search
Back to results

3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study

Primary Purpose

WOUNDS INJURIES

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wound and per-wound assessments While using Device
Sponsored by
3M
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for WOUNDS INJURIES

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Subject is at least 22 years old at time of consent. Subject OR Legal Authorized Representative is able to provide informed consent. Subject has been confirmed to have a chronic, acute, traumatic, sub-acute, or dehisced wound, partial-thickness burn, ulcer (such as diabetic, pressure or venous insufficiency), flap or graft. Exclusion Criteria: Subject is pregnant prior to application of the initial dressing* *Women who have had surgical sterilization by a medically accepted method (i.e. tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for > 12 months will not be required to undergo pregnancy testing. Subject has been diagnosed with a malignancy in the wound. Subject has untreated osteomyelitis. Subject has an untreated systemic infection. Subject has active cellulitis in the peri-wound area. Subject has a known allergy or hypersensitivity to study materials: dressing(s), and/or dressing components such as acrylic or silicone adhesives or polyurethane. Subject has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures. Subject has had radiation directly to the wound area. Subject 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. Subject has necrotic tissue with eschar present. NOTE: After debridement of necrotic tissue and complete removal of eschar, Veraflo™ Therapy may be used. Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days of Visit 1. Subject has non-enteric or unexplored fistula. Subject has a wound with any unexplored tunneling present. Subject has inadequate hemostasis at the wound site, as determined by the investigator. Subject has a wound with non-protected exposed vessels, anastomotic sites, organ, or nerves.

Sites / Locations

  • 3M

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments

Arm Description

Subject will have Veraflo™ Cleanse Choice Complete™ dressing applied and used per instructions for use. 3D imaging and wound / peri-wound skin characteristics will be taken during the treatment.

Outcomes

Primary Outcome Measures

ADE/SADE
Subject incidence of Adverse Device Events (ADEs) and Serious ADEs (SADEs) during the use of the device.

Secondary Outcome Measures

Total Wound Area (%)
Percent change in total wound area (%) from baseline to end-of-study.
Non-viable Tissue (%)
Change in the percentage of non-viable tissue from baseline to end-of-study.
Total Wound Volume (%)
Change in the percentage of total wound volume (%) from baseline to end-of-study.

Full Information

First Posted
February 14, 2023
Last Updated
June 26, 2023
Sponsor
3M
search

1. Study Identification

Unique Protocol Identification Number
NCT05748392
Brief Title
3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study
Official Title
A Post-market, Multicenter, Prospective, Single-arm Study Evaluating Safety and Performance of the Veraflo™ Cleanse Choice Complete™ Dressing
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No longer required.
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (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 purpose of this external clinical study is to demonstrate the safety and performance of the Veraflo™ Cleanse Choice Complete™ Dressing Kit which will be used in conjunction with the V.A.C.® Ulta™ Therapy Unit, utilizing V.A.C. Veraflo™ Therapy instillation functions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
WOUNDS INJURIES

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments
Arm Type
Other
Arm Description
Subject will have Veraflo™ Cleanse Choice Complete™ dressing applied and used per instructions for use. 3D imaging and wound / peri-wound skin characteristics will be taken during the treatment.
Intervention Type
Device
Intervention Name(s)
Wound and per-wound assessments While using Device
Intervention Description
3D imaging and wound and per-wound skin characteristics will be conducted initially, at dressing changes and at end of treatment/study.
Primary Outcome Measure Information:
Title
ADE/SADE
Description
Subject incidence of Adverse Device Events (ADEs) and Serious ADEs (SADEs) during the use of the device.
Time Frame
Up to 14 days
Secondary Outcome Measure Information:
Title
Total Wound Area (%)
Description
Percent change in total wound area (%) from baseline to end-of-study.
Time Frame
Up to 14 days
Title
Non-viable Tissue (%)
Description
Change in the percentage of non-viable tissue from baseline to end-of-study.
Time Frame
Up to 14 days
Title
Total Wound Volume (%)
Description
Change in the percentage of total wound volume (%) from baseline to end-of-study.
Time Frame
Up to 14 days
Other Pre-specified Outcome Measures:
Title
Debridement
Description
Subject incidence of bedside debridement. Subject incidence of operating room debridement. Number of avoided debridement procedures in the operating room based on physician assessment.
Time Frame
Up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subject is at least 22 years old at time of consent. Subject OR Legal Authorized Representative is able to provide informed consent. Subject has been confirmed to have a chronic, acute, traumatic, sub-acute, or dehisced wound, partial-thickness burn, ulcer (such as diabetic, pressure or venous insufficiency), flap or graft. Exclusion Criteria: Subject is pregnant prior to application of the initial dressing* *Women who have had surgical sterilization by a medically accepted method (i.e. tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for > 12 months will not be required to undergo pregnancy testing. Subject has been diagnosed with a malignancy in the wound. Subject has untreated osteomyelitis. Subject has an untreated systemic infection. Subject has active cellulitis in the peri-wound area. Subject has a known allergy or hypersensitivity to study materials: dressing(s), and/or dressing components such as acrylic or silicone adhesives or polyurethane. Subject has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures. Subject has had radiation directly to the wound area. Subject 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. Subject has necrotic tissue with eschar present. NOTE: After debridement of necrotic tissue and complete removal of eschar, Veraflo™ Therapy may be used. Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days of Visit 1. Subject has non-enteric or unexplored fistula. Subject has a wound with any unexplored tunneling present. Subject has inadequate hemostasis at the wound site, as determined by the investigator. Subject has a wound with non-protected exposed vessels, anastomotic sites, organ, or nerves.
Facility Information:
Facility Name
3M
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55144
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study

We'll reach out to this number within 24 hrs