Status:
COMPLETED
A Clinical Study to Assess the Safety and Clinical Performance of a New Dressing (PICO7Y) in Breast Surgery Patients
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Oncoplastic Breast Surgery
Bilateral Surgery
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
The purpose of the study is to assess the use of a wound dressing system called PICO7Y following a two-sided breast surgery. PICO7Y is a new dressing system made to treat two incisions/wounds at the s...
Detailed Description
It is thought that Negative Pressure Wound Therapy may have numerous mechanisms of action when used to manage surgical incisions, including reducing oedema, stimulating perfusion and managing exudate....
Eligibility Criteria
Inclusion
- The subject must have understood and provided written informed consent (reference section 9.1)
- Female subjects who must be at least eighteen (18) years of age.
- Willing and able to make all required study visits.
- Able to follow instructions.
- 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.
- Subjects whose incisions will fit comfortably within the area of the pad of the dressing sizes provided.
Exclusion
- 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.
- 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.
- 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.
- Subjects with a local infection, close or at the site of the incision, at the time of surgery
- Subjects with incisions that are actively bleeding unless haemostasis has been achieved.
- Subjects with a genetic or acquired disease capable of negatively impact the closed incision healing.
- Subjects with a history of poor compliance with medical treatment.
- Subjects who have participated previously in this clinical trial.
- Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- Individuals from vulnerable populations including pregnant women and adult females over 75 years.
- Subjects who have received adjuvant chemotherapy within the last 30 days prior to surgery.
- Patients who at the end of the surgery have only one breast operated.
Key Trial Info
Start Date :
March 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03835845
Start Date
March 8 2019
End Date
February 29 2020
Last Update
June 21 2022
Active Locations (5)
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1
Academic Hospital Maastricht
Maastricht, Netherlands, 6229
2
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
3
Royal Free Hospital
London, United Kingdom, NW3 2QG
4
Whythenshawe Hospital
Manchester, United Kingdom, M23 9LT