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Clinical Evaluation of Bedside Pulse Lavage Irrigation Device

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Northwestern University

Status

Withdrawn

Conditions

Healthy

Treatments

Device: Pulsed lavage (Stryker Pulsavac Plus)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01457183
STU00037071
SP0003917 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Lavage group
Experimental group
Description:
Healthy subjects with intact skin will be lavaged within the device in 3 locations on their bodies.
Treatment:
Device: Pulsed lavage (Stryker Pulsavac Plus)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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