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

Wounds and Injuries Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03722485
• Other study ID #: KCI.CLEANSE.CHOICE.2017.02
• Status: Terminated
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: April 19, 2022

Study information

• Verified date: June 2023
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Granulation Tissue
• Wound Healing
• Wounds and Injuries

Intervention

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.

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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Missouri	Columbia	Missouri
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Northwell Health System - North Shore University Hospital	Manhasset	New York
United States	New York University - Winthrop Hospital	Mineola	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Banner-University Medical Center Phoenix	Phoenix	Arizona
United States	University of Arizona	Tucson	Arizona
United States	Medstar Georgetown University Hospital	Washington	District of Columbia
United States	South Shore Hospital Center for Wound Healing	Weymouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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