Clinical trial NCT03835845: A Clinical Study to Assess the Safety and Clinical Performance of a New Dressing (PICO7Y) in Breast Surgery Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncoplastic Breast Surgery
Bilateral Surgery
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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. Post-operative oedema in the peri-wound tissue is thought to limit tissue perfusion and high levels of wound fluid loss have been correlated with increased risk of post-operative infection and dehiscence23. Application of NPWT to the closed wound has been reported to improve patient comfort through reduced dressing changes and to lessen the period during which post-operative fluid discharges from the incision. Xia et al (2014)24 demonstrated that in 20 patients with infected wounds, NPWT resulted in significantly increased blood flow in the wounds when compared to pre application levels. In a study by Young et al (2013)25 four patients with pressure ulcers had oedema and wound bed thickness assessed during follow-up. They demonstrated a rapid reduction of peri-wound tissue oedema over four days and a 20% increase in the thickness of the wound bed by seven days of therapy.

Risk factors such as smoking and obesity have shown to increase complications follow oncoplastic surgery26 and it is possible that such populations could benefit more from the application of the NPWT. Furthermore there are a number of bilateral or multi wound indications where provision of a single device with the Y connection may represent a cost saving to the healthcare system. However, ultimately the use of NPWT for oncoplastic breast surgery closed incisions will be judged on whether it can increase the healing success rate while minimising complications. Holt and Murphy (2015)27 assessed the use of PICO single use NPWT system when applied to 24 patients with closed incisions following therapeutic resection. The contralateral breast underwent simultaneous symmetrising breast reduction with standard care dressings applied allowing for direct comparison. Although the cohort was too small to draw meaningful statistical conclusions they noted a lower incidence of wound breakdown (4.2% vs. 16.7%) and shorter time to healing (10.7 days vs. 16.1 days) in the NPWT group. However, this difference was partly attributed to the more extensive and complex nature of the therapeutic surgery. Similarly in a category of patients undergoing breast surgery with primary wound closure, Pellino et al (2014)19 showed significantly lower surgical site events when treated with PICO.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Clinical performance PICO 7Y NPWT system within 7 days of surgery
timeFrame: within 7 days of surgery
measure: Clinical performance PICO 7Y NPWT system
timeFrame: within 14 days of surgery
measure: Clinical performance PICO 7Y NPWT system within 30 days of surgery
timeFrame: within 30 days of surgery
measure: Safety of the PICO7Y NPWT system through number of Adverse Events, Device Deficiencies and Serious Adverse Events.
timeFrame: 1 year
Secondary outcomes:
measure: Rate of successful healing at day 30
timeFrame: up to Day 30
measure: Clinician Acceptability
timeFrame: 1 year
measure: Patient Acceptability
timeFrame: 1 year
measure: Ease of Application
timeFrame: 1 year
measure: Comfort
timeFrame: up to Day 7
measure: Ease of Removal
timeFrame: 1 year
measure: Dressing Wear Time
timeFrame: 1 year
measure: Incidence of Surgical Site Complications
timeFrame: up to Day 30
measure: Evaluate change in health-related quality of life
timeFrame: up to Day 30
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Academic Hospital Maastricht
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Manchester
country: United Kingdom
facility: Whythenshawe Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham Breast Institute
Study officials:
affiliation: Oncoplastic Breast Surgeon
name: John Murphy, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Smith & Nephew - Global Clinical Strategy
name: Brian Gilchrist, PhD
role: STUDY_CHAIR
References: