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NCT04606004 · ClinicalTrials.gov registry record · NA
Perianal Maceration in Pediatric Ostomy Closure Patients
A NA study of Postoperative Complications and Ileostomy - Stoma, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT04606004: Completed NA study of Postoperative Complications and Ileostomy - Stoma, sponsored by University of Pittsburgh.
NCT04606004 is a NA study of Postoperative Complications and Ileostomy - Stoma that has completed, run by University of Pittsburgh. The registered enrollment target is 7 participants, below the 562-participant average among 20 other Postoperative Complications trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04606004, a NA study of Postoperative Complications and Ileostomy - Stoma, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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)
Conditions Studied
Interventions
- OTHER Stool application
- OTHER Standard of care skincare
Study Locations (1)
Pennsylvania
- Children's Hospital of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-11-24 |
| Est. Completion | 2021-05-07 |
| Phase | NA |
What the finished NCT04606004 record still lists
NCT04606004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 562-participant average among 20 other Postoperative Complications trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Postoperative Complications appearing as the primary indexed condition, and to 2 interventions - of which Stool application is the first listed.
NCT04606004 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04606004 about?
NCT04606004 is a clinical study titled "Perianal Maceration in Pediatric Ostomy Closure Patients". 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 random...
What is the current status of trial NCT04606004?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2020-11-24. Estimated completion is 2021-05-07.
What conditions does trial NCT04606004 study?
This clinical trial studies the following conditions: Postoperative Complications, Ileostomy - Stoma, Perianal Dermatitis, Diaper Dermatitis, Colostomy Site.
What interventions are being tested in trial NCT04606004?
The interventions under investigation include: Stool application (OTHER), Standard of care skincare (OTHER).
Who is sponsoring clinical trial NCT04606004?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04606004 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04606004's enrollment target sits among peer trials
7 21st of 20 the lowest of 20 other Postoperative Complications trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Complications trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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