Skin InjuryNCT07864298
Cohesive Bandage Fixation of Pulse Oximeter Probes and Skin Condition in Preterm Neonates
A study testing Cohesive bandage fixation of pulse oximeter probe and Standard adhesive fixation of pulse oximeter probe in people with Skin Injury and Premature Birth, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Pulse oximeter probes are used to continuously monitor oxygen levels in newborn babies in intensive care. These probes are usually attached to the baby's hand or foot with adhesive tape and must be moved to a new site every few hours. Read more about this study
- Who is it for?
- Ages 0 years to 28 days
- Conditions the study is for
- Skin Injury, Premature Birth, Medical Adhesive Related Skin Injury
- What is being tested?
- Cohesive bandage fixation of pulse oximeter probe and Standard adhesive fixation of pulse oximeter probe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 years to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age 32 0/7 to 36 6/7 weeks
- Birth weight 1500 g or more
- Requiring continuous pulse oximetry monitoring, expected to last at least 16 hours
- No primary skin lesion, congenital anomaly or active dermatological disease
- Written informed consent from a parent
Who cannot join
- Hydrops fetalis or generalized peripheral edema
- Systemic corticosteroid, immunosuppressive or vasoactive drug use
- Impaired peripheral circulation in the extremities to be used for probe application
- Skin changes due to uremia or cholestasis
- Receiving phototherapy or topical pharmacological application to the skin
- Receiving sedation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Uskudar University
Istanbul, Istanbul, 34000
Tuğba Karakuş Türker, PhD, +905439599371, tugba.karakusturker@uskudar.edu.tr
About this study
Official title: Effect of Cohesive Bandage Fixation of Pulse Oximeter Probes on Skin Condition at the Probe Site in Preterm Neonates: A Randomized Controlled Trial
Pulse oximeter probes are used to continuously monitor oxygen levels in newborn babies in intensive care. These probes are usually attached to the baby's hand or foot with adhesive tape and must be moved to a new site every few hours. Repeatedly sticking and removing adhesive can damage the delicate skin of premature babies.
The investigators have developed a new way to secure the probe without any adhesive touching the skin: the probe's adhesive side is attached to a soft, self-adhering (cohesive) bandage that wraps around the baby's hand or foot. The bandage sticks only to itself, not to the skin.
The purpose of this study is to find out whether securing the probe with a cohesive bandage protects the skin better than the standard method of taping the probe directly to the skin. Sixty-four premature babies (born at 32 to 36 weeks) will be randomly placed in one of two groups. In both groups, the probe will be placed on each hand and foot for four hours in turn, for a total of 16 hours. The skin under the probe will be photographed and scored by two nurses who do not know which method was used.
Read the detailed description
Background: The skin of preterm neonates has an immature stratum corneum and a weak dermal-epidermal junction, which makes it vulnerable to epidermal stripping when medical adhesives are removed. The pulse oximeter probe is one of the most frequently applied and repositioned adhesive devices in the neonatal intensive care unit. Probe-related skin injuries, including adhesive-related and pressure-related damage and burns, have been reported. Existing preventive approaches (barrier films, silicone tapes, hydrocolloid dressings) reduce but do not eliminate adhesive contact with the skin. No published randomized controlled trial has tested a fixation method specific to pulse oximeter probes.
Intervention: In the experimental group, a piece of latex-free cohesive bandage (5 cm wide, length 1.5 times the circumference of the application site) is prepared. Two openings matching the probe's light-emitting diode and photodetector windows are cut into the bandage. The probe's original adhesive surface is attached to the bandage, and the free ends of the bandage are wrapped around the extremity so that they adhere only to each other. Alignment of the emitter and detector is verified. Wrap tension is standardized with a capillary refill test (refill within 2 seconds after 5 seconds of pressure proximal to the probe) and the absence of visible skin indentation. In the control group, the probe is applied directly to the skin according to routine practice and manufacturer instructions; the same capillary refill check is performed.
Exposure schedule: In both groups, the probe is rotated across four sites (right foot, left foot, right hand, left hand) at four-hour intervals. Each site carries the probe only once, for a total exposure of 16 hours per infant. A safety check (capillary refill, skin redness, probe displacement) is performed at the second hour of each application.
Outcome assessment: All four sites are photographed before any probe application (baseline). Each site is photographed again 30 minutes after probe removal under standardized conditions (fixed 20 cm distance, ring LED lighting, locked white balance, scale and color reference card in frame). Images are coded, presented in random order, and scored independently by two observers blinded to group allocation using the Neonatal Skin Condition Score adapted to the probe site.
Randomization: A computer-generated block randomization list with variable block sizes (4 and 6) is prepared by an independent statistician. Allocations are concealed in sequentially numbered, opaque, sealed envelopes.
Pilot phase: Before the main study, 8 to 10 neonates will be included in a pilot phase to test the adapted scoring form, photography setup and interobserver agreement, and to compare oxygen saturation readings between cohesive bandage and standard adhesive fixation (Bland-Altman analysis). Pilot data will not be included in the main analysis.
