A prospective, randomized, intra-patient, comparative, open, multi-centre study to evaluate the efficacy of a Single-Use Negative Pressure Wound Therapy (NPWT) System (PICO) on the prevention of postsurgical incision healing complications in patients undergoing reduction mammoplasty - The effectivity of a negative pressure system (PICO)

Smith&Nephew, Inc0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•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

•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of poor compliance with medical treatment;12 * Patients who have participated in this trial previously and who were withdrawn;13 * Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct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

发起方

Smith&Nephew, Inc