Introduction
External fixation is widely applied to restore skeletal integrity.[1] One frequent complication after external fixation is pin site infection. The etiology of pin site infections is multifactorial, and aspects such as the surgical technique (performing pin insertion), the patients' general condition, and the type of implants used seem to play a role.[2] Reported pin site infection rates vary in the literature ranging from 0.8% to 100%.[345678] The most commonly applied classification was introduced by Checketts et al.[9] Here, infections are classified into minor (Grade 1-3) and major (Grade 4-6) infections, whereby in cases of the latter, removal of the pins is advisable. Guidelines to pin site care were developed during the Royal College of Nursing (UK) meeting in 2010, and further surveys were conducted to approach a consensus.[10111213] However, pin site care protocols are still heterogeneous in terms of used material and frequency, and some authors suggest no treatment at all.[2141516] The latest Cochrane review on pin site care including 11 studies concluded that an optimal strategy could not be identified.[17] The missing consensus was also noted by Ktistakis et al., who conducted a systematic review based on 13 manuscripts reporting different methods of pin site care.[2] Furthermore, a meta-analysis conducted in 2008 pooling data of three studies[181920] found insufficient evidence to recommend the application of pin site cleansing solutions.[21] Thus, hitherto, no gold standard exists. Therefore, this study aimed at providing an overview of current pin site care recommendations and evaluating their efficiency in terms of infection rates.
Methods
A systematic review of the literature was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.[22]
The databases Medline, PubMed, Embase, and Cochrane Library were searched using the keywords “pin site care,” OR “pin site dressing,” OR “pin site infection” OR “external fixator.” Time period was set from 1980 to September 2021. To identify relevant articles, titles and abstracts were initially screened. Furthermore, reference lists of identified articles were screened. Articles were considered eligible, if they included comparative studies of different pin site care protocols and if they reported the infection rate as a complication to external fixator application. Exclusion criteria were (1) published in any other language than English, (2) no description of the pin site care protocol, and (3) no reports of outcomes. Studies reporting solely on treatment pin site infection or comparing the use of different pin types were excluded. A total of 380 manuscripts were screened. 20 articles met the inclusion criteria [Figure 1 and Table 1]. The following data were retrieved and tabulated: the pin site care protocol including material, frequency, open/sealed regime, time to first dressing, the number of participants and pins inserted, indication and fixation device, and the infection rate. Where applicable, infections were classified as minor (grade 1-3) and major (grade 4-6) in accordance with the Checketts–Otterburn classification.[9]
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Figure 1: PRISMA flow diagram presenting the process of identification, screening, eligibility, and final inclusion of relevant articles. PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Table 1: Studies reporting the comparison between pin site care protocols or the comparison between pin site care and no pin site care
The ROBINS-I tool was used to assess the risk of bias in nonrandomized studies.[40] The Effective Public Health Practice Project (EPHPP) tool was applied for quality assessment rating first the components selection bias, study design, confounders, blinding, data collection and method, withdrawals, and dropouts, which are then summarized in a global rating including strong, moderate, and weak quality.[41] Finally, the Coleman Methodology Score (CMS) was used, assessing the methodology with 10 criteria based on the subsection of the Consolidated Standards of Reporting Trials (CONSORT) statement, resulting in a score between 0 and 100. A score of 100 would indicate that the study does not include change, various biases, and confounding factors.[4243] The selected studies were rated by two researchers, and individual ratings were compared to reach consensus on each component. In the case of lack of consensus, a third person was involved.
Results
A total of 20 articles were included, involving 1428 patients. Of these, 17 studies (85%) compared different materials. In eight articles, pin site care with antimicrobial agents was associated with a reduced infection rate, whereas in nine articles, no significant difference was observed. In addition, three studies were devoted to compare the effect of pin site care with no pin site care,[141535] of which two reported a reduced infection rate associated with pin site care. Three studies investigated the optimal frequency of care.[233638] None of them reported a statistically significant difference between daily or weekly pin site care. In the majority of studies (n = 16), the pin sites were sealed, and the influence of dressed pin sites versus open pin sites was not investigated. In total, infection rates ranged from 8% to 90.3%. A total of n = 11 (55%) studies were designed as a prospective, randomized controlled trial and n = 7 (35%) were prospective controlled studies. Only one study incorporated a retrospective design,[34] and one study reported retrospectively assessed results of a control group.[37] The risk of bias evaluated with the ROBINS-I tool was moderate (n = 5) to low (n = 4) in the nonrandomized studies. The quality assessment with the EPHPP tool yielded strong (n = 10) and moderate (n = 10) global ratings. The ones rated as moderate showed limitations in the component blinding and withdrawals and dropouts, as the latter were not described in these studies. The mean CMS was 53.1 ± 11.2 (range 27-71). Here, mainly points were lost as the follow-up time was restricted to the time of pin removal.
Discussion
Pin site infection is a frequent complication after external fixation. Hitherto, no-gold-standard of pin site dressing exists, and latest reviews concluded that evidence for the most ideal protocol is lacking. Thus, pin site care protocols reported in the literature were systematically reviewed and evaluated in terms of infection rates. In total, 20 articles were considered eligible for analysis.
Of these, 55% studies were designed as a prospective, randomized controlled trials. Considering that only one randomized controlled trial was identified in two systematic reviews carried out in 2004, evidence has been increasing until today.[4445] No identified study showed a high risk of biases evaluated with the ROBINS-I tool. Furthermore, the quality assessment revealed that the included studies were of strong-to-moderate quality, and no major concerns in study design and execution were found. However, there was a heterogeneity of study purposes including (i) comparison of the frequency of pin site care, (ii) comparison of distinct materials, and (iii) comparing pin site care to no pin site care. Some studies even incorporated different frequency and materials in their study design, which makes pooling of the data for meta-analysis challenging. Especially, the chosen control group differed highly between studies, and often more than one parameter was changed in the pin site care protocol. Notwithstanding, the results indicate an advantage in terms of reduced infection rates of pin site care over no pin site care. Further, it is suggested that daily versus weekly pin site care does not yield statistically significant different infection rates.
Concerning the optimal cleansing solution or dressing type, no recommendations can be drawn based on this review. The included studies implemented multiple agents for pin site cleaning and dressing ranging from Dermol, chlorhexidine, sodium chloride, saline, povidone-iodine, paraffin ointment, hydrogen, peroxide silver sulfadiazine, polyhexamethylene biguanide to leptospermum honey. Only a slight superiority of chlorhexidine over saline was suggested; however, evidence to guide the choice is not strong.[16]
Previously, also, the role of pin site crust as a biological dressing and its effectiveness in the prevention of pin site infection were reviewed. Findings suggested that the pin side crust acts as a barrier and, thus, has similar properties to a dressing reducing infection rates and may not need removal.[46] In the present review, only one study was included comparing crust removal and crust retainment. Hereby, however, the removal resulted in lower infection rates.[42]
One additional limitation is that multiple endpoints of pin site care are used in the literature such as soft tissue status, mechanical stability of fixation, and radiological findings. To enable a comparison and consistency of the results, here, only the infection rate was evaluated as an outcome, as for this aspect, a commonly accepted classification is available.[9] To reduce the heterogeneity in the literature on pin site care and to reach a consensus on the most optimal dressing to prevent the development of infections, researchers are encouraged to plan future studies meticulously. Here, only one factor of the protocol should be targeted for consistency, either addressing the frequency of pin site care, the cleansing agent, or the type of dressing, respectively. Further, when reporting results as many details as possible should be given such as the time of the first dressing, time of the follow-up, as well as adequate details of the surgical procedure and the patient collective including possible risk factors. In addition, the type of pins used should be given, as for instance, advances in antimicrobial coating can further influence the prevention of pin site infections.[47]
In conclusion, the literature on pin site care is heterogeneous, and a consensus on the optimal dressing to reduce infection rates is still missing. Thus, no recommendation can be drawn regarding the optimal cleansing solution and dressing type. However, based on this review, a benefit of pin site care compared to no pin site care is suggested. Further, minimal pin care was not associated with significantly worse outcomes, and hence, the need of laborious protocols including frequent cleaning or the use of antimicrobial agents remains questionable.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
REFERENCES
1. Lally P, Seligson D, Stanwyck TS. The new challenges of physical therapy for external fixation treatment of fractures* J Orthop Sports Phys Ther. 1981;2:171–6
2. Ktistakis I, Guerado E, Giannoudis PV. Pin-site care: Can we reduce the incidence of infections? Injury. 2015;46(Suppl 3):S35–9
3. Combs K, Frick S, Kiebzak G. Multicenter study of pin site infections and skin complications following pinning of pediatric supracondylar humerus fractures Cureus. 2016;8:e911
4. McKenzie JC, Rogero RG, Khawam S, McDonald EL, Nicholson K, Shakked RJ, et al Incidence and risk factors for pin site infection of exposed kirschner wires following elective forefoot surgery Foot Ankle Int. 2019;40:1154–9
5. Hsu LP, Schwartz EG, Kalainov DM, Chen F, Makowiec RL. Complications of K-wire fixation in procedures involving the hand and wrist J Hand Surg Am. 2011;36:610–6
6. Bue M, Bjarnason AÓ, Rölfing JD, Larsen K, Petruskevicius J. Prospective evaluation of pin site infections in 39 patients treated with external ring fixation J Bone Jt Infect. 2021;6:135–40
7. Parameswaran AD, Roberts CS, Seligson D, Voor M. Pin tract infection with contemporary external fixation: How much of a problem? J Orthop Trauma. 2003;17:503–7
8. Antoci V, Ono CM, Antoci V Jr., Raney EM. Pin-tract infection during limb lengthening using external fixation Am J Orthop (Belle Mead NJ). 2008;37:E150–4
9. Checketts RG, MacEachem AG, Otterbum MBastiani Gde, Apley AG, Goldberg A. Pin Track Infection and the Principles of Pin Site Care Orthofix External Fixation in Trauma and Orthopaedics. 2000 London Springer London:97–103
10. Timms A, Pugh H. Pin site care: Guidance and key recommendations Nurs Stand. 2012;27:50–5
11. Walker JA, Scammell BE, Bayston R. A web-based survey to identify current practice in skeletal pin site management Int Wound J. 2018;15:250–7
12. Limb AT. Pin site care: Guidance and key recommendations Nurs Stand. 2012;27:50–6
13. Campbell F, Watt E. An exploration of nursing practices related to care of orthopaedic external fixators (pin/wire sites) in the Australian context Int J Orthop Trauma Nurs. 2020;36:100711
14. Camathias C, Valderrabano V, Oberli H. Routine pin tract care in external fixation is unnecessary: A randomised, prospective, blinded controlled study Injury. 2012;43:1969–73
15. Kao HK, Chen MC, Lee WC, Yang WE, Chang CH. A prospective comparative study of pin site infection in pediatric supracondylar humeral fractures: Daily pin care versus. No pin care Arch Orthop Trauma Surg. 2014;134:919–23
16. Kazmers NH, Fragomen AT, Rozbruch SR. Prevention of pin site infection in external fixation: A review of the literature Strategies Trauma Limb Reconstr. 2016;11:75–85
17. Lethaby A, Temple J, Santy-Tomlinson J. Pin site care for preventing infections associated with external bone fixators and pins Cochrane Database Syst Rev. 2013;3:CD004551 PMID: 24302374
18. Egol KA, Paksima N, Puopolo S, Klugman J, Hiebert R, Koval KJ. Treatment of external fixation pins about the wrist: A prospective, randomized trial J Bone Joint Surg Am. 2006;88:349–54
19. Henry C. Pin sites: Do we need to clean them? Pract Nur. 1996;7:12–7
20. Patterson MM. Multicenter pin care study Orthop Nurs. 2005;24:349–60
21. Lethaby A, Temple J, Santy J. Pin site care for preventing infections associated with external bone fixators and pins. Cochrane Database Syst Rev. 2008;8. doi: 10.1002/14651858.CD004551.pub2 Update in: Cochrane Database Syst Rev. 2013;12:CD004551 PMID: 18843660
22. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al The PRISMA 2020 statement: An updated guideline for reporting systematic reviews Syst Rev. 2021;10:89
23. W-Dahl A, Toksvig-Larsen S, Lindstrand A. No difference between daily and weekly pin site care: A randomized study of 50 patients with external fixation Acta Orthop Scand. 2003;74:704–8
24. W-Dahl A, Toksvig-Larsen S. Pin site care in external fixation sodium chloride or chlorhexidine solution as a cleansing agent Arch Orthop Trauma Surg. 2004;124:555–8
