A Quasi-experimental Study to Explore the Effect of Barrier Cream on the Peristomal Skin of Patients With a Tracheostomy

Peristomal skin problems represent one of the most common complications of a tracheostomy. A quasi-experimental study was conducted among patients ages 18 to 65 years hospitalized in a Turkish university hospital ear-nose-throat clinic between August 15, 2013, and December 15, 2013, to compare the effect of using or not using a barrier cream on the peristomal skin with regard to pH, moisture, temperature, color, odor, turgor, infections, and lesions after tracheostomy surgery.Patients were selected using a purposeful sampling method and included if they had not undergone another operation for a complication (eg, pneumothorax, tube misplacement, hemorrhage) within 24 hours following the tracheostomy operation. In phase 1 of the study, 9 registered nurses were observed 3 times each by the researcher, who completed an observation form. From these observations and related nursing textbooks, the researcher developed a protocol entitled “Nursing Care Steps for Patients with a Tracheostomy.” This protocol was followed during phase 2 of the study during which participants were alternately assigned to either the intervention (a barrier cream containing dimethicone, acrylate terpolymer, oils, paraffin, water, dicapryladipate, isopropyl palmitate, and PPG-15 stearyl ether followed by gauze) or control (gauze only) group (n = 30 each) and observed for 7 days. Demographic characteristics were gathered for each patient upon admission to the study. Peristomal skin was assessed in terms of pH, temperature, and moisture (relative humidity [RH]) using a surface pH meter, surface thermometer, and digital skin moisture tester, as well as for lesions, infection, and maceration. Findings were documented on a skin condition assessment form. Twenty-four (24) hours post surgery, the barrier cream plus gauze was applied over peristomal area in the study group and gauze dressing only in the control group. Peristomal skin pH, moisture, and temperature were within the normal range for both groups during all observations throughout the study but closer to normal ranges in the intervention group. Mean peristomal skin pH in the intervention group was significantly higher (5.452 ± 0.043) than in the control group (5.123 ± 0.057; P <.001), mean peristomal skin moisture in the control group (46.90 ± 0.132 RH) was significantly greater than in the intervention group (41.71 ± 0.774 RH; P <.001), and mean peristomal skin temperature in the control group (33.59 ± 1.3˚ C) was significantly higher than in the intervention group (31.64 ± 0.607˚ C; P <.001). In both groups, Staphylococcus epidermidis was the most commonly cultured microorganism, and S aureus was the most cultured pathological microorganism in addition to the normal skin flora. Peristomal skin condition was maintained for both the intervention and control groups. Use of a barrier cream to protect tracheostomy peristomal skin beneath absorbent dressings (eg, gauze) is recommended, but additional short-term and long-term studies are needed. 

A tracheostomy is an opening that is created by placing a tube into the trachea to allow airway patency and is considered one of the earliest lifesaving methods.^1,2 According to descriptive and review studies,^3-7 tracheostomy-related complications (between 5% and 40%) include pneumothorax, tube misplacement, tracheal stenosis, tracheoesophageal fistula, hemorrhage, airway obstruction, and peristomal skin problems (38.5%). According to descriptive studies,^3,5,8-11 peristomal skin problems represent some of the most common complications and can emerge as irritant dermatitis, peristomal skin irritation, allergic dermatitis, mechanical trauma, infection, or granuloma development.

Dennis-Rouse and Davidson⁹ used the problem-intervation-control-outcome method to explore peristomal skin complications and related nursing interventions and concluded maceration was the most common complication; to prevent this problem, nurses used gauze dressings but they stated more efficient materials were needed to prevent peristomal skin complications.⁹ Fasunla et al¹² conducted a descriptive study to determine the prevalence of granuloma after tracheostomy surgery. The authors reviewed case files of patients who had a tracheostomy between 1993 and 2007 in Nigeria. Of the 256 patients who had a tracheostomy in this study, 133 (51.95%) had prior orotracheal intubation for 10 to 21 days. Peristomal granuloma developed in 16 (6.25%) cases and stomal infection in 14 (4.3%). Onakoya at al¹³ conducted a retrospective review of tracheostomy complications over a 10-year period (1991–2002) in the Department of Otorhinolaryngology in University College Hospital, Ibadan, Nigeria. Among the 179 tracheostomies performed on 168 patients, 69 complications (38.6%) related to peristomal skin were documented, with an tracheostomy-related mortality rate of 2.2%. Infection was the most common complication of tracheostomy (43%). Although these issues are not severe enough to threaten the patient’s life, they can prolong hospital stay, decrease quality of life, and increase recovery time and cost.⁹

