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NCT Number: NCT05223270

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

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".

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Key information

Conditions

Pressure Injury Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

22 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wound dressing under the NIMV mask

Other

wound dressing under the NIMV mask

Primary outcomes

  1. pressure injury stage

    Time frame: 1st day

    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.

  2. pressure injury stage

    Time frame: 2nd day

    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.

  3. pressure injury stage

    Time frame: 3rd day

    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.

  4. pressure injury stage

    Time frame: 4th day

    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.

  5. pressure injury stage

    Time frame: 5th day

    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.

  6. pressure injury stage

    Time frame: 6th day

    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.

  7. pressure injury stage

    Time frame: 7th day

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 3, 2022
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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