Back to resultsthe Effect of Different Wound Dressing on Prevention of Pressure ınjury Related to NIMV Mask
Primary Purpose
Pressure Injury
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
wound dressing under the NIMV mask
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Injury focused on measuring noninvasive mechanical ventilation, pressure injury, wound dressing
Eligibility Criteria
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
Sites / Locations
- Istanbul Medipol University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
intervention group-1
intervention group-2
control group
Arm Description
Hydrocolloid wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group.
Hydrocelluler wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group.
Patients in this group were treated without placing an additional dressing under the NIMV mask.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05223270
First Posted
August 16, 2021
Last Updated
January 25, 2022
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05223270
Brief Title
the Effect of Different Wound Dressing on Prevention of Pressure ınjury Related to NIMV Mask
Official Title
The Effect of Different Wound Dressing on Prevention of Pressure Injury Related to Noninvasive Mechanical Ventilation Mask in Patients With Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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".
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury
Keywords
noninvasive mechanical ventilation, pressure injury, wound dressing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
semi-experimental study with post test, control group
Masking
Participant
Allocation
Non-Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group-1
Arm Type
Experimental
Arm Description
Hydrocolloid wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group.
Arm Title
intervention group-2
Arm Type
Experimental
Arm Description
Hydrocelluler wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients in this group were treated without placing an additional dressing under the NIMV mask.
Intervention Type
Other
Intervention Name(s)
wound dressing under the NIMV mask
Intervention Description
wound dressing under the NIMV mask
Primary Outcome Measure Information:
Title
pressure injury stage
Description
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.
Time Frame
1st day
Title
pressure injury stage
Description
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.
Time Frame
2nd day
Title
pressure injury stage
Description
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.
Time Frame
3rd day
Title
pressure injury stage
Description
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.
Time Frame
4th day
Title
pressure injury stage
Description
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.
Time Frame
5th day
Title
pressure injury stage
Description
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.
Time Frame
6th day
Title
pressure injury stage
Description
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.
Time Frame
7th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pınar Dogan, Asst.Prof.
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
the Effect of Different Wound Dressing on Prevention of Pressure ınjury Related to NIMV Mask
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