Phase
Condition
Orthopedic Surgery
Cardiac Surgery
Orthopedics
Treatment
Prevena Plus Incision Management System with Prevena Dressings
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is at least 22 years of age on the date of informed consent
Subject can provide informed consent
Subject requires a surgical procedure for 1 of the 4 specialty treatment groups (ie,lower extremity orthopedic procedure, abdominal or C-section procedure, sternotomy,or vascular procedure)
Subject is willing and able to return for all scheduled study visits.
Subject has 1 or more of the following risk factors for post-surgical complications:
BMI ≥ 30
diabetes
history of smoking
immune suppression or receiving drugs that can cause immune suppression (eg,steroids, chemotherapeutic medications, and/or antimetabolites)
high risk for malnutrition, as indicated by 2 or more of the following1:
insufficient energy intake
loss of muscle mass
loss of subcutaneous fat
localized or generalized fluid accumulation that may mask weight loss
diminished functional status as measured by hand-grip strength
OR -
has malnutrition, as determined by the investigator
neutropenia
cardiac, pulmonary, liver, or renal disease
history of previous surgery or radiation in the treatment area
Subject is pre-operatively assessed to undergo a procedure with a CDC WoundClassification of:
Class I (Clean): An uninfected operative wound in which no inflammation isencountered, and the respiratory, alimentary, genital, or uninfected urinarytract is not entered
OR -
Class II (Clean Contaminated): An operative wound in which the respiratory,alimentary, genital, or uninfected urinary tract are entered under controlledconditions and without unusual contamination
Subject has a closed post-surgical incision for which the anticipated duration ofPrevena Therapy is more than 11 days
Exclusion
Exclusion Criteria:
Subject is female and, except in the case of C-section procedures, is pregnant orlactating prior to surgery
Subject has signs of an infection in the surgical area or has signs of a systemicinfection at the time of surgery
Subject is a chronic opioid user, defined per the CDC guidelines as opioid use for > 3 months, at the time of enrollment
Subject has any of the following:
condition(s) that, in the opinion of the investigator, cause the patient to bean overall health risk that is unsuitable for the surgery
known sensitivity to the study product components (drape and/or dressingmaterials in direct contact with the closed incision or skin)
known sensitivity to silver
skin cancer localized at or in proximity to the incision site
intraoperative issue(s) that precludes the use of Prevena Therapy
Subject is preoperatively assessed to undergo a procedure with a CDC WoundClassification of:
Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaksin sterile technique or gross spillage from the gastrointestinal tract
OR -
Class IV (Dirty-Infected): Old traumatic wounds with retained devitalizedtissue and those that involve existing clinical infection or perforated viscera
Subject is enrolled in another interventional clinical study
Study Design
Connect with a study center
Insight Hospital and Medical Center
Chicago, Illinois 60616
United StatesSite Not Available
IU Health
Fishers, Indiana 46037
United StatesSite Not Available
Sinai Hospital of Baltimore
Baltimore, Maryland 21215
United StatesActive - Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United StatesSite Not Available
Bryan Heart
Lincoln, Nebraska 68506
United StatesActive - Recruiting
WakeMed Heart & Vascular
Raleigh, North Carolina 27610
United StatesActive - Recruiting
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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