PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

Smith & Nephew

Status

Completed

Conditions

Delayed Healing

Treatments

Device: PICO

Study type

Interventional

Funder types

Industry

Identifiers

NCT01640366

CE/US/11/01/PIC

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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Patients who have participated in this trial previously and who were withdrawn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