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

Completed

• Conditions: breast cancer surgery; Oncoplastic breast surgery; 10006295

• Registration Number: NL-OMON48115
• Lead Sponsor: Smith&Nephew, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

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
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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess clinical performance and safety of the PICO 7Y NPWT system through<br /><br>its capacity to deliver negative pressure consistently at -80 mmHg, to both the<br /><br>reconstructed breast and the contralateral breast, during a period of 7 days<br /><br>including the rate of leakage.</p><br>