Stoma Care Products Represent A Common and Previously Underreported Source of Peristomal Contact Dermatitis
Stoma Care Products Represent A Common and Previously Underreported Source of Peristomal Contact Dermatitis
Contact Dermatitis
doi:10.1111/cod.12678
Summary Background. Peristomal dermatitis is a common complication for the >700 000
patients in the United States with an ostomy. The role of stoma skin care products in peri-
stomal dermatitis is poorly understood.
Objective. To evaluate stoma skin care products as a cause of peristomal dermatitis.
Methods. A retrospective chart review of patients with peristomal dermatitis at four aca-
demic hospitals from January 2010 to March 2014 was performed. Patient demograph-
ics, clinical information and use test and patch test results were documented.
Results. Eighteen patients identified as having peristomal dermatitis were tested. Twelve
of these had peristomal contact dermatitis. We identified numerous stoma skin care
products as triggers of irritant and/or allergic contact dermatitis. The most common
stoma skin care product used and/or involved in dermatitis was Cavilon™ No Sting Barrier
Film.
Conclusions. Our data support a paradigm shift whereby healthcare workers treating
patients with peristomal dermatitis, which is currently considered to be a reaction mainly
to bodily fluids, must now consider those products used to protect the skin as potential
triggers for this disease. Therefore, patients with peristomal dermatitis should be tested
with their stoma skin care agents to determine the need for removal or change of these
products. Additionally, full ingredient labelling by manufacturers would help identify new
allergens and irritants.
Key words: allergic contact dermatitis; irritant contact dermatitis; ostomy; patch test;
peristomal dermatitis; skin barrier; skin care products; stoma.
Correspondence: Assistant Professor Jonathan H. Zippin, Department of Dermatology, Joan and Sanford I Weill Medical College of Cornell University, 1305
York Avenue 9th Floor, New York, NY 10021, USA. Tel: +1 646 962 5511; Fax: +1 646 962 0033. E-mail: [email protected]
Conflicts of interest: V. R. Belum, B. D. Cressey, P. Scheinman, D. Silvestri, N. McEntee and V. Livingston have no conflicts of interest to declare; J. H. Zippin is
the founder of CEP Biotech and has no conflicts of interest regarding the content of the manuscript; M. E. Lacouture has a speaking, consultant or advisory
role with Advancell, Amgen, AstraZeneca, Aveo, Bayer, Biopharm Communications, Bristol-Myers Squibb, Clinical Care Options, Envision Communications,
Galderma, Genentech, GlaxoSmithKline, Helsinn, Institute for Medical Education and Research, Lindi Skin, Merck, Novocure, OSI Pharmaceuticals, Permanyer,
Pfizer, Sandoz, and Sanofi Aventis.
Funding sources: This study was funded in part through the NIH/NCI Cancer Center Support Grant P30 CA008748, and K08 CA 160657.
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Contact Dermatitis 1
STOMA CARE PRODUCTS AND PERISTOMAL CONTACT DERMATITIS • CRESSEY ET AL.
It is estimated that >700 000 patients in the United States Product testing was performed either as a use test or
are living with a stoma (colostomy, ileostomy, ileal con- a patch test. In most patients (1–15), the use test was
duit, or urostomy) (1). These patients receive regular employed, as the product being tested is normally either
stoma care in wound ostomy and continence clinics, and applied and then occluded under adhesive dressings or
complicated cases are sometimes referred to the derma- is the adhesive dressing itself. For the use test, we identi-
tologist for management. Peristomal skin disorders rep- fied an area of uninvolved skin of ∼10 cm2 on which to
resent the most common postoperative complication in apply the product. If the patient was tested by our staff,
ostomates, and the incidence ranges from 15% to 65% the back was chosen. Otherwise, if the patient was unable
(2, 3). It has been estimated that these events account to come to the office three times in 1 week and was able
for more than one-third of stoma care clinic visits, result- to reapply the product to their own skin as instructed,
ing in a substantial economic burden on the patient and we utilized the arm or abdomen, and instructed patients
the healthcare system (2). Peristomal skin is constantly to treat this area as if it were their ostomy site. Stoma
exposed to a number of substances, including urine, fae- skin care products were applied ‘as is’ to accurately mimic
ces, medicaments, ostomy pouch systems, and stoma the conditions under which the products would be used.
