Title
Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness Wounds
Hydromechanical Cleansing With V.A.C. VERAFLO CLEANSE CHOICE™ Dressing and NPWTi-d vs. Collagenase Ointment in the Management of Full-thickness Wounds
Phase
N/ALead Sponsor
KCIStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Wounds and Injuries Wound Healing Granulation TissueIntervention/Treatment
Collagenase Ointment ...Study Participants
44Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.
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.
Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
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: total surface area measuring ≥ 16 cm2, including a minimum width of 2 cm (before removal of eschar at the bedside and excluding undermining). < 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.
| Event Type | Organ System | Event Term | Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) | Collagenase Ointment |
|---|
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.
The percent change in total wound volume (%) from baseline to Day 6-9 upon the final dressing removal.
The percent change in total wound area (%) from baseline to Day 6-9 upon the final dressing removal.
Physician assessment of the need for surgical debridement upon completion of study treatment up to Day 6-9.
