4.3 Delivery phase and Prototyping
The first part was delivered consisting of a medical silicone sheet, with dimensions of 8.5 x 5.5 cm, and thickness of 3 to 4 mm (Figure 1). It was affixed underneath the fixed bulkhead of the second part. The spring was made of Eastman Tritan (modulus of elasticity of 1.55x109 Pa) (Figure 2 and Table 2).
The final parameters of the spring (and of the entire compression system) to obey the therapeutic limits were the thickness of 14mm, diameter of 76.2mm, width of 20mm and length of 60mm, in which the spring 6b (highlighted in table 2) has been chosen.
The third part was delivered composed of synthetic material in elastic mesh, with an adhesive resin plate in all its surroundings (Figure 3). Thus, as the mesh was stretched over the second part, force was exerted on the compressor mechanism, generating pressure on the skin and scarring. When the maximum deflection of the spring was reached, the surrounding peripheral region was attached to the patient’s skin.
5. Discussion
The proposal of the present study originated from a need observed in clinical practice for the treatment of fibroproliferative scars, with emphasis on the keloid. The treatment of this scar is currently with multifactorial therapies, aiming to deal with its various morphophysiological aspects. In this sense, the literature corroborates the association of therapeutics (Berman et al., 2017; Ogawa, 2010).
Keloid compression is an indispensable tactic in the therapeutic arsenal. There are several options of devices for this purpose, but, only for keloids located in the ear. The use of these devices, as an adjuvant therapy, have been associated with decreasing the rate of relapse after surgical resection (Ogawa et al., 2013; Rathee et al., 2014; Tanaydin et al., 2016; Thierauf et al., 2017). Unfortunately, for other topographies, especially in the anterior thorax, a high prevalence site, there are no particular devices for compression therapy (Atiyeh et al., 2013; Macintyre & Baird, 2006).
Friedstat and Hultman (Friedstat & Hultman, 2014) published a systematic review, which included four articles with 234 patients regarding the use of compressive garment, and three articles with 226 patients with the association of the same clothing and silicone sheets. The authors reported conflicting results in isolated and polymer-associated compression therapy. They concluded that, although fibroproliferative scars are a common occurrence in burn patients, both the number of studies and their therapeutic consensus are limited. Better quality studies are therefore needed, specifically for the use of compression, silicone alone and in combination. Thus, the standardization of a clinical trial, using a standard compressor device could, in theory, minimize bias and elucidate many questions of this therapy.
The meta-analysis published by Anzarut (Anzarut, Olson, Singh, Rowe, & Tredget, 2009) concluded that compression therapy with compression garments did not alter the general characteristics of burn scars. It improved its height, although this result was of questionable clinical importance. The effects of compression therapy remained unproven, while the potential morbidity and cost were relevant points. The authors concluded that the current evidence lacks additional research to examine the efficacy compression therapy. In clinical practice, physical improvements are also observed and also reported by patients. For these reasons, the use of a proper keloid compression device would standardize therapy and improve the quality of scientific evidence.
The magnitude of the pressure on the scar is crucial in compression therapy (Friedstat & Hultman, 2014). Firstly, too much pressure on the keloid could cause tissue ischemia and, consequently, necrosis and a critical wound (Atiyeh et al., 2013). A wound in a pathological scar is a disastrous complication. Moreover, this lesion could evolve unfavorably with infection, healed by second intention and, consequently, present recurrence and aggravate the local tissue inflammation (Berman et al., 2017). On the other hand, low pressure is inefficient (Atiyeh et al., 2013). Second, the maintenance time of the compression is also relevant. There is preference for long periods, between 08 to 12 hours, uninterrupted, daily, for months in a row (Macintyre & Baird, 2006). These characteristics were relevant in the decisions taken during the brainstorming for the standardization and prototyping of the device developed.
Thus, the present device is an alternative for pressure therapy on keloid scars, with the exception of the ear. Similar to devices used in the ear, which have a mechanism to exert the scar compression; and, unlike those for the treatment of burn scars that uses compressive garments; the device presented showed the benefits of both situations. It is easy to apply, simple, lightweight and discreet. The design thinking methodology helped to understand patients’ needs to address the long-term treatment of their scars, allowing after various brainstorming, experimentation, and prototyping to validate the final device.
Finally, the developed device has the potential to increase access and improve the treatment of patients with keloid. There is simplification of the therapeutic procedure, associating the necessary materials to its integral practice. This could help to reduce costs and the adoption of new technologies brings better quality to the patient.
6. Conclusion
A device for keloid pressure therapy was developed and prototyped using the Design Thinking methodology.
Acknowledgement
We thank the Universidade Federal de São Paulo, its Center for Innovation and Technology, and the Postgraduate Program for encouraging research and innovation.
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