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ACCELERATE: Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness Wounds

Sponsor
3M (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03722485
Collaborator
(none)
60
Enrollment
15
Locations
2
Arms
35.6
Anticipated Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.

Condition or Disease Intervention/Treatment Phase
  • Device: Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)
  • Biological: Collagenase Ointment
 N/A

Detailed Description

This study evaluates changes in wound bed surface area of clean, healthy viable tissue in subjects with full-thickness wounds using negative pressure wound therapy with instillation of saline solution versus a collagenase ointment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hydromechanical Cleansing With V.A.C. VERAFLO CLEANSE CHOICE™ Dressing and NPWTi-d vs. Collagenase Ointment in the Management of Full-thickness Wounds
Actual Study Start Date :
Dec 12, 2018
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)

V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution

Device: Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)
Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
Other Names:
  • V.A.C. VeraFlo Cleanse Choice
  • V.A.C.Ulta Therapy Unit

    		•
    Active Comparator: Collagenase Ointment

    Collagenase Ointment

    Biological: Collagenase Ointment
    Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change in Wound Bed Surface Area (cm2) [6-9 days of treatment]

      The percent change in the wound bed surface area (cm2) considered to be clean, healthy, and viable from baseline to Day 6-9 upon the final dressing removal.

    Secondary Outcome Measures

    1. Percent change in total wound volume (cm3) [6-9 days of treatment]

      The percent change in total wound volume (cm3) from baseline to Day 6-9 upon the final dressing removal.

    2. Percent change in total wound area (cm2) [6-9 days of treatment]

      The percent change in total wound area (cm2) from baseline to Day 6-9 upon the final dressing removal.

    3. Physician assessment of need for debridement [6-9 days of treatment]

      Physician assessment of the need for surgical debridement upon completion of study treatment up to Day 6-9.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    The Subject:

    1. is anticipated to be hospitalized for the duration of treatment (minimum of 6 days).

    2. is ≥ 18 years of age.

    3. or their legally authorized representative is able to provide informed consent.

    4. has been diagnosed with a wound (eg, chronic, acute, traumatic, or dehisced wounds) and/or ulcer (ie, full- thickness wounds) that meets the following criteria:

    5. total surface area measuring ≥ 16 cm2, including a minimum width of 2 cm (before removal of eschar at the bedside and excluding undermining).

    6. < 20 cm across (edge-to-edge) at any point perpendicular to the wound edges.

    7. has, in the opinion of the investigator, no more than 2/3 of the 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.

    8. 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:
    The Subject:

    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 periwound area.

    5. has a known allergy or hypersensitivity to study materials: collagenase ointment, dressing(s), 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 area.

    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 bedside 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 a wound with any tunneling present.

    13. has inadequate hemostasis at the wound site, as determined by the investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner-University Medical Center Phoenix Phoenix Arizona United States 85006
    2 University of Arizona Tucson Arizona United States 85724
    3 Medstar Georgetown University Hospital Washington District of Columbia United States 20007
    4 Northwestern University Chicago Illinois United States 60611
    5 Rush University Medical Center Chicago Illinois United States 60612
    6 South Shore Hospital Center for Wound Healing Weymouth Massachusetts United States 02190
    7 University of Massachusetts Medical School Worcester Massachusetts United States 01655
    8 University of Missouri Columbia Missouri United States 65211
    9 Mercy Saint Louis Missouri United States 63141
    10 Northwell Health System - North Shore University Hospital Manhasset New York United States 11030
    11 New York University - Winthrop Hospital Mineola New York United States 11501
    12 Ohio State University Medical Center Columbus Ohio United States 43210
    13 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    14 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    15 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15261

    Sponsors and Collaborators

    • 3M

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    3M
    ClinicalTrials.gov Identifier:
    NCT03722485
    Other Study ID Numbers:
    • KCI.CLEANSE.CHOICE.2017.02
    First Posted:
    Oct 29, 2018
    Last Update Posted:
    Apr 12, 2021
    Last Verified:
    Apr 1, 2021
    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:
    Wounds and Injuries

    Study Results

    No Results Posted as of Apr 12, 2021