The effect of adhesive dressing edges on cutaneous irritancy and skin barrier function.
OBJECTIVE
To assess the effect of repeated application and removal of adhesive edges from wound-care products on cutaneous irritancy and barrier function in normal volunteer subjects.


METHODS
This was a study using a 'repeat-insult patch test'. Adhesive edges from six commonly used wound-care products were applied continuously to the same site (six applications over a 14-day period) in 30 normal volunteer subjects. The test sites were assessed clinically before product reapplication using established ranking scales for cutaneous erythema. The cumulative irritancy score (CIS) for each test site was determined by adding the erythema scores at days 3, 5, 8, 10, 12 and 15. At the study end the barrier function of each test site was assessed by measuring transepidermal water loss (TEWL).


RESULTS
The CIS showed that the products fall into two distinct groups, with Mepilex, Tielle and Allevyn giving low scores and Biatain, Comfeel and DuoDERM higher scores. Statistical analysis indicated significant differences (p < 0.05) between Mepilex and Biatain, Mepilex and Comfeel, Mepilex and DuoDERM, Tielle and Biatain, Allevyn and Biatain. The mean TEWL values also indicated that the products fall into two distinct groups: Mepilex, Tielle and Allevyn with low mean values close to that of normal adjacent back skin and Biatain, Comfeel and DuoDERM with much higher mean values. Statistical analysis indicated that Mepilex, Tielle and Allevyn were not significantly different from normal skin (p < 0.05), whereas Biatain, Comfeel and DuoDERM were significantly higher than normal skin and the other products tested.


CONCLUSIONS
The results show clear differences between products; the clinical scores and TEWL measurements indicate that the products fall into two distinct groups. This novel approach seems able to discriminate between adhesive borders and may be useful during product development and in selecting products for clinical trials.
Dykes
P J
PJ
Cutest Systems, Cardiff, UK. peter.dykes@cutest.co.uk
D000269:Adhesives / Q000009:adverse effects*; D000328:Adult; D000368:Aged; D001458:Bandages / Q000009:adverse effects*; D047070:Bandages, Hydrocolloid / Q000009:adverse effects; D017453:Dermatitis, Irritant / Q000145:classification / Q000209:etiology* / Q000473:pathology; D016002:Discriminant Analysis; D005260:Female; D006801:Humans; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D009930:Organic Chemicals / Q000009:adverse effects; D018579:Patient Selection; D011140:Polyurethanes / Q000009:adverse effects; D012720:Severity of Illness Index; D023422:Skin Irritancy Tests; D012879:Skin Physiological Phenomena / Q000187:drug effects; D014870:Water Loss, Insensible / Q000187:drug effects / Q000502:physiology
D000269:Adhesives; D009930:Organic Chemicals; D011140:Polyurethanes; C081143:allevyn; C093472:comfeel