Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05686902 |
| Other study ID # |
781 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Izmir Katip Celebi University |
| Contact |
Esra ARDAHAN AKGÜL, Asst. Prof. |
| Phone |
+00902323293535 |
| Email |
esra.ardahan[@]ikcu.edu.tr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
