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271
J Bras Econ Saúde 2019;11(3): 271-82
ARTIGO DE OPINIÃO
OPINION ARTICLE Silicone tape versus micropore tape to prevent
medical adhesive-related skin injuries:
systematic review and meta-analysis
Fita de silicone versus fita microporosa para
prevenção de lesão cutânea relacionada a adesivos
médicos: revisão sistemática e metanálise
André Soares Santos1,2, Aline Cunha Terra1,3, José Luiz dos Santos Nogueira1,
Kenya Valéria Micaela de Souza Noronha2, Juliana de Oliveira Marcatto4,
Mônica Viegas Andrade2
DOI: 10.21115/JBES.v11.n3.p271-82
ABSTRACT
Objective: This study aims to compare the efficacy and safety of silicone tapes compared to
microporous tapes in patients with fragile skin. Methods: A systematic review of the scientific
literature was carried out. Clinical trials that compared silicone tape for medical use with the
microporous tape in preterm newborns, newborns, children, elders, or people with increased risk of
MARSI were included. This report followed the principles of the PRISMA statement. Results: Three
randomized controlled trials were included. The silicone tape was associated with fewer injuries
(RR = 0.53; p-value = 0.03), but no difference was found in terms of prevention of moderate or
severe injuries (RR = 0.25; p-value = 0.20). Silicone tapes produce significantly less edema/erythema
response than microporous tapes in children (MD = -0.42; p-value < 0.0001). The quality of evidence
was considered very low. Conclusion: The evidence suggests that silicone tapes may be gentler to
patients’ skin than microporous tapes. However, no study reported data on the outcomes of interest.
The studies have small samples, a short time horizon, and the quality of evidence was considered
very low. There is insufficient information to allow the recommendation of silicone tapes to prevent
skin injuries compared to microporous tapes.
RESUMO
Objetivo: O objetivo deste estudo é avaliar a eficácia e a segurança das fitas de silicone compa-
radas às fitas microporosas em pacientes com pele frágil. Métodos: Uma revisão sistemática da
literatura foi conduzida. Ensaios clínicos que compararam a fita de silicone para uso médico com a
fita microporosa em pacientes prematuros, neonatos, crianças, idosos ou pessoas com risco aumen-
tado de lesão por adesivos médicos foram incluídos. Esse relato seguiu os princípios do relatório
PRISMA. Resultados: Três ensaios clínicos randomizados foram incluídos. As fitas de silicone foram
associadas a menor risco de lesões (RR = 0,53; valor-p = 0,03), mas não foi observada diferença em
termos de lesões moderadas ou graves (RR = 0,25; valor-p = 0,20), e produziram significativamente
Receive d on: 03/15/2019. Approved fo r publication on: 09/29/2019.
1. Núcleo de Avaliação de Tecnologias em Saúde (NATS-HC/UFMG) – Universidade Federal de Minas Ger ais, Belo Horizonte, MG, Brazil.
2. Department of Economical Sciences – School of Economical Sciences – Universidade Federal de Minas Gerais, Belo Horizonte,
MG, Brazil.
3. Department of Applied Nursing – Nursing School – Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.
4. Department of Maternal Child Nursing – Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.
Information on aid received in the form of financing, equipment or medicines: This study was funded by the Brazilian
research promoting organizations Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq ), Instituto de Avaliação de
Tecnologias em Saúde (IATS) and Fundação de Amparo à Pesquisa do Estado de Minas G erais (Fapemig). No pharmaceutical industries
contributed with resources for this study.
Congress: This study was not yet presented in any event. It was, though, submitted to the ISPOR Latin America 2019 that
happened between September 12
th
and 14
th
in Bogota, Colombia. It is original and was not submitted to any other journal. All the
authors collaborated with the final manuscript.
Conflict of interests: The authors declare to have no conflicts of interest that could influence the results.
Corresponding author: André Soares Santos. Depar tamento de Ciências Econômicas, Faculdade de Ciências Econômic as, sala 2064,
Universidade Federal de Minas Gerais. Av. Presidente Antônio Carlos, 6627 – Pampulha, Belo Horizonte, MG, Br azil. CEP 31270-901.
Telephone: +55 (31) 99180-8788. E-mail: andresantos111@ufmg.br
Keywords:
surgical tape, skin, wounds and
injuries, biomedical technology
assessment, review
Palavras-chave:
fita cirúrgica, pele, ferimentos e
lesões, avaliação da tecnologia
biomédica, revisão
Santos AS, Terra AC, Nogueira JLS, Noronha KVMS, Marcatto JO, Andrade MV
272 J Bras Econ Saúde 2019;11(3): 271-82
Introduction
Medical adhesives are used to affix external components
to patient skin in procedures of all medical specialties. They
comprise a variety of products, such as tapes, dressings,
electrodes, and others (McNichol et al., 2013; Farris et al., 2015;
Ratliff, 2017). Medical tapes are a base that acts as a carrier
for an adhesive. The type of base and adhesive incorporated
into the tape determine its properties and performance.
Some types of adhesive are acrylates, silicones, hydrogels,
hydrocolloids, latex, and polyurethanes. A firm pressure
applied to the surface activates the adhesive by increasing
its contact area with the skin (Cutting, 2008; McNichol et
al., 2013; Ratliff, 2017). The nature of the support, whether
paper, plastic, silk, cloth, elastic, or foam, is associated with
the stretching, conformability, and stiffness of the adhesive
(Ratliff, 2017). The objective of medical tapes is to provide safe
affixation for critical and non-critical devices and products
as well as to facilitate the protection and healing of the
skin. However, cutaneous trauma related to its repetitive
application and removal is prevalent and underestimated.
These injuries are associated with pain, risk of infections,
delayed healing, decreased quality of life, and increased
treatment costs (Cutting, 2008; Konya et al., 2010; Maene,
2013; McNichol et al., 2013; Zeng et al., 2016).
