Pressure InjuryNCT06325215
The Effect of Hydrocolloid to Prevent Nasal Injuries in Preterm Infants
A study testing Hidrocolloid Bant in people with Pressure Injury, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of using hydrocolloid tapes in preventing pressure injuries on the nose and columella regions caused by non-invasive mechanical ventilation (NIMV) in preterm infants. Read more about this study
- Who is it for?
- Ages 24 to 37 weeks
- Conditions the study is for
- Pressure Injury
- What is being tested?
- Hidrocolloid Bant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2022to 5 Nov 2022
- 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 24 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Were born at less than 37 weeks of gestation,
- Were admitted to the neonatal intensive care unit,
- Received non-invasive mechanical ventilation support for at least 4 days,
- Were approved for inclusion in the study by their families.
Who cannot join
- Have been intubated,
- Have congenital anomalies,
- Have a history of nasal trauma,
- Have skin diseases,
- Have sensitivity or allergies to hydrocolloid tape.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abide-i Hurriyet Cad. Istanbul University-Cerrahpaşa, Florence Nightingale Faculty of Nursing
Istanbul, 34381
About this study
Official title: The Impact of Hydrocolloid on Preventing Pressure Injuries in the Nose and Columella of Preterm Infants: " A Randomized Controlled Trial"
The aim of this study is to evaluate the effect of using hydrocolloid tapes in preventing pressure injuries on the nose and columella regions caused by non-invasive mechanical ventilation (NIMV) in preterm infants.
Read the detailed description
The aim of this study is to evaluate the effect of using hydrocolloid tapes in preventing pressure injuries on the nose and columella regions caused by non-invasive mechanical ventilation (NIMV) in preterm infants.
This study is a, prospective randomized controlled trial.The research population comprised 56 premature neonates born at 37 weeks of gestation or less, who received NIMV support in the neonatal intensive care unit (NICU) between May 2022 and November 2022. Participants were randomly assigned to one of two groups; the first group (n=28) received hydrocolloid band application, while the second group (n=28) served as the control group. "Data Collection Form", "Neonatal Skin Risk Assessment Scale (NSRAS)", "Neonatal Skin Condition Score (NSCS)" and "Pressure Injury Staging Scale (PISS)" were used for data collection.
Intervention Tools:
For the NIMV of premature infants, Alpha brand nasal cannulas were used. The nasal cannula has soft binasal tips and is suitable for both low and high flow oxygen usage. A new sterile cannula was used for each infant.
Abfen-Farma brand Nasalnem Nasal Ointment was used for premature infants. Nasalnem Nasal Ointment aids in healing wounds inside the nose, resolving problems such as mucosa regeneration and mucosal wounds, supporting the mucosa, and alleviating issues like crusting and dryness.
In the hydrocolloid barrier group, Hartmann brand hydrocolloid tape was used.Hydrocolloid tape is a type of dressing used in wound care, consisting of a flexible, water-resistant adhesive containing a gel-forming substance such as pectin, gelatin or cellulose. Hydrocolloid tapes create a moist environment by being applied directly onto the wound, which accelerates healing and helps prevent infection. The adhesive layer of the dressing forms a barrier that protects the wound from external contaminants while providing support and reducing friction. Hydrocolloid tapes are available in various shapes and sizes and have the ability to remain in place for several days without needing to be changed. This feature can be beneficial in terms of patients, caregivers and cost-effectiveness .
Hydrocolloid band group (n=28): In this group, after the columella and nose areas of preterm infants were cleaned and dried with sterile water, hydrocolloid bands were placed on the areas where the nasal cannula made contact. NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. If the hydrocolloid bands melted or detached, they were removed, the area was cleaned, and then reapplied. The nose and columella regions of preterm infants were evaluated every 12 hours for a total of 4 days/96 hours using the NSRAS scale for skin risk status, the NSCS scale for dryness, redness and peeling status, and the PISS scale for the occurrence of pressure injuries.
Control group (n=28): Preterm infants in this group were subjected to the routine procedure of the NICU. According to the clinic's routine procedure, after cleaning and drying the columella and nose areas with sterile water, NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. The nose and columella regions of preterm infants were evaluated every 12 hours for a total of 4 days/96 hours using the NSRAS scale for skin risk status, the NSCS scale for dryness, redness and peeling status and the PISS scale for the occurrence of pressure injuries.
