Phase
Condition
Pressure Ulcer
Pressure Ulcers
Skin Wounds
Treatment
Cohealyx
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must meet all the following criteria to be eligible for participation:
The patient has a staged surgical procedure planned that requires autografting fortreatment of a full thickness wound.
The patient is hospitalized within 3 days of injury.
The surgical excision occurs within 5 days post-injury.
The patient (or parent/guardian/legally authorized representative) is willing andable to comply with all study procedures and visit schedule.
The patient (or parent/guardian/legally authorized representative) agrees to abstainfrom any other treatment of the study area or enrollment in another interventionalclinical trial for the duration of his/her participation in the study (26 weekspost-autografting).
In the opinion of the investigator, the patient (or parent/guardian/legallyauthorized representative) must be able to:
Understand the full nature and purpose of the study, including possible risksand adverse events,
Understand instructions, and
Provide voluntary written informed consent
Exclusion
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible for participation:
Clinical signs of wound infection at study area.
The patient has a medical condition, is using medications or receiving treatments (e.g., immune deficiency) that may compromise patient safety or the trialevaluations or objectives.
The patient is unable to understand English or Spanish.
The patient has a known hypersensitivity to bovine-derived collagen, porcine, oraloe vera materials.
Presence of a medical condition where the patient's life expectancy is less than 1year (e.g., malignancy).
Study Design
Study Description
Connect with a study center
University of South Alabama
Mobile, Alabama 36604
United StatesSite Not Available
University of South Alabama
Mobile 4076598, Alabama 4829764 36604
United StatesSite Not Available
Valleywise Health
Phoenix, Arizona 85008
United StatesSite Not Available
University of Arizona
Tucson, Arizona 85724
United StatesSite Not Available
Valleywise Health
Phoenix 5308655, Arizona 5551752 85008
United StatesSite Not Available
University of Arizona
Tucson 5318313, Arizona 5551752 85724
United StatesSite Not Available
Medstar Washington Hospital Center
Washington D.C., District of Columbia 20010
United StatesSite Not Available
Medstar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesSite Not Available
Univ of Iowa
Iowa City, Iowa 52242
United StatesSite Not Available
Univ of Iowa
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
The University of Kansas Health
Kansas City, Kansas 66160
United StatesSite Not Available
The University of Kansas Health
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
University of Louisville
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
University Medical Center
New Orleans, Louisiana 70112
United StatesSite Not Available
University Medical Center
New Orleans 4335045, Louisiana 4331987 70112
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Mercy Hospital Springfield
Springfield, Missouri 65804
United StatesSite Not Available
Mercy Hospital Springfield
Springfield 4409896, Missouri 4398678 65804
United StatesSite Not Available
University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
United StatesSite Not Available
University Medical Center of Southern Nevada
Las Vegas 5506956, Nevada 5509151 89102
United StatesSite Not Available
University of Rochester
Rochester, New York 14642
United StatesSite Not Available
University of Rochester
Rochester 5134086, New York 5128638 14642
United StatesSite Not Available
Akron Children's Hospital
Akron, Ohio 44308
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Akron Children's Hospital
Akron 5145476, Ohio 5165418 44308
United StatesSite Not Available
Ohio State University
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
JPS Health Network
Fort Worth, Texas 76104
United StatesSite Not Available
Texas Tech University
Lubbock, Texas 79430
United StatesSite Not Available
JPS Health Network
Fort Worth 4691930, Texas 4736286 76104
United StatesSite Not Available
Texas Tech University
Lubbock 5525577, Texas 4736286 79430
United StatesSite Not Available
Chippenham Hospital
Richmond, Virginia 23225
United StatesSite Not Available
Chippenham Hospital
Richmond 4781708, Virginia 6254928 23225
United StatesSite Not Available

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