Influence of Time of Permanence of Dressing Following Breast Reconstruction on Skin Colonization and on Surgical Site Infection Rates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Surgical site infection (SSI)
研究概览
简要总结
This randomized clinical trial was designed to assess the influence of time of dressing after breast reconstruction procedures on surgical site infections rates and skin colonization.
详细描述
The rates of surgical site infections (SSI) after clean operations range from 1 to 2%. However, infection rates in the breast surgical literature tend to be higher, with reported rates ranging from 2 to 30%. In plastic surgery operations, to minimize the risk of SSI is imperative, since even minor infections are able to complicate the healing process and harm the cosmetic result.
The Centers for Disease Control and Prevention has established guidelines for postoperative incision care. However, there is no recommendation to cover an incision closed primarily beyond 48 hours, nor on the appropriate time to shower or bathe with an uncovered incision. This remains an unresolved issue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •candidate to immediate or delayed breast reconstruction after mastectomy or segmental mastectomy
排除标准
- •use of antibiotics at the time of the operation
- •presence of skin lesions on the surgical site
- •body mass index over 35Kg/m2
- •hard smoking
研究组 & 干预措施
Postoperative day 1
Dressing was removed on the first postoperative day
干预措施: Incisions covered for 1 day (Other)
Postoperative day 6
Dressing was removed on the 6th postoperative day
干预措施: Incisions covered for 6 days (Other)
结局指标
主要结局
Surgical site infection (SSI)
时间窗: 30th postoperative day and one year after operation
Patients are followed weekly by a masked surgeon in regard to SSI, until the 30th postoperative day.CDC's criteria and classification was adopted.Patients are reevaluated at the end of the first year after operation.
次要结局
- Skin colonization(6 days postoperatively)
- Patients self assessments(2 weeks postoperatively)
研究者
Daniela Francescato Veiga
Professor
Federal University of São Paulo