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NCT07864298
Cohesive Bandage Fixation of Pulse Oximeter Probes and Skin Condition in Preterm Neonates
Conditions: Skin Injury, Premature Birth, Medical Adhesive Related Skin Injury
Sex: All
Ages: 0 Years – 28 Days
Healthy volunteers: No
Phase: NA
Enrollment: 64
Sponsor: Uskudar University
Location: Uskudar University Istanbul Istanbul
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. 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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07864298). StuddyBuddy aggregates publicly available trial information.