- Conditions
- Pressure Injury
- Being tested
- Hidrocolloid Bant
- Keywords
- nasal injuries, hidrocolloid tape, collumela, non-invasive mechanic ventilation, preterm infants
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hidrocolloid BantOther
In this group, after the columella and nasal area of preterm infants were cleaned and dried with sterile water, hydrocolloid dressings were applied to the areas in contact with the nasal cannula. NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. If the hydrocolloid dressings melted or peeled off, they were removed, the area was cleaned, and then reapplied.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocolloid tape group | Experimental | In this group, after the columella and nasal area of preterm infants were cleaned and dried with sterile water, hydrocolloid dressings were applied to the areas in contact with the nasal cannula. NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. If the hydrocolloid dressings melted or peeled off, they were removed, the area was cleaned, and then reapplied. In the data collection process, assessments of the included preterm infants were conducted by two nurses. The upper lip, nasal passages, nasal septum, and columella region of the preterm infants were evaluated. Receives: Other: Hidrocolloid Bant |
| Control group | No intervention | In this group, premature infants underwent the routine procedure of the NICU. As per the clinic's routine procedure, after cleaning and drying the columella and nasal area with sterile water, NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. In the data collection process, assessments of the included preterm infants were conducted by two nurses. The upper lip, nasal passages, nasal septum, and columella region of the preterm infants were evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Skin Condition Score
he measuring tool consists of three items, each with an assessment criterion. These are dryness, erythema, and skin integrity impairment/peeling, respectively. The first item; Dryness (1=Normal, no signs of dryness, 2= Dry skin, visible flaking, 3= Very dry skin, cracking/fissures), the second item; Redness (1= No signs of redness, 2= Visible redness in less than 50% of the body surface, 3= Visible redness in more than 50% of the body surface), the third item; Skin Integrity Impairment / Peeling (1= No signs, 2= Limited impairment/peeling in a small area, 3= Extensive impairment/peeling). Developed in a triple Likert scale format, each item of the scale receives scores from 1 (one) to 3 (three). The lowest score that can be obtained from the scale is 3, and the highest score is 9; with a high total score indicating poor skin condition in the newborn.
Measured: every 12-hour shift over 4 days for assessment
Pressure İnjury Staging Scale
The scale consists of six stages:
- Stage: Non-blanchable erythema that does not fade with pressure on intact skin, II. Stage: Partial thickness loss of dermis and blistering, III. Stage: Loss involving full thickness of skin and subcutaneous tissue, IV. Stage: Full thickness tissue loss (bone/muscle visible), Unstageable / Unclassifiable Stage: Loss of all layers of skin or tissues (depth unknown), Suspected Deep Tissue Injury: Depth Unknown.
Measured: every 12-hour shift over 4 days for assessment
Secondary outcomes (1)
Neonatal Skin Risk Assessment Scale
This scale consists of six parameters specific to the newborn population (general physical condition, mental state, mobility, activity, nutrition, and moisture), and it is adjusted according to gestational age. Each parameter is scored from 1 to 4. The total score ranges from 6 to 24. A high score indicates an increased risk of skin integrity impairment in the newborn, whereas a low score indicates a low risk of skin integrity impairment.
Measured: every 12-hour shift over 4 days for assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start5 May 2022
- Primary completion29 Oct 2022
- Study completion5 Nov 2022
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.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Experimantal
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Caglar, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325215
- Sponsor's protocol ID
- SCaglar
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Hydrocolloid on Preventing Pressure Injuries in the Nose and Columella of Preterm Infants: " A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT06325215
- Acronym / sponsor ID
- SCaglar
- Conditions
- Pressure Injury
- Keywords
- nasal injuries, hidrocolloid tape, collumela, non-invasive mechanic ventilation, preterm infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 29 Oct 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 22 Mar 2024 (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.
The aim of this study is to evaluate the effect of using hydrocolloid tapes in preventing pressure injuries on the nose and columella regions caused by non-invasive mechanical ventilation (NIMV) in preterm infants.
Detailed description
The aim of this study is to evaluate the effect of using hydrocolloid tapes in preventing pressure injuries on the nose and columella regions caused by non-invasive mechanical ventilation (NIMV) in preterm infants.
This study is a, prospective randomized controlled trial.The research population comprised 56 premature neonates born at 37 weeks of gestation or less, who received NIMV support in the neonatal intensive care unit (NICU) between May 2022 and November 2022. Participants were randomly assigned to one of two groups; the first group (n=28) received hydrocolloid band application, while the second group (n=28) served as the control group. "Data Collection Form", "Neonatal Skin Risk Assessment Scale (NSRAS)", "Neonatal Skin Condition Score (NSCS)" and "Pressure Injury Staging Scale (PISS)" were used for data collection.
Intervention Tools:
For the NIMV of premature infants, Alpha brand nasal cannulas were used. The nasal cannula has soft binasal tips and is suitable for both low and high flow oxygen usage. A new sterile cannula was used for each infant.
Abfen-Farma brand Nasalnem Nasal Ointment was used for premature infants. Nasalnem Nasal Ointment aids in healing wounds inside the nose, resolving problems such as mucosa regeneration and mucosal wounds, supporting the mucosa, and alleviating issues like crusting and dryness.
