Perianal Maceration in Pediatric Ostomy Closure Patients
Completed · Not applicable
Conditions studied: Perianal Dermatitis, Diaper Dermatitis, Postoperative Complications, Colostomy Site, Ileostomy - Stoma
In brief
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.
Key facts
- Study ID
- NCT04606004
- Run by
- University of Pittsburgh
- People needed
- 7
- Starts
- 2020-11-24
- Expected to finish
- 2021-05-07
- Last updated by the study team
- 2021-06-01
Who can join
Age: 0 and older, up to 3. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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