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

Primary Purpose

Wounds and Injuries, Wound Healing, Granulation Tissue

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)
Collagenase Ointment
Sponsored by
3M
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries

Eligibility Criteria

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

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.

Sites / Locations

  • Banner-University Medical Center Phoenix
  • University of Arizona
  • Medstar Georgetown University Hospital
  • Rush University Medical Center
  • South Shore Hospital Center for Wound Healing
  • University of Missouri
  • Northwell Health System - North Shore University Hospital
  • New York University - Winthrop Hospital
  • Ohio State University Medical Center
  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)

Collagenase Ointment

Arm Description

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

Collagenase Ointment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 25, 2018
Last Updated
June 19, 2023
Sponsor
3M
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1. Study Identification

Unique Protocol Identification Number
NCT03722485
Brief Title
Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness Wounds
Acronym
ACCELERATE
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Enrollment challenges and business reasons.
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
April 19, 2022 (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
Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries, Wound Healing, Granulation Tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)
Arm Type
Experimental
Arm Description
V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
Arm Title
Collagenase Ointment
Arm Type
Active Comparator
Arm Description
Collagenase Ointment
Intervention Type
Device
Intervention Name(s)
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)
Other Intervention Name(s)
V.A.C. VeraFlo Cleanse Choice, V.A.C.Ulta Therapy Unit
Intervention Description
Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
Intervention Type
Biological
Intervention Name(s)
Collagenase Ointment
Intervention Description
Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
Primary Outcome Measure Information:
Title
Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal.
Description
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.
Time Frame
baseline and 6-9 days of treatment
Secondary Outcome Measure Information:
Title
Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
Description
The percent change in total wound volume (%) from baseline to Day 6-9 upon the final dressing removal.
Time Frame
baseline and 6-9 days of treatment
Title
Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
Description
The percent change in total wound area (%) from baseline to Day 6-9 upon the final dressing removal.
Time Frame
baseline and 6-9 days of treatment
Title
Physician Assessment of Need for Wound Debridement
Description
Physician assessment of the need for surgical debridement upon completion of study treatment up to Day 6-9.
Time Frame
6-9 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Facility Information:
Facility Name
Banner-University Medical Center Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
South Shore Hospital Center for Wound Healing
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Facility Name
Northwell Health System - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
New York University - Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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