Pressure InjuryNCT05223270
the Effect of Different Wound Dressing on Prevention of Pressure ınjury Related to NIMV Mask
A study testing wound dressing under the NIMV mask in people with Pressure Injury, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 22 to 86 years
- Conditions the study is for
- Pressure Injury
- What is being tested?
- wound dressing under the NIMV mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- patients with pre-treatment pressure injuries in the facial area, patients with diabetes mellitus, patients with mental or psychological problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Wound Dressing on Prevention of Pressure Injury Related to Noninvasive Mechanical Ventilation Mask in Patients With Respiratory Failure
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".
Read the 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.
- Conditions
- Pressure Injury
- Being tested
- wound dressing under the NIMV mask
- Keywords
- noninvasive mechanical ventilation, pressure injury, wound dressing
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound dressing under the NIMV maskOther
wound dressing under the NIMV mask
| Study group | Role | What they receive |
|---|---|---|
| intervention group-1 | Experimental | Hydrocolloid wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group. Receives: Other: wound dressing under the NIMV mask |
| intervention group-2 | Experimental | Hydrocelluler wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group. Receives: Other: wound dressing under the NIMV mask |
| control group | No intervention | Patients in this group were treated without placing an additional dressing under the NIMV mask. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st day
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.
Measured: 2nd day
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.
Measured: 3rd day
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.
Measured: 4th day
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.
Measured: 5th day
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.
Measured: 6th day
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.
Measured: 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Oct 2019
- Primary completion1 Nov 2019
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- semi-experimental study with post test, control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pınar dogan, Istanbul Medipol University Hospital
- Investigators
- Pınar Dogan, Asst.Prof., Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223270
- Sponsor's protocol ID
- 1019181716
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be presented as a Clinical Study Report.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Wound Dressing on Prevention of Pressure Injury Related to Noninvasive Mechanical Ventilation Mask in Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT05223270
- Acronym / sponsor ID
- 1019181716
- Conditions
- Pressure Injury
- Keywords
- noninvasive mechanical ventilation, pressure injury, wound dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- semi-experimental study with post test, control group
| Arm | Type | Receives |
|---|---|---|
| intervention group-1 | Experimental | Other: wound dressing under the NIMV maskHydrocolloid wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group. |
| intervention group-2 | Experimental | Other: wound dressing under the NIMV maskHydrocelluler wound dressings were placed on the pressure areas under the NIMV mask of the patients in this group. |
| control group | No intervention | –Patients in this group were treated without placing an additional dressing under the NIMV mask. |
Who may qualify
- Ages
- 22 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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,
Key exclusion criteria (1 listed)
- patients with pre-treatment pressure injuries in the facial area, patients with diabetes mellitus, patients with mental or psychological problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wound dressing under the NIMV maskwound dressing under the NIMV mask | Other | intervention group-1, intervention group-2 |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Yes. It will be presented as a Clinical Study Report.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pınar Dogan, Asst.Prof. study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wound dressing under the NIMV mask in people with Pressure Injury, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pressure injury stage (time frame: 1st day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.