CompletedNot Applicable

Perianal Maceration in Pediatric Ostomy Closure Patients

United States7 participantsStarted 2020-11-24

Plain-language summary

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.

Who can participate

Age range

1 Day – 3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT04606004

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-07

View on ClinicalTrials.gov More Perianal Dermatitis trials