Perianal Maceration in Pediatric Ostomy Closure Patients

NCT04606004 | Completed

• 1 other identifier: STUDY20030192
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Perianal skin maceration in the group receiving the intervention vs. the control group

  this will be measured by uploading pictures or visual inspections and utilizing a validated diaper dermatitis scale (total severity score for the scale is 0-6, a higher score (6) indicates a worse outcome)

  from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery)

Secondary Outcomes (3)

• The number & identification of influencing characteristics/variables of perianal skin breakdown

  from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery)

• Incidence of complications (safety and tolerability of intervention) from application of stool between ileostomies vs. colostomies

  from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery)

• Explore parent compliance of application of stool at home vs. staff (RN) compliance of application of stool when inpatient

  from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery)

Study Arms (2)

Experimental (standard of care + stool application)

EXPERIMENTAL

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.

Other: Stool application; Other: Standard of care skincare

Control group (standard of care)

ACTIVE COMPARATOR

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.

Other: Standard of care skincare

Interventions

Stool application OTHER

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.

Experimental (standard of care + stool application)

Standard of care skincare OTHER

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.

Control group (standard of care); Experimental (standard of care + stool application)

Eligibility Criteria

• Age: 1 Day - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Robert Morris University: collaborator

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (9)

• Dasgupta R, Langer JC. Evaluation and management of persistent problems after surgery for Hirschsprung disease in a child. J Pediatr Gastroenterol Nutr. 2008 Jan;46(1):13-9. doi: 10.1097/01.mpg.0000304448.69305.28.

  PMID: 18162828 BACKGROUND

• Gray M. Incontinence-related skin damage: essential knowledge. Ostomy Wound Manage. 2007 Dec;53(12):28-32.

  PMID: 18184980 BACKGROUND

• Heimall LM, Storey B, Stellar JJ, Davis KF. Beginning at the bottom: evidence-based care of diaper dermatitis. MCN Am J Matern Child Nurs. 2012 Jan-Feb;37(1):10-6. doi: 10.1097/NMC.0b013e31823850ea.

  PMID: 22072018 BACKGROUND

• Keller DS, Khorgami Z, Swendseid B, Khan S, Delaney CP. Identifying causes for high readmission rates after stoma reversal. Surg Endosc. 2014 Apr;28(4):1263-8. doi: 10.1007/s00464-013-3320-x. Epub 2013 Nov 27.

  PMID: 24281432 BACKGROUND

• Babuna Kobaner G, Sun GP, Ozkaya E. A recalcitrant case of Jacquet erosive diaper dermatitis after surgery for Hirschsprung disease in a boy with Waardenburg-Shah syndrome. Dermatol Online J. 2018 Jun 15;24(6):13030/qt8fk4t4rm.

  PMID: 30142718 BACKGROUND

• Lim YSL, Carville K. Prevention and Management of Incontinence-Associated Dermatitis in the Pediatric Population: An Integrative Review. J Wound Ostomy Continence Nurs. 2019 Jan/Feb;46(1):30-37. doi: 10.1097/WON.0000000000000490.

  PMID: 30608338 BACKGROUND

• Rodriguez-Poblador J, Gonzalez-Castro U, Herranz-Martinez S, Luelmo-Aguilar J. Jacquet erosive diaper dermatitis after surgery for Hirschsprung disease. Pediatr Dermatol. 1998 Jan-Feb;15(1):46-7. doi: 10.1046/j.1525-1470.1998.1998015046.x.

  PMID: 9496804 BACKGROUND

• Shin HT. Diaper dermatitis that does not quit. Dermatol Ther. 2005 Mar-Apr;18(2):124-35. doi: 10.1111/j.1529-8019.2005.05013.x.

  PMID: 15953142 BACKGROUND

• Tamaki K, Yokomori K. Diaper dermatitis with granuloma following surgery for Hirschsprung's disease. J Dermatol. 1987 Jun;14(3):262-5. doi: 10.1111/j.1346-8138.1987.tb03573.x. No abstract available.

  PMID: 3312348 BACKGROUND

Related Links

• Skin benefits from continuous topical administration of a zinc oxide/petrolatum formulation by a novel disposable diaper.
• Effects of potato-derived protease inhibitors on perianal dermatitis after colon resection for long-segment hirschsprung's disease.
• Prevention of diaper dermatitis in infants-a literature review.
• Etiologic factors in diaper dermatitis: the role of feces.
• Faecal composition after surgery for hirschsprung's disease
• Factors determining the severity of perianal dermatitis after enterostoma closure of pediatric patients

MeSH Terms

Conditions

Diaper Rash; Postoperative Complications

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Victoria Morando, RN

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Kelly Austin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 28, 2020
• Study Start: November 24, 2020
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Approximately 6- 9months following publication. No end date.
• Access Criteria: Individual participant data that underlie the results reported in this article, after deidentification. With whomever would like to access it for any purpose. Mechanism yet to be determined.

Locations

US (1)