Textbooks^14-16 most commonly recommend gauze to protect peristomal skin from secretions in patients with a tracheostomy. However, the use of gauze dressings can persistently increase skin moisture as they absorb secretions, subsequently contributing to tissue deterioration.^9,12,13 As a result, studies on tracheostomy care have focused on alternative materials/methods to protect peristomal skin, including foam and barrier cream.^9,17,18 These alternative methods studies aimed only to identify health professionals’ views of the products; studies comparing the protective abilities of these materials/methods to prevent peristomal skin problems in patients with a tracheostomy are limited. Results of a randomized clinical trial with a crossover study to compare gauze to a skin barrier for management of patients with tracheostomies in Taiwan by Chuang at al¹⁹ found the use of a solid skin barrier for tracheostomy care was associated with lower occurrences of impaired skin integrity. Ahmadinegad et al²⁰ conducted a double-blind, randomized clinical trial (N = 80) to explore the efficacy of a dressing with absorbent foam versus a gauze dressing used to prevent tracheostomy site infection; 11 patients (13.75%) developed a tracheostomy site infection, 7 (17.5%) in the gauze group and 4 (10%) in the foam group. Gram-negative bacteria (particularly Acinetobacter) were common in the gauze group, and gram-positives (most commonly Staphylococcus epidermidis) were found in the foam group.

Decreasing the number of peristomal skin complications can prevent prolonged hospital stays and costly interventions.²⁰ Maintaining peristomal skin with an efficient product is the first step in nursing care of these patients. Using a barrier cream on peristomal skin has been shown in randomized clinical studies^19,20 to be an efficient way to maintain the skin condition for patients with a tracheostomy. 

The purpose of this quasi-experimental study was to explore the effect of using a barrier cream on the peristomal skin of patients with a tracheostomy. 

Patient selection. Patients ages 18 to 65 years hospitalized in the ear-nose-throat unit of a university hospital post-tracheostomy surgery between August 15, 2013, and December 15, 2013, were selected using a purposeful sampling method. Participants were randomly assigned to an intervention or control group (n = 30 each) according to the order of hospitalization (ie, first patient was enrolled in the control group, second patient to the intervention group, and so on). Participants were included if they had not undergone another operation for a complication (eg, pneumothorax, tube misplacement, hemorrhage) within 24 hours following the tracheostomy operation. All participants completed the Demographic Characteristic Form upon acceptance into the study.

Ethical considerations. Ethical approval was obtained from the Hacettepe University Non-Invasive Ethical Committee (permission number: 16969557-334). Written permission was obtained from the medical services director of the adult hospital, and informed consent was obtained from each patient. 

Procedures. 

Phase 1. The first phase of the study was conducted to identify provision of peristomal care to patients. Nine (9) nurses were observed 3 times by the researcher over a 3-week period during at least 2 working shifts (08.00–16.00 and 16.00–24.00), and an observation form was used to document the provision of peristomal care to patients. Observations of actual nursing care steps and expected care steps from fundamentals of nursing textbooks^14-16 were analyzed. From these observations and nursing textbook^14-16 materials, researchers developed a protocol entitled “Nursing Care Steps for Patients with a Tracheostomy.” This protocol was used by researchers when providing tracheostomy peristomal skin care to patients in both the intervention and control groups during the second phase of the study. 

Phase 2. For both groups, peristomal skin care started 24 hours after the tracheostomy was placed. First, the researcher cleaned the peristomal skin with sterile gauze saturated with normal saline and dried the skin with sterile gauze. Next, the researcher assessed the peristomal skin in terms of pH, moisture, temperature, color, odor, turgor, and lesions and recorded the results on the Peristomal Skin Assessment Form, which was developed for this study by researchers. After cleaning and assessment, barrier cream (consisting of dimethicone, acrylate terpolymer, oils, paraffin, water, dicapryladipate, isopropyl palmitate, and PPG-15 stearyl ether) was applied to the study group’s peristomal skin as a thin layer every 24 hours and covered with sterile gauze dressing. In the control group, gauze dressing only was provided and changed a minimum of every 8 hours by the researcher after the peristomal skin was cleansed. As was described, the frequency of peristomal skin care differed for the study group. Because the barrier cream needs to be maintained on the area for at least 24 hours, skin care was provided only once a day for the 7 consecutive days of the study. The researcher used gauze dressing directly over the peristomal skin in the control group and over the barrier cream in the intervention group (see Table 1). During the first 5 days, patients experienced large amounts of secretion, so nurses changed just the sterile gauze dressing on the peristomal area for both study and control groups 1 to 3 times a day. 

Data collection. Data were collected using 3 paper-and-pencil data forms developed by the researcher.

Observation Form. The Observation Form was used to document the provision of peristomal care to patients by researchers during phase 1. The form included 3 open-ended questions: 1) What type of materials are used for tracheostomy care? 2) Which steps do the nurses follow for peristomal care? 3) Which steps do nurses follow during care? The researcher observed the nurses and noted all related tracheostomy care. The nurse responses also included materials used for peristomal care.

Demographic Characteristics Form. The Demographic Characteristics Form was used to collect the sociodemographic characteristics of the patients (age, gender, body mass index [BMI], medical diagnosis, reason for opening the tracheostomy, tracheostomy cannula type, smoking habits, and presence of a chronic disease). BMI was calculated by the researcher using patient height and weight data documented at the beginning of phase 2.

Skin Assessment Form. The Skin Condition Assessment Form was developed and completed by researchers to monitor and record peristomal area pH, temperature, and moisture along with changes (lesions, local symptoms of infection, maceration) in the peristomal skin every 24 hours. Peristomal pH was measured using a surface pH meter (device range 0.0–14.0). Skin moisture was measured using a digital skin moisture tester (device range 0%–99.9% relative humidity [RH]). Temperature was measured using an infrared surface thermometer (device range -50˚ C–1050˚ C). Peristomal color was assessed as pale (lasting for the first 72 hours) that progressed to normal or red (lasting 4–21 days) that progressed to normal as part of the wound healing process.^14,15 Odor was classified as existent or nonexistent, turgor was classified as maintained (no problem) and not maintained (problem such as edema noted), and presence of lesions (skin breakdown) was noted. This instrument also was designed to monitor and record the microbiological burden of the skin by recording the presence of microorganisms and their specific species. Microbiological swab cultures were obtained for both the intervention and control groups on the first and last days of tracheostomy peristomal skin care. Swab cultures were collected by the researcher and immediately (maximum 30 minutes) sent to the laboratory for assessment. 

Data analysis. The data were collected via the paper/pencil documents and transferred into and analyzed using SPSS version 16.0 (SPSS Inc, Chicago, IL). Calculated BMI was entered for statistical analysis. Descriptive statistics (frequencies and percentages) were calculated for the patient sociodemographic characteristics and types of isolated microorganisms. The distributions of daily peristomal area pH, moisture, and temperature over the 7-day period were analyzed using repeated measures analysis of variance with Greenhouse-Geisser correction. Peristomal skin variables were compared between the intervention and control groups using t tests. A P value <.05 was considered statistically significant.

Demographic characteristics. Sixty (60) patients were enrolled during phase 2, 30 in the intervention and 30 in the control group. The majority of the patients in both groups was hospitalized due to a cancer diagnosis in the upper respiratory tract (23; 38.3%), were male (41; 68.3%), and 55 to 65 years of age (35; 58.3%). More than half of the patients in the control (19; 63.3%) and intervention (16; 53.3%) groups had a normal BMI (18.5–24.9). The majority of the patients in both groups used a plastic cannula (control group: 20; 66.6%; intervention group: 27; 90.0%). The distribution of patients who smoked (control group: 14; 46.7%; intervention group: 15; 50.0%) was similar. Approximately half of the patients in each group had a chronic disease (hypertension, hyperlipidemia, and diabetes mellitus): 14 (46.7%) in the control group and 16 (53.3%) in the intervention group (see Table 2). 

Peristomal skin variables. Peristomal skin pH was between 5 and 6, moisture was 40% to 55%, and temperature ranged from 25˚ C to 35˚ C for both groups (60; 100%) during all observations for the 7 days of the study. Peristomal skin color was observed as normal in both groups, and no lesions, symptoms of local infection, maceration, or malodor were detected in the peristomal skin in either group during all observations. 

The mean peristomal skin pH in the intervention group (5.452 ± 0.043) was significantly higher than in the control group (5.123 ± 0.057). The mean peristomal skin moisture in the control group (46.90 ± 0.132 RH) was significantly greater than in the intervention group (41.71 ± 0.774 RH), and the mean peristomal skin temperature in the control group (33.59 ± 1.3˚ C) was significantly higher (31.64 ± 0.607˚ C). In summary, the 7-day distributions of mean pH, moisture, and temperature were significantly different between the 2 groups (P <.05) (see Table 3). 

 Types of microorganisms. S epidermidis was the microorganism most cultured in the intervention (16 swab cultures) and control (20 swab cultures) groups on days 1 and 7. S aureus was the pathological microorganism most reproduced in addition to the normal skin flora in both the intervention (n = 1) and control (n = 3) groups on days 1 and 7. The microorganism types detected in the peristomal area did not change over the 7-day period. None of patients was on antibiotics when cultures were performed during study.

In both the intervention and control groups in the present study, peristomal skin color was found to be normal, and pH, moisture, and temperature measurements were within the normal ranges. No evidence of malodor, lesions, infection, or maceration was noted. Therefore, no peristomal skin problems were encountered, which might be explained by the short duration of monitoring (7 hospital days). 

