breast cancer surgery Oncoplastic breast surgery
Conditions
Interventions
None listed
Sponsors
Smith&Nephew, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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 barrier skin wipes for patients with fragile skin. 4. Subjects with a local infection, close or at the site of the incision, at the time of surgery 5. Subjects with incisions that are actively bleeding unless haemostasis has been achieved. 6. Subjects with a genetic or acquired disease capable of negatively impact the closed incision healing. 7. Subjects with a history of poor compliance with medical treatment. 8. Subjects who have participated previously in this clinical trial. 9. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study. 10. Individuals from vulnerable populations including pregnant women and adult females over 75 years. 11. Subjects who have received neo adjuvant chemotherapy within the last 30 days prior to surgery. 12. Patients who at the end of the surgery have only one breast operated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess clinical performance and safety of the PICO 7Y NPWT system through its capacity to deliver negative pressure consistently at -80 mmHg, to both the reconstructed breast and the contralateral breast, during a period of 7 days including the rate of leakage. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the clinical performance and safety of the PICO 7Y NPWT system within 30 days of surgery, the following evidence is taken into account: * The rate of successful wound healing at 14 and 30 days of surgery. The wound healing is successful if there are no signs of surgical site complications (SSC) such as persistent exudate, dehiscence, necrosis, seroma, hematoma or infection. * The incidence of SSC including infection, dehiscence or delayed wound healing at day 14 and day 30. Please note delayed wound healing is healing that takes longer than 10 days. * The visual appearance rating of quality of wound closure. Healing rates will be considered overall and separately for the oncologic side and the contralateral side (this is because the risks are different). * The pain experienced by the subject during the use of the PICO 7Y NPWT system. * The dressing wear time (time in days) and the number of dressings used per surgical site. * To evaluate change in health related quality of life, associated with treatment, measured using change of the EQ-5D 5L scores from baseline to Day 7 and Day 30. Exploratory * To assess clinician acceptability of PICO 7Y dressing at 7 days, and clinician satisfaction with the outcome at 30 days. * To assess patient acceptability of PICO 7Y dressing at 7 days. * To assess ease of application & removal of the PICO 7Y dressing. * To assess patient comfort during wear. Safety * Analysis of adverse events experienced by subjects over a 30-day follow-up period. * Device-related adverse events and device deficiencies (quality issues) during the period subjects receive NPWT therapy with PICO 7Y. | — |
Countries
Netherlands
Outcome results
None listed