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

Not Applicable

Terminated

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

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.

Recruitment & Eligibility

Inclusion Criteria

The Subject:

is anticipated to be hospitalized for the duration of treatment (minimum of 6 days).
is ≥ 18 years of age.
or their legally authorized representative is able to provide informed consent.
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.
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.
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:

has been diagnosed with malignancy in the wound.
has untreated osteomyelitis.
has an untreated systemic infection.
has active cellulitis in the periwound area.
has a known allergy or hypersensitivity to study materials: collagenase ointment, dressing(s), and/or dressing components such as acrylic adhesives or polyurethane.
has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
has had radiation directly to the wound area.
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.
has eschar in the wound that cannot be removed by bedside sharp and/or mechanical debridement.
is participating in another interventional clinical trial for the duration of the study.
has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities.
has a wound with any tunneling present.
has inadequate hemostasis at the wound site, as determined by the investigator.

Arm && Interventions

Group	Intervention	Description
Collagenase Ointment	Collagenase Ointment	Collagenase Ointment
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)	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

Primary Outcome Measures

Name	Time	Method
Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal.	baseline and 6-9 days of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Physician Assessment of Need for Wound Debridement	6-9 days of treatment	Physician assessment of the need for surgical debridement upon completion of study treatment up to Day 6-9.
Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.	baseline and 6-9 days of treatment	The percent change in total wound area (%) from baseline to Day 6-9 upon the final dressing removal.
Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.	baseline and 6-9 days of treatment	The percent change in total wound volume (%) from baseline to Day 6-9 upon the final dressing removal.

Locations (10): University of Arizona
🇺🇸
Tucson, Arizona, United States
Northwell Health System - North Shore University Hospital
🇺🇸
Manhasset, New York, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Banner-University Medical Center Phoenix
🇺🇸
Phoenix, Arizona, United States
Medstar Georgetown University Hospital
🇺🇸
Washington, District of Columbia, United States
University of Missouri
🇺🇸
Columbia, Missouri, United States
South Shore Hospital Center for Wound Healing
🇺🇸
Weymouth, Massachusetts, United States
New York University - Winthrop Hospital
🇺🇸
Mineola, New York, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States