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Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers

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ClinicalTrials.gov Identifier: NCT03522714
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Northwestern University

Brief Summary:
The primary objective is to compare the efficacy of the FIS on closure rate to the AFB after 2 weeks of operative debridement and closure.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Device: Fluid Immersion Simulation System Device: Air Fluidized Bed System Not Applicable

Detailed Description:

Secondary Objectives:

  1. Compare the complication rate in each treatment group during the acute postoperative period (2 weeks).
  2. Comparisons of the inflammatory and bacterial microbiomes of pressure ulcers following surgical therapy.
  3. Comparisons of baseline patient characteristics and their relationship to both early and late pressure ulcer recurrence, and complication rates.
  4. Assessment of outcomes and complications associated with flap technique and surgeon guided descriptions of the operative closure.
  5. Compare the absolute costs associated with the FIS System against AFB system.
  6. Compare the acceptance of each system by subjects and nursing staff, including the parameter of patient comfort at 7 and 14 days postoperative.
  7. Assessing the incidence of complications and additional treatments needed following the two week study period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 allocation ratio
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Controlled Trial Evaluating the Effectiveness of the Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System in the Acute Post-Operative Management of Surgically Closed Pressure Ulcers
Actual Study Start Date : August 8, 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Active Comparator: Fluid Immersion Simulation System (FIS)
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Device: Fluid Immersion Simulation System
Dolphin Fluid Immersion Simulation® System Mattress will be used
Other Name: FIS, Dolphin

Active Comparator: Air Fluidized Bed System (AFB)
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
Device: Air Fluidized Bed System
Air Fluidized Bed (Clinitron) will be used.
Other Name: AFB, Clinitron




Primary Outcome Measures :
  1. wound healing rate [ Time Frame: 2 weeks ]
    Comparison of success of closure between treatment groups.


Secondary Outcome Measures :
  1. Complication rate [ Time Frame: 2 weeks ]
    Comparison of complication rate, including dehiscence between treatment groups.

  2. Bacterial reduction rate [ Time Frame: 2 weeks ]
    surgical debridement and their subsequent relation to complications and time to closure in each group.

  3. Differences in bacterial speciation pressure ulcer microbiome. [ Time Frame: 2 weeks ]
    determined by quantitative cultures and PCR analysis. Comparisons will be made between biopsies taken prior to and following the initial operative debridement, following any subsequent debridements, and prior to operative closure.

  4. Differences in antibiotic resistance pressure ulcer microbiome. [ Time Frame: 2 weeks ]
    Determined by quantitative cultures and PCR analysis. Comparisons will be made between biopsies taken prior to and following the initial operative debridement, following any subsequent debridements, and prior to operative closure.

  5. Differences in total bacterial count [ Time Frame: 2 weeks ]
    Determined by culture and quantitative PCR analysis. Comparisons will be made between biopsies taken prior to and following the initial operative debridement, following any subsequent debridements, prior to operative closure, and two weeks following definitive closure.

  6. Differences in pressure ulcer microbiome [ Time Frame: 2 weeks ]
    PCR assays conducted by PathoGenius Laboratory™. Comparisons will be made between biopsies taken prior to and following the initial operative debridement, following any subsequent debridements, and prior to operative closure.

  7. Inflammatory markers in the pressure ulcer protein and PCR assays. [ Time Frame: 2 weeks ]
    Quantitative and qualitative analysis of inflammatory markers prior to and following the initial operative debridement, following any subsequent debridements, and prior to operative closure.

  8. Evaluation of patient characteristics spasticity, medications, ulcer history) and their relation to early and late recurrences as well as complications. [ Time Frame: 2 weeks ]
    Evaluation of patient characteristics (age, comorbidities, nutritional parameters, spasticity, medications, ulcer history) and their relation to early and late recurrences as well as complications.

  9. Adverse event rate according to flap technique [ Time Frame: 2 weeks ]
    Comparison of outcomes and complication rates based on flap technique.

  10. Total costs incurred [ Time Frame: 2 weeks ]
    Total costs incurred including treatment costs, the costs of associated complications, cost of the hospital stay, and any other unforeseen costs during the two week study period following operative closure.

  11. Differences in quantitative patient and nurse survey responses [ Time Frame: 2 weeks ]
    Differences in quantitative patient and nurse survey responses regarding acceptability and tolerance of each therapeutic modality, including patient comfort.

  12. follow up [ Time Frame: 1 year ]
    Regular follow-up via phone interviews to assess for additional complications and need for additional therapies or surgical procedures up to 1 year after surgical closure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. will be admitted as an inpatient
  2. is ≥ 18 years of age and ≤ 85 years of age at time of consent
  3. is able to provide his/her own informed consent
  4. is deemed by the investigators to be reasonably compliant
  5. has a pressure ulcer meeting criteria for stage III or IV
  6. has not participated in a clinical trial within the past 30 days
  7. has a 30-day wound history available if the wound has been previously treated

Exclusion Criteria:

  1. has a life expectancy of < 12 months
  2. is not healthy enough to undergo surgery for any reason
  3. has a history of radiation therapy
  4. is, in the opinion of the investigator, noncompliant
  5. has a history of > 3 closures of pressure ulcers in the same site
  6. has a history of a bleeding disorder
  7. has severe fecal incontinence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522714


Contacts
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Contact: Jing Liu, MD 3126953908 jing-liu@northwestern.edu

Locations
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United States, Illinois
Northwestern Memorial Hospital Plastic Surgery Recruiting
Chicago, Illinois, United States, 60611
Contact: Jing Liu, MD    312-695-3908    jing-liu@northwestern.edu   
Principal Investigator: Robert D Galiano, MD         
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Robert D Galiano, MD Northwestern Medicine
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Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT03522714    
Other Study ID Numbers: STU00200584
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Northwestern University:
support surface, pressure ulcer, flap closure
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases