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Experimental (standard of care + stool application) for Postoperative Complications

N/A
Waitlist Available
Led By Victoria Morando, RN
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery)
Awards & highlights

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.

Eligible Conditions
  • Postoperative Complications
  • Diaper Rash
  • Ileostomy
  • Perianal Dermatitis
  • Colostomy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interventional procedure
Secondary outcome measures
Explore parent compliance of application of stool at home vs. staff (RN) compliance of application of stool when inpatient
Incidence of complications (safety and tolerability of intervention) from application of stool between ileostomies vs. colostomies
The number & identification of influencing characteristics/variables of perianal skin breakdown

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental (standard of care + stool application)Experimental Treatment2 Interventions
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.
Group II: Control group (standard of care)Active Control1 Intervention
Will follow standard of care for skin care pre-operatively. They will not be applying ostomy stool output to the skin but can apply an OTC skin barrier such as Aquaphor, Desitin, or Vitamin A\&D if the patient is experiencing skin redness from urine incontinence.

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Who is running the clinical trial?

University of PittsburghLead Sponsor
1,762 Previous Clinical Trials
16,347,996 Total Patients Enrolled
2 Trials studying Postoperative Complications
701 Patients Enrolled for Postoperative Complications
Robert Morris UniversityUNKNOWN
Victoria Morando, RNPrincipal InvestigatorUniversity of Pittsburgh
~1 spots leftby Sep 2025
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