Comparison of Two Different Solutions for Peristomal Skin Care in Patients With Pediatric Stoma

NCT05686902 | Completed

• 1 other identifier: 781
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of two different skin care solutions used in stoma care on peristomal skin integrity and compare them with each other.

Conditions

Colostomy Site

Outcome Measures

Primary Outcomes (4)

• skin pH measurement around stoma

  skin pH measurement around stoma will be measured with a portable device brand BRD

  change between the 0th and the 7th day

• Skin temperature measurement around stoma

  Skin temperature measurement around stoma will be measured with a portable infrared device.

  change between the 0th and the 7th day

• skin moisture around the soma

  percent of (%)skin moisture around the soma will be measured with a portable device brand BRD

  change between the 0th and the 7th day

• Pittman Ostomy Complication Severity Index

  It is a 9-parameter evaluation scale developed by Joyce Pittman in 2014, and its validity and reliability in Turkish were performed by Arslantaş et al. in 2019. The purpose of the scale is to evaluate the frequency and severity of early postoperative complications during follow-up in individuals with stoma. This index Evaluates leakage, peristomal irritant dermatitis, pain, bleeding in or around the stoma, stomal necrosis, stenosis, retraction, mucocutaneous separation, and hyperplasia All complications 0 to 3 (0 = absent, 1 = mild, 2 = moderate, 3 = severe) (The total score ranges from 0 to 27. Higher scores indicate more severe ostomy complications)

  change between the 0th and the 7th day

Study Arms (2)

PH 5.5 BABY SHAMPOO GROUP

EXPERIMENTAL

Distilled water+Ph 5.5 baby shampoo for stoma care of patients in the first group

Other: CLEANING SOLUTION

SERUM PHYSIOLOGIC GROUP

ACTIVE COMPARATOR

0.9% saline solution for stoma care of patients in the second group

Other: CLEANING SOLUTION

Interventions

CLEANING SOLUTION OTHER

The difference in peristomal skin integrity between the groups will be examined.

PH 5.5 BABY SHAMPOO GROUP; SERUM PHYSIOLOGIC GROUP

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients who volunteered to participate in the study and received Informed Voluntary Consent from their parents.
• Products used in routine clinical care in skin care (distilled water + baby shampoo), patients for whom the use of 0.9% saline is appropriate
• Patients who do not have any other underlying disease that may affect peristomal skin integrity
• Patients included in the study from the 0th day following the colostomy opening
• Patients who can be observed at least on the 7th day

You may not qualify if:

• Patients who did not volunteer to participate in the study and who could not obtain Informed Voluntary Consent from their parents
• Patients with a stoma other than a colostomy (ileostomy, etc.)
• Products used in routine clinical care in skin care (distilled water + baby shampoo), patients for whom the use of 0.9% saline is not suitable
• Patients with another underlying disease that may affect peristomal skin integrity
• Patients on the 1st day and after the colostomy opening
• Patients who cannot be observed for at least 7 days

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• Dr. Behcet Uz Children's Hospital: collaborator

Study Sites (1)

Behçet Uz Hospital

Izmir, Turkey (Türkiye)

Location

Study Officials

• Esra ARDAHAN AKGÜL, Asst. Prof.

  İzmir Katip Çelebi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 17, 2023
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: October 20, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)