A Medical Adhesive-Related Skin Injury (MARSI) is a
manifestation of cutaneous abnormality that persists for
more than 30 minutes after the removal of an adhesive
(McNichol et al., 2013; Farris et al., 2015; Zhao et al., 2018a).
Repeated or improper applications and removals, as well
as the selection of an inappropriate type of tape for a
particular location without considering the purpose or the
patient’s skin type, can cause skin injuries associated with
tapes (Maene, 2013). Some of the most common types of
adhesive-related injuries are: i. skin stripping, which occurs
when the epidermis is removed by the repeated application
and removal of the tape, denuding and wounding the skin
(Cutting, 2008; Maene, 2013; Ratliff, 2017; Zhao et al., 2018a);
ii. skin tears, which can occur by applying and removing
the tapes or by its friction in patients with fragile skin (e.g.,
older people and newborns), causing skin layers to separate
(Maene, 2013; Ratliff, 2017; Zhao et al., 2018a); iii. tension blisters,
which occur when the tape stretches the skin and, to restore
its former shape, it pulls epidermal layers (Maene, 2013; Ratliff,
2017; Zhao et al., 2018a); and iv. dermatitis, which occurs when
irritants get stuck between the skin and the adhesive (Maene,
2013; Zhao, et al., 2018a).
Several authors have studied the prevalence and incidence
of MARSIs over the years. Ratliff (2017), in a study with patients
aged 52-83 years, reported that 5.8% of them (7/120) arrived
at the clinic with medical-adhesive related wounds. In six of
seven patients, the wound was associated with the removal
of paper tapes, either by a health professional (N = 4) or by
the patient himself (N = 2) (Ratliff, 2017). Farris et al. (2 015 )
observed an average daily prevalence of MARSIs of 13% in two
care units of a US teaching hospital. This average was higher in
the group of individuals between 65 and 74 years-old (20.9%).
Regarding severity, 85.5% of the injuries were considered mild,
13.6% moderate, and 0.8% severe (Farris et al., 2015). Zhao et
al. (2018a) observed a prevalence of 19.7% of MARSI in four
tertiary hospitals in China. Mechanical lesions (5.0%, 35/697),
contact dermatitis (14.8%, 103/697), folliculitis (1.0%, 7/697) and
damage associated with moisture (1.3%, 9/697) were reported.
Among the mechanical injuries, skin tears (0.9%, N = 6), skin-
stripping (1.3%, N = 9), and tension blisters (2.4%, N = 17) were
the most common (Zhao et al., 2018b).
Fragile skins are particularly susceptible to MARSI.
Although there is no formal definition for fragile or at-risk skin,
they are usually characterized by thin skins that tear easily.
Genetic predisposition, aging, ethnicity, dermatological
conditions, other medical conditions (e.g., diabetes, infections,
renal failure, heart failure), malnutrition, dehydration,
some drugs (e.g., corticosteroids, chemotherapeutics,
immunosuppressants and anticoagulants), and sun exposure
are associated to this susceptibility (Cutting, 2008; Denyer,
2011; Grove et al., 2013; McNichol et al., 2013; Manriquez et
al., 2014; Ratliff, 2017). Older adults’ skin is thinner, contains
less fat, is less resistant to shear forces, has decreased blood
circulation, and exhibits weakened dermal-epidermal
junctions, making it more fragile and susceptible to trauma
than the skin of a healthy adult. Newborn skin is 40% to 60%
thinner than an adult skin, primarily due to the presence of
fewer layers of epidermal cells in the stratum corneum and
to the cohesion between dermis and epidermis, creating
a less efficient protection (Noonan et al., 2006; Grove et al.,
2013, 2014; Maene, 2013; McNichol et al., 2013; Ratliff, 2017).
The dermis of a premature newborn is deficient in structural
proteins, lacks the coverage of the vertex and tears easily. The
poor stratum corneum integrity increases the risk of water loss,
thermal instability, and infections (Eichenfield & Hardaway,
menos edema/eritema que fitas microporosas em crianças (MD = -0,42; valor-p < 0,0001). A quali-
dade da evidência foi considerada baixa. Conclusão: A evidência sugere que as fitas de silicone são
mais gentis à pele dos pacientes que as fitas microporosas. No entanto, nenhum estudo incluído
reportou dados sobre os desfechos de interesse. Os estudos tinham amostras pequenas, horizonte
temporal curto e qualidade de evidência muito baixa. A informação existente é insuficiente para
possibilitar a recomendação das fitas de silicone para prevenção de lesões cutâneas em compara-
ção com as fitas microporosas.
Silicone tape for patients with fragile skin
Fita de silicone para pacientes com pele frágil
273
J Bras Econ Saúde 2019;11(3): 271-82
Appendix A. Research question posed in PICO format
P - Population Patients with fragile skin
I - Intervention Silicone tape
C - Comparator Microporous tape
O - Outcomes Medical Adhesive-Related Injuries, length of inpatient stay,
incidence of infections
S - Setting Hospital
1999). Konya et al. (2010) reported an incidence of 15.5% of
tape injuries in patients older than 65 years old. Noonan
et al. (2006) observed that 8% (20/253) of the children and
infants admitted to a tertiary teaching hospital presented
skin-stripping by application and removal of adhesive tapes.
Many of these injuries were considered preventable (Noonan
et al., 2006; Chang et al., 2016).
Based on that, professionals of a teaching hospital in
Brazil requested the incorporation of a silicone adhesive
tape for patients with fragile skin. Currently, the hospital
uses microporous tapes for the fixation of sensors, probes,
and dressings. According to the applicant, the use of this
tape causes an increase in the superficial tension of the skin
with time and during the removal it favors the occurrence of
MARSIs, characterized by skin abrasion, erythema, and even
ulcerations. From the request for the incorporation of silicone
tapes, arguing that these are safer for patients and may also
be cost-effective, a systematic review was conducted to
compare silicone tapes with microporous tapes for patients
with fragile skin or at increased risk of developing MARSIs.
This assessment is in the interest of various institutions that
currently face this decision. To our knowledge, there are no
published systematic reviews that address this problem.
