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
1 other identifier
interventional
102
1 country
1
Brief Summary
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".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 16, 2021
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedAugust 12, 2024
August 1, 2024
1 month
August 16, 2021
August 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
Study Arms (3)
intervention group-1
EXPERIMENTALHydrocolloid wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group.
intervention group-2
EXPERIMENTALHydrocelluler wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group.
control group
NO INTERVENTIONPatients in this group were treated without placing an additional dressing under the NIMV mask.
Interventions
wound dressing under the NIMV mask
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- patients with pre-treatment pressure injuries in the facial area, patients with diabetes mellitus, patients with mental or psychological problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Medipol University
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pınar Dogan, Asst.Prof.
Medipol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst.Prof.
Study Record Dates
First Submitted
August 16, 2021
First Posted
February 3, 2022
Study Start
October 1, 2019
Primary Completion
November 1, 2019
Study Completion
August 1, 2020
Last Updated
August 12, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- It will be used in the period from the completion of the study to the publication of the article (average 15 months).
- Access Criteria
- Supporting meta-analysis studies that need the data of the study can be shared.
It will be presented as a Clinical Study Report.