Clinical trial NCT04682925: Effect of Evidence-Based Skin Care and Hydrocolloid Dressing in the Prevention of Nasogastric-Related Pressure Injury
Official title: Effect of Evidence-Based Skin Care and Hydrocolloid Dressing in the Prevention of Nasogastric-Related Pressure Injury: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Device Site Injury
Nasogastric Tube
Pressure Injury
Keywords: medical device
medical device-associated pressure injury
nasogastric tube
hydrocolloid dressing
skin care
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
Collaborators: name: Necmettin Erbakan University
First posted: 2020-12-24
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Controlled Clinical Trial
Primary purpose: PREVENTION

Brief summary: This study was planned as a prospective randomized controlled clinical trial to determine the effect of evidence-based skin care interventions and hydrocolloid dressings in preventing nasogastric induced pressure injuries in critically ill patients.

Detailed description: Intensive care patients in whom a large number of medical devices are applied during the treatment and care process are at risk for medical device-related pressure injuries.One of the most common medical tools applied to these patients is the nasogastric tube.These tubes, which are applied to provide nasal decompression and enteral nutrition, cause pressure injuries in the nasal mucosa and nasal wings of the patients.These wounds prevent the patient from feeding, delay the healing process by causing the nasogastric tube to be pulled, delay the healing process, cause the patient to experience discomfort and pain by re-inserting the tube from the other nostril, and increase the cost of treatment and care.Guidelines for prevention of pressure injuries, which include evidence-based recommendations, report that these wounds can be prevented with evidence-based skin care interventions and hydrocolloid dressings. This study was planned as a prospective randomized controlled clinical trial to determine the effect of evidence-based skin care interventions and hydrocolloid dressings in preventing nasogastric induced pressure injuries in critically ill patients. In the literature, there is no study evaluating the effect of evidence-based skin care and / or hydrocolloid dressings on pressure injuries caused by nasogastric tube. Therefore, a study demonstrating that hydrocolloid dressing reduce pressure injuries to the nasal arch due to non-invasive mechanical ventilation were referenced in the sample calculation. In the sample selection, it was determined that the rate of pressure injury (n: 27/49) developed more in those who did not use hydrocolloids than those who were used (n: 6/73). In the sample calculation made in the G \* Power (3.1.9.2) program, it was determined that a total of 56 patients, including at least 28 patients in each study group, should be included in the sample. It was predicted that 20% of the sample could be lost during the data collection process, and in this study, which was planned with three arms (control, skin care, hydrocolloid dressing), it was determined that the research sample should be 102, with at least 34 patients on each arm. The patients included in the study will be assigned to the experimental group (skin care, hydrocolloid dressing) and control group by balanced block randomization method according to the randomization list in a ratio of 1: 1:1. In the study, block randomization was performed by a statistician based on the patients age. The final evaluation of the patients included in the study will be made on the day of the wound in those with pressure sores. In other patients, it will be performed on the 18th day of the nasogastric tube, considering the literature data that pressure injuries occur within 2-7 and 11 ± 6.17 days after tube insertion. For those whose nasogastric tube is removed before the 18th day, the last follow-up will be done on the day the tube is removed. For the implementation of the study, permission was obtained from the ethics committee of Republic of Turkey Ministry of Health, Turkey Pharmaceuticals and Medical Devices Agency Ethics Committee, and work permit was obtained from Necmettin Erbakan University Meram Medical Faculty Hospital Chief Physician. Patients/patient guardian included in the study sample will be informed before the study that the purpose of the study and participation in the study is in line with the principle of volunteering, and "Informing and Consent of Volunteers Consent Form" will be signed.

Data collection tools;

* Personal Information Form,
* The form containing the characteristics of the treatment and care process in the Intensive Care Unit
* The form containing the features associated with the nasogastric tube,
* A chart recording the state of nasogastric tube pressure injury, the area of occurrence and its stage, Independent variables
* Identifying features of patients,
* Evaluations and follow-ups during the treatment and care process,
* Interventions to prevent nasogastric tube pressure injury (routine clinical care, evidence-based skin care interventions, hydrocolloid dressing) Dependent variables
* Pressure injury originating from nasogastric tube Evaluation of the Data In the evaluation of the descriptive data obtained from the research, number, percentage, average and standard deviation will be used; The conformity of the data to normal distribution will be determined by Kolmogorov-Smirnov test and normal distribution curve, Skewness and Kurtosis test, and when the data show normal distribution, parametric tests will be used, and nonparametric tests will be used in the analysis of data that do not conform to the normal distribution. Significance will be evaluated within the confidence interval of 95%, p \<0.05 will be taken.

İmplementation of the research Patients who are 18 years of age or older, who have a nasogastric tube inserted after admission to the intensive care unit, and whose nasogastric tube stay is planned to be at least 48 hours will be included in the sample group.

Participants in the experimental group( evidence-based skin care), evidence-based skin care interventions in the guidelines to prevent medical device-related pressure injuries will be applied twice daily to the nasal mucosa and nasal wing under the nasogastric tube.

Participants in the experimental group( hydrocolloid dressing), hydrocolloid dressing will be applied daily to the nasal mucosa and nasal wing of the patients under the nasogastric tube to prevent pressure injuries caused by medical devices.

Participants in the control group will be given no intervention , these patients will receive the routine care(dressing change and nasal skin cleaning once a day) applied in the intensive care unit.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older,
* Having written permission from relatives and / or him / her,
* A nasogastric tube is inserted after admission to the Intensive Care Unit,
* In accordance with the literature reporting that nasogastric tube-induced pressure injuries occur on the second day after nasogastric tube, patients with a planned nasogastric tube stay of at least 48 hours will be included.

Exclusion Criteria:

* Do not sign the informed consent form,
* A nasogastric tube inserted during admission to the Intensive Care Unit,
* If there is irritation or wound in the nasal mucosa, nasal arch, nasal wings and surrounding tissue before the nasogastric tube is inserted,
* A rash that does not fade with pressure on the nasal arch, nose wings and surrounding tissue before the nasogastric tube is inserted,
* Nasogastric tube position change is contraindicated.
* Nasal intubation is applied before the nasogastric tube is inserted,
* If nasogastric tube stay is planned to be shorter than 48 hours, patients will not be included.

Primary outcomes:
measure: rate of pressure injury from nasogastric tube
timeFrame: Each participant will be followed for 18 days
Secondary outcomes:
measure: The most effective intervention in preventing pressure injuries caused by nasogastric tube
timeFrame: Each participant will be followed for 18 days
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
affiliation: Necmettin Erbakan University
name: SERPİL YÜKSEL, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Necmettin Erbakan University
name: ALPER YOSUNKAYA, PhD
role: STUDY_DIRECTOR
affiliation: Necmettin Erbakan University
name: MAİDE YEŞİLYURT, MSc
role: STUDY_DIRECTOR
References: