A new and simple suturing technique applied after surgery to correct ingrown toenails may improve clinical outcomes: A randomized controlled trial

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A new and simple suturing technique applied after surgery to correct ingrown toenails may improve clinical outcomes: a randomized trial

Esat UYGUR*, Engin ÇARKÇI, Ahmet ŞENEL, Bahattin KEMAH, Yalçın TURHAN

Esat UYGUR: MD, Orthopaedics and Traumatology, Erciş State Hospital, Van, Turkey.

esatuygur@gmail.com

Engin ÇARKÇI: MD, Orthopaedics and Traumatology, Erciş State Hospital, Van, Turkey.

drengincarkci@hotmail.com

Ahmet ŞENEL: MD, Orthopaedics and Traumatology, İstanbul Training and Research

Hospital, İstanbul, Turkey. ahmetsenel23@gmail.com

Bahattin KEMAH: MD, Orthopaedics and Traumatology, Goztepe Training and Research

Hospital, İstanbul, Turkey. bahattinkemah.md@gmail.com

Yalçın TURHAN: Ass Prof, Orthopaedics and Traumatology, Düzce University Hospital,

Düzce, Turkey. yturhan_2000@yahoo.com

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In the present study, we investigated the efficacy of a new suturing technique applied after the 5

Winograd procedure has been completed. 6

Methods: 7

This study was prospective, randomized, and controlled. In total, 128 patients were recruited 8

and divided into two groups. The outcomes of those treated with the new suturing technique 9

(group I) were compared with those of patients treated with the traditional suturing technique 10

(group II), both of which were applied after the Winograd procedure had been completed. The 11

clinical outcomes and recurrence rates of the two groups were compared. 12

Results: 13

Patients in group I required significantly more time to return to work or school than did those 14

in group II (p = .015). We found no significant difference between youths (age < 18 years, 15

n=55) and adults (age ≥ 19 years, n=69) in this context (p = .161). The recurrence rate was 16

significantly higher in group II than in group I (p = .011). The extent of satisfaction was 17

significantly higher in group I (p = .042). 18

Conclusions: Our new suturing technique is associated with lower recurrence and higher 19

satisfaction rates. However, the times elapsing before shoes could be worn were similar in the 20

two groups. 21

22

Keywords: Ingrown toenails 23 Onychocryptosis 24 Operative treatment 25 Suturing technique 26 Recurrence 27

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Ingrown toenails are encountered frequently in clinical orthopedic practice, 29

mostly in young subjects, causing major losses of work and school time. Various 30

conservative operative techniques have been described. Taping, packing, gutter 31

insertion, and nail-brace fitting are well-known conservative methods [1]. The 32

Winograd technique has proven to be reliable since it was first described in 1929 [2-33

8]. Other operative techniques include nail avulsion, wedge resection, removal of the 34

lateral nail folds, and chemical matrixectomy [3,6]. 35

In 2014, the first author developed a new and simple suturing technique 36

applied after the Winograd procedure has been completed [9]. In the present study, we 37

explored whether the new technique afforded better clinical outcomes, especially in 38

terms of recurrence and the time required for healing. We compared the new and 39

traditional suturing techniques in terms of recurrence rate, the time taken to return to 40

work or school, and the time that elapsed before shoes could be worn. 41

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43

This prospective, randomized controlled study was approved by our 44

institutional review board. In total, 128 patients were recruited and divided into two 45

groups (Table 1). Written informed consent was obtained from all patients or their 46

family members. A total of 124 patients completed all scheduled follow-up visits. 47

The exclusion criteria were onychomycosis, onycholysis, dystrophic nails, 48

nails affected both medially and laterally, concomitant peripheral vascular disease, 49

and/or diabetes mellitus. Bilateral (right and left big toes) cases were included and 50

they were considered as separate cases. Heifetz staging (commonly used to evaluate 51

ingrown toenails) was performed before surgery [10]. All evaluations were clinical in 52

nature; no radiographic or microbiological test was performed. 53

The Winograd procedure was performed by the first two authors (i.e., one 54

surgeon per patient; two surgeons in total involved in the trial) in all patients. Patients 55

were assigned into groups by order of application and both surgeons treated members 56

of both groups in a random manner. After treatment, patients were followed at 2 57

weeks (with suture removal), and then at 1 and 6 months. At first two visits, all 58

patients were asked when they had been able to wear shoes and when they had 59

returned to work or school. Patients who were not working were asked when they 60

were able to go shopping while wearing their usual shoes. At month 6, many of the 61

patients were examined to detect recurrence and others were telephoned to obtain 62

final data. All patients were asked to report (by telephone) ingrown toenail recurrence 63

during at least the first 12 months after surgery. 64

To eliminate any possible sex-based difference, we conducted sex-specific 65

comparison of data from patients treated using the new and traditional suturing 66

techniques. We also compared youths (12–18 years of age) and older patients (≥19 67

years of age) between groups. We recorded the time taken to return to work or school, 68

the time elapsing before shoes could be worn, recurrence, and patient satisfaction 69

(rated as “low,” “moderate,” or “high”; Table 2). 70

71

2.1. Operative technique 72

To reduce inflammation, patients were preoperatively prescribed lateral nail-73

fold massage, bulky shoes and povidone/iodine footbaths. Although patients with 74

Heifetz stage I and II nails were not prescribed antibiotics, patients with stage III nails 75

were administered oral cefazolin (Sagent Pharmaceuticals, Schaumburg, IL, USA). 76

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the traditional suturing technique was employed (Figure 2). All sutures were made 92

with sharp, non-absorbable operative 3/0 monofilament (Figure 1e). 93

A compression bandage was applied after surgery. The use of an anti-94

inflammatory agent and foot elevation were recommended to all patients. Cefazolin 95

was given for 1 week after surgery to patients with Heifetz stage III nails. The stitches 96

were removed 2 weeks after surgery. 97

All patients were encouraged to wear bulky shoes, and to walk and return to work or 98

school as soon as possible. 99

100

2.2. Statistical analysis 101

All statistical analyses were performed using SPSS software (ver. 15.0; SPSS 102

Inc., Chicago, IL, USA). We set the Cohen's d effect size to 0.5 and required 80% 103

statistical power; the a priori sample size was thus 64 per group. Categorical variables 104

are presented as numbers with percentages, and numerical variables are presented as 105

means with standard deviations. As the numerical variables were not distributed 106

normally, the Mann–Whitney U-test was used to compare data from the two groups. 107

The significance of between-group differences in categorical variables was tested 108

using the chi-squared test. When incongruence was evident, we performed Monte 109

Carlo simulation. P values < 0.05 were considered to reflect statistical significance. 110

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Four patients moved to other cities during the follow-up period; we thus 113

collected final data from 124 of the 128 patients. Demographic features were similar 114

between the groups, except for the sex proportion; males were more predominant in 115

study group (p < .001; Table 1). The mean age of all patients was 22.8 (range, 12–48) 116

years. The average follow-up time was 14.1 (range, 12–20) months. Group data are 117

shown in Table 1. 118

Overall, 23% of patients had Heifetz stage I, 58% had stage II, and 18% had 119

stage III conditions; these grade distributions did not differ between groups (Table 1). 120

Group I patients returned to work/school significantly later than did group II patients 121

(p = .015). No significant difference was evident between youths (age < 18 years) and 122

adults (age ≥ 19 years) in this context (p = .161; Table 2). 123

The recurrence rate was significantly higher in group II than in group I (p = 124

.011). The extent of satisfaction was significantly higher in group I (p = .042). No 125

significant difference was evident between youths and adults in terms of recurrence (p 126

= .953) or satisfaction (p = .887; Table 2). No significant difference was evident 127

between groups (p = .537), or between youths and adults (p = .244), in terms of the 128

time elapsing before shoes could be worn (Table 2). 129

Table 3 lists details of recurrence in youths and adults; no significant between-130

group difference was evident. 131

132

Complications 133

Recurrence developed in 9 patients treated with the new technique and 20 of 134

those treated with traditional suturing. The recurrence dates are listed in Table 3. 135

Pain/tenderness and nail-fold exudation were considered to reflect recurrence. No 136

patient in group I required revision surgery; five patients in group II did require such 137

surgery. The drainage complaints of all other patients resolved upon antibiotic 138

treatment; pain/tenderness reduced over time, with no medication required (Figure 139

3a–c). 140

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Ingrown toenails (onychocryptosis) are common worldwide; the condition 142

usually develops in the second or third decade of life [5]. Patient complaints include 143

painful toes, purulent drainage, and pain when walking; the ability to work is 144

seriously affected [1,11]. Good treatment options should facilitate early recovery and 145

be associated with low recurrence rates. 146

An ingrown toenail is also termed “unguis incarnates.” The nail grows into the 147

skin of the nail fold, thus aberrantly invading the skin. To solve this problem, we 148

advocate that the nail-fold skin should be placed under the nail. The present 149

prospective clinical trial was designed to explore this hypothesis using a new simple 150

suturing technique developed by the senior author [9]. The knot technique developed 151

by Ince et al. also emphasizes the importance of laying the skin under the nail [12]. 152

