Clinical trial NCT05223270: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Injury
Keywords: noninvasive mechanical ventilation
pressure injury
wound dressing
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 102
Sex: ALL
Minimum age (years): 22
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: semi-experimental study with post test, control group
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: pressure injury stage
timeFrame: 1st day
measure: pressure injury stage
timeFrame: 2nd day
measure: pressure injury stage
timeFrame: 3rd day
measure: pressure injury stage
timeFrame: 4th day
measure: pressure injury stage
timeFrame: 5th day
measure: pressure injury stage
timeFrame: 6th day
measure: pressure injury stage
timeFrame: 7th day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: Pınar Dogan, Asst.Prof.
role: STUDY_DIRECTOR
References: