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

NCT ID: NCT05223270

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-08-01

Brief Summary

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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

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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.

Conditions

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Pressure Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

semi-experimental study with post test, control group
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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intervention group-1

Hydrocolloid wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group.

Group Type EXPERIMENTAL

wound dressing under the NIMV mask

Intervention Type OTHER

wound dressing under the NIMV mask

intervention group-2

Hydrocelluler wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group.

Group Type EXPERIMENTAL

wound dressing under the NIMV mask

Intervention Type OTHER

wound dressing under the NIMV mask

control group

Patients in this group were treated without placing an additional dressing under the NIMV mask.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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wound dressing under the NIMV mask

wound dressing under the NIMV mask

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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pınar dogan

Asst.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pınar Dogan, Asst.Prof.

Role: STUDY_DIRECTOR

Medipol University

Locations

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Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1019181716

Identifier Type: -

Identifier Source: org_study_id

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