Polyethylene Nail Brace for Ingrown Toenails Treatment: A Randomized Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Design and Sample
2.2. Subjects
2.3. Ethics Considerations
2.4. Sample Size
2.5. Procedures
2.6. Data Collection and Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Conflicts of Interest
References
- Lloyd-Davies, R.W.; Brill, G.C. The aetiology and out-patient management of ingrowing toe-nails. Br. J. Surg. 1963, 50, 592–597. [Google Scholar] [CrossRef]
- Langford, D.T.; Burke, C.; Robertson, K. Risk factors in onychocryptosis. Br. J. Surg. 1989, 76, 45–48. [Google Scholar] [CrossRef] [PubMed]
- DeLauro, N.M.; DeLauro, T.M. Onychocryptosis. Clin. Podiatr. Med. Surg. 2004, 21, 617–630. [Google Scholar] [CrossRef] [PubMed]
- Martínez-Nova, A.; Sánchez-Rodríguez, R.; Alonso-Peña, D. A new onychocryptosis classification and treatment plan. J. Am. Podiatr. Med. Assoc. 2007, 97, 389–393. [Google Scholar] [CrossRef]
- Mozena, J.D. The Mozena Classification System and treatment algorithm for ingrown hallux nails. J. Am. Podiatr. Med. Assoc. 2002, 92, 131–135. [Google Scholar] [CrossRef]
- Woo, S.-H.; Kim, I.-H. Surgical pearl: Nail edge separation with dental floss for ingrown toenails. J. Am. Acad. Dermatol. 2004, 50, 939–940. [Google Scholar] [CrossRef]
- Hidalgo, S. Clasificación de las patologías ungueales Estadística de la clínica podológica de la UB. Rev. Esp. Podol. 1999, 10, 349–408. [Google Scholar]
- Rodríguez, E. Tratamiento de la onicocriptosis con formación de mamelon carnoso y/o fibrosado. Rev. Esp. Podol. 1992, 3, 71–75. [Google Scholar]
- Di Chiacchio, N.; Kadunc, B.V.; Trindade de Almeida, A.R.; Madeira, C.L. Treatment of transverse overcurvature of the nail with a plastic device: Measurement of response. J. Am. Acad. Dermatol. 2006, 55, 1081–1084. [Google Scholar] [CrossRef]
- Kruijff, S.; van Det, R.J.; van der Meer, G.T.; van den Berg, I.C.M.A.E.; van der Palen, J.; Geelkerken, R.H. Partial Matrix Excision or Orthonyxia for Ingrowing Toenails. J. Am. Coll. Surg. 2008, 206, 148–153. [Google Scholar] [CrossRef]
- Harrer, J.; Schöffl, V.; Hohenberger, W.; Schneider, I. Treatment of ingrown toenails using a new conservative method: A prospective study comparing brace treatment with Emmert’s procedure. J. Am. Podiatr. Med. Assoc. 2005, 95, 542–549. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Wallace, W.A.; Milne, D.D.; Andrew, T. Gutter treatment for ingrowing toenails. Br. Med. J. 1979, 2, 168–171. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Kim, K.-D.; Sim, W.-Y. Surgical pearl: Nail plate separation and splint fixation—A new noninvasive treatment for pincer nails. J. Am. Acad. Dermatol. 2003, 48, 791–792. [Google Scholar] [CrossRef] [PubMed]
- Márquez, S.; Castro, A.; Pérez, A.; Bejínez, M.A.; Coheña, M. Tratamiento de la onicocriptosis mediante ortonixia con lámina plástica de polietileno. Podol. Clínia 2011, 12, 104–111. [Google Scholar]
- Okada, K.; Okada, E. Novel treatment using thioglycolic acid for pincer nails. J. Dermatol. 2012, 39, 996–999. [Google Scholar] [CrossRef] [PubMed]
- Effendy, I.; Ossowski, B.; Happle, R. Pincer nail. Conservative correction by attachment of a plastic brace. Hautarzt 1993, 44, 800–802. [Google Scholar]
- Van Oirschot, H.; De Heus, M.; Van Mameren, H. Behandlung von eingewachsenen zehennägeln: Effektivität der orthonyxie im vergleich zu chirurgischen maßnahmen. Der Fuss 1994, 45, 40–44. [Google Scholar]
- Erdogan, F.G.; Erdogan, G. Long-Term Results of Nail Brace Application in Diabetic Patients with Ingrown Nails. Dermatol. Surg. 2008, 34, 84–87. [Google Scholar] [CrossRef]
- Iribarren, C.; Delgado, A. Técnica MLU. Técnica modificadora de la morfología de la lámina ungueal. Revistapodología 2006, 9, 14–16. [Google Scholar]
- Cabo, J.; Macián, C. Tratamiento de la onicocriptosis mediante ortonixia. Podol. Clínica 2007, 8, 164–171. [Google Scholar]
- Erdogan, F.G. A simple, pain-free treatment for ingrown toenails complicated with granulation tissue. Dermatol. Surg. 2006, 32, 1388–1390. [Google Scholar] [CrossRef] [PubMed]
- Ishibashi, M.; Tabata, N.; Suetake, T.; Omori, T.; Sutou, Y.; Kainuma, R.; Yamauchi, K.; Ishida, K. A simple method to treat an ingrowing toenail with a shape-memory alloy device. J. Dermatol. Treat. 2008, 19, 291–292. [Google Scholar] [CrossRef]
- Kim, J.-Y.; Park, J.S. Treatment of Symptomatic Incurved Toenail with A New Device. Foot Ankle Int. 2009, 30, 1083–1087. [Google Scholar] [CrossRef] [PubMed]
- Moriue, T.; Yoneda, K.; Moriue, J.; Matsuoka, Y.; Nakai, K.; Yokoi, I.; Nibu, N.; Miyamoto, I.; Kubota, Y. A simple therapeutic strategy with super elastic wire for ingrown toenails. Dermatol. Surg. 2008, 34, 1729–1732. [Google Scholar] [CrossRef]
- Matsumoto, K.; Hashimoto, I.; Nakanishi, H.; Kubo, Y.; Murao, K.; Arase, S. Resin splint as a new conservative treatment for ingrown toenails. J. Med. Investig. 2010, 57, 321–325. [Google Scholar] [CrossRef] [Green Version]
- Erdogan, F.G. A Quantitative Method for Measuring Forces Applied by Nail Braces. J. Am. Podiatr. Med. Assoc. 2011, 101, 247–251. [Google Scholar] [CrossRef]
- Moon, S.H.; Shin, M.K.; Haw, C.R. Clinical study of efficacy of super elastic wire for ingrown nails of great toe. Korean J. Dermatol. 2013, 51, 94–101. [Google Scholar]
- Tseng, J.T.-P.; Ho, W.-T.; Hsu, C.-H.; Lin, M.-H.; Li, C.-N.; Lee, W.-R. A Simple Therapeutic Approach to Pincer Nail Deformity Using a Memory Alloy: Measurement of Response. Dermatol. Surg. 2013, 39, 398–405. [Google Scholar] [CrossRef] [PubMed]
- Kim, J.Y.; Park, S.Y.; Jin, S.P.; Yoon, H.S.; Cho, S.; Park, H.S. Quick and easy correction of a symptomatic pincer nail using a shape memory alloy device. Dermatol. Surg. 2013, 39, 1520–1526. [Google Scholar] [CrossRef]
- Park, S.-W.; Park, J.-H.; Lee, J.-H.; Lee, D.-Y.; Lee, J.-H.; Yang, J.-M. Treatment of ingrown nail with a special device composed of shape-memory alloy. J. Dermatol. 2014, 41, 292–295. [Google Scholar] [CrossRef]
- Guler, O.; Tuna, H.; Mahirogullari, M.; Erdil, M.; Mutlu, S.; Isyar, M. Nail Braces as an Alternative Treatment for Ingrown Toenails: Results From a Comparison With the Winograd Technique. J. Foot Ankle Surg. 2015, 54, 620–624. [Google Scholar] [CrossRef]
- Arik, H.O.; Arican, M.; Gunes, V.; Kose, O. Treatment of Ingrown Toenail with a Shape Memory Alloy Device. J. Am. Podiatr. Med. Assoc. 2016, 106, 252–256. [Google Scholar] [CrossRef]
- Cameron, P.F. Ingrowing toenails: An evaluation of two treatments. Br. Med. J. (Clin. Res. Ed.) 1981, 283, 821–822. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Senapati, A. Conservative Outpatient Management of Ingrowing Toenails. J. R. Soc. Med. 1986, 79, 339–340. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Connolly, B.; Fitzgerald, R.J. Pledgets in ingrowing toenails. Arch. Dis. Child. 1988, 63, 71–72. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Reijnen, J.A.; Goris, R.J. Conservative treatment of ingrowing toenails. Br. J. Surg. 1989, 76, 955–957. [Google Scholar] [CrossRef] [PubMed]
- Ilfeld, F.W. Ingrown toenail treated with cotton collodion insert. Foot Ankle 1991, 11, 312–313. [Google Scholar] [CrossRef]
- Salasche, S.J.; Schulte, K.W.; Neumann, N.J.; Ruzicka, T. Surgical Pearl: Nail splinting by flexible tube—A new noninvasive treatment for ingrown toenails. J. Am. Acad. Dermatol. 1998, 39, 629–630. [Google Scholar] [CrossRef]
- Lazar, L.; Erez, I.; Katz, S. A conservative treatment for ingrown toenails in children. Pediatr. Surg. Int. 1999, 15, 121–122. [Google Scholar] [CrossRef]
- You, M.Y.; Chong, J.H.; Kim, H.U.; Ihm, C.W. Clinical features of 27 cases of ingrowing toenails and treatment with flexible plastic tube insertion. Korean J. Dermatol. 2001, 39, 782–788. [Google Scholar]
- Gupta, S.; Sahoo, B.; Kumar, B. Treating Ingrown Toenails by Nail Splinting with a Flexible Tube: An Indian Experience. J. Dermatol. 2001, 28, 485–489. [Google Scholar] [CrossRef] [PubMed]
- Abby, N.S.; Roni, P.; Amnon, B.; Yan, P. Modified Sleeve Method Treatment of Ingrown Toenail. Dermatol. Surg. 2002, 28, 852–855. [Google Scholar] [CrossRef] [PubMed]
- Kim, Y.-J.; Ko, J.-H.; Choi, K.-C.; Lee, C.-G.; Lim, K.-J. Nail-splinting technique for ingrown nails: The therapeutic effects and the proper removal time of the splint. Dermatol. Surg. 2003, 29, 745–748. [Google Scholar] [CrossRef] [PubMed]
- Ozawa, T.; Yabe, T.; Ohashi, N.; Harada, T.; Muraoka, M.; Ishii, M. A splint for pincer nail surgery: A convenient splinting device made of an aspiration tube. Dermatol. Surg. 2005, 31, 94–98. [Google Scholar] [CrossRef]
- Nazari, S. A simple and practical method in treatment of ingrown nails: Splinting by flexible tube. J. Eur. Acad. Dermatol. Venereol. 2006, 20, 1302–1306. [Google Scholar] [CrossRef]
- Lee, J.I.; Lee, Y.B.; Oh, S.T.; Park, H.J.; Cho, B.K. A clinical study of 35 cases of pincer nails. Ann. Dermatol. 2011, 23, 417–423. [Google Scholar] [CrossRef] [Green Version]
- Doğan, F.; Altıparmak, M.; Eskitaşçıoğlu, T.; Özyazgan, İ. A conservative treatment of ingrown toenails: Splinting technique with cyanoacrylate. Eur. J. Plast. Surg. 2013, 36, 715–718. [Google Scholar] [CrossRef]
- Ceren, E.; Gokdemir, G.; Arikan, Y.; Purisa, S. Comparison of Phenol Matricectomy and Nail-Splinting With a Flexible Tube for the Treatment of Ingrown Toenails. Dermatol. Surg. 2013, 39, 1264–1269. [Google Scholar] [CrossRef]
- AlGhamdi, K.M.; Khurram, H. Nail tube splinting method versus lateral nail avulsion with phenol matricectomy: A prospective randomized comparative clinical trial for ingrown toenail treatment. Dermatol. Surg. 2014, 40, 1214–1220. [Google Scholar] [CrossRef]
- Taheri, A.; Mansoori, P.; Alinia, H.; Lewallen, R.; Feldman, S.R. A Conservative Method to Gutter Splint Ingrown Toenails. JAMA Dermatol. 2014, 150, 1359. [Google Scholar] [CrossRef]
- Gutiérrez-Mendoza, D.; De Anda Juárez, M.; Ávalos, V.F.; Martínez, G.R.; Domínguez-Cherit, J. “Cotton Nail Cast”: A simple solution for mild and painful lateral and distal nail embedding. Dermatol. Surg. 2015, 41, 411–414. [Google Scholar] [CrossRef] [PubMed]
