Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

Banner-University Medical Center Phoenix
Phoenix, Arizona 85006
Contact:
Eric Chickris
chickris@arizona.edu

More Details

Status
Recruiting
Sponsor
KCI USA, Inc.

Study Contact

Natalie Hernandez
210-515-4211
nhernandez7@mmm.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.