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

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

Study Overview

• Status: Terminated
• Conditions: Wounds and Injuries; Wound Healing; Granulation Tissue
• Intervention / Treatment: Device: Negative Pressure Therapy w/ instillation and dwell (NPWTi-d); Biological: Collagenase Ointment

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalie Hernandez; Phone Number: 210-515-4211; Email: nhernandez7@mmm.com
• Study Contact Backup: Name: Anthony Tate; Phone Number: 210-515-4060; Email: actate@mmm.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner-University Medical Center Phoenix
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Massachusetts
    • Weymouth, Massachusetts, United States, 02190
      • South Shore Hospital Center for Wound Healing
  • Missouri
    • Columbia, Missouri, United States, 65211
      • University of Missouri
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Health System - North Shore University Hospital
    • Mineola, New York, United States, 11501
      • New York University - Winthrop Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.	The 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.	The 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	Physician assessment of the need for surgical debridement upon completion of study treatment up to Day 6-9.	6-9 days of treatment

Collaborators and Investigators

• Sponsor: 3M

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): April 19, 2022
• Study Completion (Actual): April 19, 2022

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: KCI.CLEANSE.CHOICE.2017.02

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