ABSTRACT
Objective
Complications such as irritant dermatitis, infection, hypergranulation tissue should not occur involving the peristomal area to maintain skin integrity. Correct stoma creation techniques and appropriate nursing care are essential to prevent complications. This study aimed to compare the effectiveness of two different skin care solutions on peristomal skin integrity.
Method
Twenty-six children with an ostomy hospitalized in the pediatric surgery intensive care unit were randomized. Stoma care of the children was performed using saline solution in Group 1, and distilled water + pH 5.5 baby shampoo in the standard care group for 7 days. On the 3rd and 7th days of the study, the peristomal skin integrity of the patients was evaluated using the peristomal integrity follow-up form and the Pittman ostomy complication severity index. The CONSORT checklist was used for the study.
Results
Concerning the measurements made on the 3rd and 7th day of the study, there was no difference between both groups in terms of peristomal temperature or Pittman ostomy complication severity index scores, but skin moistures measured on the 7th day differed (p=0.01).
Conclusion
The findings suggest that the use of distilled water + pH 5.5 baby shampoo as part of peristomal skin care may help maintain better skin moisture by the 7th day compared to saline solution, although no significant differences were observed between both groups in terms of skin temperature or complication severity.
INTRODUCTION
A stoma refers to the surgical opening of a section of the intestine—either a loop or separate proximal and distal segments—onto the abdominal wall skin. It may be created in patients with congenital anomalies such as anorectal malformation, Hirschsprung’s disease, intestinal atresia, trauma, or perineal burns(1). Stoma-related complications such as prolapse, stenosis, retraction, or parastomal hernia may occur, in addition to systemic complications like fluid-electrolyte imbalance and vitamin B12 deficiency(2).
Peristomal complications are localized skin problems around the stoma site including irritant dermatitis, infections, hypergranulation tissue, bleeding, or necrosis, most of which result from continuous exposure to stoma effluents(2). Although many peristomal complications are reported to develop after the first postoperative week, early skin changes such as irritant dermatitis, erythema, and moisture imbalance may become manifest within the first days following stoma creation. These early alterations are clinically important, as they may progress into more severe complications if not properly managed. Therefore, close monitoring and appropriate skin care interventions during the first postoperative week are critical for preventing long-term peristomal skin damage.
According to the Wound, Ostomy, and Continence Nurses Society, a healthy peristomal skin is defined as “an area which is intact, similar in color and texture to adjacent skin, free of inflammation, and without manifesting altered sensitivity such as itching, burning, or pain”(3). To achieve this goal, comprehensive nursing assessment and the use of appropriate cleansing solutions are essential. Skin moisture and temperature are important indicators of peristomal skin integrity. Increased moisture may lead to maceration of the periostomal skin and facilitate skin breakdown, while changes in skin temperature may reflect inflammation or impaired perfusion. Therefore, maintaining optimal moisture balance and stable skin temperature is essential in preventing peristomal complications.
Different cleansing solutions have been used in stoma care, such as distilled water, saline solution, mild pH-balanced baby shampoos, or (historically) antiseptic solutions(4-6). Saline solution is widely used due to its isotonic nature, which preserves tissue integrity without disrupting the skin barrier. It has been shown to support skin hydration without causing irritation(7, 8). Therefore, it was selected as a comparator in this study. Baby shampoo, although not routinely recommended, continues to be used in some clinics as part of “standard care” because of its mild pH and cleansing properties(9, 10). Given that our institution still applies baby shampoo in routine stoma care, this study aimed to compare its effects with those of saline solution in maintaining peristomal skin integrity in children.
MATERIALS and METHODS
This study aimed to compare the effect of two different solutions used in stoma care on peristomal skin integrity.
The hypotheses of this study are as follows:
H1-1: Children who receive skin care with saline solution experience fewer ostomy-related complications compared to those who receive care with distilled water + pH 5.5 baby shampoo.
H1-2: Children who receive skin care with saline solution have lower peristomal skin temperature compared to those who receive care with distilled water + pH 5.5 baby shampoo.
H1-3: Children who receive skin care with saline solution have higher peristomal skin moisturization compared to those who receive care with distilled water + pH 5.5 baby shampoo.
Study Design
This study was a prospective randomized controlled trial conducted between November 2023 and November 2024 in the pediatric surgery intensive care unit of a tertiary hospital (Figure 1). The study was registered at the U.S. National Library of Medicine Clinical Trials (NCT05686902, registration date: 06.01.2023).
Participants
Children with (a) a newly created stoma, (b) available parental informed consent (c) and follow-up data encompassing at least 7 days postoperatively (d) but without underlying conditions affecting peristomal skin integrity (e.g., obesity, malnutrition, corticosteroid therapy, atopic dermatitis, psoriasis)(11) were included in the study. Exclusion criteria were: (a) allergy to cleansing solutions, (b) early stoma closure within 7 days, (c) parental withdrawal of consent, or (d) need to switch cleansing solution during the study.
Randomization and Allocation
After obtaining baseline data on postoperative day 0, participants were randomized into two groups (n=13):
Standard Care Group: Whose periostomal skin was cleansed with distilled water + pH 5.5 baby shampoo (routine clinical practice in this unit).
Saline Group: Whose periostomal skin was cleansed with with 0.9% normal saline solution.
Randomization was performed by Researcher-1 using simple random sampling via a web-based tool (www.random.org). Each eligible participant was assigned a unique number and allocated accordingly. Due to the nature of the intervention, the caregiver nurse (Researcher-2) could not be blinded to allocation of the groups. However, both the outcome assessor (Researcher-3) and data analyst (Researcher-4) were blinded to group allocation to minimize assessment and analysis bias.
Intervention Protocols
All stoma care was performed once daily using the assigned cleansing solution. The pouching system was replaced daily by Researcher-2. Other aspects of nursing care continued according to routine clinical protocols.
The cleansing procedure was standardized for all participants. The peristomal area was cleaned once daily using sterile gauze soaked with the assigned solution. Approximately 10 mL of solution was used for each application. The solution was applied gently without friction, allowed to remain in contact with the skin for approximately 10 seconds, and then (if applicable) rinsed with distilled water. The cleansed area was subsequently dried using sterile gauze by gentle patting. Care was taken to ensure complete dryness before applying the pouching system.
Outcomes
The primary outcome of this study was the early postoperative complications, assessed using the Pittman ostomy complication severity index.
The secondary outcomes were peristomal skin temperature measured with a routinely calibrated infrared thermometer and peristomal skin moisture on day 7, measured with the OEM SK-8 Digital Skin Moisture Analyzer.
Sample Size and Power Analysis
Sample size was calculated using G*Power 3.1.9.2.(12). Assuming a medium effect size (d=0.50), α=0.05, and 80% power for detecting a difference in the primary outcome (skin moisture at day 7), assessment of a minimum of 13 participants per group (total n=26) was required.
Data Collection Tools
Demographic data form was used to collect information on age, sex, and medical diagnosis of the children.
Peristomal skin integrity follow-up form was used to collect information on skin moisture and temperature on days 0, 3, and 7. Skin moisture was measured using the Digital Skin Moisture Analyzer (OEM SK-8), which provides percentage-based hydration values. The device was calibrated according to the manufacturer’s instructions before each measurement session. Skin temperature was measured using a non-contact (Wohler) infrared thermometer, routinely calibrated by the biomedical unit of the hospital.
Pittman Ostomy Complication Severity Index(13)
This scale is a 9-item assessment tool developed by Joyce Pittman in 2014, with its Turkish validity and reliability established by Arslantaş et al.(14) The purpose of using this scale was to assess the frequency and severity of early-stage postoperative complications in individuals with stomas during follow-up. This index assesses leakage, peristomal irritant dermatitis, pain, bleeding within or around the stoma, stoma necrosis, stenosis, retraction, mucocutaneous separation, and hyperplasia. All complications are scored on a Likert-like scale ranging from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). The total score ranges from 0 to 27 points. Higher scores indicate more severe ostomy complications. The content validity index score of the scale is 0.971.
Statistical Analysis
Data were analyzed using SPSS 26.0. Descriptive statistics were presented as means ± standard deviation or percentages. The Kolmogorov-Smirnov test was used to assess normality of data distribution(15). Independent Student’s t-test or Mann-Whitney U test was applied for continuous variables, and chi-square test for categorical variables. Analysis of Covariance (ANCOVA) was performed to adjust for confounders (age, sex, diagnosis, stoma type). The level of statistical significance was set at p≤0.05.
Ethical Statement
The research protocol was approved by the Clinical Research Ethics Committee of the University of Health Sciences Türkiye, İzmir Faculty of Medicine, Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital (IRB no: 2022121-05, date: 08.12.2022). The researcher informed the children’s parents about the purpose of the study, and written informed consent forms were obtained from the parents who agreed to participate in the study.
RESULTS
Demographics
The participants’ median age was 19.5 days, and 53.8% were female. The most common indication for creation of a stoma was Hirschsprung’s disease (38.5%), and 73.1% of the patients had a colostomy. There were no significant baseline differences between the groups regarding age (p=0.41), gender (p=0.61), diagnosis (p=0.69), or type of stoma (p=0.19) (Table 1).
Primary Outcome
Peristomal Complications (Pittman Ostomy Complication Severity Index)
At baseline, all children had a Pittman Index score of 0. On day 3, scores were slightly higher in the saline group, while on day 7, scores were higher in the baby shampoo group. However, these differences were not statistically significant (day 3: p=0.65, day 7: p=0.09).
Importantly, most often peristomal complications (dermatitis, irritant redness, minor bleeding at the skin edge) were recorded. No major stoma-related complications (e.g., necrosis due to vascular insufficiency, retraction, prolapse) were observed during the 7-day follow-up period (Table 2).
