PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

A Prospective, Randomized, Intra-patient, Comparative, Open, Multi-centre Study to Evaluate the Efficacy of a Single-Use NPWT System on the Prevention of Incision Healing Complications in Patients Undergoing Reduction Mammoplasty

The purpose of this study is to see if the use of a single-use negative pressure wound therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing complications following breast reduction surgery and to assess the medium-term aesthetic appearance and quality of the resultant scar, compared with standard of care dressings.

The aim of the present study is to assess the efficacy and cost-effectiveness of the Single-Use Negative Pressure Wound Therapy (NPWT) system (PICO) with regard to the reduction of postsurgical incision healing complications during the immediate postoperative treatment phase, and to assess the medium-term aesthetic appearance and quality of the resultant scar, in patients undergoing reduction mammoplasty, compared to standard care.

Inclusion Criteria:

• Female patient's ≥ 18 years old
• The patient is able to understand the trial and is willing to consent to the trial
• Patient has undergone an elective surgical procedure for bilateral reduction mammoplasty
• Patients postsurgical incisions are of similar length

Exclusion Criteria:

• Pregnant or lactating females
• Patients on steroids or other immune modulators known to impact healing which may affect scar appearance
• Patients with tattoos in the area of the incisions
• Patients with skin conditions (Cutis laxa etc.) that would result in poor healing or widened scars
• Patients with a known significant history of scar problems i.e. hypertrophic scaring or keloids
• Patients who in the opinion of the investigator may not complete the study for any reason
• Patients with a known history of poor compliance with medical treatment
• Patients who have participated in this trial previously and who were withdrawn
• Patients with known allergies to product components (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)
• Incisions that are actively bleeding
• Exposure of blood vessels, organs, bone or tendon at the base of the reference wound
• Incisions > 12 inches (30cm) max linear dimension