Back to resultsEvaluation of V.A.C. VERAFLO CLEANSE CHOICE™ Dressing Using Normal Saline to Promote Increased Healthy Wound Bed Tissue
Primary Purpose
Wound, Wound Heal, Wounds and Injuries
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Wound
Eligibility Criteria
Inclusion Criteria:
- is anticipated to be hospitalized for the duration of treatment.
- is ≥22 years of age or their legally authorized representative is able to provide informed consent.
- 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.
- 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.
- 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:
- has been diagnosed with malignancy in the wound.
- has untreated osteomyelitis.
- has an untreated systemic infection.
- has active cellulitis in the peri wound area.
- has a known allergy or hypersensitivity to study materials: dressing and/or dressing components such as acrylic adhesives or polyurethane.
- has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
- has had radiation directly to the wound.
- 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.
- has eschar in the wound that cannot be removed by beside or sharp and/or mechanical debridement.
- is participating in another interventional clinical trial for the duration of the study.
- has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities.
- has inadequate hemostasis at the wound site, as determined by the investigator.
Sites / Locations
- Joseph M. Still Research Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
V.A.C. VERAFLO CLEANSE CHOICE™ with Normal Saline
Arm Description
Outcomes
Primary Outcome Measures
Percent change in wound bed surface area (cm2) of clean, healthy, viable tissue
Secondary Outcome Measures
Percent change in total wound volume (cm3)
Percent change in total wound area (cm2)
Physician assessment of the need for surgical debridement
This will be a subjective assessment made by the Investigator of Yes or No
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04026334
Brief Title
Evaluation of V.A.C. VERAFLO CLEANSE CHOICE™ Dressing Using Normal Saline to Promote Increased Healthy Wound Bed Tissue
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient subject accrual rate
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
August 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound, Wound Heal, Wounds and Injuries, Granulation Tissue, Negative-pressure Wound Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
V.A.C. VERAFLO CLEANSE CHOICE™ with Normal Saline
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline
Intervention Description
-125mmHg, 10 minute soak time, 3.5 hours of negative pressure therapy
Primary Outcome Measure Information:
Title
Percent change in wound bed surface area (cm2) of clean, healthy, viable tissue
Time Frame
Baseline to Day 6-9
Secondary Outcome Measure Information:
Title
Percent change in total wound volume (cm3)
Time Frame
Baseline to Day 6-9
Title
Percent change in total wound area (cm2)
Time Frame
Baseline to Day 6-9
Title
Physician assessment of the need for surgical debridement
Description
This will be a subjective assessment made by the Investigator of Yes or No
Time Frame
Day 6-9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
is anticipated to be hospitalized for the duration of treatment.
is ≥22 years of age or their legally authorized representative is able to provide informed consent.
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.
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.
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:
has been diagnosed with malignancy in the wound.
has untreated osteomyelitis.
has an untreated systemic infection.
has active cellulitis in the peri wound area.
has a known allergy or hypersensitivity to study materials: dressing and/or dressing components such as acrylic adhesives or polyurethane.
has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
has had radiation directly to the wound.
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.
has eschar in the wound that cannot be removed by beside or sharp and/or mechanical debridement.
is participating in another interventional clinical trial for the duration of the study.
has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities.
has inadequate hemostasis at the wound site, as determined by the investigator.
Facility Information:
Facility Name
Joseph M. Still Research Foundation
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of V.A.C. VERAFLO CLEANSE CHOICE™ Dressing Using Normal Saline to Promote Increased Healthy Wound Bed Tissue
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