baxter Healthcare Corporation
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed