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

Background:

Medical tapes can be traumatic to skin, with the adhesive potentially lifting a layer of the stratum corneum with each application and removal. Such trauma can contribute to skin breakdown, especially in patients who are elderly or have otherwise fragile skin.

 Objective:

To determine the relative gentleness of an investigational silicone tape in comparison to a marketed “gold standard” tape recognized for its gentleness in cosmetic surgery and neonatal care ¹.

 Design:

This was a controlled, randomized, partially-blinded, bilateral study with a three-prong multidimensional evaluation of TEWL, expert skin grader and subject questionnaires.

 Both tapes were applied to, worn 24 hours and removed from the medial and distal sections of the volar forearms with an untreated middle section as control. Tape locations were randomized.  There were nine applications and removals of the test materials over 11 days with assessments on days 1, 4, 7 and 11.

 Participants:

27 healthy subjects, at least 55 years old and free of skin problems on the volar forearms, participated in the study.

 Results:

The new silicone tape had significantly lower TEWL compared to the gold-standard tape at (Day 1 p=0.0216, 4 p <0.0001, 7 p < 0.0001, 11 p< 0.0001).

 The silicone tape also resulted in lower denudation scores than the gold-standard tape at Days 4, 7 and 11 (p<0.0001). There were no significant differences in erythema and edema scoring.

 The results of a subject questionnaire showed 44% of the subjects preferred or strongly preferred the silicone tape compared to 19% for the marketed tape; 37% had no preference. Rating of pain upon removal trended higher for the marketed tape than for the silicone tape.

 Conclusions:

The new silicone tape proved to be significantly gentler to the skin compared to the “gold standard” gentle tape as assessed by both objective and subjective measures.