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

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ClinicalTrials.gov Identifier: NCT04026334
Recruitment Status : Terminated (Insufficient subject accrual rate)
First Posted : July 19, 2019
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.

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

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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

Resource links provided by the National Library of Medicine


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




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



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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.

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): NCT04026334


Locations
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United States, Georgia
Joseph M. Still Research Foundation
Augusta, Georgia, United States, 30909
Sponsors and Collaborators
KCI USA, Inc.
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Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT04026334    
Other Study ID Numbers: KCI.CLEANSE.CHOICE.2019.01
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Wounds and Injuries