Statistical analysis: The unit of analysis is the application site. Because the four sites of each infant are not independent, a linear mixed-effects model will be used, with infant as a random effect and group, baseline score and site (hand/foot) as fixed effects. Analysis will follow the intention-to-treat principle, with a per-protocol sensitivity analysis.
- Being tested
- Cohesive bandage fixation of pulse oximeter probe, Standard adhesive fixation of pulse oximeter probe
- Keywords
- newborn, Pulse Oximetry, Cohesive Bandage, Skin Condition, Nursing Care, Neonatal Intensive Care Unit, Neonatal Skin Condition Score
- Medical subject headings
- Premature Birth, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohesive bandage fixation of pulse oximeter probeOther
The adhesive surface of the pulse oximeter probe is attached to a latex-free cohesive bandage (5 cm wide, length 1.5 times the circumference of the site) with openings matching the emitter and detector windows. The bandage ends adhere only to each other, so no adhesive contacts the skin. Wrap tension is checked with a capillary refill test.
Standard adhesive fixation of pulse oximeter probeOther
The pulse oximeter probe is applied directly to the skin with its original adhesive according to routine practice and manufacturer instructions.
| Study group | Role | What they receive |
|---|---|---|
| Cohesive Bandage Fixation | Experimental | The pulse oximeter probe is attached to a cohesive bandage wrapped around the extremity, with no adhesive contact with the skin. The probe is rotated across four extremities at four-hour intervals (16 hours in total). Receives: Other: Cohesive bandage fixation of pulse oximeter probe |
| Standard Adhesive Fixation | Active comparator | The pulse oximeter probe is applied directly to the skin with its own adhesive according to routine practice and manufacturer instructions. The probe is rotated across four extremities at four-hour intervals (16 hours in total). Receives: Other: Standard adhesive fixation of pulse oximeter probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Skin Condition Score (NSCS) total score at the probe application site
Skin condition at each probe application site is assessed with the Neonatal Skin Condition Score adapted to the probe site. The score includes three items (dryness, erythema, skin breakdown), each scored from 1 to 3; the total score ranges from 3 (best) to 9 (worst). Scoring is performed on standardized photographs by two independent observers blinded to group allocation, and the mean of the two observers' scores is used.
Measured: 30 minutes after probe removal at the end of each 4-hour application (up to 16 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group randomized controlled trial with 1:1 allocation. Each infant contributes four probe application sites.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba KARAKUS TURKER, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864298
- Sponsor's protocol ID
- KOHESIF-SPO2-2026
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the small sample size of neonatal participants and the need to protect patient confidentiality, including standardized skin photographs. Aggregated results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cohesive Bandage Fixation of Pulse Oximeter Probes on Skin Condition at the Probe Site in Preterm Neonates: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07864298
- Acronym / sponsor ID
- KOHESIF-SPO2-2026
- Keywords
- newborn, Pulse Oximetry, Cohesive Bandage, Skin Condition, Nursing Care, Neonatal Intensive Care Unit, Neonatal Skin Condition Score
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 7 Oct 2026 (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.
Pulse oximeter probes are used to continuously monitor oxygen levels in newborn babies in intensive care. These probes are usually attached to the baby's hand or foot with adhesive tape and must be moved to a new site every few hours. Repeatedly sticking and removing adhesive can damage the delicate skin of premature babies.
The investigators have developed a new way to secure the probe without any adhesive touching the skin: the probe's adhesive side is attached to a soft, self-adhering (cohesive) bandage that wraps around the baby's hand or foot. The bandage sticks only to itself, not to the skin.
The purpose of this study is to find out whether securing the probe with a cohesive bandage protects the skin better than the standard method of taping the probe directly to the skin. Sixty-four premature babies (born at 32 to 36 weeks) will be randomly placed in one of two groups. In both groups, the probe will be placed on each hand and foot for four hours in turn, for a total of 16 hours. The skin under the probe will be photographed and scored by two nurses who do not know which method was used.
Detailed description
Background: The skin of preterm neonates has an immature stratum corneum and a weak dermal-epidermal junction, which makes it vulnerable to epidermal stripping when medical adhesives are removed. The pulse oximeter probe is one of the most frequently applied and repositioned adhesive devices in the neonatal intensive care unit. Probe-related skin injuries, including adhesive-related and pressure-related damage and burns, have been reported. Existing preventive approaches (barrier films, silicone tapes, hydrocolloid dressings) reduce but do not eliminate adhesive contact with the skin. No published randomized controlled trial has tested a fixation method specific to pulse oximeter probes.
