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

KCI USA, Inc

Status: Terminated

Conditions: Granulation Tissue; Wound Healing; Wounds and Injuries

Treatments: Biological: Collagenase Ointment; Device: Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03722485

KCI.CLEANSE.CHOICE.2017.02

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

44 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

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

Collagenase Ointment

Active Comparator group

Description:

Collagenase Ointment

Treatment:

Biological: Collagenase Ointment