1. Introduction
Keloid is a pathological fibroproliferative scar and represents a
challenge in wound care (Jumper, Paus, & Bayat, 2015; Ogawa, 2011;
Ogawa, Akaishi, Kuribayashi, & Miyashita, 2016). In clinical practice,
it is mainly characterized by intense pruritus, pain and scar hyperemia
(Berman, Maderal, & Raphael, 2017). Also, it has an exuberant
progressive vertical (elevation in relation to the skin plane) and
horizontal growths (expansion on the skin) beyond the original wound
boundaries, similar to a benign neoplasia (Ferreira, Gragnani, Furtado,
& Hochman, 2009). It does not regress spontaneously and it is exclusive
of healing in humans (Ramos, Gragnani, & Ferreira, 2008). It has been
associated with increased psychology morbidity and anxiety (Furtado et
al., 2011), resulting in low self-esteem and body image disorder,
especially if it is present in socially exposed areas.
It does not have a definitive treatment due to the incomplete knowledge
of its etiology. On the other hand, some therapeutics directed at its
known risk factors alleviates clinical symptoms and remodel macro and
microscopic aspects of the pathological scar mainly by reducing the
local inflammatory intensity (Chang, Deng, Yeong, Wu, & Yeh, 2008). One
of these therapeutics is the compression therapy on the scar tissue
(Stella, Castagnoli, & Gangemi, 2008).
Currently, the literature is not yet conclusive in determining the value
or range of values for safe and effective compressive therapy (Atiyeh,
El Khatib, & Dibo, 2013; Macintyre & Baird, 2006), as well as the
period and routine of use. The pressure exerted on the tissue should not
exceed the limit of 28 to 32 mmHg, referring to the arterial capillary
pressure of the skin, avoiding local ischemia (Sharp, Pan, Yakuboff, &
Rothchild, 2016). The compression is then indicated to be used
continuously for at least 12 to 23 hours a day, removing it only for
hygiene and laundry purposes (compression garments), for the period
followed from 06 to 12 months (Macintyre & Baird, 2006; Stella et al.,
2008). The compression therapy can be associated with silicone sheets
(BERMAN et al., 2007; Van den Kerckhove et al., 2001). This association
aims to complement the mechanical action of compression, contemplating
the physical and chemical characteristics of the scar tissue and skin
(Hassel, Löser, Koenen, Kreuter, & Hassel, 2011; Sharp et al., 2016).
Although the mechanism of action of silicone on healing is still
unclear, a number of explanations are proposed, notably increased local
temperature (Musgrave, Umraw, Fish, Gomez, & Cartotto, n.d.), improved
tissue hydration (Branagan, Chenery, & Nicholson, 2000; Suetake, Sasai,
Zhen, & Tagami, 2000), increased oxygen tension and the polarization of
the scar tissue caused by the negative static electric charge generated
by the movement of the silicone (Hirshowitz et al., 1998; O’Brien &
Jones, 2013).
Compression therapy is expensive because the garment is usually
tailor-made and must be replaced as it is worn by the patient’s growth,
loss or weight gain (Macintyre & Baird, 2006). Moreover, clothing is
uncomfortable, added to daily and continuous use, which diminishes its
adhesion in the medium and long terms (Macintyre & Baird, 2006).
Innovation is a perceived and considerable value in the task of creating
relevant solutions focused on the needs of others. These solutions are
developed based on the difficulties and problems exhibited by patients
in outpatient clinical practice. Design Thinking is a methodological
tool capable of addressing the needs observed in patients during
clinical practice, under a human-centered thinking model. Design
Thinking is based on three main pillars, Empathy, Collaboration and
Experimentation (Ferreira, Song, Gomes, Garcia, & Ferreira, 2015).
Several devices exist and are marketed exclusively for the purpose of
compressing scars on the ears, especially for the ear lobes (Chamaria,
De Sousa, Aras, & Mascarenhas, 2016; Rathee, Kundu, & Tamrakar, 2014).
However, keloid at other high prevalent topographies such as the
anterior thoracic, the back, deltoid regions, face, abdomen and limbs,
could also benefit from compressive therapy. To date, a specific device
for keloid compression, similar to those for the ear, is unknown without
the use of compressive garment and other associated products.
2. Objective
To develop and prototype a device to apply compression on keloid using
design thinking methodology.
3. Materials and Methods
3.1. Anteriority Search
A search in Medline database was performed using descriptors and terms
defined in the Medical Subject Headings (MeSH). The keywords used,
including their derivatives (singular and plural) were: