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

October 14, 2024 updated by: KCI USA, Inc

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: baseline and 6-9 days of treatment
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
Time Frame: baseline and 6-9 days of treatment
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
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.
6-9 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KCI USA, Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
3M

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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