Phase
Condition
Surgery
Pressure Ulcer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient ≥18 years old
Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
Subjects undergoing revision total knee arthroplasty or revision total hiparthroplasty
Subjects provide informed consent, which will consist of reading, signing, and datingthe informed consent document after the Investigator, sub-Investigator or otherdesignated study staff member has explained the study procedures, risks, and contactinformation
Subjects deemed able to understand and comply with study visit schedule and procedures
Exclusion
Exclusion Criteria:
Wounds that require daily inspection
Active bleeding within the surgical site
Pregnant, lactating females, or females of childbearing potential not willing topractice an effective method of contraception
Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospitalstay following surgery to achieve therapeutic INR levels
Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT)
Subjects undergoing primary total joint procedures
Subjects with a known history of poor compliance with medical treatment
Subjects who have participated in this trial previously and who were withdrawn 9 .Subjects with known allergies to product components (silicone adhesives andpolyurethane films (direct contact with wound), acrylic adhesives (direct contact withskin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within thedressing)
Study Design
Connect with a study center
Rothman Institute
Philadelphia, Pennsylvania 19148
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.