Randomized Controlled Trial to Reduce Surgical Site Infections in Breast Cancer Surgery With Clorhexidine Gluconate Securement Dressing (Tegaderm CHG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Number of subjects with drain bulb fluid bacterial colonization at the first and second week postoperative.
研究概览
简要总结
Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of sick woman could delay the adjuvant therapy and result increase morbidity and mortality. Also this increased costs associated with health care.Surgical drains have been noted as a potential source for surgical site infections. The primary aim of the study is to determine if chlorhexidine occlusive dressings applied to the intervention drain sites effectively decreases rates of bacterial colonization in drain fluid and drain tips compared to standard care.
详细描述
Following approval by the National Cancer Institute Review Board, eligible subjects will be recruited prospectively from the Breast Cancer Department at National Cancer Institute, México from November 2016 to November 2017. Individuals with confirmed cancer undergoing total mastectomy (TM), modified radical mastectomy (MRM) and/or axillary lymph node dissection (ALND) in which surgical drains are going to be used will be identified through the surgical scheduling sheet. If the subjects are eligible according to the inclusion criteria, the will be interviewed by one of the main researchers. In the initial interview the informed consent will be read and signed. Also the study coordinator will collect the data of interest from the medical records and will register it in a data collection sheet specially created for this project.
Following informed consent, participants will be randomize to either the standard drain care regimen or the drain antisepsis regimen by a computerized randomization program, using dynamic allocation and stratifying by surgical procedure (radical surgery or conservative surgery). Subjects who had bilateral cancer underwent to the same regimen for both sides. The operating surgeon will know the assigned treatment arm at the end of the surgery.
The surgery will consist on placing a chlorhexidine gluconate occlusive adhesive dressing to the drains side at the end of the surgery. The dressing will be changed each 7 (+-1) days until the drain is removed.
All the participants and the principal take-carers, despite of the group of participation, will be personal instructed by a member of the research team in the first hours of the postoperative, before the departure. In addition, they will be given paper based instructions for the general care of the drain and the surgery wound.
For the experimental group, the dressing will be changed each 7(+-1) days; The site of the insertion must be cleaned with 70% concentration isopropyl alcohol towels. The evaluation and quantification of the drained fluid will be done every 12 hours as it is done usually in these patients.
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
- None
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
- •Females minimum age 18 able to give informed consent
- •Breast cancer confirmed by histopathology
- •Patients undergoing unilateral or bilateral mastectomy with or without immediate expander reconstruction.
排除标准
- •Patients who deny informed consent
- •Prior radiation therapy to the sick breast.
- •Pregnant or breastfeeding women
- •Patients undergoing immediate breast reconstruction with Deep Inferior
- •Epigastric Perforator (DIEP) o Transverse Rectus Abdominal Muscle techniques (TRAM) .
- •Emergency procedures
- •Documented allergy to chlorhexidine gluconate
- •Antibiotic use in the fourteen days prior to surgical date
- •Patients with a history or suspicion of breast cancer surgery outside the INCan in the previous three months.
- •Patients who do not speak spanish, diagnosed with a psychiatric disorder and in whom a minimum follow-up of 14 days couldn't be feasible because of operative difficulties (eg.
- •place of residence or reference to other health institutions).
研究组 & 干预措施
Antiseptic occlusive dressing group
A chlorhexidine gluconate occlusive adhesive dressing (Tegaderm CHG) will be applied to the intervention drain sites and changed every seven days.
干预措施: Antiseptic occlusive dressing group (Device)
Standard care
Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site and the tubing with a cotton swab dipped in rubbing alcohol.
结局指标
主要结局
Number of subjects with drain bulb fluid bacterial colonization at the first and second week postoperative.
时间窗: Approximately 1 or 2 weeks after surgery
Bacterial growth was defined as plate growth \>10\*5 colony forming unit (CFU). Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.
Number of subjects with drain tip bacterial colonization at removal.
时间窗: Approximately at the second and/or third week after surgery
Bacterial growth was defined as plate growth \>15 CFU by semiquantitative technique or \>10\*5 CFU by sonication and fluid culture. Drains were removed at variable times across patients, per clinical indication.
次要结局
- Number of Subjects With Surgical Site Infection Within 30 Days(Approximately 30 days after surgery)
研究者
MYRNA CANDELARIA, MD PHD
Ethics Commissioner
National Institute of Cancerología