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

Not Applicable

Completed

• Conditions: Pressure Injury
• Interventions: Other: wound dressing under the NIMV mask

• Registration Number: NCT05223270
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2019-11-01
• Study Completion: 2020-08-01
• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-02-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group-2	wound dressing under the NIMV mask	Hydrocelluler wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group.
intervention group-1	wound dressing under the NIMV mask	Hydrocolloid wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group.

Primary Outcome Measures

Name	Time	Method
pressure injury stage	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.

Trial Locations

Locations (1)

Istanbul Medipol University; 🇹🇷 Istanbul, Turkey