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

Pressure Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223270
• Other study ID #: 1019181716
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2021
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 86 Years

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Wounds and Injuries

Intervention

Other:
• wound dressing under the NIMV mask
wound dressing under the NIMV mask

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1st day
Primary	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.	2nd day
Primary	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.	3rd day
Primary	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.	4th day
Primary	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.	5th day
Primary	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.	6th day
Primary	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.	7th day