skin care products such as barrier films and adhesive Liquid or spray products were applied to dry skin in par-
paste/removers. The above can result in a variety of peri- allel with changing the ostomy dressing. The site was
stomal events, including physical skin abrasion and/or then covered with adhesive dressing that is known to
infections, dermatologic conditions (pyoderma gangreno- not react with the patient’s skin, in an attempt to mimic
sum, psoriasis, etc.), and contact dermatitis (4). Bodily flu- clinical occlusion. Exposure was continued for 2–7 days,
ids are known to constitute an important cause of peris- and reactions were then assessed. For those who were
tomal dermatitis. To protect the peristomal skin, medical able come to the office for all three appointments, our
professionals recommend the application of stoma skin staff photographed and recorded skin findings. For those
care products designed to prevent peristomal irritation. who were unable to come to all three appointments,
Because of the presence of known allergens/irritants in if the patient noted a reaction, pictures were taken by
peristomal skin products (e.g. fragrances and colopho- family or home care nurses. For all patients, sites were
nium), we reasoned that stoma skin care products may examined for epidermal changes including, but not lim-
represent a previously unappreciated cause of peristomal ited to, erythema, oedema, vesiculation, or ulceration. In
dermatitis. Allergic contact dermatitis (ACD) has been some instances, the brand name of the stoma care prod-
infrequently reported (0.5–4.7%) (5–8), but, when it is uct could not be confirmed, so the general product cate-
present, it is often caused by stoma skin care products (9). gory only is listed. All data were recorded in a Microsoft
The role of these products as irritants is also poorly under- Excel database, and descriptive frequencies were used to
stood. Most of the evidence in the literature is in the form summarize the data.
of case reports and case series, and there are no large-scale Patients 16–18 were patch tested with stoma care
studies reporting on these events (8, 10). Herein, we eval- products as follows: ConvaTec™ Sur-fit Natura Stom-
uate irritant and allergic aetiologies for peristomal der- ahesive wafer, Coloplast™ Sensura Wafer, Hollister™
matitis, and identify commonly used products as culprits. Wafer, Durahesive™ Wafer, Eakin™ material, Hollister™
Adapt Material, Coloplast™ Strip Paste, Coloplast™ Wafer,
Hollister™ Adapt Barrier Ring and Tegaderm were applied
Methods as a 2-cm2 piece of wafer under paper tape occlusion for
We utilized an Institutional Review Board-approved retro- 48 h (patients 16 and 17); Cavilon™ No-Sting Barrier
spective chart review of patients with peristomal dermati- Film was applied as the pledget form of the product
tis who were managed by dermatologists at the Memorial directly to the skin and covered with tape (patient 17);
Sloan Kettering Cancer Center, New York-Presbyterian or a small amount of ConvaTec™ Stomahesive Protective
Hospital & Weill Cornell Medical Center, Tufts Medical Powder, Cavilon™ No Sting Barrier Film, ConvaTec™
Center, and UMass Memorial Medical Center, during a Stomahesive Paste, Adapt stoma powder® , Mupirocin
4-year period (January 2010 to March 2014). In most Ointment, Desonide 0.05% Cream, Alkare™ Protective
cases, the status of the peristomal skin lesions was noted Wipe, StomaCare™ Wipe or Smith & Nephew™ No Sting
clinically and also according to the validated Studio Alter- Skin-Prep Wipe was placed on a Finn Chamber® ‘as is’,
azioni Cutanee Stomali (SACS™ ) instrument, which was allowed to dry, and occluded for 48 h (patients 16 and
originally developed by wound ostomy continence nurses 18). In most cases, areas were examined again 48 h after
and surgeons for objective assessment and classification application of the product, and then again 48 h after
(Fig. S1) (4, 11). removal, that is, on day (D) 4. Regardless of the method
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
2 Contact Dermatitis
STOMA CARE PRODUCTS AND PERISTOMAL CONTACT DERMATITIS • CRESSEY ET AL.