Secondary Outcomes
Peristomal Skin Temperature
Baseline skin temperatures were similar across groups. On days 3 and 7, the baby shampoo group had slightly lower skin temperatures, but the differences regarding peristomal skin temperatures between both groups were not statistically significant (p=0.51 and p=0.65, respectively).
Peristomal Skin Moisture
At baseline, there was no significant difference between groups in terms of peristomal skin moisture. On day 3, the saline group showed higher mean skin moisture compared to the baby shampoo group, but this intergroup difference did not reach statistical significance (p=0.057). On day 7, the intergroup difference became significant, with higher moisture levels in the saline group (p=0.01) (Table 2).
After adjustment for age, sex, diagnosis, and stoma type using ANCOVA, the saline group maintained significantly higher skin moisture at day 7 (mean difference =5.048, standard error =2.057, p=0.02) (Table 3, Figure 2).
Clinical Significance
Since there is no established clinically important and minimum difference in the literature regarding peristomal skin integrity in children using either of the stoma cleansing solutions, clinical significance was based on the premise that a post hoc effect size exceeding the a priori effect size is considered clinically significant—a method also cited in the literature(16). Accordingly, in this study, a post-hoc power analysis confirmed that the achieved effect size (1.04) and power (0.81) exceeded the planned thresholds (0.50 and 0.80, respectively), supporting the clinical relevance of the observed difference in skin moisture. Since the achieved effect size and power of the study are greater than the priori effect size (0.50) and power (0.80) the finding was considered to be clinically significant.
DISCUSSION
We conducted this randomized controlled study to compare the effect of saline solution versus pH 5.5 baby shampoo on peristomal skin integrity in children with newly created stomas.
Our results showed that there were no significant differences in skin temperature or complication severity scores between both groups. In our study, no significant difference was found in peristomal skin temperature between groups which may indicate that both cleansing solutions are similarly effective in preventing inflammation in the early postoperative period. Also, no significant intergroup difference was observed in Pittman index scores. In contrast to our findings, Kulawik-Pióro’s study concluded that the use of shampoo-like products could damage the lipids and proteins in the stratum corneum layer of the skin around the stoma, thereby increasing the risk of complications(17). Consistent with our results, D’ Ambrosio’s study also concluded that peristomal skin complications were less common in the early postoperative period(18). This finding may be explained by the short follow-up period and the low incidence of serious complications in the early phase which suggests that, although both solutions are used in clinical practice, the saline solution may be more effective in maintaining skin moisture—a critical factor in preventing long-term peristomal damage.
Our results showed that skin moisture was significantly higher in the saline group by day 7. Pars and Çavuşoğlu(19) compared saline solution with, pH 5.5 baby soap, and hydrogel, reporting that skin moisturization was higher in the saline group. Although hydrogel was included in that study, current evidence does not support hydrogel for routine peristomal skin care, as it is primarily indicated for wound management rather than preventive stoma care. Salami et al.(20) compared chlorhexidine, saline solution, and tap water in wound healing, showing that saline solution maintained better skin hydration. Although chlorhexidine has been evaluated for its use as a stoma cleansing agent, guidelines advise against its use on peristomal skin due to irritation risk. Karaca and Korkmaz(21) found that saline solution was more effective in maintaining peristomal skin moisture and temperature compared with barrier cream. Similarly, barrier creams are not routinely recommended for peristomal skin, except in special circumstances of significant irritation
Baby cleansers with pH 5.5 are formulated to be mild and support physiological skin balance(22). However, randomized studies on newborn skin care have demonstrated that soaps and shampoos can increase transepidermal water loss and alter skin pH(23). This finding may explain why the baby shampoo group in our study had lower skin moisture by day 7. Although saline solution is widely recommended, some studies suggest that mild cleansers may improve skin comfort and provide cleansing efficiency without damaging the skin barrier(9). Additionally, a study by Qin et al.(24) suggests that warm water is the most appropriate cleansing product. However, inconsistent findings in the literature highlight the need for further conduction of high-quality randomized studies.
Clinical Implications
Making distinction between peristomal complications (e.g., irritant dermatitis, minor bleeding, redness) and stoma-related complications (e.g., necrosis due to ischemia, retraction, prolapse) is essential for guiding both research and clinical practice. In our study, only peristomal complications were observed within the 7-day follow-up, reinforcing the need to focus on appropriate cleansing methods as preventive measures.
Strengths and Limitations
Its randomized design, the use of validated assessment tools, and the blinding of both the outcome assessor and the data analyst can be assessed as the strengths of this study. Limitations include the small sample size, and the short 7-day follow-up period. The study is planned to be repeated by measuring skin pH, and using different solutions in a larger sample size.
CONLUSION
For nurses and caregivers, these findings are clinically meaningful. Saline is widely available cost-effective solution, and its relevant use is supported by guidelines. In contrast, baby shampoo continues to be used in some clinics despite limited supporting evidence. Our study contributes to clarifying this practice gap and may support the standardization of pediatric stoma care protocols.
