Influence of Dressing Wear Time on Skin Colonization After Breast Augmentation With Prosthesis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- skin colonization
研究概览
简要总结
This study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.
详细描述
Augmentation mammaplasty is currently one of the most performed plastic surgery procedures. It is a clean operation, and surgical site infection (SSI) rates are low. However, a SSI, since a minor one, leads to the failure of the procedure. Thus, minimizing SSI risks is imperative.
The Centers for Disease Control and Prevention (CDC) provides recommendations concerning prevention of SSI.No recommendation is offered for some practices, either because there is a lack of consensus regarding their efficacy or because of the available scientific evidence is insufficient to support their adoption.
CDC´s "Guideline for Prevention of Surgical Site Infection" recommends protecting with a sterile dressing for 24 to 48 hours an incision that has been closed primarily. There is no recommendation to cover the incision beyond 48 hours. One major risk factor for SSI is the presence of bacteria at surgical site.Thus, this trial was designed to verify the influence of dressing wear time on skin colonization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •candidate to breast prosthesis implantation
- •body mass index under 30Kg/m2
排除标准
- •pregnancy, delivery or breast feeding during the last 12 months
- •body mass index over 30Kg/m2
- •breast cancer history
- •previous breast surgery
- •hard smoking
研究组 & 干预措施
Postoperative day 6
Dressing is removed on the sixth postoperative day
干预措施: augmentation mammaplasty (Procedure)
Postoperative day 1
Dressing is removed on the first postoperative day
干预措施: augmentation mammaplasty (Procedure)
结局指标
主要结局
skin colonization
时间窗: 6 days postoperatively
skin colonization will be measured through semi-quantitative cultures of samples collected pre-dressing and on 6th postoperative day.
次要结局
- surgical site infection(30 days postoperatively)
研究者
Daniela Francescato Veiga
Professor
Federal University of São Paulo