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.
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 textbooks14-16 were analyzed. From these observations and nursing textbook14-16 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.