Methods
A systematic review of the scientific literature was carried
out to evaluate the efficacy, safety, and effectiveness of
the silicone tapes in comparison to microporous tapes in
patients with fragile skin. We included studies conducted
with premature patients, neonates, infants, children, elders,
or patients with high susceptibility to MARSI. This report
followed the principles of the PRISMA statement (Moher et
al., 2009).
Research question
Does silicone tape provide a lower risk of skin injuries or
infections and a shorter length of stay than microporous
tape when used to affix medical products to patients with
fragile skin? The research question posed in PICO format is
available in Supplementary Materials – Appendix A.
Search strategy
A systematic search of the scientific literature was conducted
in Medline (via PubMed), The Cochrane Library, and Lilacs
for epidemiological studies reporting head-to-head
comparisons between the silicone adhesive tape and the
microporous (acrylate) adhesive tape in patients at risk of
developing MARSI. An additional search was performed
on the references of included studies and Google Scholar.
Searches were conducted on August 9th, 2018, and repeated
on February 5th, 2019. References were imported to EndNote®
7.5 to remove the duplicates and then transported to
Microsoft Excel® 2013 for the selection process. Contacts were
made with the companies 3M and Parafix, to obtain more
information and references that had not been identified.
3M submitted four articles, three of which had already been
identified. The other was a survey, which was included in the
selection process. The company Parafix forwarded a booklet.
Search strategies and results by database are available in
Supplementary Materials – Appendix B.
Selection criteria
Clinical trials that compared silicone tape with microporous
tape for medical use in preterm newborns, newborns,
children, elders, or people with increased risk of MARSI
were included. The status of the elderly in Brazil includes
people aged 60 years old or more (Brasil, 2003); therefore,
this review included studies that reported the median age
of participants older than 60 years. There was no restriction
for date, language, or location restrictions. In phase 1, the
references were selected based on the title and abstract by
two independent researchers (AS and TA) and divergences
were resolved by consensus. In phase 2, the full texts were
assessed. Again, divergences were decided by consensus.
In phase 3, data were collected regarding the outcomes
indicated in the research question by one researcher (AT) and
checked by another (AS). A list of articles excluded in phase
2 with motives is available in Supplementary Materials –
Appendix C.
Data analysis
A qualitative synthesis was initially presented with the
results from the included trials. The quantitative synthesis
was constructed in Review Manager® 5.3. Since the study
populations were considered too different to aggregate
in a meta-analysis, the software was used as a convenient
way to calculate and present data extracted from the
original articles.
Santos AS, Terra AC, Nogueira JLS, Noronha KVMS, Marcatto JO, Andrade MV
274 J Bras Econ Saúde 2019;11(3): 271-82
Appendix B. Search strategies
Children, neonates, preterm
Database Strategy N
PubMed
(((((((((randomized controlled trial[Publication Type]) OR (controlled clinical trial[Publication Type]) OR
(randomized[Title/Abstract]) OR (placebo[ Title/Abstract]) OR (drug therapy[MeSH Subheading]) OR
(randomly[Title/Abstract]) OR (trial[ Title/Abstract]) OR (groups[Title/Abstract])) NOT ((animals[MeSH Terms])
NOT (humans[MeSH Terms])))) OR ((“Cohort Studies”[Mesh]) OR (cohort study) OR (studies, cohort) OR (study,
cohort) OR (concurrent studies) OR (studies, concurrent) OR (concurrent study) OR (study, concurrent) OR
(historical cohort studies) OR (studies, historical cohort) OR (cohort studies, historical) OR (cohort study,
historical) OR (historical cohort study) OR (study, historical cohort) OR (analysis, cohort) OR (analysis, cohort)
OR (cohort analyses) OR (cohort analysis) OR (closed cohort studies) OR (cohort studies, closed) OR (closed
cohort study) OR (cohort study, closed) OR (study, closed cohort) OR (studies, closed cohort) OR (incidence
studies) OR (incidence study) OR (studies, incidence) OR (study, incidence) OR (cohort studies) OR (cohort) OR
(cohort analysis) OR (cohort study) OR (prospective cohort) OR (retrospective cohort) OR (retrospective cohort
study) OR (prospective cohort study) OR (“Follow-Up Studies”[Mesh]) OR (follow up studies) OR (follow-up
study) OR (studies, follow-up) OR (study, follow-up) OR followup studies OR (followup study) OR (studies,
followup) OR (study, followup) OR (“Epidemiologic Studies”[Mesh] OR “Cross-Sectional Studies”[Mesh] OR
“Retrospective Studies”[Mesh] OR “Longitudinal Studies”[Mesh] OR “Prospective Studies”[Mesh]))) OR Case-
