PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

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- Patients who have participated in this trial previously and who were withdrawn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