In the hydrocolloid barrier group, Hartmann brand hydrocolloid tape was used.Hydrocolloid tape is a type of dressing used in wound care, consisting of a flexible, water-resistant adhesive containing a gel-forming substance such as pectin, gelatin or cellulose. Hydrocolloid tapes create a moist environment by being applied directly onto the wound, which accelerates healing and helps prevent infection. The adhesive layer of the dressing forms a barrier that protects the wound from external contaminants while providing support and reducing friction. Hydrocolloid tapes are available in various shapes and sizes and have the ability to remain in place for several days without needing to be changed. This feature can be beneficial in terms of patients, caregivers and cost-effectiveness .
Hydrocolloid band group (n=28): In this group, after the columella and nose areas of preterm infants were cleaned and dried with sterile water, hydrocolloid bands were placed on the areas where the nasal cannula made contact. NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. If the hydrocolloid bands melted or detached, they were removed, the area was cleaned, and then reapplied. The nose and columella regions of preterm infants were evaluated every 12 hours for a total of 4 days/96 hours using the NSRAS scale for skin risk status, the NSCS scale for dryness, redness and peeling status, and the PISS scale for the occurrence of pressure injuries.
Control group (n=28): Preterm infants in this group were subjected to the routine procedure of the NICU. According to the clinic's routine procedure, after cleaning and drying the columella and nose areas with sterile water, NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. The nose and columella regions of preterm infants were evaluated every 12 hours for a total of 4 days/96 hours using the NSRAS scale for skin risk status, the NSCS scale for dryness, redness and peeling status and the PISS scale for the occurrence of pressure injuries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Experimantal
| Arm | Type | Receives |
|---|---|---|
| Hydrocolloid tape group | Experimental | Other: Hidrocolloid BantIn this group, after the columella and nasal area of preterm infants were cleaned and dried with sterile water, hydrocolloid dressings were applied to the areas in contact with the nasal cannula. NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. If the hydrocolloid dressings melted or peeled off, they were removed, the area was cleaned, and then reapplied. In the data collection process, assessments of the included preterm infants were conducted by two nurses. The upper lip, nasal passages, nasal septum, and columella region of the preterm infants were evaluated. |
| Control group | No intervention | –In this group, premature infants underwent the routine procedure of the NICU. As per the clinic's routine procedure, after cleaning and drying the columella and nasal area with sterile water, NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. In the data collection process, assessments of the included preterm infants were conducted by two nurses. The upper lip, nasal passages, nasal septum, and columella region of the preterm infants were evaluated. |
Who may qualify
- Ages
- 24 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Were born at less than 37 weeks of gestation,
- Were admitted to the neonatal intensive care unit,
- Received non-invasive mechanical ventilation support for at least 4 days,
- Were approved for inclusion in the study by their families.
Key exclusion criteria (5 listed)
- Have been intubated,
- Have congenital anomalies,
- Have a history of nasal trauma,
- Have skin diseases,
- Have sensitivity or allergies to hydrocolloid tape.
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 |
|---|---|---|
| Hidrocolloid BantIn this group, after the columella and nasal area of preterm infants were cleaned and dried with sterile water, hydrocolloid dressings were applied to the areas in contact with the nasal cannula. NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. If the hydrocolloid dressings melted or peeled off, they were removed, the area was cleaned, and then reapplied. | Other | Hydrocolloid tape group |
Primary outcome
Neonatal Skin Condition Score
Time frame: every 12-hour shift over 4 days for assessment
he measuring tool consists of three items, each with an assessment criterion. These are dryness, erythema, and skin integrity impairment/peeling, respectively. The first item; Dryness (1=Normal, no signs of dryness, 2= Dry skin, visible flaking, 3= Very dry skin, cracking/fissures), the second item; Redness (1= No signs of redness, 2= Visible redness in less than 50% of the body surface, 3= Visible redness in more than 50% of the body surface), the third item; Skin Integrity Impairment / Peeling (1= No signs, 2= Limited impairment/peeling in a small area, 3= Extensive impairment/peeling). Developed in a triple Likert scale format, each item of the scale receives scores from 1 (one) to 3 (three). The lowest score that can be obtained from the scale is 3, and the highest score is 9; with a high total score indicating poor skin condition in the newborn.
Pressure İnjury Staging Scale
Time frame: every 12-hour shift over 4 days for assessment
The scale consists of six stages: I. Stage: Non-blanchable erythema that does not fade with pressure on intact skin, II. Stage: Partial thickness loss of dermis and blistering, III. Stage: Loss involving full thickness of skin and subcutaneous tissue, IV. Stage: Full thickness tissue loss (bone/muscle visible), Unstageable / Unclassifiable Stage: Loss of all layers of skin or tissues (depth unknown), Suspected Deep Tissue Injury: Depth Unknown.
1 secondary outcome
Neonatal Skin Risk Assessment Scale
Time frame: every 12-hour shift over 4 days for assessment
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 22 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hidrocolloid Bant in people with Pressure Injury, run by Istanbul University - Cerrahpasa 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 4 inclusion and 5 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 22 Mar 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?
Neonatal Skin Condition Score (time frame: every 12-hour shift over 4 days for assessment). The study lists 2 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 22 Mar 2024.