Control Studies[MeSH Terms]) OR Review[Publication Type])) AND (((((((((((((((((((Surgical Tape[MeSH Terms])
OR Tape, Surgical[Text Word]) OR Surgical Tapes[ Text Word]) OR Surgical Tape[ Text Word]) OR Skin Tape[Text
Word]) OR Skin Tapes[ Text Word]) OR Tape, Skin[Text Word]) OR Tapes, Skin[Text Word]) OR Adhesive Surgical
Tape[Text Word]) OR Adhesive Surgical Tapes[Text Word]) OR Surgical Tape, Adhesive[Text Word]) OR Surgical
Tapes, Adhesive[Text Word]) OR Tape, Adhesive Surgical[Text Word]) OR Tapes, Adhesive Surgical[Text Word])
OR Adhesive Tape, Surgical[Text Word]) OR Adhesive Tapes, Surgical[Text Word]) OR Surgical Adhesive
Tape[Text Word]) OR Surgical Adhesive Tapes[Text Word]) OR Tape, Surgical Adhesive[Text Word])) AND
((((((((((((((((((((((((((((((((Infant, Newborn[MeSH Terms]) OR Infant, Newborn[Text Word]) OR Infants, Newborn[Text
Word]) OR Newborn Infant[Text Word]) OR Newborn Infants[Text Word]) OR Newborns[Text Word]) OR
Newborn[Text Word]) OR Neonate[Text Word]) OR Neonates[Text Word]) OR Premature Birth[MeSH Terms]) OR
Premature Birth[Text Word]) OR Birth, Premature[Text Word]) OR Births, Premature[Text Word]) OR Premature
Births[Text Word]) OR Preterm Birth[Text Word]) OR Birth, Preterm[Text Word]) OR Births, Preterm[Text
Word]) OR Preterm Births[Text Word]) OR Infant, Premature[MeSH Terms]) OR Infants, Premature[Text
Word]) OR Premature Infant[Text Word]) OR Preterm Infants[Text Word]) OR Infant, Preterm[Text Word]) OR
Infants, Preterm[Text Word]) OR Preterm Infant[Text Word]) OR Premature Infants[Text Word]) OR Neonatal
Prematurity[Text Word]) OR Prematurity, Neonatal[Text Word])) OR Infant[MeSH Terms]) OR Infant[Text Word])
OR Infants[ Text Word])
26
The Cochrane
Library
ID Search
#3 Surgical Tap
#4 Adhesive Surgical Tapes
#5 Tape
#6 Infant, Newborn
#7 Newborn
#8 Infant
#9 Premature Birth
#10 premature
#13 #3 or #4 or #5
#15 #6 or #7 or #8 or #9 or #10
#16 #15 and #13
#17 silicone
#19 #16 and #18
9
Lilacs
(tw:((tw:(Infant, Newborn)) OR (tw:(Recém-Nascido)) OR (tw:(Recién Nacido)) OR (tw:(Newborn)) OR
(tw:(Infant, Premature )) OR (tw:(Recien Nacido Prematuro )) OR (tw:(Recém-Nascido Prematuro )) OR (tw:(Bebê
Prematuro)) OR (tw:(Pré-Termo)) OR (tw:(Prematuro)))) AND (tw:((tw:(Surgical Tape)) OR (tw:(Cinta Quirúrgica ))
OR (tw:(Fita Cirúrgica)) OR (tw:(Micropore)) OR (tw:(microporosa)) OR (tw:(Tape))))
19
Silicone tape for patients with fragile skin
Fita de silicone para pacientes com pele frágil
275
J Bras Econ Saúde 2019;11(3): 271-82
Elder
Database Strategy N
PubMed
((((((((“Cohort Studies”[Mesh]) OR (cohort study) OR (studies, cohort) OR (study, cohort) OR (concurrent
studies) OR (studies, concurrent) OR (concurrent study) OR (study, concurrent) OR (historical cohort studies)
OR (studies, historical cohort) OR (cohort studies, historical) OR (cohort study, historical) OR (historical cohort
study) OR (study, historical cohort) OR (analysis, cohort) OR (analysis, cohort) OR (cohort analyses) OR (cohort
analysis) OR (closed cohort studies) OR (cohort studies, closed) OR (closed cohort study) OR (cohort study,
closed) OR (study, closed cohort) OR (studies, closed cohort) OR (incidence studies) OR (incidence study) OR
(studies, incidence) OR (study, incidence) OR (cohort studies) OR (cohort) OR (cohort analysis) OR (cohort
study) OR (prospective cohort) OR (retrospective cohort) OR (retrospective cohort study) OR (prospective
cohort study) OR (“Follow-Up Studies”[Mesh]) OR (follow up studies) OR (follow-up study) OR (studies, follow-
up) OR (study, follow-up) OR followup studies OR (followup study) OR (studies, followup) OR (study, followup)
OR (“Epidemiologic Studies”[Mesh] OR “Cross-Sectional Studies”[Mesh] OR “Retrospective Studies”[Mesh] OR
“Longitudinal Studies”[Mesh] OR “Prospective Studies”[Mesh]))) OR (((randomized controlled trial[Publication
Type]) OR (controlled clinical trial[Publication Type]) OR (randomized[Title/Abstract]) OR (placebo[Title/
Abstract]) OR (drug therapy[MeSH Subheading]) OR (randomly[Title/Abstract]) OR (trial[Title/Abstract])
OR (groups[Title/Abstract])) NOT ((animals[MeSH Terms]) NOT (humans[MeSH Terms])))) OR Case-Control
Studies[MeSH Terms]) OR Review[Publication Type])) AND (((((((((((((((((((Frail Elderly[MeSH Terms]) OR Frail
Elderly[Text Word]) OR Elderly, Frail[Text Word]) OR Frail Elders[Text Word]) OR Elder, Frail[Text Word]) OR
Elders, Frail[Text Word]) OR Frail Elder[Text Word]) OR Functionally-Impaired Elderly[Text Word]) OR Elderly,
Functionally-Impaired[Text Word]) OR Functionally Impaired Elderly[Text Word]) OR Frail Older Adults[Text
Word]) OR Adult, Frail Older[Text Word]) OR Adults, Frail Older[Text Word]) OR Frail Older Adult[Text Word])
OR Older Adult, Frail[Text Word]) OR Older Adults, Frail[Text Word]) OR Aged[Text Word]) OR Aged[MeSH
Terms]) OR Elderly[Text Word])) AND (((((((((((((((((((Surgical Tape[MeSH Terms]) OR Tape, Surgical[Text Word]) OR
Surgical Tapes[ Text Word]) OR Surgical Tape[ Text Word]) OR Skin Tape[Text Word]) OR Skin Tapes[ Text Word])
OR Tape, Skin[Text Word]) OR Tapes, Skin[Text Word]) OR Adhesive Surgical Tape[Text Word]) OR Adhesive
Surgical Tapes[ Text Word]) OR Surgical Tape, Adhesive[Text Word]) OR Surgical Tapes, Adhesive[Text Word]) OR
Tape, Adhesive Surgical[Text Word]) OR Tapes, Adhesive Surgical[Text Word]) OR Adhesive Tape, Surgical[Text
Word]) OR Adhesive Tapes, Surgical[Text Word]) OR Surgical Adhesive Tape[Text Word]) OR Surgical Adhesive
Tapes[Text Word]) OR Tape, Surgical Adhesive[Text Word])
149
The Cochrane
Library
ID Search
#1 Frail Elderly
#2 Aged
#3 Surgical Tap
#4 Adhesive Surgical Tapes
#5 Tape
#11 elder
#12 #1 or #2 or #11
#13 #3 or #4 or #5
#14 #12 and #13
#17 silicone
#18 #14 and #17
36
Lilacs
(tw:((tw:(Aged)) OR (tw:(Anciano)) OR (tw:(Idoso)) OR (tw:(Idosa)) OR (tw:(Frail Elderly )) OR (tw:(Anciano Frágil))
OR (tw:(Idoso Fragilizado)) OR (tw:(Elder)))) AND (tw:((tw:(Surgical Tape)) OR (tw:(Cinta Quirúrgica )) OR (tw:(Fita
Cirúrgica)) OR (tw:(Micropore)) OR (tw:(microporosa)) OR (tw:(Tape))))
153
Medical Adhesive-Related Skin Injury
PubMed
(((((Adhesives) OR Adhesives[Text Word]) OR Adhesive[Text Word]) OR Tissue Adhesives[MeSH Terms])) AND
(((((((((((((((((((Degloving Injuries) OR Degloving Injuries[Text Word]) OR Degloving Injury[Text Word]) OR Injuries,
Degloving[Text Word]) OR Injury, Degloving[Text Word]) OR Skin Avulsion[Text Word]) OR Avulsion, Skin[Text
Word]) OR Avulsions, Skin[Text Word]) OR Skin Avulsions[Text Word]) OR Degloving Wounds[Text Word]) OR
Degloving Wound[Text Word]) OR Skin Avulsion Injuries[Text Word]) OR Avulsion Injuries, Skin[Text Word]) OR
Avulsion Injury, Skin[Text Word]) OR Injuries, Skin Avulsion[Text Word]) OR Injury, Skin Avulsion[Text Word]) OR
Skin Avulsion Injury[Text Word])) OR medical adhesive-related skin injury)
23
Santos AS, Terra AC, Nogueira JLS, Noronha KVMS, Marcatto JO, Andrade MV
276 J Bras Econ Saúde 2019;11(3): 271-82
The Cochrane
Library
ID Search
#1 Adhesives
#2 Tissue Adhesives
#3 Adhesive$
#4 #1 or #2 or #3
#5 medical adhesive-related skin injury
#6 Degloving Injuries
#7 Skin Avulsion
#8 Skin Avulsion Injuries
#9 #6 OR #7 OR #8 OR #5
#10 #4 and #9
6
Lilacs (tw:(adhesive*)) AND (tw:((tw:(medical adhesive-related skin injury)) OR (tw:((tw:(Degloving Injur*)) OR
(tw:(Skin Avulsion Injury)) OR (tw:(Skin Avulsion*)))))) 1
Contributions from the producer companies 4
Snowballing 2
Total 428
Total after duplicate removal 411
References in the second phase 13
Included references 3
Appendix C. List of excluded studies in the second phase of the selection process
Study Motive
Anderson A, Foster RS, Brand R, Blyth CC, Kotecha RS. Acute Onset of Pustules at the Site of Tape
Placement in an Immunocompromised Infant with Acute Myeloid Leukemia. Pediatr Dermatol.
2014;31:609–610.
Study Design
Cutting KF. Impact of adhesive surgical tape and wound dressings on the skin, with reference to
skin stripping. J Wound Care 2008; 17: 157-62.
Study Design
Denyer J: Reducing pain during the removal of adhesive and adherent
products.Br J Nurs. 2011, 20:S28. S30-S35.
Study Design
Farris MK , Petty M , Hamilton J , Walters SA , Flynn MA . Medical adhesive related skin injury among
adult acute care patients: a single-center observational study . J Wound Ostomy Continence Nurs.
2015;42(6):589-598.
Intervention
Maene, B. Hidden costs of medical tape-induced skin injuries. Wounds UK, v. 9, n. 1, p. 46–50, 2013. Study Design
Manriquez B.; Smith, G., S. . L. et al. Evaluation of a new silicone adhesive tape among clinicians caring for
patients with fragile or at-risk skin. Adv Skin Wound Care, v. 27, n. 4, p. 163–170, abr. 2014.
Study Design
Ratliff, C. R. Descriptive study of the frequency of medical adhesive-related skin injuries in a vascular
clinic. J Vasc Nurs, v. 35, n. 2, p. 86–89, 2017.
Intervention
Zhao, H. et al. Medical Adhesive–Related Skin Injury Prevalence at the Peripherally Inserted Central
Catheter Insertion Site. Journal of Wound, Ostomy and Continence Nursing, v. 45, n. 1, p. 22–25, 2018a.
Intervention
Zhao, H. et al. Prevalence of medical adhesive-related skin injury at peripherally inserted central catheter
insertion site in oncology patients. The Journal of Vascular Access, v. 19, n. 1, p. 23–27, 19 jan. 2018b.
Intervention
Breternitz M, Flach M, Prässler J, Elsner P, Fluhr JW. Acute barrier disruption by adhesive tapes is
influenced by pressure, time and anatomical location: integrity and cohesion assessed by sequential
tape stripping. A randomized, controlled study. Br J Dermatol. 2007 Feb;156(2):231-40.
Intervention
Silicone tape for patients with fragile skin
Fita de silicone para pacientes com pele frágil
277
J Bras Econ Saúde 2019;11(3): 271-82
Figure 1. Study flow diagram.
Quality assessment
To evaluate the methodological quality of the studies, the
Cochrane Collaboration Risk of Bias Scale for randomized
clinical trials was applied (Higgins & Green, 2011). The Grading
of Recommendations Assessment, Development and
Evaluation (GRADE) system was used to evaluate the level of
evidence and strength of recommendation. The quality of
the evidence was classified into four levels: high, moderate,
low, and very low (Guyatt et al., 2008c; Guyatt et al., 2008a;
Guyatt et al., 2008b; Guyatt et al., 2008d; Higgins & Green,
2011; Brasil, 2014; Toma et al., 2017 ).
Results
Study selection
Four hundred eleven references were included in the
selection process after duplicate removal. In the first
phase, 398 of these were excluded by title and abstract.
The concordance rate among the reviewers in the first phase
was higher than 0.96. Of the 13 references evaluated in the
second phase, only three randomized controlled trials were
included (Figure 1). The study by Grove et al. (2014) eval uated
the effect of silicone tapes and microporous tape in infants
and children. We included the study by Grove et al. (2013)
because it comprised patients older than 55 years, and the
median age was 63 years, although they were healthy. Also, we
included the study by Zeng et al. (2016) because it comprised
patients at risk of developing MARSIs. The median age in this
study was 62 and 63.5 years for the populations randomized
to the silicone and acrylate tapes, respectively. The general
characteristics and main results of the included studies are
available in Supplementary Materials – Appendix D.
Qualitative analysis
The studies showed a statistically significant difference in
skin-stripping favoring the silicone tape (Grove et al., 2013,
2014; Zeng et al., 2016). Two of the three studies showed no
significant difference between tapes on the formation of
erythema and edema (Grove et al., 2013; Zeng et al., 2016). This
difference was only observed in infants and children (Grove
et al., 2014). The difference in pain and discomfort during
tape removal was significant in two studies (Grove et al.,
2014; Zeng et al., 2016). One study demonstrated less keratin
removal with silicone tape (Grove et al., 2014), and another, by
the same author and funder, showed less transdermal water
loss with silicone tape (Grove et al., 2013). Only one of the
studies showed a significant patient preference for silicone
tape (Zeng et al., 2016).
All three studies showed data suggesting a difference in
efficacy between the two types of tapes but did not include
this data in the analyzes. Two studies reported the loss of
tapes (Grove et al., 2013, 2014). In one, four silicone tapes and
no microporous tape were lost (Grove et al., 2014). In another,
the author suggests that situations where the tape area might
422 records identified through
database searching
PubMed = 198
The Cochane Library = 51
Lilacs = 173
6 additional records identified
through other sources
3M = 4
Google Scholar = 0
Snowballing = 2
411 records after
duplicates removed
411 records screened
13 full-text articles
assessed for eligibility
3 studies included in
qualitative synthesis
3 studies included in
quantitative synthesis
(meta-analysis)
10 full-text articles
excluded for:
Study type (5)
Intervention (5)
398 records excluded for:
Population (85)
Intervention (221)
Outcome (1)
Study design (87)
Comparator (2)
Other duplicates (2)
get exposed to moisture or secretions are not suitable for
the use of silicone tape (Zeng et al., 2016). One study reports
that the edge lifts were significantly more common with the
silicone tape (Grove et al., 2014). None of the studies reported
the relative risk of total injuries, severe or moderate injuries,
and infections, and the difference in length of hospital stay
between the silicone tape and the microporous tape.
Santos AS, Terra AC, Nogueira JLS, Noronha KVMS, Marcatto JO, Andrade MV
278 J Bras Econ Saúde 2019;11(3): 271-82
Appendix D. General Characteristics of included studies
Study Grove et al., 2013
General characteristics Objectives: To compare gentleness of a silicone tape to a microporous tape.
Methods: Daily placement and removal of tapes, except for weekends, in 2 of 3 loci in the forearm.
Population: Healthy volunteers with I, II or III Fitzpatrick skin types.
N = 28
Age: 55 or older (average: 63 years-old)
Time horizon: 11 days
Limitations: Data collected from healthy individuals.
Safety Erythema/Edema
Silicone tape: day 1 – 0.60; day 4 – 0.82; day 7 – 0.90; day 11 – 0.94. P-value<0.001e
Paper tape: day 1 – 0.73; day 4 – 0.80; day 7 – 0.97; day 11 – 1.16. P-value<0.001e
Control: day 1 – 0; day 4 – 0.02; day 7 – 0.05; day 11 – 0.13.
Skin stripping
Silicone tape: day 1 – 0; day 4 – 0.02; day 7 – 0.08; day 11 – 0.13
Microporous tape: day 1 – 0.06; day 4 – 0.39; day 7 – 0.51; day 11 – 1.
Control: day 1 – 0; day 4 – 0; day 7 – 0; day 11 – 0.01.
Study Grove et al., 2014
General characteristics Objectives: To compare gentleness of a silicone tape to a microporous tape in healthy children and babies.
Methods: One placement and removal of tapes 24-hours later.
Population: Healthy children with I, II or III Fitzpatrick skin type.
N = 24
Age: 6 to 48 months
Sex: 13 females/11 males
Time horizon: 24 hours
Limitations: Data from healthy children; single placement and removal of tapes.
Efficacy Loss of tapes
Silicone tape: 4
Microporous tape: 0
Safety Erythema/Edema
Silicone tape: 0.93 ± 0.14
Microporous tape: 1.35 ± 0.11
P-value = 0.0129
Skin stripping
Silicone tape: 0.00
Microporous tape: 0.29 ± 0.11
P-value = 0.0039
Discomfort
Silicone tape: 0.5
Microporous tape: 3.3
P-value = 0.0002
Keratin removal
Silicone tape: 8.7 ± 0.5
Microporous tape: 15.7 ± 1.3
P-value < 0.0001
Study Zeng et al., 2016
General characteristics Objectives: To compare the incidence of skin injuries and patient satisfaction of two medical tapes.
Methods: Placement and removal of tapes during surgery.
Population: Patients with elective surgery planned, under general anesthesia, using endotracheal tube.
N = 60
Age: median = 62 and 63.5 years-old for silicone and acrylate tapes, respectively.
Interventions: Silicone tape vs. Microporous tape
Time horizon: 6 months
Limitations: Single placement and removal; lack of standard method to place and remove tapes.
Efficacy Loss of tapes
Silicone tape: 1
Microporous tape: 2
Silicone tape for patients with fragile skin
Fita de silicone para pacientes com pele frágil
279
J Bras Econ Saúde 2019;11(3): 271-82
Safety Erythema/Edema
Silicone tape: 33%
None - 20
Mild - 9
Moderate - 1
Severe - 0
Extreme - 0
Microporous tape: 50%
None - 15
Mild - 12
Moderate - 2
Severe - 1
Extreme - 0
Skin stripping
Silicone tape: 0%
None - 30
Mild - 0
Moderate - 0
Severe - 0
Extreme - 0
Microporous tape: 1.3%
None - 26
Mild - 3
Moderate - 1
Severe - 0
Extreme - 0
Satisfaction
Eyelid tape
Silicone tape: 4.53 (0.51).
Microporous tape: 3.83 (0.69).
P-value < 0.001
Face tape
Silicone tape: 4.57 (0.50).
Microporous tape: 3.87 (0.70).
P-value < 0.001
aSignificantly different than control; bSignificantly different than control; cSignificantly different than silicone tape; dSignificantly dif ferent than silicone tape; eSignifi-
cantly dif ferent than untreated control.
Quantitative analysis
The data quantitatively assessed suggest that the silicone
tapes are associated to less MARSIs (RR = 0.53; 95% CI =
0.30 to 0.94; p-value = 0.03; 1 study; Figure 2). No significant
difference was demonstrated in terms of prevention of
moderate or severe injuries, probably due to small sample
sizes and number of events (RR = 0.25; 95% CI = 0.03 to
2.11; p-value = 0.20; 1 study; Figure 3). Silicone tapes
produce significantly less edema/erythema response than
microporous tapes in children (MD = -0.42; 95% CI = -0.60
to –0.24; p-value < 0.0001; 1 study; Figure 4), but not in
adults [MD = -0.13; 95% CI = -0.94 to 0.68; p-value = 0.75;
1 study (Grove et al., 2013)]. No significant difference in
preference for each tape were demonstrated considering
children’s parents [RR = 1.30; 95% CI = 0.71 to 2.37; p-value
= 0.39; 1 study (Grove et al., 2014)] or adult patients [RR =
2.40; 95% CI = 0.90 to 5.88; p-value = 0.06; 1 study (Grove
et al., 2013)]. Patient satisfaction score was higher for the
silicone tape than microporous tape, though [EYELIDS: MD
= 0.70; 95% CI = 0.39 to 1.01; p-value < 0.0001; 1 study; FACE:
MD = 0.70; 95% CI = 0.39 to 1.01; p-value < 0.0001; 1 study
(Zeng et al., 2016)].
Figure 2. Incidence of injuries on patients with fragile skin.
Favours [Silicone tape] Favours [Micropore]
0.01 0.1 1 10 100
Risk Ratio
M-H, Fixed, 95% CI
Risk Ratio
M-H, Fixed, 95% CIWeightTotalEvents
Events
Silicone tape
Study or subgroup
Zeng et al. 2016
Total (95% CI)
Total events
30 30
10
10
30 19
19
30 100.0%
100.0%
0.53 [0.30, 0.94]
0.53 [0.30, 0.94]
Micropore
Total
Heterogeneity: Not applicable
Test for overall eect: Z = 2.19 (P = 0.03)
Santos AS, Terra AC, Nogueira JLS, Noronha KVMS, Marcatto JO, Andrade MV
280 J Bras Econ Saúde 2019;11(3): 271-82
Figure 3. Incidence of moderate or severe skin injuries in patients with fragile skin.
Figure 4. Erythema and edema response to a single application and removal of tapes in patients with fragile skin.
Figure 5. Risk of bias of included studies.
Favours [Silicone tape] Favours [Micropore]
0.01 0.1 1 10 100
Risk Ratio
M-H, Fixed, 95% CI
Risk Ratio
M-H, Fixed, 95% CIWeightTotalEvents
Events
Silicone tape
Study or subgroup
Zeng et al. 2016
Total (95% CI)
Total events
30 30
1
1
30 4
4
30 100.0%
100.0%
0.25 [0.03, 2.11]
0.25 [0.03, 2.11]
Micropore
Total
Heterogeneity: Not applicable
Test for overall eect: Z = 1.27 (P = 0.20)
Favours [Silicone tape] Favours [Micropore]
-0.5 0
-0.25 0.25 0.5
Mean Dierence
IV, Random, 95% CI
Mean Dierence
IV, Random, 95% CIWeightTotalMean
Mean
Silicone tape
Study or subgroup
Grove et al. 2014
Total (95% CI)
Total events
20 24
0.93
SD
0.3352
SD
0.275220 1.35 24 100.0%
100.0%
-0.42 [-0.60, -0.24]
-0.42 [-0.60, -0.24]
Micropore
Total
Heterogeneity: Not applicable
Test for overall eect: Z = 4.48 (P < 0.00001)
Quality assessment
In general, we found low risk of bias for random sequence
generation and incomplete outcome data. Still, a high risk
of bias for the masking of participants, personnel, and data
assessors, and selective reporting were observed. Two of the
three studies were funded by 3M (Grove et al., 2013, 2014),
producer of the 3M™ Kind Removal Silicone Tape, and the
other did not report sources of funding (Zeng et al., 2016)
(Figure 5). The quality assessment of the evidence and the
recommendation strength through GRADE indicated that the
level of evidence is very low and that the recommendation
is weak in favor of the technology for all assessed outcomes
(Supplementary Materials – Appendix E).
Grove et al., 2013
Grove et al., 2014
Grove et al., 2016
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
+ + –
–
–? ? ?
?
?
–
– –
–+ +
+
++
+ +
Discussion
This systematic review presented data that do not conclusively
demonstrate the efficacy and safety advantages of silicones
tapes compared to microporous tapes when used to affix
materials in patients with fragile skin or high-risk of injury.
