Clinical Evaluation of Bedside Pulse Lavage Irrigation Device

Not Applicable

Withdrawn

• Conditions: Healthy
• Interventions: Device: Pulsed lavage (Stryker Pulsavac Plus)

• Registration Number: NCT01457183
• Lead Sponsor: Northwestern University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subjects must be healthy and willing to complete the study procedures.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States