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出境医 / 临床实验 / Evaluation of V.A.C. VERAFLO CLEANSE CHOICE™ Dressing Using Normal Saline to Promote Increased Healthy Wound Bed Tissue

Evaluation of V.A.C. VERAFLO CLEANSE CHOICE™ Dressing Using Normal Saline to Promote Increased Healthy Wound Bed Tissue

Study Description
Brief Summary:
The study goal is to evaluate the ability of the V.A.C. ULTA™ Negative Pressure Wound Therapy System and V.A.C. VERAFLO CLEANSE CHOICE ™ (VFCC) dressing system with saline as an irrigant in increasing viable tissue in full thickness wounds (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) with difficult to manage bioburden and slough.

Condition or disease Intervention/treatment Phase
Wound Wound Heal Wounds and Injuries Granulation Tissue Negative-pressure Wound Therapy Device: V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Hydromechanical Cleansing Using Normal Saline With V.A.C. VERAFLO CLEANSE CHOICE™ Dressing and NPWT-d to Promote Increased Healthy Wound Bed Tissue
Actual Study Start Date : July 25, 2019
Actual Primary Completion Date : August 28, 2020
Actual Study Completion Date : August 28, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: V.A.C. VERAFLO CLEANSE CHOICE™ with Normal Saline Device: V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline
-125mmHg, 10 minute soak time, 3.5 hours of negative pressure therapy
Outcome Measures
Primary Outcome Measures :
  1. Percent change in wound bed surface area (cm2) of clean, healthy, viable tissue [ Time Frame: Baseline to Day 6-9 ]

Secondary Outcome Measures :
  1. Percent change in total wound volume (cm3) [ Time Frame: Baseline to Day 6-9 ]
  2. Percent change in total wound area (cm2) [ Time Frame: Baseline to Day 6-9 ]
  3. Physician assessment of the need for surgical debridement [ Time Frame: Day 6-9 ]
    This will be a subjective assessment made by the Investigator of Yes or No


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. is anticipated to be hospitalized for the duration of treatment.
  2. is ≥22 years of age or their legally authorized representative is able to provide informed consent.
  3. has a full thickness wound (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) measuring ≥4cm in length and ≥4cm in width (before removal of eschar at the bedside) excluding undermining/tunneling.
  4. has, in the opinion of the investigator, no more than 2/3 of the visible wound bed surface area considered to be clean, healthy, and viable. If eschar is present at baseline, it must be removed by bedside debridement prior to assessing the percentage of clean, healthy, and viable wound bed.
  5. has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) and is willing to take precautionary measures to prevent pregnancy during the duration of the study (up to 9 days).

Exclusion Criteria:

  1. has been diagnosed with malignancy in the wound.
  2. has untreated osteomyelitis.
  3. has an untreated systemic infection.
  4. has active cellulitis in the peri wound area.
  5. has a known allergy or hypersensitivity to study materials: dressing and/or dressing components such as acrylic adhesives or polyurethane.
  6. has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
  7. has had radiation directly to the wound.
  8. has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history.
  9. has eschar in the wound that cannot be removed by beside or sharp and/or mechanical debridement.
  10. is participating in another interventional clinical trial for the duration of the study.
  11. has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities.
  12. has inadequate hemostasis at the wound site, as determined by the investigator.
Contacts and Locations

Locations
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United States, Georgia
Joseph M. Still Research Foundation
Augusta, Georgia, United States, 30909
Sponsors and Collaborators
KCI USA, Inc.
Tracking Information
First Submitted Date  ICMJE July 18, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date December 21, 2020
Actual Study Start Date  ICMJE July 25, 2019
Actual Primary Completion Date August 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019) 		Percent change in wound bed surface area (cm2) of clean, healthy, viable tissue [ Time Frame: Baseline to Day 6-9 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Percent change in total wound volume (cm3) [ Time Frame: Baseline to Day 6-9 ]
  • Percent change in total wound area (cm2) [ Time Frame: Baseline to Day 6-9 ]
  • Physician assessment of the need for surgical debridement [ Time Frame: Day 6-9 ]
    This will be a subjective assessment made by the Investigator of Yes or No
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Percent change in total wound volume (cm3) [ Time Frame: Baseline to Day 6-9 ]
  • Percent change in total wound area (cm2) [ Time Frame: Baseline to Day 6-9 ]
  • Physician assessment of the need for surgical debridement [ Time Frame: Day 6-9 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of V.A.C. VERAFLO CLEANSE CHOICE™ Dressing Using Normal Saline to Promote Increased Healthy Wound Bed Tissue
Official Title  ICMJE Evaluation of Hydromechanical Cleansing Using Normal Saline With V.A.C. VERAFLO CLEANSE CHOICE™ Dressing and NPWT-d to Promote Increased Healthy Wound Bed Tissue
Brief Summary The study goal is to evaluate the ability of the V.A.C. ULTA™ Negative Pressure Wound Therapy System and V.A.C. VERAFLO CLEANSE CHOICE ™ (VFCC) dressing system with saline as an irrigant in increasing viable tissue in full thickness wounds (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) with difficult to manage bioburden and slough.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Wound
  • Wound Heal
  • Wounds and Injuries
  • Granulation Tissue
  • Negative-pressure Wound Therapy
Intervention  ICMJE Device: V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline
-125mmHg, 10 minute soak time, 3.5 hours of negative pressure therapy
Study Arms  ICMJE Experimental: V.A.C. VERAFLO CLEANSE CHOICE™ with Normal Saline
Intervention: Device: V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 17, 2020) 		8
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2019) 		15
Actual Study Completion Date  ICMJE August 28, 2020
Actual Primary Completion Date August 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. is anticipated to be hospitalized for the duration of treatment.
  2. is ≥22 years of age or their legally authorized representative is able to provide informed consent.
  3. has a full thickness wound (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) measuring ≥4cm in length and ≥4cm in width (before removal of eschar at the bedside) excluding undermining/tunneling.
  4. has, in the opinion of the investigator, no more than 2/3 of the visible wound bed surface area considered to be clean, healthy, and viable. If eschar is present at baseline, it must be removed by bedside debridement prior to assessing the percentage of clean, healthy, and viable wound bed.
  5. has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) and is willing to take precautionary measures to prevent pregnancy during the duration of the study (up to 9 days).

Exclusion Criteria:

  1. has been diagnosed with malignancy in the wound.
  2. has untreated osteomyelitis.
  3. has an untreated systemic infection.
  4. has active cellulitis in the peri wound area.
  5. has a known allergy or hypersensitivity to study materials: dressing and/or dressing components such as acrylic adhesives or polyurethane.
  6. has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
  7. has had radiation directly to the wound.
  8. has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history.
  9. has eschar in the wound that cannot be removed by beside or sharp and/or mechanical debridement.
  10. is participating in another interventional clinical trial for the duration of the study.
  11. has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities.
  12. has inadequate hemostasis at the wound site, as determined by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026334
Other Study ID Numbers  ICMJE KCI.CLEANSE.CHOICE.2019.01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party KCI USA, Inc.
Study Sponsor  ICMJE KCI USA, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account KCI USA, Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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