Perianal Maceration in Pediatric Ostomy Closure Patients
Condition: Perianal Dermatitis; Diaper Dermatitis; Postoperative Complications; Colostomy Site; Ileostomy - Stoma
MeSH terms: Dermatitis; Diaper Rash; Postoperative Complications
Study type: Interventional

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.
    

Detailed description: 
      After consent, participants will be assigned to either a treatment group or control group
      using a 2-group comparative pilot design. For this pilot study to ensure adequate balance,
      subjects will be assigned using every other technique. After consent is obtained, a one-time
      pH stool sample will be collected either at the outpatient visit or at the inpatient's
      bedside.

      Pre-Operatively (about 4 weeks prior to ostomy closure)

      Intervention Group:

      The parent or the inpatient healthcare provider (if patient is hospitalized at any point
      within the 4 weeks prior to ostomy closure) will follow standard of care for skin care
      pre-operatively, which is either no application of barrier cream, or an application of an
      over the counter skin barrier such as Aquaphor, Desitin, or Vitamin A&D if the patient is
      experiencing skin redness from urine incontinence. 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. 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. 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. Parents
      will be asked to upload images of their child's diaper area at least once weekly onto the
      MyCHP Portal (if their child is not inpatient) in order to monitor their skin for breakdown
      from and while performing the intervention. If at any time redness occurs, the parent will be
      asked to upload an additional picture to the MyCHP Patient Portal for investigator/clinician
      review or for visual inspection (if inpatient) and corresponding measurement of perianal skin
      breakdown. Upon visual inspection or image inspection, the co-investigator/ clinician will
      provide review, corresponding measurement with a validated diaper dermatitis scale, and
      provide appropriate clinical guidance.

      Compliance and Assessment: A preoperative compliance log will be used with every stool
      application by the parent at home or healthcare provider. This log will ask who applied the
      stool, how long stool was on the skin, description of stool, skin description, what brand of
      diapers and wipes were used, diet information, etc. They will notify the researchers if there
      are worsening skin concerns at home. Weekly and as needed images of buttocks areas will be
      uploaded into the CHP Patient Portal for clinical/research review by the parent, or weekly
      visual inspections as needed assessments by the principal investigator or co-investigators
      for hospitalized patients pre-operatively. On day of closure there will be a one time
      assessment to get a baseline assessment of skin prior to surgery. Compliance logs will also
      be turned in at this time.

      Control Group:

      Skin care inpatient and outpatient:

      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 over the counter skin barrier such as Aquaphor,
      Desitin, or Vitamin A&D if the patient is experiencing skin redness from urine incontinence.
      One-time assessment on day of closure to ensure no application of stool to buttocks area was
      conducted during pre-operative period and to get a baseline assessment.

      ------ Post Operatively Post op day 1 - 1st post-operative appt (approximately 1-month)
      Intervention Group and Control Group

      Standard of care skin creams including 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. The
      parents and/or health care providers will use home-made wipes (water moistened gauze) to
      clean the skin. Healthcare providers and/or parents will provide q2h diaper checks. If there
      is worsening of the skin condition or concerns, the healthcare provider will notify the
      enterostomal nurse and place a new skin care consult. Additional interventions suggested by
      the enterostomal nurse may include BID(twice daily) Aveeno soaks, BID Domeboro soaks, or blow
      by 02 to the buttocks.

      With each diaper change, the caregiver and/or the nurse will assess the child's diaper area.

        -  Twice weekly and as needed images of buttocks areas will be uploaded onto the CHP
           (Children's Hospital of Pittsburgh) Patient Portal for both groups once outpatient. The
           investigators will provide review and corresponding measurement with a validated diaper
           dermatitis scale.

        -  Weekly and as needed visual inspections of buttocks area for clinical/research review
           when still inpatient.

      At postoperative visit:

      Return of preoperative log if previously forgot. The parent will fill out a questionnaire at
      this time. There will be one more assessment of their skin at this appointment.

      Electronic Medical Record (EMR) Review An electronic medical record review will be performed
      to collect information necessary for this study including demographic data (age, gender,
      race), gestational age, initial diagnosis, comorbidities, type of ostomy, duration of ostomy,
      reason for stoma closure, height/weight percentiles (at birth & at closure), formula vs
      breast milk, diet at time of closure, diet information, inpatient vs outpatient, intervention
      vs control, length of stay, medication use (antibiotics, cholestyramine, Imodium, Metamucil,
      etc.), post-operative complications, skin assessments, any additional skin care interventions
      (aveeno soaks, domeboro soaks, blow by 02, nystatin, etc.), labs, length of stay, previous
      ostomy complications/revisions/surgeries, and if discharged home prior to closure,etc.

      Compliance log Compliance logs will be reviewed for the following: If they were
      compliant/non-compliant with the study, type of diapers (brand, cloth, pull-ups), type of
      water used to clean (fresh vs well), frequency of feeds, diet, etc.
    

Intervention name(s): Stool application; Standard of care skincare
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention