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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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- •Patients who have participated in this trial previously and who were withdrawn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
结局指标
主要结局
Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively
时间窗: 21 days postoperatively
The primary variable of whether or not the incision developed a healing complication within 21 days of surgery was defined as the presence of at least one of the following: 1. Infection (superficial or deep), 2. Dehiscence (partial, superficial or deep), 3. Delayed healing (defined as incision not closed within 7 days of the first surgical procedure). All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.
次要结局
- Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively(21 days postoperatively)
- Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively(21 days postoperatively)
- Number of Hematoma's Occurring up to and 21 Days Postoperatively(21 days postoperatively)
- Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively(21 days postoperatively)
- Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively(90 days postoperatively)
- Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively(Within 10 days postoperatively)
- Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively(Within 7 days postoperatively)
- Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively(21 days postoperatively)