Clinical trial NCT03722485: Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness Wounds
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
Overall status: TERMINATED
Phase: NA
Conditions: Wounds and Injuries
Wound Healing
Granulation Tissue
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2018-10-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal.
timeFrame: baseline and 6-9 days of treatment
Secondary outcomes:
measure: Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
timeFrame: baseline and 6-9 days of treatment
measure: Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
timeFrame: baseline and 6-9 days of treatment
measure: Physician Assessment of Need for Wound Debridement
timeFrame: 6-9 days of treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner-University Medical Center Phoenix
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Weymouth
country: United States
facility: South Shore Hospital Center for Wound Healing
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Manhasset
country: United States
facility: Northwell Health System - North Shore University Hospital
state: New York
city: Mineola
country: United States
facility: New York University - Winthrop Hospital
state: New York
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References: