G. L. Grove, Ph.D.; C. Zerweck, Ph.D., cyberDERM inc. Broomall , PA , and B.P. Ekholm ; G.E. Smith ; N.I. Koski , 3M St. Paul, MN  

Both the silicone adhesive tape * and the control paper tape † were both found to be gentle to the skin of healthy infants:

● The silicone adhesive tape * exhibited significantly less erythema than the control paper tape † upon removal 24 hours after application

● There were no differences observed in visual skin stripping (denudation) scores

● There was significantly less discomfort at removal for the silicone adhesive tape * compared to the control paper tape †

● There was significantly less edge lift with the control paper tape † compared to the silicone adhesive tape *

● The silicone adhesive tape * removed significantly less skin cell protein (hence skin cells) than the control paper tape † upon removal 24 hours after application

● There was a slight parental preference toward the silicone adhesive tape * compared to the control paper tape †

Background

Footnotes:* 3M™ Kind Removal Silicone Tape† 3M™ Micropore™ Paper Tape

AcknowledgementsSponsored by: 3M Health Care

Poster design by Lutz Consulting LLC

Results

PRESENTED AT: The WOCN Society’s 44th Annual Conference, June 9-13, 2012, Charlotte, North Carolina

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

The objective of this study was to determine the relative gentleness of a silicone adhesive tape * in comparison to a marketed tape † that is recognized for its gentleness and used as a mainstay in cosmetic surgery and in neonatal care with infants and pediatrics.

References:1. Lund CH, Nonato LB, Kuller JM, Franck LS, Cullander C, Durand DJ. Disruption of barrier function in neonatal skin associated with adhesive

removal. J Pediatr. Sep 1997;131(3):367-372.2. Baharestani MM. An overview of neonatal and pediatric wound care knowledge and considerations. Ostomy Wound Management. Jun

2007;53(6):34-36, 38, 40, passim.3. Voepel-Lewis T, Zanotti J, Dammeyer JA, Merkel S. Reliability and validity of the face, legs, activity, cry, consolability behavioral tool in assessing

acute pain in critically ill patients. Am J Crit Care. Jan 2010;19(1):55-61.

Figure 3: Silicone adhesive tape requires less force of removal because it has more “spring” than traditional adhesives. The energy of the adhesive bond is able to dissipate through the adhesive rather than the skin. Removal of the tape does not pull the skin up the same way as with traditional adhesives, thus reducing the pain and trauma associated with tape removal.

Traditional Adhesive

Silicone Adhesive

Figure 1: Schematic comparison of the differences in the mechanism of adhesion of traditional acrylate adhesives and silicone adhesives.Traditional Acrylic Adhesive

Initial Application Over Time

Limited initial contact leaves gaps in the adhesive-skin interface which requires a higher initial adhesive strength to provide effective adhesion. Over time the adhesive flows into the gaps and the strength of the bond increases.

Silicone Adhesive

Initial Application Over Time

The silicone adhesive is softer and has a lower surface tension than traditional adhesives, allowing it to quickly conform to the contours of the skin providing immediate secure and comfortable fixation that remains constant over time.

Figure 2: Over time the silicone adhesive tape provides a more constant adhesive strength compared to traditional acrylic adhesives which increase over time.

Initial Application 24 Hours 48 Hours

Score Erythema & Edema Severity Score0 No visible response

1Mild response. Diffused, patchy, not well-defined, just barely perceived erythema. No perceivable edema.

2Moderate response. Perceivable erythema is obvious, with diffused redness. Pink or red in color, area well defined. No edema.

3Severe response. Obvious erythema. Definite red in color, area well defined. Edema present.

4 Extreme response. Bright, fiery red erythema. Edema is present.

Score Denudation Severity Score0 No sign of denudation

1 Trace amount of denudations in epidermis. (Slight glazed appearance).

2Partial thickness denudations (first sign of pitting in the skin) extending up to the glistening layer of the epidermis. (Moist and/or wet surface).

3 Full thickness denudations extending into the dermis. (Exudates present on the test site).

4Full thickness denudations extending into the dermis or in combination with an extreme Erythema/Edema response.

Overview: This study compared the relative gentleness of two surgical tapes *,† on the backs of healthy infants. Each tape was applied and removed once from the designated test sites after 24 hours of wear time.

Subjects: 24 healthy full term infants participated in this study (11 male, 13 female, median age 37.0 months, range 9.1 to 46.7).

Test Sites and Test Samples: Each infant had two test sites that were located on the upper back (intrascapular region) with one on each side of the back. Samples of each of the two test tapes 1 x 1.5 inch in size were applied to one of the two test sites in a randomized and standardized fashion. Test tapes were also removed in a standardized fashion after about 24 hours of dwell time following a written procedure.

Expert Grader Assessments: Test sites were evaluated for erythema/edema, skin stripping (denudation), and skin tears at baseline and approximately 30 minutes after tape removal and compared with the Wilcoxon matched-pairs signed-rank test.

Discomfort Assessments: The infants were videotaped just prior to and during the tape removal process. The videotapes were viewed by a blinded assessor and scored for discomfort using the Faces, Legs, Activity, Cry, and Consolability (FLACC) published procedure.3 The net change from baseline score was analyzed and differences were assessed with a one-sided Wilcoxon signed-rank test.

Erythema & EdemaResults are presented in Figure 4. There was a modest increase in erythema with of both test tapes compared to Baseline (zero for both tapes). There was no edema present on any of the test sites for any of the test subjects. It is noteworthy that the mean erythema response for both tapes was mild. However, the silicone adhesive tape exhibited a significantly lower mean response than the control paper tape (p=0.0129).

Skin Stripping/DenudationsResults are presented in Figure 5 There was very little skin stripping observed with either tape. None of the infants in the silicone tape group exhibited any stripping at all, and there was only sporadic and low level stripping observed with the control paper tape. There was no significant difference in the mean level of stripping between the two test tapes.

Skin TearsThere were no observations of skin tears on any of the subjects at any time during the study.

Discomfort AssessmentsResults are presented in Figure 6. There was significantly less discomfort at removal for the silicone adhesive tape than the control paper tape. The mean net change from baseline for the FLACC scores was 0.4 for the silicone adhesive tape compared to 3.25 for the control paper tape (p=0.0002).

Tape Edge Lift AssessmentsResults are presented in Figure 7. There was a low level of edge lift for both tapes and most tapes stay in place for the expected wear time, but the control paper tape exhibited significantly (p<0.0001) less edge lift than the silicone adhesive tape. It should be noted that the infants participating in this study were healthy and normally active. Therefore, caution should be taken in projecting these results to a NICU environment where the infants would most likely be much less active. It is likely that these results represent a worse case scenario for edge lift.

Methods

Tape Edge Lift: A lift Assessment was taken just prior to tape removal on day 2 by staff other than the expert grader or FLACC assessor. Lift was assessed according to the following scale: 0 = No Lift, 0.5 = Corner lift only, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76-99%, 5 = Tape is missing. Differences were assessed with the Wilcoxon matched-pairs signed-rank test.

Tape Protein Removal Measurements: Quantification of skin cell removal by the tapes was accomplished using a validated bicinchoninic acid (BCA) colormetric detection and protein quantification assay. Log-transformed BCA scores were analyzed using a mixed effects model with subject as a random effect and sample as the fixed effect.

Hair Count: The number of hairs on each sample of tape were counted using a low power stereo microscope.

Parent Preference: At the end of the study the attending parent of each infant was asked a question about which tape they would prefer to be used on their child. They were asked to rate their preference for the tapes with a 0 = Not selected or no preference, 1 = prefer, or 2 = strongly prefer. Differences were assessed with the Wilcoxon matched-pairs signed-rank test.

CategoryFLACC Scoring Criteria3

0 1 2

Face No particular expressionOccasional grimace or frown, withdrawn, disinterested

Frequent to constant quivering chin, clenched jaw

Legs Normal position or relaxed Uneasy, restless, tense Kicking, or legs drawn up

ActivityLying quietly, normal position, moves easily

Squirming, shifting back and forth, tense Arched, rigid or jerking

Cry No cry (awake or asleep)Moans or whispers; occasional complaint

Crying steadily, screams or sobs, frequent complaints

Consolability Content, relaxed

Reassured by occasional touching hugging or being talked to, distractible Difficult to console or comfort

One of the most common causes of skin trauma in neonatal intensive care units (NICU) is the removal of adhesive tapes and dressings necessary to secure life support and monitoring equipment to the patient’s skin.1 Epidermal stripping secondary to tape and adhesive dressing removal is most common in neonates born before 27 weeks of gestation and is the primary cause of skin breakdown in the NICU.2 A fundamental characteristic of traditional acrylate based adhesive products is that the adhesion profile changes significantly over time (Figures 1 & 2). Acrylate adhesives tend to have a much lower initial adhesion than they do at 24 or 48 hours after application, the change in adhesion is often 2 to 4 fold. Therefore, adhesives that provide safe and effective adhesion when first applied may cause more skin trauma at the time of removal. In contrast, a new silicone adhesive tape* has been introduced that provides more consistent adhesion over time and removes more gently due to unique properties of the adhesive (Figure 3).

Objective

Silicone Tape Technology Overview

Tape Protein Removal MeasurementsResults are presented in Figure 8. There was significantly less protein removed from the skin with silicone adhesive tape than with the control paper tape (p<0.0001). These results lend credence to the more gentle nature of silicone adhesive tape compared to the control paper tape; however, since there was little visual skin stripping observed in this study (Figure 5), it is difficult to interpret the clinical significance of protein removal data.

Hair RemovalFour infants had hair removed by the silicone adhesive tape only, one had hair removed by the control paper tape only, and one had hair removed by both. The total number of hairs removed was not significantly different between the two tapes.

Parent PreferenceThere was a slight preference among the parents of the infants participating in the study for the silicone adhesive tape, however this difference was not statistically significant.

0.0

1.0

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Erythema & Edema ScoreFigure 4: Erythema & Edema

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Silicone Adhesive Tape * Control Paper Tape †

Barely Perceived Erythema

Pink or red in color, area well defined (no edema)

Definite red in color, area well defined (edema present)

Bright, fiery red in color, area well defined (edema present)

0.93 ± 0.141.35 ± 0.11

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Erythema & Edema ScoreFigure 5: Stripping/Denudations

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Silicone Adhesive Tape * Control Paper Tape †

Trace amount of denudationsSlight glazed appearance

Partial thickness denudationsMoist and/or wet surface

Full thickness denudationsExudate present

Full thickness denudationsExudate present

0.29 ± 0.110.000

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Silicone Adhesive TapeControl Paper Tape

Figure 6: Discomfort Assessments

Mea

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CC

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imum

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Before Removal After Removal

3.3 ± 0.6

1.0 ± 0.50.6 ± 0.30.6 ± 0.3

Silicone Adhesive Tape *

Control Paper Tape †

0123456789

10

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0 0.05 1 2 3 4 5

Silicone Adhesive…Control Paper Tape

Figure 7: Edge Lift Assessments

Silicone Adhesive Tape *Control Paper Tape †

No Lift Corner Only

1%-25% 26-50% 51%-75% 76%-99% Tape Missing

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Study Conclusions

18.7 ± 2.0

18.7 ± 2.0

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Erythema & Edema ScoreFigure 8: Protein Removal Measurements

Silicone Adhesive Tape * Control Paper Tape †

BC

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15.7 ± 1.3

8.7 ± 0.5

Skin Skin Skin SkinAdhesive Flows into gap over time

Gap