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.
References
Anzarut, A., Olson, J., Singh, P., Rowe, B. H., & Tredget, E. E.
(2009). The effectiveness of pressure garment therapy for the prevention
of abnormal scarring after burn injury: a meta-analysis. Journal
of Plastic, Reconstructive & Aesthetic Surgery , 62 (1), 77–84.
doi:10.1016/j.bjps.2007.10.052
Atiyeh, B. S., El Khatib, A. M., & Dibo, S. A. (2013). Pressure garment
therapy (PGT) of burn scars: evidence-based efficacy. Annals of
Burns and Fire Disasters , 26 (4), 205–212. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/24799851
Berman, B., Maderal, A., & Raphael, B. (2017). Keloids and Hypertrophic
Scars. Dermatologic Surgery , 43 , S3–S18.
doi:10.1097/DSS.0000000000000819
BERMAN, B., PEREZ, O. A., KONDA, S., KOHUT, B. E., VIERA, M. H.,
DELGADO, S., … LI, Q. (2007). A Review of the Biologic Effects,
Clinical Efficacy, and Safety of Silicone Elastomer Sheeting for
Hypertrophic and Keloid Scar Treatment and Management.Dermatologic Surgery , 33 (11), 1291–1303.
doi:10.1111/j.1524-4725.2007.33280.x
Branagan, M., Chenery, D. H., & Nicholson, S. (2000). Use of infrared
attenuated total reflectance spectroscopy for the in vivo measurement of
hydration level and silicone distribution in the stratum corneum
following skin coverage by polymeric dressings. Skin Pharmacology
and Applied Skin Physiology , 13 (3–4), 157–164.
doi:10.1159/000029921
Chamaria, A., De Sousa, R. F., Aras, M. A., & Mascarenhas, K. (2016).
Surgical excision and contoured custom made splint to treat helical
keloid. Indian Journal of Plastic Surgery : Official Publication
of the Association of Plastic Surgeons of India , 49 (3),
410–414. doi:10.4103/0970-0358.197250
Chang, L.-W., Deng, W.-P., Yeong, E.-K., Wu, C.-Y., & Yeh, S.-W.
(2008). Pressure Effects on the Growth of Human Scar Fibroblasts.Journal of Burn Care & Research , 29 (5), 835–841.
doi:10.1097/BCR.0b013e3181848c1c
Ferreira, F. K., Song, E. H., Gomes, H., Garcia, E. B., & Ferreira, L.
M. (2015). New mindset in scientific method in the health field: Design
Thinking. Clinics (Sao Paulo, Brazil) , 70 (12), 770–772.
doi:10.6061/clinics/2015(12)01
Ferreira, L. M., Gragnani, A., Furtado, F., & Hochman, B. (2009).
Control of the skin scarring response. Anais Da Academia
Brasileira de Ciencias , 81 (3), 623–629. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/19722029
Friedstat, J. S., & Hultman, C. S. (2014). Hypertrophic Burn Scar
Management. Annals of Plastic Surgery , 72 (6), S198–S201.
doi:10.1097/SAP.0000000000000103
Furtado, F., Hochman, B., Ferrara, S. F., Dini, G. M., Nunes, J. M. C.,
Juliano, Y., & Ferreira, L. M. (n.d.). What factors affect the quality
of life of patients with keloids? Revista Da Associacao Medica
Brasileira (1992) , 55 (6), 700–704. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/20191224
Ghassemi, P., Shupp, J. W., Travis, T. E., Gravunder, A. J., Moffatt, L.
T., & Ramella-Roman, J. C. (2015). A portable automatic pressure
delivery system for scar compression therapy in large animals. The
Review of Scientific Instruments , 86 (1), 015101.
doi:10.1063/1.4904842
Hassel, J. C., Löser, C., Koenen, W., Kreuter, A., & Hassel, A. J.
(2011). Promising results from a pilot study on compression treatment of
ear keloids. Journal of Cutaneous Medicine and Surgery ,15 (3), 130–136. doi:10.2310/7750.2011.10015
Hirshowitz, B., Lindenbaum, E., Har-Shai, Y., Feitelberg, L., Tendler,
M., & Katz, D. (1998). Static-electric field induction by a silicone
cushion for the treatment of hypertrophic and keloid scars.Plastic and Reconstructive Surgery , 101 (5), 1173–1183.
Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/9529199
Jumper, N., Paus, R., & Bayat, A. (2015). Functional histopathology of
keloid disease. Histology and Histopathology , 30 (9),
1033–1057. doi:10.14670/HH-11-624
Keller, K., Krenzer-Scheidemantel, G., & Meyer, T. (2011).
Systematische Analyse des Kompressionsdruckes in der
Kompressionstherapie zur Narbenbehandlung im Kindesalter mittels des
Kikuhime®-Drucksensors. Zentralblatt Für Chirurgie - Zeitschrift
Für Allgemeine, Viszeral-, Thorax- Und Gefäßchirurgie , 139 (06),
638–642. doi:10.1055/s-0031-1271362
Macintyre, L., & Baird, M. (2006). Pressure garments for use in the
treatment of hypertrophic scars–a review of the problems associated
with their use. Burns : Journal of the International Society for
Burn Injuries , 32 (1), 10–15. doi:10.1016/j.burns.2004.06.018
Musgrave, M. A., Umraw, N., Fish, J. S., Gomez, M., & Cartotto, R. C.
(n.d.). The effect of silicone gel sheets on perfusion of hypertrophic
burn scars. The Journal of Burn Care & Rehabilitation ,23 (3), 208–214. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/12032371
O’Brien, L., & Jones, D. J. (2013). Silicone gel sheeting for
preventing and treating hypertrophic and keloid scars. Cochrane
Database of Systematic Reviews , (9), CD003826.
doi:10.1002/14651858.CD003826.pub3
Ogawa, R. (2010). The Most Current Algorithms for the Treatment and
Prevention of Hypertrophic Scars and Keloids. Plastic and
Reconstructive Surgery , 125 (2), 557–568.
doi:10.1097/PRS.0b013e3181c82dd5
Ogawa, R. (2011). Mechanobiology of scarring. Wound Repair and
Regeneration : Official Publication of the Wound Healing Society
[and] the European Tissue Repair Society , 19 Suppl 1 , s2-9.
doi:10.1111/j.1524-475X.2011.00707.x
Ogawa, R., Akaishi, S., Kuribayashi, S., & Miyashita, T. (2016).
Keloids and Hypertrophic Scars Can Now Be Cured Completely: Recent
Progress in Our Understanding of the Pathogenesis of Keloids and
Hypertrophic Scars and the Most Promising Current Therapeutic Strategy.Journal of Nippon Medical School = Nippon Ika Daigaku Zasshi ,83 (2), 46–53. doi:10.1272/jnms.83.46
Ogawa, R., Huang, C., Akaishi, S., Dohi, T., Sugimoto, A., Kuribayashi,
S., … Hyakusoku, H. (2013). Analysis of Surgical Treatments for
Earlobe Keloids. Plastic and Reconstructive Surgery ,132 (5), 818e-825e. doi:10.1097/PRS.0b013e3182a4c35e
Ramos, M. L. C., Gragnani, A., & Ferreira, L. M. (2008). Is There an
Ideal Animal Model to Study Hypertrophic Scarring? Journal of Burn
Care & Research , 29 (2), 363–368.
doi:10.1097/BCR.0b013e3181667557
Rathee, M., Kundu, R., & Tamrakar, A. (2014). Custom made pressure
appliance for presurgical sustained compression of auricular keloid.Annals of Medical and Health Sciences Research , 4 (Suppl
2), S147-51. doi:10.4103/2141-9248.138040
Sharp, P. A., Pan, B., Yakuboff, K. P., & Rothchild, D. (2016).
Development of a Best Evidence Statement for the Use of Pressure Therapy
for Management of Hypertrophic Scarring. Journal of Burn Care &
Research : Official Publication of the American Burn Association ,37 (4), 255–264. doi:10.1097/BCR.0000000000000253
Stella, M., Castagnoli, C., & Gangemi, E. N. (2008). Postburn Scars: An
Update. The International Journal of Lower Extremity Wounds ,7 (3), 176–181. doi:10.1177/1534734608323057
Suetake, T., Sasai, S., Zhen, Y.-X., & Tagami, H. (2000). Effects of
silicone gel sheet on the stratum corneum hydration. British
Journal of Plastic Surgery , 53 (6), 503–507.
doi:10.1054/bjps.2000.3388
Tanaydin, V., Beugels, J., Piatkowski, A., Colla, C., van den Kerckhove,
E., Hugenholtz, G. C. G., & van der Hulst, R. R. (2016). Efficacy of
custom-made pressure clips for ear keloid treatment after surgical
excision. Journal of Plastic, Reconstructive & Aesthetic
Surgery : JPRAS , 69 (1), 115–121.
doi:10.1016/j.bjps.2015.09.013
Tejiram, S., Zhang, J., Travis, T. E., Carney, B. C., Alkhalil, A.,
Moffatt, L. T., … Shupp, J. W. (2016). Compression therapy
affects collagen type balance in hypertrophic scar. The Journal of
Surgical Research , 201 (2), 299–305.
doi:10.1016/j.jss.2015.10.040
Thierauf, J., Walther, M., Rotter, N., Scheithauer, M.-O., Hoffmann, T.
K., & Veit, J. A. (2017). Treatment of ear keloids: algorithm for a
multimodal therapy regimen. European Archives of
Oto-Rhino-Laryngology , 274 (11), 3859–3866.
doi:10.1007/s00405-017-4714-5
Van den Kerckhove, E., Stappaerts, K., Boeckx, W., Van den Hof, B.,
Monstrey, S., Van der Kelen, A., & De Cubber, J. (2001). Silicones in
the rehabilitation of burns: a review and overview. Burns :
Journal of the International Society for Burn Injuries , 27 (3),
205–214. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/11311512