- Maeda, N.; Mizuno, N.; Ichikawa, K. Nail abrasion: A new treatment for ingrown toe-nails. J. Dermatol. 1990, 17, 746–749. [Google Scholar] [CrossRef] [PubMed]
- Stoduto, M.; Palomo, P. Onicocriptosis en pediatría: Estudio clínico del tratamiento conservador. Rev. Int. Cienc. Podol. 2014, 8, 83–89. [Google Scholar]
Treatment Period | Follow-Up Period | |||
---|---|---|---|---|
No Recurrence | Recurrence | No Recurrence | Recurrence | |
Experimental Group | 33 (71.74%) | 13 (28.26%) | 36 (78.26%) | 10 (21.74%) |
Control Group | 2 (4.17%) | 46 (95.83%) | 4 (8.33%) | 44 (91.67%) |
Initial Nail Width | Nail Width after 2 Months | Nail Width after 4 Months | Nail Width after 6 Months | Nail Width after 12 Months | |
---|---|---|---|---|---|
Mean | 12.86 ± 2.70 | 13.88 ± 2.55 | 14.41 ± 2.57 | 15.01 ± 2.67 | 14.03 ± 2.57 |
Minimum | 4.83 | 6.20 | 6.88 | 7.04 | 5.49 |
Maximum | 16.78 | 17.60 | 17.98 | 18.25 | 17.52 |
Nail Brace Techniques | |||||
---|---|---|---|---|---|
Studies | Year | Nº Cases | Treatment Time | Follow-Up Time | Effectiveness Rate |
Van Oirschot et al. [17] | 1994 | 85 | Average 9 sessions | - | 76.5% * |
Kim and Sim [13] | 2003 | 14 | 1 month | 12 months | 100% |
Harrer et al. [11] | 2005 | 21 | - | 6–12 months | 81% * |
Erdogan [18] | 2008 | 7 | - | 6 months | 100% |
Iribarren and Delgado [19] | 2006 | 10 | - | - | 100% |
Cabo and Macián [20] | 2007 | - | 141 days | - | 82% * |
Erdogan and Erdogan [21] | 2006 | 21 | 4.1 ± 2.36 months | 2 years | 71.4% * |
Kruijff et al. [10] | 2008 | 47 | - | 12 months | 82.98% * |
Ishibashi et al. [22] | 2008 | 14 | - | 3 months | 100% |
Kim and Park [23] | 2009 | 31 | 3 weeks | 13.3 ± 4.9 months | 93.55% |
Moriue et al. [24] | 2008 | 5 | - | >6 months | 100% |
Matsumoto et al. [25] | 2010 | 61 | 9.3 months | 10 months | 91.8% |
Erdogan [26] | 2011 | 21 | 6–10 months | - | 100% |
Okada and Okada [15] | 2012 | 106 | ≥5 days | 4.6 months (range 2–12 months) | 92.45% |
Moon et al. [27] | 2013 | 15 | - | 9 months (range 5–12 months) | 86.67% |
Tseng et al. [28] | 2013 | 43 | 2–3 months | 6 months | 95.35% |
Kim et al. [29] | 2013 | 21 | 2–3 weeks | Foreseen: 12 weeks Later: 37.9 ± 21.3 weeks (range 16–84 weeks) | 90.5% (12 weeks) 57.14% (range 16 to 84 weeks) |
Park et al. [30] | 2014 | 31 | From 2–3 weeks or more (41 days) | 161 days | 77.4% * |
Guler et al. [31] | 2015 | 74 | Until cure and correction nail curve | 12.7 ± 3.9 months | 91.9% |
Arik et al. [32] | 2016 | 41 | 4–6 weeks | Range 6–12 months (8.6 ± 2.1 months) | 80.5% * |
This study | 46 | 6 months | 6 months | 78.26% * | |
Nail reeducation techniques | |||||
Lloyd-Davies and Brill [1] | 1963 | 100 | - | 2 years | 60% * |
Wallace et al. [12] | 1979 | Study 1 (retrospective): 25. Study 2 (prospective): 36 | 6 weeks10–12 weeks | 6 months | 52% (retrospective study) * 56% (rrospective study) * |
Cameron [33] | 1981 | 100 | 3.5–4 months | 6 months | 61% * |
Senapati [34] | 1986 | 25 | - | 2–56 weeks (of 23.7 ± 14.3 weeks) | 79% * |
Connolly and Fitzgerald [35] | 1988 | 61 | - | 2.5 years | 72% * |
Reijnen y Goris [36] | 1989 | Stage I: 20 Stage II: 47 Stage III: 52 Total: 119 | From 2 weeks until pain disappeared | 2 years | 96% (stage I and II) * 38% (stage III) * |
Ilfeld [37] | 1991 | 43 | - | - | 97.68% * |
Salasche et al. [38] | 1998 | 62 | - | 2 years | 100% * |
Lazar et al. [39] | 1999 | 20 | 3–9 weeks | - | 95% * |
