A Clinical Study to Assess the Safety and Clinical Performance of a New Dressing (PICO7Y) in Breast Surgery Patients
Condition: Oncoplastic Breast Surgery; Bilateral Surgery
Study type: Interventional

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.
    

Intervention name(s): PICO7Y
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment