Adhesive Tape Trauma Evaluation of Two Gentle Tapes in Healthy Human Infant Subjects

Background:

One of the most common causes of skin trauma in neonatal intensive care units is removal of adhesive tapes and dressings necessary to secure life support and monitoring equipment to the patient’s skin¹.

 Objective:

The objective of this study was to determine the relative gentleness of an investigational silicone tape in comparison to a marketed  tape recognized for its gentleness and used as a mainstay in cosmetic surgery and neonatal care² in infants and pediatrics.

 Design:

This was a controlled, randomized, partially-blinded, bilateral study with a three-prong multidimensional evaluation of skin cell quantification (Bicinchoninic acid protein quantitation assay), expert skin grader and assessments of subject pain using the pediatric FLACC (Face, Legs, Activity, Cry, Consolability) scores.

 Both tapes were applied bilaterally, worn for 24 hours and removed from the upper back.  Tape locations were randomized.

 Participants:

Twenty-four healthy infants between the ages of 9-47 months of age, and free of skin problems on the upper back participated in the study.

 Results:

The silicone tape resulted in lower erythema response than the gold-standard tape (p=0.0129). There were no significant differences in denudation scoring.

The silicone tape also resulted in a significantly lower change from baseline in FLACC scores (p=0.0002) and BCA results (p<0.0001) compared with gold-standard tape.

 Conclusions:

The investigational silicone tape showed a lower erythema response, removed fewer skin cells and caused less pain than the gentle tape.  Both tapes proved to be gentle to the skin as assessed by skin disruption upon removal of the tape.