Description
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 Wound Classification of:
- * Class I (Clean): An uninfected operative wound in which no inflammation is encountered, and the respiratory, alimentary, genital, or uninfected urinary tract is not entered
- * OR -
- * Class II (Clean Contaminated): An operative wound in which the respiratory, alimentary, genital, or uninfected urinary tract are entered under controlled conditions and without unusual contamination
- * 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:
- * condition(s) that, in the opinion of the investigator, cause the patient to be an overall health risk that is unsuitable for the surgery
- * known sensitivity to the study product components (drape and/or dressing materials 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 Wound Classification of:
- * Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
- * OR -
- * Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
- * Subject is enrolled in another interventional clinical study
Ages Eligible for Study:
22 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No