Phase
Condition
Knee Replacement
Treatment
Avance Solo Negative Pressure Wound Therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent
Patient ≥ 18 years
Elective unilateral revision THA or TKA.
High risk patients for surgical wound complications as deemed by investigators
Primary closure technique by suture or staples
Linear or curvilinear incisions ≤ 25 cm in length
The patient able to understand the study and is willing to consent to the clinicalinvestigation
Patients able to understand how to operate with the negative pressure system at home
Exclusion
Exclusion Criteria:
The need for emergency surgery
Multiple Incision Approach at the time of surgery (alternative approach from primarysurgery using 1 incision is permitted)
Patients requiring bilateral revision total hip or knee arthroplasty surgery
Active infections of the offending joint.
History of multiple infections in the offending joint
Patients with known allergies to product components (silicone adhesives andpolyurethane films (direct contact with wound), acrylic adhesives (direct contactwith skin), polyethylene fabrics and superabsorbent powders (polyacrylates) (withinthe dressing)
Subjects with contraindications (as per the Avance Solo Instructions for use)
Pregnant, breastfeeding females, or females of childbearing potential not willing touse contraception for the duration of the investigation
Patients with presence of remote skin infection or active systemic infection at thetime of revision surgery.
Patient with incisions > 25cm in length or type of incisions that cannot besufficiently covered by Avance Solo Border dressing (i.e., the wound pad does notoverlap the edges of the incision by at least 1.5 cm as per the IFU)
Use of surgical glue as part of incisional closure method
Patients who in the opinion of the investigator may not complete or comply withfollow up treatment for any reason
Patients participating in ongoing clinical investigations, or during the past 30days, that may impact the outcome of this investigation based on the judgement ofthe investigator.
Any clinically significant condition that, in the investigator's opinion, wouldsignificantly impair the subject's ability to comply with the study
Study Design
Connect with a study center
MedStar Health
Washington, District of Columbia 20001
United StatesActive - Recruiting
FORE
Tampa, Florida 33606
United StatesSite Not Available
Ortho Indy
Indianapolis, Indiana 46077
United StatesActive - Recruiting
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
Twin Cities Orthopedics
Minneapolis, Minnesota 55435
United StatesActive - Recruiting
St. Louis University
Saint Louis, Missouri 63110
United StatesSite Not Available
St. Louis University
St. Louis, Missouri 63110
United StatesSite Not Available
Northwell
Garden City, New York 11040
United StatesActive - Recruiting
Bon Secours Mercy Health
Youngstown, Ohio 45103
United StatesSite Not Available
St Thomas Hospital
Nashville, Tennessee 37129
United StatesSite Not Available
Spokane Joint Replacement Center
Spokane, Washington 99218
United StatesActive - Recruiting
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