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临床试验/NCT06310070
NCT06310070招募中不适用

3D Printed Personalized Ostomy Appliance

Carilion Clinic2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Incidence of Leaks

研究概览

简要总结

The goal of this clinical trial is to learn about the effectiveness of using a 3D scan for a personal ostomy appliance. The main question it aims to answer is:

• Whether or not a 3D scan of a stoma reduces leakages and improves patient quality of life in regard to using a personalized ostomy appliance.

Participants will

  • Spend 2 weeks with their standard of care ostomy appliance
  • Spend 2 weeks with their personalized ostomy appliance made from a 3D scan
  • Participate in daily surveys and weekly quality of life surveys conducted over the phone

详细描述

Formation of an ostomy is an operation that connects a hollow viscus, such as the bowel, to the skin. An ostomy appliance is worn to collect waste around the stoma, the externalized viscus organ. Ostomy appliances are emptied several times a day and are exchanged as infrequently as once per week or as frequently as multiple times per day. Unfortunately, half of all patients with an ostomy will suffer from complications such as peristomal skin breakdown, skin irritation, leaks, and bleeding. Stoma measuring guides are used to measure the ostomy appliance to achieve a well-fit skin barrier and prevent peristomal skin complications. Leaks both dramatically decrease patients' quality of life and result in skin irritation and other complications including infections.

Investigators propose utilizing advances in 3D scanning, computer-aided design (CAD) modeling, and 3D manufacturing to create a personalized ostomy appliance.

Site investigators will develop a 3D personalized ostomy appliance protocol featuring three phases: first, the patient's stoma is scanned using a 3D scanner in CRSudio2; second, the raw scan is edited using personalized variables to create a filtered mesh; third, the filtered mesh is printed to provide an ostomy template to the patient and currently available ostomy appliances are modified using a laser cutter to provide a personalized ostomy appliance to the patient. The selection of commercially available ostomy appliance will be done in coordination with the ostomy nursing team. Based upon the patient's body habitus and stoma, the ostomy nurse will select the recommended appliance that is available at Carilion Clinic. This will be the appliance that is customized using the laser cutter.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-100 years old
  • Must have had current ostomy appliance for > 6 weeks - if patients with stomas less than 6 weeks are included, their personalized templates will not be useful once the stoma size has changed after their initial scan.
  • Must have experienced > 1 leakage in the week leading up to day of consent. - If patients are not experiencing leakages, then there will be no baseline data to compare effectiveness of the post-3D appliance intervention.
  • Participants must be able to consent for themselves
  • Access to phone AND computer with internet access. Patient must be able to provide electronic mailing address for e-consent documentation and REDCap surveys.

排除标准

  • Concern for patient being able to be reached over the phone or reliable internet access for REDCap survey completion
  • Existing peri-stomal skin breakdown including ulceration or mucocutaneous separation.
  • Diagnosis of infection around the peristomal region. (erythema is NOT an exclusion criteria)

研究组 & 干预措施

Receiving 3D Personalized Ostomy Appliance

Experimental

The personalized ostomy appliances are designed based off of a 3D scan. We will scan your ostomy to create a 3D picture in the computer system that is an exact copy of your ostomy using plastic. We then apply computer aided design (CAD) tools to modify your normal ostomy baseplates.

干预措施: 3D Printed Personalized Ostomy Appliance (Device)

结局指标

主要结局

Incidence of Leaks

时间窗: 28 days

Number of leaks experienced on a daily basis by participant

次要结局

  • Overall patient satisfaction(28 days)
  • Number of appliances(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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