Nursing Interventions on Prevention Medical Device Related Pressure Injury (MDRPI)

NCT06513936 | Active Not Recruiting

• 1 other identifier: Skin care
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the effect of implementing nursing interventions on preventing medical device related pressure injury in critically ill patients. Research hypothesis: Critically ill patients who experienced nursing interventions have a significantly lower risk of developing medical device related pressure injury than those who do not.

Conditions

Medical Device Site Erosion

Keywords

Nursing interventions; Pressure ulcer

Outcome Measures

Primary Outcomes (1)

• Pressure Ulcer occurrence

  Pressure Ulcer Grading based on 6 stages stage. Score 1 refer to the better outcome, while score 6 is the worse outcome

  7 days

Secondary Outcomes (2)

• ICU length

  30 days

• Mechanical ventilator days

  7 days

Study Arms (2)

Skin care bundle

EXPERIMENTAL

Patient who received the intervention

Procedure: The skin care Bundle

Control group

PLACEBO COMPARATOR

Patient who receive routine intervention

Procedure: Routine care

Interventions

The skin care Bundle PROCEDURE

S- Secure device and protect the skin with dressings K- Keep repositioning more frequently than twice daily Inspect the skin under the device more than twice daily N- Nutrition and hydration C- Choose the correct size and type of medical device A- Avoid placing devices over sites of prior or existing pressure injury R- Report MDRPI correctly and immediately E- Educate staff on the correct use of devices and prevention of skin breakdown

Skin care bundle

Routine care PROCEDURE

Routine care delivered in the unit

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Newly admitted patient to ICU with no skin break down

You may not qualify if:

• Patients with skin break down will excluded from the study

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Faculty of nursing

Damanhūr, Egypt

Location

Related Publications (2)

• Pittman J, Gillespie C. Medical Device-Related Pressure Injuries. Crit Care Nurs Clin North Am. 2020 Dec;32(4):533-542. doi: 10.1016/j.cnc.2020.08.004. Epub 2020 Oct 7.

  PMID: 33129412 BACKGROUND

• de Assis IIC, Estevam Dos Santos J, Valadares Sinicio Abib ML, Furtado Bueno L, de Mendonca Figueiredo Coelho M, Nogueira Cortez D, Teixeira Moraes J. Medical Device-Related Pressure Injury in an Intensive Care Unit: A Cross-Sectional Study. Wound Manag Prev. 2021 Nov;67(11):26-32.

  PMID: 35030095 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Computer-generated permuted block randomization will be used to assign patients to one of two groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arm groups will be included control group arm (receive standard care) study group arm (receive skin care bundle)

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 22, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

EG (1)