Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Grade 3 or Higher Pressure Ulcers.

This study evaluates changes in wound bed surface area of clean, healthy viable tissue in
subjects with Grade 3 or higher pressure ulcers using negative pressure wound therapy with
instillation of saline solution versus a collagenase ointment.

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 full-thickness pressure ulcer/injury (at least grade 3)
measuring ≥ 4 cm in length and ≥ 4 cm in width (before removal of eschar at the
bedside).

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 greater than 5 mm of undermining and/or tunneling present beyond the
wound edge.

13. has inadequate hemostasis at the wound site, as determined by the investigator.