25. Davies R, Holt N, Nayagam S. The care of pin sites with external fixation J Bone Joint Surg Br. 2005;87:716–9
26. Camilo AM, Bongiovanni JC. Evaluation of effectiveness of 10% polyvinylpyrrolidone-iodine solution against infections in wire and pin holes for Ilizarov external fixators Sao Paulo Med J. 2005;123:58–61
27. Grant S, Kerr D, Wallis M, Pitchford D. Comparison of povidone-iodine solution and soft white paraffin ointment in the management of skeletal pin-sites: A pilot study J Orthop Nurs. 2005;9:218–25
28. Cavusoglu AT, Er MS, Inal S, Ozsoy MH, Dincel VE, Sakaogullari A. Pin site care during circular external fixation using two different protocols J Orthop Trauma. 2009;23:724–30
29. Chan CK, Saw A, Kwan MK, Karina R. Diluted povidone-iodine versus saline for dressing metal-skin interfaces in external fixation J Orthop Surg (Hong Kong). 2009;17:19–22
30. Ogbemudia AO, Bafor A, Edomwonyi E, Enemudo R. Prevalence of pin tract infection: The role of combined silver sulphadiazine and chlorhexidine dressing Niger J Clin Pract. 2010;13:268–71
31. Yuenyongviwat V, Tangtrakulwanich B. Prevalence of pin-site infection: The comparison between silver sulfadiazine and dry dressing among open tibial fracture patients J Med Assoc Thai. 2011;94:566–9
32. Lee CK, Chua YP, Saw A. Antimicrobial gauze as a dressing reduces pin site infection: A randomized controlled trial Clin Orthop Relat Res. 2012;470:610–5
33. Britten S, Ghoz A, Duffield B, Giannoudis PV. Ilizarov fixator pin site care: The role of crusts in the prevention of infection Injury. 2013;44:1275–8
34. Kazi HA, de Matas M, Pillay R. Reduction of halo pin site morbidity with a new pin care regimen Asian Spine J. 2013;7:91–5
35. Cam R, Korkmaz FD. The effect of long-term care and follow-up on complications in patients with external fixators Int J Nurs Pract. 2014;20:89–96
36. Lu D, Wang T, Chen H, Sun LJ. Management of pin tract infection in pediatric supracondylar humerus fractures: A comparative study of three methods Eur J Pediatr. 2017;176:615–20
37. Lazarides AL, Hamid KS, Kerzner MS. Novel use of active leptospermum honey for ringed fixator pin site care in diabetic charcot deformity patients Foot Ankle Spec. 2018;11:117–22
38. Subramanyam KN, Mundargi AV, Potarlanka R, Khanchandani P. No role for antiseptics in routine pin site care in Ilizarov fixators: A randomised prospective single blinded control study Injury. 2019;50:770–6
39. Ferguson D, Harwood P, Allgar V, Roy A, Foster P, Taylor M, et al The PINS trial: A prospective randomized clinical trial comparing a traditional versus an emollient skincare regimen for the care of pin-sites in patients with circular frames Bone Joint J. 2021:103–85–B:279–85–B
40. Sterne JA, Hernán MA, Reeves BC, Savović J, Berkman ND, Viswanathan M, et al ROBINS-I: A tool for assessing risk of bias in non-randomised studies of interventions BMJ. 2016;355:i4919
41. Thomas BH, Ciliska D, Dobbins M, Micucci S. A process for systematically reviewing the literature: Providing the research evidence for public health nursing interventions Worldviews Evid Based Nurs. 2004;1:176–84
42. Longo UG, Rizzello G, Loppini M, Locher J, Buchmann S, Maffulli N, et al Multidirectional instability of the shoulder: A systematic review Arthroscopy. 2015;31:2431–43
43. Coleman BD, Khan KM, Maffulli N, Cook JL, Wark JD. Studies of surgical outcome after patellar tendinopathy: Clinical significance of methodological deficiencies and guidelines for future studies. Victorian Institute of Sport Tendon Study Group Scand J Med Sci Sports. 2000;10:2–11
44. Williams H, Griffiths P. The effectiveness of pin site care for patients with external fixators Br J Community Nurs. 2004;9:206–10
45. Temple J, Santy J. Pin site care for preventing infections associated with external bone fixators and pins Cochrane Database Syst Rev. 2004
46. Georgiades DS. A systematic integrative review of pin site crusts Orthop Nurs. 2018;37:36–42
47. Akilapa O, Gaffey A. Hydroxyapatite pins for external fixation: Is there sufficient evidence to prove that coated pins are less likely to be replaced prematurely? Acta Orthop Traumatol Turc. 2015;49:410–5
