Colostomy SiteNCT05686902
Comparison of Two Different Solutions for Peristomal Skin Care in Patients With Pediatric Stoma
A study testing CLEANING SOLUTION in people with Colostomy Site, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Colostomy Site
- What is being tested?
- CLEANING SOLUTION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Solutions for Peristomal Skin Care in Patients With Pediatric Stoma: A Randomized Controlled Clinical Study
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.
Read the detailed description
ABSTRACT
The research was planned as a randomized controlled experiment. Simple stratified randomization according to age will be done. The purpose of the study will be explained to the children and their parents who agreed to participate in the study and their consent will be obtained.
Study Groups: In the study, there will be 2 groups with 12 patients in each group.
- Distilled water+Ph 5.5 baby shampoo for stoma care of patients in the first group (routine care of the clinic)
- 0.9% saline solution for stoma care of patients in the second group Randomization: It will be provided as 2 groups, using the Random Sequence Generator on www.random.org. The randomization provided by the program can be accessed from the link https://www.random.org/integers/?num=24\&min=1\&max=24\&col=2\&base=10\&format=html\&rnd=new.
Intervention Procedure: After obtaining written consent, peristomal skin integrity of all participants will be evaluated on day 0 post-op prior to randomization.
Peristomal Skin Integrity Assessment:
- Stoma circumference skin pH measurement
- Skin temperature measurement around stoma
- Measurement of skin moisture around the soma
- Pittman Ostomy Complication Severity Index measurement (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) Between the 0th and 7th day following the stoma opening, stoma care will be applied to the patients by the same researcher every day, through the skin care solution specific to the group they are in. Peristomal skin integrity of the patients will be evaluated on the 3rd and 7th days of the study. Only children who can be observed from day 0 following stoma opening and whose stoma can be cared for for at least 7 days will be included in the study. The skin pH value around the stoma will be evaluated with the BRD Digital Ph Meter, the temperature measurement will be evaluated with the infrared thermometer used routinely in the clinic, and the humidity measurement will be evaluated with the BRD Digital Skin Moisture Analyzer.
Statistical Analysis: A researcher who does not know which group the patients are in will perform the statistical analysis of the study using the single-blind method. Analysis of the data obtained from the research will be carried out in IBM® SPSS Statistics Version 22 program. Age, gender, etc. of the patients in the study. demographic characteristics will be given as number and percentage distributions. Comparisons of numerical variables between groups; It will be evaluated with a non-parametric or parametric appropriate test by looking whether the normal distribution condition is met. In the study, the statistical significance value was determined as p<0.05.
- Conditions
- Colostomy Site
- Being tested
- CLEANING SOLUTION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLEANING SOLUTIONOther
The difference in peristomal skin integrity between the groups will be examined.
| Study group | Role | What they receive |
|---|---|---|
| PH 5.5 BABY SHAMPOO GROUP | Experimental | Distilled water+Ph 5.5 baby shampoo for stoma care of patients in the first group Receives: Other: CLEANING SOLUTION |
| SERUM PHYSIOLOGIC GROUP | Active comparator | 0.9% saline solution for stoma care of patients in the second group Receives: Other: CLEANING SOLUTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin pH measurement around stoma
skin pH measurement around stoma will be measured with a portable device brand BRD
Measured: 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.
Measured: 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
Measured: 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)
Measured: change between the 0th and the 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Jan 2024
- Primary completion1 Jul 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colostomy SiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Behcet Uz Children's Hospital
- Responsible party
- Principal investigator, ESRA ARDAHAN AKGUL, Izmir Katip Celebi University
- Investigators
- Esra ARDAHAN AKGÜL, Asst. Prof., Principal investigator, İzmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686902
- Sponsor's protocol ID
- 781
- Status last verified
- Oct 2024
- First submitted
- 30 Dec 2022
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Solutions for Peristomal Skin Care in Patients With Pediatric Stoma: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05686902
- Acronym / sponsor ID
- 781
- Conditions
- Colostomy Site
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Dr. Behcet Uz Children's Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ABSTRACT
The research was planned as a randomized controlled experiment. Simple stratified randomization according to age will be done. The purpose of the study will be explained to the children and their parents who agreed to participate in the study and their consent will be obtained.
Study Groups: In the study, there will be 2 groups with 12 patients in each group.
- Distilled water+Ph 5.5 baby shampoo for stoma care of patients in the first group (routine care of the clinic)
- 0.9% saline solution for stoma care of patients in the second group Randomization: It will be provided as 2 groups, using the Random Sequence Generator on www.random.org. The randomization provided by the program can be accessed from the link https://www.random.org/integers/?num=24\&min=1\&max=24\&col=2\&base=10\&format=html\&rnd=new.
Intervention Procedure: After obtaining written consent, peristomal skin integrity of all participants will be evaluated on day 0 post-op prior to randomization.
Peristomal Skin Integrity Assessment:
- Stoma circumference skin pH measurement
- Skin temperature measurement around stoma
- Measurement of skin moisture around the soma
- Pittman Ostomy Complication Severity Index measurement (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) Between the 0th and 7th day following the stoma opening, stoma care will be applied to the patients by the same researcher every day, through the skin care solution specific to the group they are in. Peristomal skin integrity of the patients will be evaluated on the 3rd and 7th days of the study. Only children who can be observed from day 0 following stoma opening and whose stoma can be cared for for at least 7 days will be included in the study. The skin pH value around the stoma will be evaluated with the BRD Digital Ph Meter, the temperature measurement will be evaluated with the infrared thermometer used routinely in the clinic, and the humidity measurement will be evaluated with the BRD Digital Skin Moisture Analyzer.
Statistical Analysis: A researcher who does not know which group the patients are in will perform the statistical analysis of the study using the single-blind method. Analysis of the data obtained from the research will be carried out in IBM® SPSS Statistics Version 22 program. Age, gender, etc. of the patients in the study. demographic characteristics will be given as number and percentage distributions. Comparisons of numerical variables between groups; It will be evaluated with a non-parametric or parametric appropriate test by looking whether the normal distribution condition is met. In the study, the statistical significance value was determined as p<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PH 5.5 BABY SHAMPOO GROUP | Experimental | Other: CLEANING SOLUTIONDistilled water+Ph 5.5 baby shampoo for stoma care of patients in the first group |
| SERUM PHYSIOLOGIC GROUP | Active comparator | Other: CLEANING SOLUTION0.9% saline solution for stoma care of patients in the second group |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLEANING SOLUTIONThe difference in peristomal skin integrity between the groups will be examined. | Other | PH 5.5 BABY SHAMPOO GROUP, SERUM PHYSIOLOGIC GROUP |
Primary outcome
skin pH measurement around stoma
Time frame: change between the 0th and the 7th day
skin pH measurement around stoma will be measured with a portable device brand BRD
Skin temperature measurement around stoma
Time frame: change between the 0th and the 7th day
Skin temperature measurement around stoma will be measured with a portable infrared device.
skin moisture around the soma
Time frame: change between the 0th and the 7th day
percent of (%)skin moisture around the soma will be measured with a portable device brand BRD
Pittman Ostomy Complication Severity Index
Time frame: change between the 0th and the 7th day
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra ARDAHAN AKGÜL, Asst. Prof. principal investigator
İzmir Katip Çelebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLEANING SOLUTION in people with Colostomy Site, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin pH measurement around stoma (time frame: change between the 0th and the 7th day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.