A Clinical Study to Assess the Safety and Clinical Performance of a New Dressing (PICO7Y) in Breast Surgery Patients

NCT03835845 | Completed

• 1 other identifier: CT1704P7Y
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 5

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 same time, and the purpose of this study is to check how the dressing is working by looking at data on how well the dressing performs while you wear it and to check if doctors and patients are happy with it. PICO7Y is based on another dressing called PICO.

Conditions

Oncoplastic Breast Surgery; Bilateral Surgery

Outcome Measures

Primary Outcomes (4)

• Clinical performance PICO 7Y NPWT system within 7 days of surgery

  To assess clinical performance 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. This will be measured by assessing the incision wound on Day 7, using CDC wound assessment criteria. Photographs will also be taken of the incision wound with treatment and after treatment.

  within 7 days of surgery

• Clinical performance PICO 7Y NPWT system

  To assess clinical performance 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. This will be measured by assessing the incision wound on Day 14 using CDC wound assessment criteria. Photographs will also be taken of the incision wound with treatment and after treatment.

  within 14 days of surgery

• Clinical performance PICO 7Y NPWT system within 30 days of surgery

  To assess clinical performance 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. This will be measured by assessing the incision wound on Day 30, using CDC wound assessment criteria. Photographs will also be taken of the incision wound with treatment and after treatment.

  within 30 days of surgery

• Safety of the PICO7Y NPWT system through number of Adverse Events, Device Deficiencies and Serious Adverse Events.

  Safety will be assessed by reporting any Adverse Events or Device deficiencies, and any Serious adverse events.

  1 year

Secondary Outcomes (9)

• Rate of successful healing at day 30

  up to Day 30

• Clinician Acceptability

  1 year

• Patient Acceptability

  1 year

• Ease of Application

  1 year

• Comfort

  up to Day 7

Study Arms (1)

PICO7Y

EXPERIMENTAL

PICO 7Y is a single-use NPWT System consisting of a small portable pump \& pump clip, 2 AA batteries, 2 large multisite dressings, 2 extension tubes and secondary fixation strips.

Device: PICO7Y

Interventions

PICO7Y DEVICE

The PICO 7Y pump maintains NPWT at -80 mmHg (nominal) to two wound surfaces simultaneously. Exudate is managed by the dressings through a combination of absorption and evaporation of moisture through the outer film. The PICO 7Y kit is intended to be used for up to 7 days on low exuding wounds. For moderately exuding wounds the system is intended to be used for up to 4 days without a dressing change. For 7 days use on moderately exuding wounds additional dressings will be supplied.

PICO7Y

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (5)

Academic Hospital Maastricht

Maastricht, 6229, Netherlands

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Whythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

Nottingham Breast Institute

Nottingham, NG5 1PB, United Kingdom

Location

Study Officials

• John Murphy, MBChB

  Oncoplastic Breast Surgeon

  PRINCIPAL INVESTIGATOR

• Brian Gilchrist, PhD

  Smith & Nephew - Global Clinical Strategy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: February 11, 2019
• Study Start: March 8, 2019
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

NL (1); GB (4)