Evaluation 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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.
Banner-University Medical Center Phoenix
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
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.
Time frame: baseline and 6-9 days of treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 6-9 days of treatment
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Rush University Medical Center
Chicago, Illinois, United States
South Shore Hospital Center for Wound Healing
Weymouth, Massachusetts, United States
University of Missouri
Columbia, Missouri, United States
Northwell Health System - North Shore University Hospital
Manhasset, New York, United States
New York University - Winthrop Hospital
Mineola, New York, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States