the Effect of Different Wound Dressing on Prevention of Pressure ınjury Related to NIMV Mask

The Effect of Different Wound Dressing on Prevention of Pressure Injury Related to Noninvasive Mechanical Ventilation Mask in Patients With Respiratory Failure

This study is aimed to examine the effect of different wound dressings on the prevention of pressure injury in the face area related to noninvasive mechanical ventilation mask. The study was completed out with 102 patients who were followed up in Chest Diseases and Thoracic Surgery Hospital between October 2019 and August 2020 and met the inclusion criteria of the study. In the study, hydrocellular and hydrocolloid wound dressing was applied to the pressure areas under the mask of noninvasive mechanical ventilation in the intervention groups, while the routine treatment process was followed in the control group. Wound dressings were obtained from HARTMANN. Study data were collected with the "Individual Characteristics Form" and "Pressure Injury Rating Scale".

Study Overview

• Status: Completed
• Conditions: Pressure Injury
• Intervention / Treatment: Other: wound dressing under the NIMV mask

Detailed Description

In the hospital where the study was conducted, patients with respiratory failure receive NIMV treatment with an oro-nasal mask. In the study, hydrocolloid and hydrocellular wound dressings were placed on the pressure areas under the mask of the patients in the intervention group. NIMV treatment was applied to the face area of the patients in the control group with an oronasal mask without using any barrier cover. The pressure areas of the patients in the intervention and control groups were evaluated with the pressure injury scale before and after the NIMV treatment. Follow-up was carried out twice a day for 7 days.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• over 18 years, receiving NIMV therapy for at least 6 hours a day, on the first day of hospitalization and followed up for at least 7 days, receiving NIMV treatment with an oro-nasal mask, tolerant of mask,

Exclusion Criteria:

• patients with pre-treatment pressure injuries in the facial area, patients with diabetes mellitus, patients with mental or psychological problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group-1; Hydrocolloid wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group.	Other: wound dressing under the NIMV mask; wound dressing under the NIMV mask
Experimental: intervention group-2; Hydrocelluler wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group.	Other: wound dressing under the NIMV mask; wound dressing under the NIMV mask
No Intervention: control group; Patients in this group were treated without placing an additional dressing under the NIMV mask.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pressure injury stage	The development of pressure injury in the facial region of the patients after the intervention was evaluated twice a day with the pressure injury scale.	1st day
pressure injury stage	The development of pressure injury in the facial region of the patients after the intervention was evaluated twice a day with the pressure injury scale.	2nd day
pressure injury stage	The development of pressure injury in the facial region of the patients after the intervention was evaluated twice a day with the pressure injury scale.	3rd day
pressure injury stage	The development of pressure injury in the facial region of the patients after the intervention was evaluated twice a day with the pressure injury scale.	4th day
pressure injury stage	The development of pressure injury in the facial region of the patients after the intervention was evaluated twice a day with the pressure injury scale.	5th day
pressure injury stage	The development of pressure injury in the facial region of the patients after the intervention was evaluated twice a day with the pressure injury scale.	6th day
pressure injury stage	The development of pressure injury in the facial region of the patients after the intervention was evaluated twice a day with the pressure injury scale.	7th day

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Director: Pınar Dogan, Asst.Prof., Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: pressure injury; wound dressing; noninvasive mechanical ventilation
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Wounds and Injuries; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: 1019181716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It will be presented as a Clinical Study Report.
• IPD Sharing Time Frame: It will be used in the period from the completion of the study to the publication of the article (average 15 months).
• IPD Sharing Access Criteria: Supporting meta-analysis studies that need the data of the study can be shared.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No