Number of
positive
No. Stoma skin care product reactions Ingredients (as listed in the MSDS/PDS/SDS)∗
Adhesive/barrier removers
1 PDI™ Adhesive Tape Remover 2 Hydrotreated heavy naphtha (petroleum), isopropyl esters
Pad fatty acids (C14–18), isopropyl alcohol, light aliphatic
solvent naphtha (petroleum), xylene
2 Reliamed® Adhesive Remover 2 C11–12 isoparaffin, petroleum naphtha, isopropyl alcohol,
Wipes isopropyl palmitate, isopropyl myristate, isopropyl
stearate, fragrance
3 Uni-Solve® Adhesive Remover 1 Isopropyl alcohol, C10–11 isoparaffin, dipropylene glycol
methyl ether, aloe extract, fragrance
4 Hollister™ Adhesive/Barrier 1 Stearic acid, ethanol, dimethylsiloxane cyclic tetramer,
Remover Wipes propylene glycol monomethyl ether, proprietary
fragrance, ethyl acetate, decahydronaphthalene
5 ConvaTec AllKare® Wipes 1 Barrier wipes: dimethyl phthalate, isopropranolol, ethyl
(barrier/adhesive remover acetate, non-hazardous ingredients
not specified) Adhesive remover wipes: D-limonene, acid-treated distillate
oil, balance of ingredients – non-hazardous
Skin barriers/fillers
6 Cavilon™ No Sting Barrier Film 5 Hexamethyldisiloxane, foam applicator, isooctane, acrylate
terpolymer, polyphenylmethylsiloxane copolymer
7 Adapt® Stoma Adhesive Paste 1 Proprietary composition
8 ConvaTec™ Stomahesive 1 Ethyl alcohol, butyl alcohol, balance of
Paste ingredients – non-hazardous
9 ConvaTec™ Stomahesive 1 –
(product not specified)
10 ConvaTec™ Durahesive 1 –
(product not specified)
11 ConvaTec™ Sur-fit Natura 1 No MSDS for this product
Stomahesive Wafer
Others
12 Adhesive tape (brand not 1 –
specified)
MSDS, material data safety sheet; PDS, product data sheet; SDS, safety data sheet.
∗ In some cases, ingredients and/or the %wt/%vol may not have been disclosed, for proprietary reasons.
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Contact Dermatitis 3
STOMA CARE PRODUCTS AND PERISTOMAL CONTACT DERMATITIS • CRESSEY ET AL.
Clinical characteristics
The peristomal skin in our patients showed a range of
clinical reaction patterns. In all cases, the peristomal
skin was erythematous, extending out from the stoma
(n = 18). In some cases, erosion (n = 1) or even ulceration
(n = 1) of the skin was noted, and in some instances vesic-
ulation. In those patients with more chronic dermatitis,
lichenification was found. The peristomal regions (quad-
rants; Fig. S1) affected at the time of presentation were
as follows: all (n = 11), right upper (n = 2), and right/left
lower (n = 1 each). Skin reactions were limited to the
area around the stoma, and reached the border of the Fig. 1. Peristomal allergic contact dermatitis around the colostomy
in a 49-year-old patient who had undergone surgery for a perianal
adhesive dressing, with rare extension beyond. Patients
adenocarcinoma. The patient showed reactivity to multiple stoma
reported symptoms ranging from pruritus alone to both skin care products: Reliamed adhesive remover wipe (++),
pain and pruritus. Most of the patients improved with oral Cavilon™ No Sting Barrier Film (+), and the PDI™ Adhesive Tape
antihistamines, topical steroids, and avoidance and/or Remover Pad (++). L1, TV as per the SACS™ instrument
change of the causative stoma skin care products; in rare (patient 13) (L = location, T = type).
instances, oral antibiotics for superinfection were needed.
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
4 Contact Dermatitis
STOMA CARE PRODUCTS AND PERISTOMAL CONTACT DERMATITIS • CRESSEY ET AL.
Fig. 3. Peristomal ulcer and dermatitis in a 41-year-old male with Fig. 5. A bullous, probably irritant, reaction to Cavilon™ No Sting
a history of Crohn’s disease and a colostomy. The patient reacted Barrier Film at the day 3 reading in a 35-year-old female with a
positively to Convatec™ Stomahesive Paste and Cavilon™ No Sting history of Crohn’s disease and an ileostomy. The patient experienced
Barrier Film (patient 16). dermatitis at her ostomy site that persisted despite changing to
several bags and products (patient 18).
Discussion
Previous reports estimated a prevalence of both allergic
and irritant peristomal contact dermatitis caused by an
external agent of 0.5–4.7% (4–8). Our series was heavily
biased by our referral population of patients with recal-
citrant peristomal dermatitis and several reactions that
were probably IRs; hence, relative frequencies cannot be
compared. We identified several stoma skin care products
(stoma skin barriers and adhesive removers) as triggers
of allergic or irritant contact dermatitis, including severe
bullous IRs to Cavilon™ No Sting Barrier Film, which has
Fig. 4. Positive patch test reaction at the day 3 reading to Cavilon™ not been previously implicated.
No Sting Barrier Film (++) in a 68-year-old woman with a history The occluded peristomal milieu, along with repeated
of ulcerative colitis and a colostomy (patient 17). ostomy bag changes involving skin stripping, mechan-
ical trauma, etc., probably renders the skin vulnerable
to contact sensitization or irritation as a result of epi-
acids), ethyl acrylate (n = 1, adhesive), hydroxyethyl dermal barrier disruption (22). In our patients, stoma
methacrylate (n = 1, adhesive), cinnamal (n = 1, fra- skin care products were the most common causative
grance), Myroxylon pereirae (balsam of Peru, n = 1, agents; however, the specific chemical components of
fragrance marker), benzalkonium chloride (n = 1, preser- those agents that are responsible are currently unknown.
vative), fragrance mix I (n = 1), glutaraldehyde (n = 1, It would be interesting to test as much as possible
disinfectant), propylene glycol (n = 1, humectant), tri- with the specific causative agents in appropriate con-
ethanolamine (n = 1, pH adjuster), and isophorone centrations and vehicles, respectively, to distinguish
diisocyanate (IPDI) (n = 1, polyurethane plastics). Pos- between allergy and irritancy. The published litera-
itive allergic patch test reactions with unlikely clinical ture suggests that the most common allergens causing
relevance were those to nickel (n = 4, metal), benzoyl per- ACD in ostomates are epoxy resins (no longer used),
oxide (n = 1, bleaching agent, initiator of polymerization), Gantrez® copolymers (ChemPoint, Bellevue, WA, USA),
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Contact Dermatitis 5
STOMA CARE PRODUCTS AND PERISTOMAL CONTACT DERMATITIS • CRESSEY ET AL.
D-limonene, and (un)known allergens in various stoma of such allergens. Our study has some limitations.
skin care products (ostomy pouching systems, skin bar- First, the retrospective study design precluded further
riers, and adhesive removers) (8, 9, 23–28). Gantrez® patch testing with individual components. In many
is a polymethylvinyl ether maleic anhydride copolymer cases, evaluation was limited to application of the
(two formulations: Gantrez® -425 and Gantrez® -335) products on uninvolved skin, as the majority of our
that is used in various personal care products, and as cancer patients refused the additional perceived bur-
an adhesive component in a range of stoma pastes. den of patch testing, with its requirement for repeated
Our literature review showed that Gantrez® -425 is a office visits.
component of Stomahesive® (ConvaTec, Greensboro, We recommend that healthcare providers (surgeons,
NC, USA), Adapt® (Hollister, Libertyville, IL, USA) and wound ostomy and continence nurses) use low
and Dansac® (Dansac, Kernersville, NC, USA) pastes, thresholds for suspecting peristomal contact dermatitis
whereas Gantrez® -335 is an ingredient in Karaya® paste caused by ostomy products, especially when the dermati-
(Hollister) (27). tis does not improve with general stoma care measures
IPDI belongs to the group of (di-)isocyanates, which are (meticulous skin care, and proper re-fitting of the appli-
used as raw materials in the manufacture of polyurethane ance) and/or follows a protracted clinical course. The
plastics (29). Despite its extensive use, there have been clinical morphology characterized by erythema in the
very few reports of contact allergy (30, 31), with mostly peristomal region involving any or all quadrants does not
respiratory symptoms gaining attention (32). The cause permit distinction between irritant and allergic reactions,
for the long-standing (∼9 months) peristomal dermati- and patch/use testing is therefore helpful. Manufacturers
tis in our IPDI-positive patient, who was a retired metal- should be required to disclose all ingredients in the prod-
worker with an ileal conduit, remains unclear, although
uct’s label and MSDSs in order (i) to enable targeted patch
IPDI may have been present in the plastic or glue of one
testing of constituents, (ii) to avoid recommendation of
of his stoma products. IPDI was not listed in the material
similar products, and (iii) to facilitate the selection of safe
safety data sheets (MSDSs).
alternative products. Treatment for peristomal contact
Marketed as a ‘hypoallergenic, non-cytotoxic liquid,’
dermatitis includes avoidance of the offending product
Cavilon™ No Sting Barrier Film is a liquid film-forming
and the use of topical corticosteroid (triamcinolone and
product that is claimed to form a waterproof barrier that
clobetasol) sprays with oral antihistamines (33). It is
acts as a protective interface against skin irritation from
noteworthy that, in this patient population, the vehi-
moisture, adhesives, epidermal stripping, friction and seal
cle in which the topical corticosteroid is administered
protective or prescription powder under an ostomy appli-
is critical, so that adhesion of the stoma appliances is
ance. Contact dermatitis caused by Cavilon™ No Sting
not impeded.
Barrier Film was relatively common (5 patients), being
more common than that caused by any other stoma skin With the increased use of ostomies as a permanent sur-
care product tested in this series. Of those 5 patients, 2 gical solution for diseases of the bowel and bladder, or as a
had severe bullous reactions to Cavilon™ No Sting Barrier temporary measure for organ rest, healthcare profession-
Film. Given the morphology in these 2 patients, a severe als can expect peristomal contact dermatitis to become
IR appears likely. Two patients who reacted to Cavilon™ more common. In conclusion, our study highlights that
No Sting Barrier Film also reacted to colophonium, and a view of peristomal dermatitis as simply a reaction of
1 reacted to both ethyl acrylate and 2-hydroxyethyl the skin to bodily fluids is incomplete, and it is impera-
methacrylate, all of which are present in many adhesives; tive that healthcare workers consider the stoma care prod-
however, 3M neither confirmed or denied their presence ucts prescribed to protect the skin as the cause of dis-
in Cavilon™ No Sting Barrier Film. It is concerning that ease. The causative products that we identified appear to
a leave-on product intended for direct skin application mirror those reported in other studies, and our results
and improvement of barrier function could cause such extend those of other authors. The zealous marketing of
a response. This highlights the importance of patch/use a plethora of stoma skin care products, some of which are
testing of peristomal dermatitis patients with all of their sources of undisclosed allergens, calls for more stringent
ostomy products. regulatory approval standards and allergen labelling on
Further studies should be focused on detailing patch products. Properly trained wound ostomy and continence
test results with individual components of stoma skin nurses, patient education and timely referral to the der-
care products sourced from manufacturers. Prospective matologist are critical to avoid peristomal complications,
studies using high-performance liquid chromatogra- reduce clinic visits, and maintain good health-related
phy may also significantly improve the characterization quality of life in ostomates.
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
6 Contact Dermatitis
STOMA CARE PRODUCTS AND PERISTOMAL CONTACT DERMATITIS • CRESSEY ET AL.
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Contact Dermatitis 7