Notably, there appears to be some advantage for the silicone
tape in terms of safety, but this was not demonstrated with
outcomes of interest such as the relative risk of injury and
severe injury, infections, length of hospital stay, sepsis, or even
mortality. Although the silicone tape shows significant results
for some of the outcomes presented (e.g., skin-stripping,
transepidermal water loss, and keratin removal from the skin),
the clinical significance of the findings is uncertain.
In December 2012, a group of 23 experts was assembled
to develop a consensus on the assessment, prevention, and
treatment of MARSIs. This meeting was funded by 3M. The
consensus recommended the use of silicone tapes, based on
evidence that silicone adhesives are associated with a lower
rate of skin injuries because of their properties. Some of the
presented advantages of these products were: lower surface
tension and constant adhesion in time, which generate a lower
risk of skin-stripping; less propensity to remove epidermal
cells; less discomfort during removal; and the fact that they are
repositionable. But they alert caution in attaching it to some
materials (e.g., silicone, plastic), and tubes because of the risk of
tape losses (McNichol et al., 2013). This consensus predates the
publication of the clinical trials included in this review.
Cutting (2008) conducted a review focusing on the
occurrence of injuries associated with surgical tapes and
dressings and their possible impact on patients, especially
the elderly and patients with skin fragility. According to the
author, the removal of acrylate, hydrocolloid, polyurethane,
Silicone tape for patients with fragile skin
Fita de silicone para pacientes com pele frágil
281
J Bras Econ Saúde 2019;11(3): 271-82
Appendix E. GRADE assessment of outcomes
Outcome
Number of studies
Risk of bias
Inconsistency
Indirectness
Imprecision
Clinically relevant outcomes?
Great magnitude of eect?
Confounder that favors the intervention?
Dose-response gradient?
Conicts of interest declared?
Quality of evidence
Strength of recommendation
Incidence of injuries 1 - + - - + + + - + Very
Low
↑?
Incidence of moderate/severe injuries 1 - + - - + + + - + Very
Low
↑?
Severity of edema/erythema after a
single application/removal of the tape
2 - + - - + - + - + Very
Low
↑?
Severity of skin stripping after a single
application and removal of the tape
2 - + - - + - + - + Very
Low
↑?
Preference for each tape 2 - + - - - - + - + Very
Low
↑?
Satisfaction with each tape 1 - + - - - + + - + Very
Low
↑?
and zinc oxide adhesives can cause trauma and pain, while
silicone adhesives provide a safe and effective level of
adhesion that, unlike acrylates, does not increase over time.
The author makes a strong recommendation for silicone
adhesives since, according to him, it has been shown that
its removal is atraumatic and painless in curative studies in
children, neonates, and adults with a variety of injuries and
skin problems (Cutting, 2008). The pain and discomfort
data were consistent with the findings of this review;
however, this outcome is not adequate for the evaluation
of the incorporation of the silicone tapes, as it has not been
demonstrated that this pain and discomfort are clinically
significant in any of the included studies.
There is a patients’ preference for silicone tapes compared
to acrylate tapes reported in one study (Zeng et al., 2016). From
another perspective, Manriquez et al. (2014) evaluated the
satisfaction of clinical professionals with the adhesive tapes
used in their work environment. They found that 92% (N =
196/213) of the respondents preferred to use silicone tape, and
90.2% (N = 184/204) would be willing to change the tape they
use for the silicone ones. Most respondents said they had no
problem with the use of silicone tape (75.1%, N = 185). Of those
who reported problems, the most commons were sliding
[N = 33 (40.7%)] and low initial adherence [N = 25 (30.9%)].
Some professionals reported skin irritation or injury [N = 13
(16.0%)]. Silicone tapes were considered better or much better
compared to the tapes used by the professionals on issues of
skin irritation, pain on removal, initial adhesion to dry skin, good
adherence to gauze and tubes, and total performance, among
other aspects. This study was not comparative, randomized, or
blinded and it was also funded by 3M (Manriquez et al., 2014).
The outcomes found in the included studies are inadequate
to support decision making. They are typically intermediate
outcomes with poor linkage to outcomes, such as transepidermal
water loss, skin-stripping, keratin removal, pain, user satisfaction,
and professional preference. In general, the sample sizes and
time horizons were small, and two of the three studies were
conducted in healthy individuals. The population of infants
and children showed a statistically significant difference in the
occurrence of edema and erythema, unlike other populations,
which is possibly associated with the greater fragility of the skin
of these patients. None of the studies selected a population
of preterm neonates, limiting the use of these data for this
particular decision (Grove et al., 2013, 2014). The quality of the
included studies was low, the level of evidence was also very
low, and the strength of recommendation was weak regarding
the technology. The relative risk of injury was not reported in
the studies, so it had to be estimated from the study by Zeng
et al. (2016), in which the skin injuries were evaluated in patients
undergoing surgery under general anesthesia. Data from a
single application and removal has minimal importance for
assessing a scenario of real-world hospitalization. The difference
Santos AS, Terra AC, Nogueira JLS, Noronha KVMS, Marcatto JO, Andrade MV
282 J Bras Econ Saúde 2019;11(3): 271-82
in the populations and data presentation between trials did not
allow data to be aggregated in a meta-analysis.
Conclusion
The evidence suggests that silicone tapes may be gentler to
patients’ skin than microporous tapes. However, the studies
were not conducted with a population of interest, and the
outcomes are not ideal for decision making. No data have
been found to justify the argument that silicone tapes reduce
infections, sepsis, or risk of death. The studies have very few
participants, a short time horizon, and the quality of evidence
is very low. Some consensuses recommend the use of silicone
tapes to avoid injury, but 3M funded these. In conclusion, there
is insufficient information to allow the recommendation of
silicone tapes to prevent skin injuries compared to microporous
tapes. Larger, longer, and methodologically better studies are
necessary to demonstrate the suggested advantage.
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