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Fluid Immersion Simulation System (FIS) for Pressure Sore

N/A
Waitlist Available
Led By Robert D Galiano, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial is comparing two methods of treating an open wound. The first is using a FIS, or a "fibrin sealant," and the second is using AFB, or "autologous fibrin glue." They will be comparing the closure rate of the wound after two weeks.

Eligible Conditions
  • Pressure Sore

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery
Secondary outcome measures
Differences in Quantitative Nurse Survey Responses
Differences in Quantitative Patient Survey Responses: Acceptability
Number of Participants With Complications

Trial Design

2Treatment groups
Active Control
Group I: Fluid Immersion Simulation System (FIS)Active Control1 Intervention
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Group II: Air Fluidized Bed System (AFB)Active Control1 Intervention
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
917,171 Total Patients Enrolled
Robert D Galiano, MDPrincipal InvestigatorNorthwestern Medicine
5 Previous Clinical Trials
3,688 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers
Robert Galiano 2015. "Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03522714.
~8 spots leftby Apr 2025
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