Cohesive Bandage Fixation of Pulse Oximeter Probes and Skin Condition in Preterm Neonates

ConditionsSkin Injury Premature Birth Medical Adhesive Related Skin Injury

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age0-28

SponsorUskudar University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Cohesive bandage fixation of pulse oximeter probe
Other intervention
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 probe
Other intervention
The pulse oximeter probe is applied directly to the skin with its original adhesive according to routine practice and manufacturer instructions.

Treatment groups

64 Participants

are divided into 2 treatment groups

Group A: Cohesive Bandage FixationExperimental treatment 1 intervention

Group B: Standard Adhesive FixationActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

30 minutes after probe removal at the end of each 4-hour application (up to 16 hours)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uskudar University

Lead sponsor

Source ClinicalTrials.gov

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