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

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

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.

Study Overview

• Status: Terminated
• Conditions: Wounds and Injuries; Wound Heal; Wound; Granulation Tissue; Negative-pressure Wound Therapy
• Intervention / Treatment: Device: V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Joseph M. Still Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in wound bed surface area (cm2) of clean, healthy, viable tissue	Baseline to Day 6-9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in total wound volume (cm3)		Baseline to Day 6-9
Percent change in total wound area (cm2)		Baseline to Day 6-9
Physician assessment of the need for surgical debridement	This will be a subjective assessment made by the Investigator of Yes or No	Day 6-9

Collaborators and Investigators

• Sponsor: 3M

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Actual): August 28, 2020
• Study Completion (Actual): August 28, 2020

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: KCI.CLEANSE.CHOICE.2019.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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