Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 664
- 试验地点
- 25
- 主要终点
- Overall PSAS score measured 3 months after the surgery
研究概览
简要总结
A surgery made by an external incision requires to stitch the subcutaneous plans, usually performed using absorbable synthetic sutures hold on wire needle. This national, prospective, multicentric, and randomized study is devoted to estimate a technique of suture of the subcutaneous plans based on an implantable medical device delivering automatically absorbable staples. This particularly innovative technique lets to expect a tolerance and an efficiency at least equivalent to the reference technique (main objective). Moreover, this technique allows to anticipate a reduction of the duration of surgical procedure and anesthetic time while limiting the risks of blood wounds of the medical staff.The medical economic part of this study will check, from the point of view of the health care hospital, wether the technique is likely to reduce the costs and time consuming theater room procedures.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 yrs to 75 yrs
- •Patient supported for a scheduled surgery :
- •For abdominoplasty, cervicotomy or suprapubic surgery With a open incision necessary for operative exposition of 10 cm or more with a straight or curved surgery incision
- •Person covered by Health Insurance
- •ECOG Performance Status 0 or 1
- •Patient's informed and written consent
排除标准
- •Incision imposing a very angular or sinuous scar for which the use of the medical device is deemed unsuited (sinuous or bayonet incisions)
- •Known history of intolerance to any component of the medical device
- •Immunocompromised patients or undergoing a long term treatment by corticosteroids or immunosuppressants
- •Known or anticipated presence of a skin infection (due to the infected skin condition, or because of underlying surgery conducted in infected territory or likely to be)
- •Dermatological disease or skin treatment in progress
- •History of radiation therapy on the surgical site or antimitotic treatment in progress
- •Pregnancy at the time of suture
- •Patients simultaneously included in another treatment protocol
- •Patients under legal guardianship
- •Non French speaking patients, refusing or unfit for the monitoring proposed in the study
结局指标
主要结局
Overall PSAS score measured 3 months after the surgery
时间窗: 3 months after the surgery
Overall PSAS score measured 3 months after the surgery(PSAS : "Patient Scar Assessment Scale")
次要结局
- Overall score of the OSAS scale(Months 3, 12 and 18)
- Aesthetic quality of the scar(Month 18)
- Quantification of accidental exposure to blood(During the surgery)
- Incremental cost-effectiveness ratio (ICER) or average cost of suture according to the procedure (wire or staple)(Day 0 (Procedure))
- Presence of scarring complications at day 8 (infection, dehiscence)(Day 8)
- Measurement of suture, surgical and anesthetic times(Day 0 (procedure))
- Overall score of the PSAS scale(Months 3, 12 and 18)