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

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

Detailed Description
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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.

Official Title
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Hydromechanical Cleansing With V.A.C. VERAFLO CLEANSE CHOICE™ Dressing and NPWTi-d vs. Collagenase Ointment in the Management of Full-thickness Wounds

Conditions
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Wounds and Injuries, Wound Healing, Granulation Tissue

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)<br>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)<br>* Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.<br>* Other names: V.A.C.Ulta Therapy Unit;|
| Active Comparator: Collagenase Ointment<br>Collagenase Ointment | Biological: Collagenase Ointment<br>* Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Total Wound Volume (%) 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. | baseline and 6-9 days of treatment | 
| Percent Change in Total Wound Area (%) 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. | baseline and 6-9 days of treatment | 
| Physician Assessment of Need for Wound Debridement | Physician assessment of the need for surgical debridement upon completion of study treatment up to Day 6-9. | 6-9 days of treatment |