Perianal Maceration in Pediatric Ostomy Closure Patients

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.

Conditions

• Perianal Dermatitis
• Diaper Dermatitis
• Postoperative Complications
• Colostomy Site
• Ileostomy - Stoma

Interventions

OTHER

Stool application

Application of stool from the stoma bag 4 weeks prior, twice daily for 10 minutes at a time. However, with the stool application no barrier cream will be applied to the skin in order for the stool to achieve penetrance to the skin. Stool application will include removing any barrier creams gently, applying a thin layer of stool with a surface area shown in illustration to ensure consistent coverage, and placing a diaper on the subject. Depending on the type of the participant's ostomy, a medication cup, syringe, and/or tongue blade provided by the researchers, may be used to aid in the application of stool. After 10 minutes of application, the caregiver or inpatient healthcare provider will remove the entire thin layer of stool gently without excessive friction, just enough to remove the stool, a dabbing motion is preferred.

OTHER

Standard of care skincare

Standard of care for skin care pre-operatively: which is either no application of barrier cream, or an application of an over the counter (OTC) skin barrier such as Aquaphor, Desitin, or Vitamin A\&D if the patient is experiencing skin redness from urine incontinence. Standard of care skin creams post op: 3M no-sting immediately post op, once begin stooling- stoma powder, 3M no-sting, Critic-aid thick barrier paste will be applied to the skin.

Sponsors & Collaborators

• Robert Morris University

  collaborator UNKNOWN

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Victoria Morando, RN · University of Pittsburgh

• Kelly Austin, MD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-24

Primary Completion

2021-05-07

Completion

2021-05-07

Countries

• United States

Study Locations