[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659236":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":24,"studyPopulation":13,"armGroups":25,"interventions":38,"overallOfficials":13,"centralContacts":47,"locations":53,"responsibleParty":66,"collaborators":13,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":13,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":13,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":99,"whyStopped":13,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Uskudar University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"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.","30 minutes after probe removal at the end of each 4-hour application (up to 16 hours)",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Two-arm, parallel-group randomized controlled trial with 1:1 allocation. Each infant contributes four probe application sites.","PREVENTION",{"masking":20,"maskingDescription":21,"whoMasked":22},"SINGLE","Due to the nature of the intervention, the nurse applying the probe cannot be blinded. Skin assessments are performed on coded photographs in which the probe and fixation method are not visible, by two independent observers blinded to group allocation.",[23],"OUTCOMES_ASSESSOR","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.\n\nIntervention: 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.\n\nExposure 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.\n\nOutcome 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.\n\nRandomization: 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.\n\nPilot 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.\n\nStatistical 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\u002Ffoot) as fixed effects. Analysis will follow the intention-to-treat principle, with a per-protocol sensitivity analysis.",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"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).",[31],"Other: Cohesive bandage fixation of pulse oximeter probe",{"label":33,"type":34,"description":35,"interventionNames":36},"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).",[37],"Other: Standard adhesive fixation of pulse oximeter probe",[39,43],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":13},"Cohesive bandage fixation of pulse oximeter probe","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.",[27],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":13},"Standard adhesive fixation of pulse oximeter probe","The pulse oximeter probe is applied directly to the skin with its original adhesive according to routine practice and manufacturer instructions.",[33],[48],{"name":49,"role":50,"phone":51,"phoneExt":13,"email":52},"Tuğba Karakuş Türker, PhD","CONTACT","+905439599371","tugba.karakusturker@uskudar.edu.tr",[54],{"facility":5,"status":13,"city":55,"state":55,"zip":56,"country":57,"countryCode":13,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Istanbul","34000","Turkey (Türkiye)",{"type":59,"coordinates":60},"Point",[61,62],28.94966,41.01384,{"lat":62,"lon":61},[65],{"name":49,"role":50,"phone":51,"phoneExt":13,"email":52},{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Tugba KARAKUS TURKER","Assistant Professor","100659236","cohesive-bandage-fixation-of-pulse-oximeter-probes-and-skin-condition-in-preterm-neonates-100659236",false,"NCT07864298","Cohesive Bandage Fixation of Pulse Oximeter Probes and Skin Condition in Preterm Neonates","Effect of Cohesive Bandage Fixation of Pulse Oximeter Probes on Skin Condition at the Probe Site in Preterm Neonates: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Gestational age 32 0\u002F7 to 36 6\u002F7 weeks\n* Birth weight 1500 g or more\n* Requiring continuous pulse oximetry monitoring, expected to last at least 16 hours\n* No primary skin lesion, congenital anomaly or active dermatological disease\n* Written informed consent from a parent\n\nExclusion Criteria:\n\n* Hydrops fetalis or generalized peripheral edema\n* Systemic corticosteroid, immunosuppressive or vasoactive drug use\n* Impaired peripheral circulation in the extremities to be used for probe application\n* Skin changes due to uremia or cholestasis\n* Receiving phototherapy or topical pharmacological application to the skin\n* Receiving sedation","ALL","0 Years","28 Days",{"count":81,"type":82},64,"ESTIMATED","INTERVENTIONAL",[85],"NA","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.\n\nThe 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.\n\nThe 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.",[88,89,90],"Skin Injury","Premature Birth","Medical Adhesive Related Skin Injury",[92,93,94,95,96,97,98],"newborn","Pulse Oximetry","Cohesive Bandage","Skin Condition","Nursing Care","Neonatal Intensive Care Unit","Neonatal Skin Condition Score","NOT_YET_RECRUITING","2026-10-02",{"date":102,"type":103},"2026-10-07","ACTUAL",{"date":105,"type":82},"2026-10",{"date":107,"type":82},"2026-11",{"name":5,"class":6},1]