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
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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. |
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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