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

NCT04682925 | Completed DMC

• 1 other identifier: MYesilyurt
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical Device Site Injury; Nasogastric Tube; Pressure Injury

Keywords

medical device; medical device-associated pressure injury; nasogastric tube; hydrocolloid dressing; skin care

Outcome Measures

Primary Outcomes (1)

• 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.

  Each participant will be followed for 18 days

Secondary Outcomes (1)

• The most effective intervention in preventing pressure injuries caused by nasogastric tube

  Each participant will be followed for 18 days

Study Arms (3)

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

EXPERIMENTAL

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

hydrocolloid (Convatec Granuflex-extra thin) dressing

EXPERIMENTAL

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

control

OTHER

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

Interventions

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

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.

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

hydrocolloid (Convatec Granuflex-extra thin) dressing DEVICE

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.

hydrocolloid (Convatec Granuflex-extra thin) dressing

control OTHER

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.

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MAİDE YEŞİLYURT: lead
• Necmettin Erbakan University: collaborator

Study Sites (1)

Necmettin Erbakan University

Konya, 42080, Turkey (Türkiye)

Location

Related Publications (1)

• Yesilyurt M, Yuksel S, Yosunkaya A. The effect of evidence-based skin care and hydrocolloid dressing in the prevention of nasogastric tube-related pressure injury: A randomized controlled clinical trial. J Tissue Viability. 2024 Nov;33(4):889-894. doi: 10.1016/j.jtv.2024.09.001. Epub 2024 Sep 12.

  PMID: 39289093 DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Bandages

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• SERPİL YÜKSEL, PhD

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

• ALPER YOSUNKAYA, PhD

  Necmettin Erbakan University

  STUDY DIRECTOR

• MAİDE YEŞİLYURT, MSc

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: Prospective Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 24, 2020
• Study Start: January 15, 2021
• Primary Completion: January 15, 2022
• Study Completion: June 15, 2022
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)