bilaterale mammoplasty
Conditions
Interventions
PICO is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting
of a small portable pump, 2 lithium batteries, 2 dressings and 10 fixation
strips. PICO is capable of delivering 80mmHg
Sponsors
Smith&Nephew, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Pre-surgery 1 * Female patient*s *18 years old 2 - The patient is able to understand the trial and is willing to consent to the trial Post-surgery;3 * Patient has undergone an elective surgical procedure for bilateral reduction mammoplasty;4 - Patients postsurgical incisions are of similar length
Exclusion criteria
Exclusion criteria: Pre-surgery Pregnant or lactating females 5 * Pregnant or lactating females;6 * Patients on steroids or other immune modulators known to impact healing which may affect scar appearance;7 * Patients with tattoos in the area of the incisions;8 * Patients with skin conditions (Cutis laxa etc.) that would result in poor healing or widened scars;9 * Patients with a known significant history of scar problems i.e. hypertrophic scaring or keloids;10 * Patients who in the opinion of the investigator may not complete the study for any reason;11 * Patients with a known history of poor compliance with medical treatment;12 * Patients who have participated in this trial previously and who were withdrawn;13 * Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct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);Post-surgery;14 - Incisions that are actively bleeding;15 - Exposure of blood vessels, organs, bone or tendon at the base of the reference wound;16 - Incisions >12 inches (30cm) max linear dimension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the difference in healing complications up to and 21 days post-operatively between postsurgical incisions treated with PICO compared with standard of care | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the aesthetic appearance and scar quality using POSAS-, VAS Questionnaires and the hydratation, elasticity and the Transepidermal Water Loss of the scar using the cutometer , the aspects of functional performance of both dressings, the ease of operation of the PICO pump, any changes in the surrounding skin condition and the assessment of a difference in the following economic assessments | — |
Countries
Netherlands
Outcome results
None listed