Study Stopped
Enrollment challenges and business reasons.
Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness Wounds
ACCELERATE
Hydromechanical Cleansing With V.A.C. VERAFLO CLEANSE CHOICE™ Dressing and NPWTi-d vs. Collagenase Ointment in the Management of Full-thickness Wounds
1 other identifier
interventional
44
1 country
10
Brief Summary
Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2018
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2018
CompletedFirst Posted
Study publicly available on registry
October 29, 2018
CompletedStudy Start
First participant enrolled
December 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2022
CompletedResults Posted
Study results publicly available
June 22, 2023
CompletedOctober 16, 2024
October 1, 2024
3.4 years
October 25, 2018
May 22, 2023
October 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal.
The Absolute Change in the Percentage of Wound bed surface area (cm2) considered to be clean, healthy, and viable from baseline to Day 6-9 upon the final dressing removal.
baseline and 6-9 days of treatment
Secondary Outcomes (3)
Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
baseline and 6-9 days of treatment
Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
baseline and 6-9 days of treatment
Physician Assessment of Need for Wound Debridement
6-9 days of treatment
Study Arms (2)
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)
EXPERIMENTALV.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
Collagenase Ointment
ACTIVE COMPARATORCollagenase Ointment
Interventions
Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
Eligibility Criteria
You may qualify if:
- The Subject:
- is anticipated to be hospitalized for the duration of treatment (minimum of 6 days).
- is ≥ 18 years of age.
- or their legally authorized representative is able to provide informed consent.
- 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:
- total surface area measuring ≥ 16 cm2, including a minimum width of 2 cm (before removal of eschar at the bedside and excluding undermining).
- \< 20 cm across (edge-to-edge) at any point perpendicular to the wound edges.
- 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.
- 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).
You may not qualify if:
- The Subject:
- has been diagnosed with malignancy in the wound.
- has untreated osteomyelitis.
- has an untreated systemic infection.
- has active cellulitis in the periwound area.
- has a known allergy or hypersensitivity to study materials: collagenase ointment, dressing(s), 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 area.
- 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 bedside 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 a wound with any tunneling present.
- has inadequate hemostasis at the wound site, as determined by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KCI USA, Inclead
- 3Mcollaborator
Study Sites (10)
Banner-University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
University of Arizona
Tucson, Arizona, 85724, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
South Shore Hospital Center for Wound Healing
Weymouth, Massachusetts, 02190, United States
University of Missouri
Columbia, Missouri, 65211, United States
Northwell Health System - North Shore University Hospital
Manhasset, New York, 11030, United States
New York University - Winthrop Hospital
Mineola, New York, 11501, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sher-ree Beekman
- Organization
- 3M
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2018
First Posted
October 29, 2018
Study Start
December 12, 2018
Primary Completion
April 19, 2022
Study Completion
April 19, 2022
Last Updated
October 16, 2024
Results First Posted
June 22, 2023
Record last verified: 2024-10