Optimization of the Nursing Time After the Use of Tissue Adhesives During the Chest Port Placement on Patients Treated With Chemotherapy, a Randomized Trial Versus Sutures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- The tissue adhesive, a technique adapted to save the nursing time. (Timed nursing time for PAC infusion)
研究概览
简要总结
Skin adhesive (Octyl cyanoacrylate - LIQUID BAND©) is increasingly used instead of suture for sutures on the superficial plane of the skin.
It is frequently used in children, in traumatology and in plastic surgery. Several randomized trials have shown satisfactory results of the glue compared to suture in terms of infections and scar dehiscence, and aesthetics after abdominoplasty and mammoplasty.
In the field of port-a-cath® placement in oncology:
- The use of skin adhesive can save substantial nursing time, which makes it possible to consider the transition of this technique into routine patient management. Potential benefits include nurses managing large numbers of patients in day hospitals, and patients no longer needing a nurse for suture removal.
- Cancer and chemotherapy toxicity can alter patients' body image and view of themselves. The presence of a scar can be traumatic for some patients. The second goal of this study is to test whether the use of glue can improve the appearance of the scar following port-a-cath® placement, an area in which there are divergent results.
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
- •Patient with age ≥ 18 years
- •Patient followed in day hospitalization in Oncology
- •Patient requiring a first CP for chemotherapy
- •Patient affiliated to a healthcare system
- •French-speaking patient
- •Patient who has given his free, informed and express oral consent
排除标准
- •Patient followed in the Pneumology department
- •Patient treated outside the GHPSJ
- •Patient with a CP for another indication than chemotherapy (nutrition, antibiotic therapy)
- •Patients with comprehension problems
- •Patients with behavior issues
- •Pregnant women
- •Patients under guardianship or curatorship
- •Patients deprived of liberty
- •Patients under court protection
研究组 & 干预措施
Skin adhesive
The scar is closed in 2 planes. The subcutaneous plane is closed with an absorbable 3/0 vicryl-type thread, the cutaneous plane is closed by applying skin adhesive. A drying time of 25 seconds is necessary to obtain a satisfactory seal.
干预措施: Skin Adhesive procedure (Procedure)
Standard suture
The scar is closed in 2 planes. The subcutaneous plane is closed with an absorbable 3/0 vicryl-type thread, the cutaneous plane is closed with the same thread with a subcutaneous stitch.
干预措施: Standard suture procedure (Procedure)
结局指标
主要结局
The tissue adhesive, a technique adapted to save the nursing time. (Timed nursing time for PAC infusion)
时间窗: 1 month
This outcome corresponds to the Timed nursing time for PAC infusion in the first cycle of chemotherapy and comparison between the 2 arms.
次要结局
- Patient's comfort(30 days)
- Physical shape of the scar (POSAS scale)(1 month)