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NCT05614869
Continuous Treatment With PREVENA Therapy for 14 Days
Conditions: Abdominal Surgery, Orthopedic Surgery, Cardiovascular Surgery, Vascular Surgery
Sex: All
Ages: 22 Years – N/A
Phase: NA
Enrollment: 226
Sponsor: 3M
Location: United States
Summary
The purpose of this study is to demonstrate the safety and effectiveness of Prevena Therapy for up to 14 days is comparable to the current approved use for up to 7 days.
The enrolled subject will undergo 1 of 4 surgery types and be evaluated for up to 90 days.
Eligibility Criteria
Inclusion Criteria:Subject is at least 22 years of age on the date of informed consentSubject can provide informed consentSubject 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 ≥ 30diabeteshistory of smokingimmune 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 intakeloss of muscle massloss of subcutaneous fatlocalized or generalized fluid accumulation that may mask weight lossdiminished functional status as measured by hand-grip strengthOR -has malnutrition, as determined by the investigatorneutropeniacardiac, pulmonary, liver, or renal diseasehistory of previous surgery or radiation in the treatment areaSubject 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 enteredOR -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 contaminationSubject has a closed post-surgical incision for which the anticipated duration of Prevena Therapy is more than 11 daysExclusion Criteria:Subject is female and, except in the case of C-section procedures, is pregnant or lactating prior to surgerySubject has signs of an infection in the surgical area or has signs of a systemic infection at the time of surgerySubject is a chronic opioid user, defined per the CDC guidelines as opioid use for > 3 months, at the time of enrollmentSubject 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 surgeryknown sensitivity to the study product components (drape and/or dressing materials in direct contact with the closed incision or skin)known sensitivity to silverskin cancer localized at or in proximity to the incision siteintraoperative issue(s) that precludes the use of Prevena TherapySubject 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 tractOR -Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated visceraSubject is enrolled in another interventional clinical study
Source: ClinicalTrials.gov (NCT05614869). StuddyBuddy aggregates publicly available trial information.