Pilot Evaluation of Cosmetic Outcome and Surgical Site Infection Rates of Coated VICRYL* Plus Antibacterial (Polyglactin 910) Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 6
- 主要终点
- Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)
研究概览
简要总结
This is a 90-day study to evaluate cosmetic outcome and Surgical Site Infection in approximately 100 patients from 6 centers in China undergoing scheduled modified radical mastectomy for breast cancer.
详细描述
Patients will be evaluated post-procedure on Days 3, 5, 7, 12, 30 and 90 for cosmetic outcome and surgical site infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older with written informed consent
- •Scheduled for a modified radical mastectomy
- •Surgical wound classified Class I/Clean using the CDC SSI Surgical Wound Classification
排除标准
- •Unable to give consent and unlikely to comply with study requirements and complete the 90-day follow up visit
- •Undergoing surgery for modified radical mastectomy with immediate breast reconstruction, cosmetic breast operations, reduction, expansion, insertion of prothesis, duct ectasia or infective breast disease or implant
- •Surgical wounds classified as Class II, III or IV using CDC SSI Surgical Wound Classification
- •Has inflammatory cancers or skin ulceration
- •Has known allergy or intolerance to triclosan
- •Has compromised wound healing or chronic immune deficiency, for example diabetes, prolonged steroid use, AIDS or substance abuse
- •Has serious heart and/or lung disease
- •Has skin scar history or family history
- •Has direct relationship to or involvement in this or other studies under the direction of the investigator or center
- •Received an experimental drug or device within 30 days prior to the planned start of treatment
研究组 & 干预措施
Chinese Silk Suture
Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
干预措施: silk suture (Device)
VICRYL* Plus Suture
Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
干预措施: VICRYL* Plus suture (Device)
结局指标
主要结局
Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)
时间窗: 30 days (+/- 5) post-operative
Post-operative cosmetic outcome assessed on surgical site photographs by an independent blinded central assessor using a validated 100 mm visual analog scale, with 0 representing the worst possible scar and 100 representing the best possible scar
次要结局
- Mean Cosmetic Outcome Score on Modified Hollander Scale(30 days)
- Mean Surgical Site Infection Score on Modified ASEPSIS Scale(Day 90)
- Mean Cosmetic Outcome Score on Modified Hollander Scale(12 days)
- Mean Surgical Site Infection Score on Modified ASEPSIS Scale(Day 3)
- Mean Surgical Site Infection Score on Modified ASEPSIS Scale(Day 5)
- Mean Surgical Site Infection Score on Modified ASEPSIS Scale(Day 7)
- Mean Surgical Site Infection Score on Modified ASEPSIS Scale(Day 12)
- Mean Surgical Site Infection Score on Modified ASEPSIS Scale(Day 30)