Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03722485
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.

Condition or disease Intervention/treatment Phase
Wounds and Injuries Wound Healing Granulation Tissue Device: Negative Pressure Therapy w/ instillation and dwell (NPWTi-d) Biological: Collagenase Ointment Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 12, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percent Change in Wound Bed Surface Area (cm2) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. total surface area measuring ≥ 16 cm2, including a minimum width of 2 cm (before removal of eschar at the bedside and excluding undermining).
    2. < 20 cm across (edge-to-edge) at any point perpendicular to the wound edges.
  5. 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.
  6. 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03722485


Contacts
Layout table for location contacts
Contact: Natalie Hernandez 210-515-4211 nhernandez7@mmm.com
Contact: Anthony Tate 210-515-4060 actate@mmm.com

Locations
Layout table for location information
United States, Arizona
Banner-University Medical Center Phoenix Recruiting
Phoenix, Arizona, United States, 85006
Contact: Eric Chickris       chickris@arizona.edu   
Contact: Patricia Teran, MS    602-255-7562    pteran@email.arizona.edu   
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Andrea Seach    520-626-8370    aseach@surgery.arizona.edu   
United States, District of Columbia
Medstar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Sebastian Pena    202-444-7288    Sebastian.Pena@gunet.georgetown.edu   
United States, Illinois
Northwestern University Withdrawn
Chicago, Illinois, United States, 60611
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Amreen Barde    312-563-7519    Amreen_Barde@rush.edu   
United States, Massachusetts
South Shore Hospital Center for Wound Healing Recruiting
Weymouth, Massachusetts, United States, 02190
Contact: Maureen DeMenna    781-624-4369    MDemenna@southshorehealth.org   
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Heather Tessier    508-856-1729    Heather.Tessier@umassmed.edu   
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65211
Contact: Jennifer Randolph    573-882-4387    RandolphJL@health.missouri.edu   
Mercy Active, not recruiting
Saint Louis, Missouri, United States, 63141
United States, New York
Northwell Health System - North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Sally Kaplan    516-562-4578    Skaplan2@northwell.edu   
New York University - Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Cindy Alsamarraie    516-663-1669    cindy.alsamarraie@nyulangone.org   
Contact: Helen Liu       Helen.Liu@nyulangone.org   
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Zoe Krebs    614-685-6374    Zoe.Krebs@osumc.edu   
United States, Pennsylvania
University of Pennsylvania Withdrawn
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Allegra Bermudez    610-217-1427    Allegra.Bermudez@jefferson.edu   
University of Pittsburgh Medical Center Withdrawn
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
KCI USA, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT03722485    
Other Study ID Numbers: KCI.CLEANSE.CHOICE.2017.02
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021

Layout table for additional information
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:
Layout table for MeSH terms
Wounds and Injuries