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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 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 387-participant average among 17 other Postoperative Complications trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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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.

Interventions

  • OTHER Stool application
  • OTHER Standard of care skincare

Study Locations (1)

Pennsylvania

  • Children's Hospital of Pittsburgh - Pittsburgh

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2020-11-24
Est. Completion 2021-05-07
Phase NA

Sponsor

University of Pittsburgh

1,238 total trials

What the Registry Record Tells You About NCT04606004

The ClinicalTrials.gov registry entry for NCT04606004 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 387-participant average among 17 other Postoperative Complications trials with a reported enrollment target (98% lower). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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