You et al. [40] | 2001 | 27 | - | 6 months | 37% * |
Gupta et al. [41] | 2001 | 39 | - | 6 months | 79.5% * |
Abby et al. [42] | 2002 | 28 | - | 4 months | 71.4% * |
Kim et al. [43] | 2003 | Group 1: 28 Group 2: 29 | Group 1: 3 days Group 2: 2 weeks | 1 year | 92.8% (treatment of 3 days) * 89.7% (treatment of 2 weeks) * |
Ozawa et al. [44] | 2005 | 9 | 2 weeks | 6–37 months (average 17.7 months) | 89.89% * |
Nazari [45] | 2006 | 32 | 7–15 days | 6 months | 93.75% * |
Lee et al. [46] | 2011 | 30 | - | Average 8.42 months | 60% * |
Doğan et al. [47] | 2013 | 16 | 2 weeks | 6 months | 100% * |
Ceren et al. [48] | 2013 | 57 | 15 days | 6 months | 87.8% * |
AlGhamdi and Khurram [49] | 2014 | 23 | 1 months | 6 months | 80% * |
Taheri et al. [50] | 2014 | 11 | ≥4 weeks | 5 months | 81.82% * |
Gutiérrez-Mendoza et al. [51] | 2015 | 10 | 2 months | 2 months | 80% * |
This study | 46 | 6 months | 6 months | 78.26% * |
Spicule Technique Effectiveness | |||||
Studies | Year | Nº Cases | Treatment Time | Follow-Up Time | Effectiveness Rate |
Maeda et al. [52] | 1990 | 22 | 15.9 months (range 3–48 months) | 6 months | 22.73% |
Stoduto and Palomo [53] | 2014 | 32 | - | - | 90.62% |
This study | 48 | 6 months | 6 months | 8.33% | |
Nail Curve Correction Studies | |||||
Studies | Year | Nº Cases | Nail Curve Correction | Observations | |
Di Chiacchio et al. [9] | 2006 | 25 | 3.04 mm | Index of nail width increases and index of height decreases after treatment | |
Lee et al. [46] | 2011 | 30 | - | - | |
Kim et al. [29] | 2013 | 21 | - | Transversal nail width decreases and width index is maintained after treatment. | |
This study | 46 | 1.8798 mm | Nail width mean decreases in the follow-up period (without orthonyxia). Tendency to increase nail curve. |
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. |
© 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
Share and Cite
Márquez-Reina, S.; Palomo-Toucedo, I.; Reina-Bueno, M.; Castillo-López, J.M.; Ortega, J.R.; Calvo-Lobo, C.; López-López, D.; Domínguez-Maldonado, G. Polyethylene Nail Brace for Ingrown Toenails Treatment: A Randomized Clinical Trial. Int. J. Environ. Res. Public Health 2020, 17, 7741. https://doi.org/10.3390/ijerph17217741
Márquez-Reina S, Palomo-Toucedo I, Reina-Bueno M, Castillo-López JM, Ortega JR, Calvo-Lobo C, López-López D, Domínguez-Maldonado G. Polyethylene Nail Brace for Ingrown Toenails Treatment: A Randomized Clinical Trial. International Journal of Environmental Research and Public Health. 2020; 17(21):7741. https://doi.org/10.3390/ijerph17217741
Chicago/Turabian StyleMárquez-Reina, Salvador, Inmaculada Palomo-Toucedo, María Reina-Bueno, José Manuel Castillo-López, Javier Ramos Ortega, César Calvo-Lobo, Daniel López-López, and Gabriel Domínguez-Maldonado. 2020. "Polyethylene Nail Brace for Ingrown Toenails Treatment: A Randomized Clinical Trial" International Journal of Environmental Research and Public Health 17, no. 21: 7741. https://doi.org/10.3390/ijerph17217741
APA StyleMárquez-Reina, S., Palomo-Toucedo, I., Reina-Bueno, M., Castillo-López, J. M., Ortega, J. R., Calvo-Lobo, C., López-López, D., & Domínguez-Maldonado, G. (2020). Polyethylene Nail Brace for Ingrown Toenails Treatment: A Randomized Clinical Trial. International Journal of Environmental Research and Public Health, 17(21), 7741. https://doi.org/10.3390/ijerph17217741