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临床试验/NCT04606004
NCT04606004已完成不适用

Perianal Maceration in Pediatric Ostomy Closure Patients

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2020年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Perianal skin maceration in the group receiving the intervention vs. the control group

研究概览

简要总结

This pilot study will explore whether preoperative application of stool from the stoma bag to the perianal area will prevent/ decrease postoperative perianal maceration in pediatric ostomy closure patients. It will also explore the overall safety and feasibility of this pilot study for larger randomized control trials. There will be a control group and an intervention group. The intervention group will apply stool from the stoma bag approximately 4 weeks prior to ostomy closure and fill out a compliance log and upload pictures weekly to the MyCHP (My Children's Hospital) portal. A validated diaper dermatitis score will be utilized in this study.

详细描述

After consent, participants will be assigned to either a treatment group or control group using a 2-group comparative pilot design. For this pilot study to ensure adequate balance, subjects will be assigned using every other technique. After consent is obtained, a one-time pH stool sample will be collected either at the outpatient visit or at the inpatient's bedside.

Pre-Operatively (about 4 weeks prior to ostomy closure)

Intervention Group:

The parent or the inpatient healthcare provider (if patient is hospitalized at any point within the 4 weeks prior to ostomy closure) will follow standard of care for skin care pre-operatively, which is either no application of barrier cream, or an application of an over the counter skin barrier such as Aquaphor, Desitin, or Vitamin A&D if the patient is experiencing skin redness from urine incontinence. In addition to standard of care, they will apply stool from the stoma bag 4 weeks prior, twice daily for 10 minutes at a time. However, with the stool application no barrier cream will be applied to the skin in order for the stool to achieve penetrance to the skin. After 10 minutes of application, the caregiver or inpatient healthcare provider will remove the entire thin layer of stool gently without excessive friction, just enough to remove the stool, a dabbing motion is preferred. Parents will be asked to upload images of their child's diaper area at least once weekly onto the MyCHP Portal (if their child is not inpatient) in order to monitor their skin for breakdown from and while performing the intervention. If at any time redness occurs, the parent will be asked to upload an additional picture to the MyCHP Patient Portal for investigator/clinician review or for visual inspection (if inpatient) and corresponding measurement of perianal skin breakdown. Upon visual inspection or image inspection, the co-investigator/ clinician will provide review, corresponding measurement with a validated diaper dermatitis scale, and provide appropriate clinical guidance.

Compliance and Assessment: A preoperative compliance log will be used with every stool application by the parent at home or healthcare provider. This log will ask who applied the stool, how long stool was on the skin, description of stool, skin description, what brand of diapers and wipes were used, diet information, etc. They will notify the researchers if there are worsening skin concerns at home. Weekly and as needed images of buttocks areas will be uploaded into the CHP Patient Portal for clinical/research review by the parent, or weekly visual inspections as needed assessments by the principal investigator or co-investigators for hospitalized patients pre-operatively. On day of closure there will be a one time assessment to get a baseline assessment of skin prior to surgery. Compliance logs will also be turned in at this time.

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
1 Day 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ostomy closure (colostomy & ileostomy)
  • ages 3 years & under (still in diapers)
  • male & female
  • Scheduled ostomy closure in approximately 4 weeks.
  • The legal guardian/parent of subject must have a personal device, such as a cell phone, that has access to internet in order to sign on to the MyCHP Portal.
  • Participants must be enrolled in the MyCHP Portal.

排除标准

  • Patients with a history of hypersensitive skin
  • dermatological diagnosis
  • ostomies other than colostomies/ileostomies
  • ages older than 3 years
  • Subjects who are not enrolled in the MyCHP Portal.
  • Subjects with parents who do not have a personal device, such as a cell phone, or access to internet.

结局指标

主要结局

Perianal skin maceration in the group receiving the intervention vs. the control group

时间窗: from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery)

this will be measured by uploading pictures or visual inspections and utilizing a validated diaper dermatitis scale (total severity score for the scale is 0-6, a higher score (6) indicates a worse outcome)

次要结局

  • The number & identification of influencing characteristics/variables of perianal skin breakdown(from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery))
  • Incidence of complications (safety and tolerability of intervention) from application of stool between ileostomies vs. colostomies(from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery))
  • Explore parent compliance of application of stool at home vs. staff (RN) compliance of application of stool when inpatient(from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Victoria Morando

Registered Nurse

University of Pittsburgh

研究点 (2)

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