CompletedNot Applicable

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

Turkey (Türkiye)22 participantsStarted 2024-01-01

Plain-language 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.

Who can participate

Age range

1 Day – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

skin pH measurement around stoma

Timeframe: change between the 0th and the 7th day

Skin temperature measurement around stoma

Timeframe: change between the 0th and the 7th day

skin moisture around the soma

Timeframe: change between the 0th and the 7th day

Pittman Ostomy Complication Severity Index

Timeframe: change between the 0th and the 7th day

Trial details

NCT IDNCT05686902

SponsorIzmir Katip Celebi University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01

View on ClinicalTrials.gov More Colostomy Site trials

Who can participate

Age range

1 Day – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

skin pH measurement around stoma

Timeframe: change between the 0th and the 7th day

Skin temperature measurement around stoma

Timeframe: change between the 0th and the 7th day

skin moisture around the soma

Timeframe: change between the 0th and the 7th day

Pittman Ostomy Complication Severity Index

Timeframe: change between the 0th and the 7th day