NCT01457183

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2011

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

October 13, 2011

Last Update Submit

December 5, 2022

Conditions

Healthy

Keywords

pulsed lavageevaluate containmentevaluate tolerability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Seals

    up to 1 day

Study Arms (1)

Lavage group

EXPERIMENTAL

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

Device: Pulsed lavage (Stryker Pulsavac Plus)

Interventions

Pulsed lavage (Stryker Pulsavac Plus)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.

Also known as: Stryker Pulsavac Plus
Lavage group

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Robert D Galiano, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 21, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations

US(1)