Clinical trial NCT04606004: Perianal Maceration in Pediatric Ostomy Closure Patients
Official title: Perianal Maceration in Pediatric Ostomy Closure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perianal Dermatitis
Diaper Dermatitis
Postoperative Complications
Colostomy Site
Ileostomy - Stoma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Robert Morris University
First posted: 2020-10-28
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Ostomy closure (colostomy \& ileostomy)
* ages 3 years \& under (still in diapers)
* male \& female
* Scheduled ostomy closure in approximately 4 weeks.
* The legal guardian/parent of subject must have a personal device, such as a cell phone, that has access to internet in order to sign on to the MyCHP Portal.
* Participants must be enrolled in the MyCHP Portal.

Exclusion Criteria:

* Patients with a history of hypersensitive skin
* dermatological diagnosis
* ostomies other than colostomies/ileostomies
* ages older than 3 years
* Subjects who are not enrolled in the MyCHP Portal.
* Subjects with parents who do not have a personal device, such as a cell phone, or access to internet.

Primary outcomes:
measure: Perianal skin maceration in the group receiving the intervention vs. the control group
timeFrame: from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery)
Secondary outcomes:
measure: The number & identification of influencing characteristics/variables of perianal skin breakdown
timeFrame: from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery)
measure: Incidence of complications (safety and tolerability of intervention) from application of stool between ileostomies vs. colostomies
timeFrame: from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery)
measure: Explore parent compliance of application of stool at home vs. staff (RN) compliance of application of stool when inpatient
timeFrame: from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Victoria Morando, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Kelly Austin, MD
role: PRINCIPAL_INVESTIGATOR
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