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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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ClinicalTrials.gov Identifier: NCT04682925
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : August 5, 2022
Sponsor:
Collaborator:
Necmettin Erbakan University
Information provided by (Responsible Party):
MAİDE YEŞİLYURT, Necmettin Erbakan University

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.

Condition or disease Intervention/treatment Phase
Medical Device Site Injury Nasogastric Tube Pressure Injury Other: skin care arm of where evidence-based practices in the implementation guide Device: hydrocolloid (Convatec Granuflex-extra thin) dressing Other: control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Randomized Controlled Clinical Trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Evidence-Based Skin Care and Hydrocolloid Dressing in the Prevention of Nasogastric-Related Pressure Injury: A Randomized Controlled Trial
Actual Study Start Date : January 15, 2021
Actual Primary Completion Date : May 15, 2022
Estimated Study Completion Date : December 15, 2022

Arm Intervention/treatment
Experimental: skin care arm of where evidence-based practices in the implementation guide
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.
Other: skin care arm of where evidence-based practices in the implementation guide
  1. The nasal mucosa and nasal skin under the nasogastric tube will be cleaned and dried twice a day with a pH-compatible cleanser.
  2. 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.
  3. Spray skin barrier will be applied twice a day after applying water-based moisturizing cream to the nasal skin under the nasogastric tube.
  4. 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.

Experimental: hydrocolloid (Convatec Granuflex-extra thin) dressing
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.
Device: hydrocolloid (Convatec Granuflex-extra thin) dressing
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.

control
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.
Other: control
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 Measures :
  1. rate of pressure injury from nasogastric tube [ Time Frame: Each participant will be followed for 18 days ]
    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 :
  1. The most effective intervention in preventing pressure injuries caused by nasogastric tube [ Time Frame: Each participant will be followed for 18 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682925


Contacts
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Contact: MAİDE YEŞİLYURT, MSc +905378777581 md91yesilyurt@gmail.com
Contact: SERPİL YÜKSEL, PhD +905052933760 syuksel@erbakan.edu.tr

Locations
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Turkey
Necmettin Erbakan University Recruiting
Konya, Turkey, 42080
Contact: MAİDE YEŞİLYURT, MSc    +905378777581    md91yesilyurt@gmail.com   
Principal Investigator: SERPİL YÜKSEL, PhD         
Sub-Investigator: ALPER YOSUNKAYA, PhD         
Sub-Investigator: MAİDE YEŞİLYURT, MSc         
Sponsors and Collaborators
MAİDE YEŞİLYURT
Necmettin Erbakan University
Investigators
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Principal Investigator: SERPİL YÜKSEL, PhD Necmettin Erbakan University
Study Director: ALPER YOSUNKAYA, PhD Necmettin Erbakan University
Study Director: MAİDE YEŞİLYURT, MSc Necmettin Erbakan University
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Responsible Party: MAİDE YEŞİLYURT, Research Assistant, Necmettin Erbakan University
ClinicalTrials.gov Identifier: NCT04682925    
Other Study ID Numbers: MYesilyurt
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: STUDY PROTOCOL
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MAİDE YEŞİLYURT, Necmettin Erbakan University:
medical device
medical device-associated pressure injury
nasogastric tube
hydrocolloid dressing
skin care
Additional relevant MeSH terms:
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Wounds and Injuries
Crush Injuries