A Prospective, Single-arm, Multi-center, Open-label Trial Evaluating the Continuous Application of Prevena Therapy for up to 14 days
L
Leonard Buller
Primary Investigator
Enrolling By Invitation
22 years or above
All
Phase
N/A
1 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
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 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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - The Principal Investigator will review the medical records to initially identify potential subjects, mention study to patients in his clinic who meet/likely meet screening criteria, ascertain interest, and inform the key personnel about patients who are interested in learning more about the study.
Detailed description of study
What will happen during the study?
- Subjects undergoing 1 of 4 types of surgery will be enrolled and treated with the PREVENA Plus Incision Management System and will be evaluated for up to 90 days.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: all
-
Age: 22 years or above
-
Gender: All
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
Updated on
13 Dec 2024.
Study ID: ORTHO-KCIUSA-PREVENA, 23422
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