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Effect of Evidence-Based Skin Care and Hydrocolloid Dressing in the Prevention of Nasogastric-Related Pressure Injury

Primary Purpose

Medical Device Site Injury, Nasogastric Tube, Pressure Injury

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
skin care arm of where evidence-based practices in the implementation guide
hydrocolloid (Convatec Granuflex-extra thin) dressing
control
Sponsored by
MAİDE YEŞİLYURT
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Medical Device Site Injury focused on measuring medical device, medical device-associated pressure injury, nasogastric tube, hydrocolloid dressing, skin care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Necmettin Erbakan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

skin care arm of where evidence-based practices in the implementation guide

hydrocolloid (Convatec Granuflex-extra thin) dressing

control

Arm Description

Participants in this arm will be given evidence-based skin care interventions, which are included in the guidelines to prevent medical device-related pressure injuries, and are implemented by the researcher nurse. After the nasogastric tube is inserted by the patient's physician.

Patients in this arm will be applied a translucent hydrocolloid cover, which is compatible with the sensitive skin structure, can be applied to all body surfaces and nasal mucosa, and allows the underlying mucosa and skin to be observed after the nasogastric tube is inserted by the patient's physician. This cover will be applied to the nasal mucosa and nasal wing under the nasogastric tube.

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

Outcomes

Primary Outcome Measures

rate of pressure injury from nasogastric tube
Pressure injury originating from nasogastric tube will be evaluated with the reliable international NPUAP / EPUAP Pressure Ulcer Classification System. In the literature, pressure injuries originating from nasogastric tube are reported to develop in 11± 5 days. Accordingly, patients will be cared for and followed up for 18 days. The day the pressure injury develops will be recorded in each group.

Secondary Outcome Measures

The most effective intervention in preventing pressure injuries caused by nasogastric tube
It recommends evidence-based practices, twice-daily skin care or daily prophylactic dressing to prevent nasogastric tube-induced pressure injuries. The most effective method to prevent pressure injury will be revealed. Pressure injury originating from nasogastric tube will be evaluated with the reliable international NPUAP / EPUAP Pressure Ulcer Classification System.

Full Information

First Posted
December 9, 2020
Last Updated
July 20, 2023
Sponsor
MAİDE YEŞİLYURT
Collaborators
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT04682925
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
MAİDE YEŞİLYURT
Collaborators
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medical Device Site Injury, Nasogastric Tube, Pressure Injury
Keywords
medical device, medical device-associated pressure injury, nasogastric tube, hydrocolloid dressing, skin care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Controlled Clinical Trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
skin care arm of where evidence-based practices in the implementation guide
Arm Type
Experimental
Arm Description
Participants in this arm will be given evidence-based skin care interventions, which are included in the guidelines to prevent medical device-related pressure injuries, and are implemented by the researcher nurse. After the nasogastric tube is inserted by the patient's physician.
Arm Title
hydrocolloid (Convatec Granuflex-extra thin) dressing
Arm Type
Experimental
Arm Description
Patients in this arm will be applied a translucent hydrocolloid cover, which is compatible with the sensitive skin structure, can be applied to all body surfaces and nasal mucosa, and allows the underlying mucosa and skin to be observed after the nasogastric tube is inserted by the patient's physician. This cover will be applied to the nasal mucosa and nasal wing under the nasogastric tube.
Arm Title
control
Arm Type
Other
Arm Description
Participants in the control group will be given no intervention , these patients will receive the routine clinical care(dressing change and nasal skin cleaning once a day) applied in the intensive care unit.
Intervention Type
Other
Intervention Name(s)
skin care arm of where evidence-based practices in the implementation guide
Intervention Description
The nasal mucosa and nasal skin under the nasogastric tube will be cleaned and dried twice a day with a pH-compatible cleanser. A water-based moisturizing cream will be applied to the nasal skin under the nasogastric tube twice a day, after care with a pH-compatible cleanser. Spray skin barrier will be applied twice a day after applying water-based moisturizing cream to the nasal skin under the nasogastric tube. The nasal mucosa and nasal skin under the nasogastric tube will be evaluated twice daily for signs of pressure-related injury. All these care interventions applied to the skin care arm will be applied together with the doctor and nurse responsible for the treatment and care of the patient.
Intervention Type
Device
Intervention Name(s)
hydrocolloid (Convatec Granuflex-extra thin) dressing
Intervention Description
The nasal skin of the patients and the surrounding skin will be cleaned with a pH-compatible cleaner, dried and a new hydrocolloid cover will be applied once a day. All these care interventions applied to the hydrocolloid dressing arm will be applied together with the physician and nurse responsible for the treatment and care of the patient.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
In routine care, the skin under the nasogastric tube is evaluated once a day for redness and wound formation by the nurse responsible for the patient's care and is cleaned and dried with appropriate cleaners.
Primary Outcome Measure Information:
Title
rate of pressure injury from nasogastric tube
Description
Pressure injury originating from nasogastric tube will be evaluated with the reliable international NPUAP / EPUAP Pressure Ulcer Classification System. In the literature, pressure injuries originating from nasogastric tube are reported to develop in 11± 5 days. Accordingly, patients will be cared for and followed up for 18 days. The day the pressure injury develops will be recorded in each group.
Time Frame
Each participant will be followed for 18 days
Secondary Outcome Measure Information:
Title
The most effective intervention in preventing pressure injuries caused by nasogastric tube
Description
It recommends evidence-based practices, twice-daily skin care or daily prophylactic dressing to prevent nasogastric tube-induced pressure injuries. The most effective method to prevent pressure injury will be revealed. Pressure injury originating from nasogastric tube will be evaluated with the reliable international NPUAP / EPUAP Pressure Ulcer Classification System.
Time Frame
Each participant will be followed for 18 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SERPİL YÜKSEL, PhD
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ALPER YOSUNKAYA, PhD
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
MAİDE YEŞİLYURT, MSc
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Study Director
Facility Information:
Facility Name
Necmettin Erbakan University
City
Konya
ZIP/Postal Code
42080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
STUDY PROTOCOL

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Effect of Evidence-Based Skin Care and Hydrocolloid Dressing in the Prevention of Nasogastric-Related Pressure Injury

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