NL-OMON48115
Completed
Not Applicable
An Observational, Prospective Multicentre Clinical Study to assess the safety and clinical performance of a New Single-use Negative Pressure Wound Therapy System (PICO 7Y) for the Simultaneous Management of Bilateral Closed Incisions in Oncoplastic Breast Surgery Patients - PICO7Y
Smith&Nephew, Inc0 sites6 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- breast cancer surgery
- Sponsor
- Smith&Nephew, Inc
- Enrollment
- 6
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The subject must have understood and provided written informed consent
- •2\. Female subjects who must be at least eighteen (18\) years of age.
- •3\. Willing and able to make all required study visits.
- •4\. Able to follow instructions.
- •5\. Subjects must be undergoing, at the same time, both an oncoplastic breast
- •surgery and a symmetrising breast reduction on the contralateral breast and
- •have closed incisions that would benefit from NPWT.
- •6\. Subjects whose incisions will fit comfortably within the area of the pad of
- •the dressing sizes provided.
Exclusion Criteria
- •1\. Contraindications (per the PICO 7Y IFU) or hypersensitivity to the use of
- •the investigational product or their components (i.e., silicone adhesives and
- •polyurethane films \[direct contact with wound], acrylic adhesives \[direct
- •contact with skin], polyethylene fabrics and super\-absorbent powders
- •\[polyacrylates]) within the dressing.
- •2\. Subjects with skin features (e.g. tattoos, skin colour, pre\-existing
- •scarring) which in the opinion of the Investigator, will interfere with the
- •study assessments.
- •3\. Suspected or confirmed allergy to any of the components of the ancillary
- •products should they be deemed required, e.g. in the case of SECURA No\-sting
Outcomes
Primary Outcomes
Not specified
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