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About
The purpose of this study is to demonstrate substantial equivalence in terms of safety to support an indication change related to the usage of Prevena Therapy for up to 14 days. The enrolled subject will undergo 1 of 4 surgery types and be evaluated for up to 90 days.
Enrollment
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Volunteers
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:
OR -
has malnutrition, as determined by the investigator
Subject is pre-operatively assessed to undergo a procedure with a CDC Wound Classification of:
OR -
Subject has a closed post-surgical incision for which the anticipated duration of Prevena Therapy is more than 11 days
Exclusion criteria
Subject is female and, except in the case of C-section procedures, is pregnant or lactating prior to surgery
Subject has signs of an infection in the surgical area or has signs of a systemic infection 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:
Subject is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:
OR -
Subject is enrolled in another interventional clinical study
Primary purpose
Allocation
Interventional model
Masking
353 participants in 1 patient group
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Central trial contact
Eric Synatschk, MS, CCRP
Data sourced from clinicaltrials.gov
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