Although the literature does not indicate how long it takes for peristomal skin problems to occur, randomized clinical trial studies with patients with a tracheostomy indicated this problem is frequently observed in the early weeks post surgery.^19-21 

Peristomal skin problems may be caused by mucin secretion from the stoma.  Mean peristomal skin moisture in the control group (46.90 ± 0.132 RH) was significantly greater than in the intervention group (41.71 ± 0.774 RH). Although the level of skin moisture differs by body part, the normal level is considered 40% to 55% RH.²² The use of barrier cream in the intervention group is likely responsible for the decreased skin moisture level because it prevented continuous contact of the skin with tracheal secretions. Various randomized clinical trial studies^23-25 that have explored the effect of using barrier cream on periwound skin to prevent maceration in patients with chronic wounds (including pressure ulcers, vascular ulcers, neuropathic [diabetic foot] ulcers) found that skin moisture was within the normal range. Although descriptive and meta-analysis studies^23,26-28 reporting the use of barrier cream to maintain the peristomal skin condition of patients with a tracheostomy are lacking, several studies reporting the use of barrier cream in wound care, especially to protect the healthy tissue around the wound, noted decreased maceration. 

The mean peristomal skin pH in the intervention group (5.452 ± 0.043) was significantly higher than in the control group (5.123 ± 0.057); in addition, it was closer to the accepted normal range of 5.5.²⁹ pH is affected by factors such as moisture and temperature that make the environment more acidic or alkaline because of their effects on hydrogen ion activity. Inverse relationships between pH and both moisture and temperature have been shown. Increased skin pH (more alkaline) causes dry and itchy skin; slightly acidic skin pH (5.5, on average) is important for maintaining the skin flora within certain limits.²⁹ In the present study, the mean peristomal skin pH, which is important for maintaining skin condition and preventing infection, was closer to the normal value when the barrier cream was applied. 

The mean peristomal skin temperature in the control group (33.59 ± 1.3˚ C) was significantly higher than in the intervention group (31.64 ± 0.607˚ C). These results suggest the barrier cream used during tracheostomy peristomal skin care in the intervention group maintained a drier, cooler environment than in the control group. The greater peristomal skin moisture and higher temperature in the control group might have contributed to the lower mean pH than in the intervention group. 

Microorganism colonization on peristomal skin was detected in both the intervention and control groups, with the greatest colonization by S epidermidis. This is one of the microorganisms that constitute >50% of the normal skin flora; therefore, the detected colonization in the peristomal skin was considered normal. Although S epidermidis is not pathogenic, it can increase the risk of infection in immunocompromised patients or following an intravenous/surgical intervention. S aureus also was found on the peristomal skin of patients in both groups. Similarly, a number of studies have reported that, separate from the normal skin flora, S aureus is the pathogenic microorganism that was cultured most often.^20,29,30 This might be related to prolonged mechanical ventilation and/or aspiration, during which breaks in sterility occur in the aseptic aspiration technique.^4,12,30,31 In humans, S aureus mostly colonizes in the nose and throat, leaking wounds, and acne and is the agent responsible for many infections. Because many antibiotic-resistant types of S aureus have emerged in intensive care units and clinics, this microorganism is considered an important problem for hospital-acquired infections in many hospitals.^5,6 Although colonization of microorganisms alone does not cause infection, it has a key role in the development of infection. Because opportunistic microorganisms may became factors for infection, patients may present symptoms of infection during their hospital stay.⁴ Therefore, patients with a tracheostomy are at risk of infection, given the treatment and accompanying disease(s) because sensitive peristomal skin may increase the risk of infection with accompanying disease(s) and their treatment.

Due to the short average of duration of hospitalization (5 to 10 days), the study was limited to 7 hospital days for each patient. In addition, involvement in the study may cause nurses to improve (placebo effect) care they are providing.

This quasi-experimental study was designed to explore the effect of barrier cream on the peristomal skin condition of patients with a tracheostomy. During the 7-day follow-up, peristomal skin condition was not compromised in either the intervention or control groups. However, significant differences in peristomal skin pH, temperature, and moisture were noted between the groups. These variables were closer to the normal ranges in the intervention than in the control group. Future studies to evaluate optimal methods for protecting the peristomal skin of tracheostomy patients, both short- and long-term, are warranted. 

Dr. Karaca is an Assistant Professor, Adiyaman University, School of Nursing, Adiyaman, Turkey. Dr. Korkmaz is an Assistant Professor, Hacettepe University Faculty of Nursing, Ankara, Turkey.

Please address correspondence to: Turkan Karaca, RN, PhD, Adiyaman University, School of Health Sciences, Nursing Department, Adiyaman,Turkey; email: turkan_20051@hotmail.com.