Intervention: In the experimental group, a piece of latex-free cohesive bandage (5 cm wide, length 1.5 times the circumference of the application site) is prepared. Two openings matching the probe's light-emitting diode and photodetector windows are cut into the bandage. The probe's original adhesive surface is attached to the bandage, and the free ends of the bandage are wrapped around the extremity so that they adhere only to each other. Alignment of the emitter and detector is verified. Wrap tension is standardized with a capillary refill test (refill within 2 seconds after 5 seconds of pressure proximal to the probe) and the absence of visible skin indentation. In the control group, the probe is applied directly to the skin according to routine practice and manufacturer instructions; the same capillary refill check is performed.
Exposure schedule: In both groups, the probe is rotated across four sites (right foot, left foot, right hand, left hand) at four-hour intervals. Each site carries the probe only once, for a total exposure of 16 hours per infant. A safety check (capillary refill, skin redness, probe displacement) is performed at the second hour of each application.
Outcome assessment: All four sites are photographed before any probe application (baseline). Each site is photographed again 30 minutes after probe removal under standardized conditions (fixed 20 cm distance, ring LED lighting, locked white balance, scale and color reference card in frame). Images are coded, presented in random order, and scored independently by two observers blinded to group allocation using the Neonatal Skin Condition Score adapted to the probe site.
Randomization: A computer-generated block randomization list with variable block sizes (4 and 6) is prepared by an independent statistician. Allocations are concealed in sequentially numbered, opaque, sealed envelopes.
Pilot phase: Before the main study, 8 to 10 neonates will be included in a pilot phase to test the adapted scoring form, photography setup and interobserver agreement, and to compare oxygen saturation readings between cohesive bandage and standard adhesive fixation (Bland-Altman analysis). Pilot data will not be included in the main analysis.
Statistical analysis: The unit of analysis is the application site. Because the four sites of each infant are not independent, a linear mixed-effects model will be used, with infant as a random effect and group, baseline score and site (hand/foot) as fixed effects. Analysis will follow the intention-to-treat principle, with a per-protocol sensitivity analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled trial with 1:1 allocation. Each infant contributes four probe application sites.
| Arm | Type | Receives |
|---|---|---|
| Cohesive Bandage Fixation | Experimental | Other: Cohesive bandage fixation of pulse oximeter probeThe pulse oximeter probe is attached to a cohesive bandage wrapped around the extremity, with no adhesive contact with the skin. The probe is rotated across four extremities at four-hour intervals (16 hours in total). |
| Standard Adhesive Fixation | Active comparator | Other: Standard adhesive fixation of pulse oximeter probeThe pulse oximeter probe is applied directly to the skin with its own adhesive according to routine practice and manufacturer instructions. The probe is rotated across four extremities at four-hour intervals (16 hours in total). |
Who may qualify
- Ages
- 0 years to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age 32 0/7 to 36 6/7 weeks
- Birth weight 1500 g or more
- Requiring continuous pulse oximetry monitoring, expected to last at least 16 hours
- No primary skin lesion, congenital anomaly or active dermatological disease
- Written informed consent from a parent
Key exclusion criteria (6 listed)
- Hydrops fetalis or generalized peripheral edema
- Systemic corticosteroid, immunosuppressive or vasoactive drug use
- Impaired peripheral circulation in the extremities to be used for probe application
- Skin changes due to uremia or cholestasis
- Receiving phototherapy or topical pharmacological application to the skin
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 |
|---|---|---|
| Cohesive bandage fixation of pulse oximeter probeThe adhesive surface of the pulse oximeter probe is attached to a latex-free cohesive bandage (5 cm wide, length 1.5 times the circumference of the site) with openings matching the emitter and detector windows. The bandage ends adhere only to each other, so no adhesive contacts the skin. Wrap tension is checked with a capillary refill test. | Other | Cohesive Bandage Fixation |
| Standard adhesive fixation of pulse oximeter probeThe pulse oximeter probe is applied directly to the skin with its original adhesive according to routine practice and manufacturer instructions. | Other | Standard Adhesive Fixation |
Primary outcome
Neonatal Skin Condition Score (NSCS) total score at the probe application site
Time frame: 30 minutes after probe removal at the end of each 4-hour application (up to 16 hours)
Skin condition at each probe application site is assessed with the Neonatal Skin Condition Score adapted to the probe site. The score includes three items (dryness, erythema, skin breakdown), each scored from 1 to 3; the total score ranges from 3 (best) to 9 (worst). Scoring is performed on standardized photographs by two independent observers blinded to group allocation, and the mean of the two observers' scores is used.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the small sample size of neonatal participants and the need to protect patient confidentiality, including standardized skin photographs. Aggregated results will be reported in publications.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cohesive bandage fixation of pulse oximeter probe and Standard adhesive fixation of pulse oximeter probe in people with Skin Injury and Premature Birth, run by Uskudar University 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğba Karakuş Türker, PhD (+905439599371, tugba.karakusturker@uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Skin Condition Score (NSCS) total score at the probe application site (time frame: 30 minutes after probe removal at the end of each 4-hour application (up to 16 hours)). 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 7 Oct 2026.