Various treatment procedures are employed for this condition. Although 153

systemic antibiotics and topical wound care are usually ineffective in the later stages 154

of the condition [2], conservative therapy is reasonable in patients with mild– 155

moderate lesions who do not complain of significant pain, substantial erythema, or 156

purulent drainage from the lateral nail edge. When the lesion is more severe or 157

conservative treatment fails, an operative approach is recommended [4,13]. 158

No consensus on the best operative technique has yet been attained. The 159

recurrence rates after operation are 1.7–27% [6,14]. Chemical matrixectomy using 160

phenol is an alternative technique associated with a low recurrence rate [15,16]. 161

However, postoperative infections are not infrequent, and alcohol burns have been 162

described in some patients [15]. 163

Operative techniques to treat this condition include partial nail avulsion and 164

complete nail excision, with or without partial matrixectomy [17]. However, the high 165

recurrence rates remain of concern [6,12]. Although Winograd reported no recurrence 166

of ingrown toenail, other authors have documented recurrence rates of 0–20% [1-167

3,12-14]. Kayalar et al. indicated that the recurrence rate increased when both sides of 168

the nail were affected [2]. In the present study, we included only patients affected on 169

one side. 170

The Winograd technique is the classical operative procedure, featuring partial 171

plate excision and subjacent destruction of the growth center. Winograd considered 172

excision of the hypertrophic folds to be unnecessary [8]. In the present study, we 173

partially excised the nail bed and lateral fold, including inflammatory granulation 174

tissue. Next, we used our new suturing technique to lay the skin fold under the nail. 175

We thus sought to reduce recurrence. Ince et al. considered that recurrence after use of 176

the Winograd technique was attributable to inadequate destruction of the germinal 177

matrix [12]. Nevertheless, we used the Winograd technique to treat both groups in the 178

present study. We found that our simple suturing technique reduced the recurrence 179

rate (p < .001; Table 2). Kayalar et al. reported a recurrence rate of 9.8% in patients 180

treated with the Winograd technique [2]; Guler et al. reported a rate of 9.4% [1]. In 181

the present study, the high relapse rate in group II was associated with pain, 182

tenderness, and fluid exudation. Had recurrence been defined as a need for repeat 183

surgery, the recurrence rate of the group treated using our new technique would be 184

zero. Indeed, in many studies, “recurrence” has not been defined clearly. In a few 185

studies, recurrence has been defined as spicule formation and ingrowth at the edge of 186

the nail [2,5]. As the recurrence rate was our principal concern in this study, we 187

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considered that all pain, tenderness, exudation, and spicule formation reflected 188

recurrence. Although nine (14%) patients in group I complained of pain, tenderness, 189

or exudation from the nail edge, none required revision surgery. The symptoms of 190

four of these nine patients resolved spontaneously; five patients exhibited serous 191

exudation from the nail edge, which was cured by antibiotic administration. 192

We compared the recurrence rates in youths and adults; recurrence was not 193

associated with age, but rather with the suturing technique used (Table 2). 194

We graded satisfaction as high, moderate, or low. Use of the new suturing 195

technique was associated with greater satisfaction than was use of the traditional 196

technique. We believe that the lower recurrence rate also improved satisfaction, but, 197

as the recurrence rates were low in both groups, the data were not amenable to 198

statistical evaluation. 199

In some trials, patients were instructed not to walk on the operated toes and 200

not to wear shoes [2,14]. In the present study, we measured the times taken to return 201

to work or school, and to the wearing of shoes. Patients were encouraged to wear 202

shoes and to return to work/school as soon as possible. After partial matrixectomy, the 203

times taken to return to work/school have averaged 12–14 days [1,5,14,16]. We found 204

that the time taken to return to work/school was significantly longer in group I. 205

However, no significant between-group difference was evident in terms of the time 206

taken to wear shoes once more. Kuru et al. also encouraged patients to return to work, 207

and found that the average time taken was 4.3 days [6]; Aydin et al. reported that 12 208

days were required [14]. Therefore, the time taken to return to work/school seems to 209

be associated with the extent of encouragement delivered by physicians. In the present 210

study, the average times taken to return to work/school in both groups were 211

considerably longer than reported previously. Although one would expect youths to 212

recover more rapidly, we found no significant difference between youths and adults in 213

terms of the time taken to return to work/school or the time elapsing before wearing 214

of shoes. Our patients were able to wear shoes quite quickly; we consider that we 215

failed to adequately emphasize the importance of a timely return to work or school. 216

Valuable features of our study included its prospective nature, randomization 217

of patients, large sample, and inclusion of younger and older patients. A limitation is 218

our collection of some data by telephone (at least 1 year after operation). Another 219

limitation is that we did not quantify the cosmetic results and also the satisfaction. 220

221

5. Conclusion: 222

In conclusion, we hypothesized that our new suturing technique would afford 223

better operative outcomes and reduced recurrence. Our new technique was associated 224

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[1] O. Guler, H. Tuna, M. Mahirogullari, M. Erdil, S. Mutlu, M. Isyar, Nail braces as 229

an alternative treatment for ingrown toenails: results from a comparison with the 230

winograd technique, J. Foot Ankle Surg. 54 (2015) 620-624. doi: 231

10.1053/j.jfas.2015.04.013. 232

[2] M. Kayalar, E. Bal, T. Toros, K. Ozaksar, Y. Gürbüz, Y. Ademoğlu, Results of 233

partial matrixectomy for chronic ingrown toenail, Foot Ankle Int. 32 (2011) 888-895. 234

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wedge resection of nail matrix (Winograd technique) in the treatment of ingrown 238

toenail, Foot Ankle Spec. 5 (2012) 241-244. doi: 10.1177/1938640012444729. 239

[5] J.Z. Huang, Y.J. Zhang, X. Ma, X. Wang, C. Zhang, L. Chen, Comparison of 240

wedge resection (Winograd procedure) and wedge resection plus complete nail plate 241

avulsion in the treatment of ingrown toenails, J. Foot Ankle Surg. 54 (2015) 395-398. 242

doi: 10.1053/j.jfas.2014.08.022 243

[6] I. Kuru, T. Sualp, D. Ferit, T. Gunduz, Factors affecting recurrence rate of 244

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[7] M. Tsunoda, K. Tsunoda, Patient-controlled taping for the treatment of ingrown 247

toenails, Ann. Fam. Med. 12 (2014) 553-555. doi: 10.1370/afm.1712. 248

[8] A.M. Winograd, A modification in the technic of operation for ingrown toe-nail. 249

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10.1111/j.1365-4632.2010.04697.x. 258

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techniques on ingrown nail treatment, Acta. Orthop. Traumatol. Turc. 49 (2015) 539-260

543. doi: 10.3944/AOTT.2015.14.0450. 261

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The English in this document has been checked by at least two professional editors, 278

both native speakers of English. For a certificate, please see: 279

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http://www.textcheck.com/certificate/kZtby3 281

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Table 1: Demographic features of the study group

284 Group I n=64 Group II n=60 p

Age (year) Mean±SD 22.1±8.4 23.9±11.2 0.793

Youth 28 (43.8 %) 27 (45.0 %) 0.889 Elder 36 (56.3 %) 33 (55.0 %) Gender n (%) Male 33 (51.6 %) 50 (83.3 %) <0.001 Female 31 (48.4 %) 10 (16.7 %) Heifetz n (%) I 15 (23.4 %) 13 (21.7 %) 0.965 II 37 (57.8 %) 36 (60.0 %) III 12 (18.8 %) 11 (18.3 %) Follow up time (month) Mean±SD 14.5±2.5 13.6±2.4 0.132

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Table 2: Statistical analyses for clinical outcomes depending on groups and age.

285 Group Age I II p Youth Adult p Time of returning to work/school (day) Mean±SD 18.0±4.8 15.8±5.59 0.015 16.4±4.9 17.4±5.6 0.161 Recurrence n (%) 9 (14.1) 20 (33.3) 0.011 13 (23.6) 16 (23.2) 0.953 Satisfaction n (%) High 56 (87.5) 44 (73.3) 0.042 44 (80.0) 56 (81.2) 0.887 Moderate 7 (10.9) 9 (15.0) 8 (14.5) 8 (11.6) Low 1 (1.6) 7 (11.7) 3 (5.5) 5 (7.2) Time of wearing shoes (day) Mean±SD 15.8±3.6 16.4±8.6 0.537 17.2±7.8 15.2±5.2 0.244

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Table 3: Recurrence allocation

286 Group I Group II 12-18 years of age n=28 ≥19 years old patients n=36 12-18 years of age n=27 ≥19 years old patients n=33 Mean Age 15.53 27.22 15.14 31 Recurrence 4 5 9 11

Mean date of recurrence

(day) 76 52 48 80

Antibiotic administration 2 3 5 4

Second surgery needed - - 4 2

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Figure 1a-e: Application of the new suturing technique after ingrown toenail surgery. 289

Figure 2: Traditional suturing technique. 290

Figure 3a: Intraoperative photograph of a patient. b: She was complaining about 291

pain, and tenderness was detected at operation area at first month of surgery. c: Her 292

complaints was resolved without any medication at control at 6 months after surgery. 293

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This study is a well designed, demonstrative study since it was prospective, randomized and controlled.

After Winograd procedure was completed for ingrown toe nail, outcomes of the new and the traditional suturing techniques were compared.

This study indicates that a simple suturing technique may improve clinical results of the surgery.

By using the new and simple suturing technique, recurrence cases after ingrown toe nail surgery would be diminished.