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 Table of Contents  
SYSTEMATIC REVIEW
Year : 2022  |  Volume : 8  |  Issue : 3  |  Page : 44-50

Do pin site cleaning techniques and solutions affect pin site infection rate in external fixation? A systematic review of randomized and nonrandomized trials


1 Department of Trauma and Orthopaedics, James Cook University Hospital, Middlesbrough, England
2 Department of Radiology, University Hospital of North Durham, Durham, England
3 Department of Health Sciences, Clinical Trials Unit, University of York, Heslington, England

Date of Submission11-Apr-2022
Date of Decision26-May-2022
Date of Acceptance27-Jul-2022
Date of Web Publication12-Oct-2022

Correspondence Address:
William Eardley
Department of Trauma and Orthopaedics, James Cook University Hospital, Middlesbrough; University of York CTU, Heslington
England
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jllr.jllr_9_22

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  Abstract 


Introduction: Infection at the pin site connecting an external fixator to the limb is a common and potentially serious complication of frame treatment. Impacted by many patient and injury factors, further variables exist in terms of the way in which pin sites are cared for. Timing and techniques used to clean pin sites vary substantially and are an attractive domain in which to intervene to decrease infection due to the extent of the associated complications and number of patients involved. Through this review, we explore the impact of cleaning techniques and solutions on pin site infection. Methodology: A systematic literature review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. PubMed, MEDLINE, Cochrane Controlled Trials Register (1996–2022), and EMBASE (1974–2022) were searched in January 2022. Results: Thirty-two articles were identified and following eligibility criteria application 14 studies were analyzed. Nine hundred and fourteen adult and child patients undergoing external fixation treatment 2003–2021 in 12 countries were included. Nine studies used an outcome measure and of these, five different outcome measures were used. The literature was graded as having either some or high concerns of bias. No pooling of data was enabled. Discussion: The literature investigating variables impacting on pin site care in terms of solutions used, technique, and timing of care is poor. Variance in methodology, populations compared, interventions, and outcomes preclude meaningful analysis or conclusions. In particular, the lack of consensus on diagnosis and classification compromises studies relating to this question. Conclusions: Pin site infection is a significant issue in patients undergoing external fixation. The available literature cannot be used to guide care. We strongly recommend a consensus is derived on methodology for studies investigating pin site care. A well-designed randomized controlled trial would carry huge value due to the numbers of patients whose care could be improved through a reduction in pin site infection. Objective: To estimate the impact of pin site cleaning techniques and solutions in preventing pin site infection in patients treated with external fixation. The question which this systematic review address is: “Does pin site cleaning techniques and solutions affect pin site infection rate in external fixation?”

Keywords: External fixation, infection, pin site


How to cite this article:
Ferguson D, Dixon J, Eardley W. Do pin site cleaning techniques and solutions affect pin site infection rate in external fixation? A systematic review of randomized and nonrandomized trials. J Limb Lengthen Reconstr 2022;8, Suppl S1:44-50

How to cite this URL:
Ferguson D, Dixon J, Eardley W. Do pin site cleaning techniques and solutions affect pin site infection rate in external fixation? A systematic review of randomized and nonrandomized trials. J Limb Lengthen Reconstr [serial online] 2022 [cited 2023 Jan 29];8, Suppl S1:44-50. Available from: https://www.jlimblengthrecon.org/text.asp?2022/8/3/44/358265




  Introduction Top


External fixation of limbs is a common feature of orthopedic care globally. It is used in acute care and also in planned, late correction of deformity or in the management of infection.[1] The field of external fixation is impacted by multiple variables including the surgical technique and mechanics of the frame applied, the underlying injury or disease, and the individual to which the frame is applied. Pin site complications threaten the ability of the frame to provide the biomechanical conditions required for its applied role. In addition to threatening the delivery of planned outcome for the limb, pin site infection poses a considerable burden on the patient and on the frame service delivering their care.[2] How the patient and their carers interact with the pin site environment will impact on the likelihood of complications and hence the success of their treatment. There are therefore multiple areas of potential improvement and questions to be addressed to optimize care.[3] The 2018 international consensus meeting on fracture-related infections identified through the Delphi process the management of external fixation hardware in relation to infection prevention as a key area lacking evidence.[4]

The regime of pin site care – that undertaking between the patient, their clinicians and the frame with regards cleaning and solutions applied to the skin-pin interface and how the pins are dressed is central to this. Put simply, the pin site is a focus for the survival of the whole patient-frame interface. Techniques for cleaning and the impact of solutions applied are the subject of this review and the rationale stems from the key role the pin site plays in the overall outcome for patient and frame service. The study of pin site care, therefore, is one of the key areas within priorities in frame care knowledge due to the pivotal role the pin site plays in the longevity of the applied frame.[2],[3],[4] This is the rationale for the study question and the subsequent review.


  Methodology Top


A systematic literature review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.[5] PubMed, MEDLINE, Cochrane Controlled Trials Register (1996–2022), and EMBASE (1974–2022) online databases were searched in January 2022. Additional studies were identified by searching bibliographies and abstracts presented at society meetings archived by the Bone and Joint Journal Proceedings (2002–2022).

Eligibility was determined through the PICO framework with the population being adults and children undergoing external fixation treatment.[6] Intervention and comparison being timing and techniques of care with focus on solutions used in cleaning pins.

Clinical studies in English reporting on patients undergoing pin site care with external fixation constructs were included. Trials without comparators were also included. Any age, gender, and indication for management were considered. Preclinical studies were excluded.

In accordance with the PICO framework, search terms were specific to external fixation, pin site, and solutions used to clean pin sites. “External fixator” and “Circular frame” and “pin site” were searched, along with synonyms and variants. Solution terms including “iodine,” “chlorhexidine,” “alcohol” and “topical anti-infective agent” as well as variants of these [Supplementary Material for full search method 1].

The outcome analyzed was any reported outcomes relating to pin site infection. The study designs included were randomized controlled trials, nonrandomized or observational studies, and case series. Data was extracted independently by two authors (W. E, J. D) using predefined data fields drawn from the Risk of Bias 2 (ROB-2) and Jadad tools to assess ROB.[7],[8]

A narrative synthesis together with a tabulation of study characteristics and results was undertaken. Intervention and control characteristics were described including cleaning fluid utilized and timing where noted. The key subgroups of interest were the fluid used to clean pin sites, the timing (frequency) of pin site care, the identification (classification), and incidence of infection.


  Results Top


Thirty-two articles were identified from the searches performed [Supplementary Material 2]. The removal of duplicates and eligibility criteria filters led to 14 articles being analyzed [Figure 1].
Figure 1: Flow chart illustrating search strategy and study inclusion

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These 14 articles reported on 914 patients (mean 62.5, 18–128) undergoing external fixation treatment 2003–2021 in 12 countries. The nature of the studies is detailed in [Table 1]. There were seven different clinical populations studied and four devices used across the articles. The most commonly applied external fixators were ilizarov circular frames (4 studies), and pin-to-bar external fixators (6 studies). Five studies investigated chlorhexidine, five investigated povidone-iodine, and three investigated sulfadiazine.
Table 1: Study characteristics and outcomes

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Ten articles were reported on adult patients only. Four included both adults and children and the average age across the population studied was 41.7 years. Ten studies involved some form of randomization of participants. Nine studies reported an outcome measure and of these nine, five different outcome measures were used, the most common being Checketts–Otterburns, utilized in grading pin site infections.

Three studies investigated time as a variable, the remainder all reported on pin site cleaning technique interventions. Pin site infections occurred in all studies with a range reported of 15%–55%.

The nature of the studies precluded any pooling of data or further analysis.

All but two of the studies reviewed had some concern or high ROB as assessed using ROB-2. For 3 of the 14 studies – reviewers recorded different outcomes – in all 3 of these cases one reviewer recorded high risk and the other some concern. In these cases, the higher risk is recorded in [Table 2].
Table 2: Risk of Bias in included studies

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  Discussion Top


The interface between the limb and any external fixation device applied to it can be likened to a challenging relationship. The bone-skin interface is affected by a milieu of environmental, temporal, physical and biological factors. The relationship however is unique and this exclusivity is fundamental to the fact that pin site care is one of the least standardized areas of orthopedic care. This special situation derives from the number of variables at play that impacts on the compound environment, both physical and biological at the pin site.

The literature is replete with suggested pin site regimes and attempts to guide this most important element of “frame maintenance.” As with any evidence base, the cycle of repeated re-evaluation and attempts to produce the “definitive answer” reveal this area of care as one for flexible bespoke interpretation, not dogmatic application of uniform practice. Our patients, our frames, and the skin and bone onto which we place them are different and this demands some flexibility in the interpretation of guidance and judicious clinical judgment.

Our question is: “Do pin site cleaning techniques and solutions affect pin site infection rate in external fixation?” Our standard searches identified articles relevant to this question and our screening processes resulted in 14 full-text articles being assessed.[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22]

The quality of the literature available to answer this question is overall poor, predominantly through either lack of generalisability (too specific a population studied), heterogeneity in study design, and reporting. Equally ROB is significant across many of the studies included. Methodological flaws characterize several of the manuscripts and this is compounded by on average, low patient numbers that in isolation preclude meaningful statistical analysis. This is not a finding unique to this work. Previous studies attempting a systematic review of the broader elements of pin site infections of which our question is one facet encountered similar difficulty.

Kazmers et al. summarized that it is unclear whether cleansing pin sites is necessary to reduce the risk of infection and also that it is unclear as to which cleaning solution produces improved outcome.[23] Illustrating the difficulties experienced in completing this review, Kazmers et al. found that any attempt at pooling data from studies detailing pin site infection was unfeasible due to the extreme degree of heterogeneity seen across retrieved manuscripts.[24]

Across all studies analyzed, significant flaws were found precluding meaningful pooled analysis. Randomization techniques are poorly reported. Lack of blinding is a threat in all retrieved manuscripts. Lack of standardization of cleaning regimes and lack of reporting of compliance with patient-delivered cleaning outside of the hospital environment again is a significant threat to the results reported. It is unclear how compliance impacts on the results of any of the studies and there is little or no standardization in care.

Some studies randomize patients to intervention and others randomize individual pin sites within external fixation constructs. Again, this further inability to standardize intervention allocation and administration is another confounding variable that precludes comparison of studies.

On first reading, it may seem that there is uniformity in some of the antiseptic solutions with many regimes using normal saline, povidone-iodine, or chlorhexidine. Unfortunately, within each agent, the dilution used and resultant concentration of the antiseptic is significantly different. Chlorhexidine for example is used in several studies however its concentration varies from 0.5% to 2% and in some instances 5%. There is variance within solutions therefore as well as between solutions.

Understanding what is a difference that is both true but is also of clinical significance is the goal for clinical trials. Heterogeneity again is a significant feature in this domain. Central to establishing the effect of an intervention, unfortunately in several of the trials included in this work, the chosen change in outcome differs considerably. Egol et al. used a complication rate (pin site infection) of 5% W-Dahl et al. used 20% as significant.[15],[19],[20] Ogbemudia however in a study predominantly including pin to bar fixators used a 25% reduction in the prevalence of pin tract infection as a minimal clinically significant difference.[14] This 20% spread of difference used to detect clinical significance indicates the huge heterogeneity in methods used when comparing similar interventions.

The most critical area of poor methodology in these studies and that which prevents any meaningful further discussion of results is in the diagnosis and classification (or grading) of pin site infection. A significant source of heterogeneity, a threat to comparison or pooling, and an area of bias, this feature of pin site care assessment and reporting is the most fundamental of all flaws affecting this work. In essence, the manner in which observers decide a pin site to be infected differs across studies. Even when a system such as that of Checketts et al. is used, it is acknowledged that this is entirely subjective.[24] We are not aware of any assessment of inter or intraobserver error in its use and this is another threat to the interpretation of the results generated. Failure to reproducibly and quantitatively diagnose and grade pin site infection threatens the validity of all studies attempting to assess the impact of cleaning techniques and solutions on pin site infection.

Further issues with the study methodology can be found. Antibiotic administration is heterogeneous across all analyzed articles. Timing of administration, nature of administration, antibiotic used, and the duration prescribed all differ. In some studies, a single agent was administered only at the time of surgery. In others, oral antibiotics are administered for several days and in yet others, intravenous prolonged courses are used.

The impact of antibiotics on external fixator pin site infection is unclear. Intuitively, it would be presumed that the administration of antibiotics after external fixator application would reduce infection in pin sites however this may not be the case. Regardless, the variance seen in antibiotic regimes is a significant confounding variable when investigating the impact of cleaning fluids or timing of pin site care. The solutions under comparison are not the only variables and as we have seen may also differ in concentration by a factor of ten.

What is homogeneous across all studies is minimal loss to follow-up and near total reported compliance with the assigned intervention. In some studies (Camathias), the patients were kept in the hospital for the duration of treatment and so compliance with nurse-delivered pin site intervention was total.[21] The majority of other studies demonstrated minimal loss to follow-up and minimal missing data. This is in part to be expected with the patient group and clinical situation. Pin site care is often termed a “regime” and regular interactions and intense clinician/patient contact is the norm. This situation is reflected in the minimal loss to follow-up and excellent data completeness.

We have demonstrated in this work the inability to use existing literature to guide pin site care. We cannot answer the question: Does pin site cleaning techniques and solutions affect pin site infection rate in external fixation? The existing literature both in isolation and when viewed as a whole is too heterogeneous and lacks consensus to enable an answer to be constructed.

We have demonstrated that the external fixation population are easy to study in terms of minimal loss to follow-up and data completeness of all studies exceeding that of most clinical trials. Aside from this, however, producing high-quality comparative work in this population is plagued with the subjective assessment and reporting of infection and inflammatory change seen at the pin bone interface. We suggest that more pragmatic outcome assessments such as patient-related pain outcomes and unplanned antibiotic prescription or attendance in the operating room for infection be used with large number studies utilizing a common injury/illness population. Study of a stated population such as adults sustaining closed or open lower limb injuries treated with circular frames using an agreed minimally clinically significant difference and unified antibiotic policy would be noteworthy. Compliance assessment with pin site care and assessed competency and frequency/compliance measurement must also feature. Similarly, the utilization of comparator antiseptics of the same concentration would also work toward addressing the methodological flaws seen in this work.


  Conclusions Top


We cannot answer the question we embarked on but are in a better position to understand what is required to do so.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.


  Supplementary Material Top





  Supplementary Material EMBASE Search Method 2: Top


Database:

[email protected] Full Text <February 04, 2022>

Embase <1974 to 2022 February 04>

# Query Results from 7 Feb 2022

1 exp External Fixator/ 6,987

2 exp detergent/ 17,946

3 exp SOAP/ 4,674

4 exp Alcohol Derivative/ 500,870

5 exp IODINE/ 27,898

6 exp Iodophor/ 753

7 exp Povidone Iodine/ 11,707

8 exp CHLORHEXIDINE/ 19,568

9 exp Disinfectant Agent/ 512,427

10 exp Topical Antiinfective Agent/ 639,562

11 exp Sodium Chloride/ 203,317

12 pin$ infection.ti, ab. 266

13 ((pin-site or pinsite or pin-tract or pintract or half pin or half-pin or wire-site or wire site) adj2 (infection or care)).ti, ab. 1,063

14 1 and 13 295

15 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 1,043,446

16 14 and 15 15

exp External Fixator

exp detergent

exp SOAP

exp Alcohol Derivative

exp IODINE

exp Iodophor

exp Povidone Iodine

exp CHLORHEXIDINE

exp Disinfectant Agent

exp Topical Antiinfective Agent

exp Sodium Chloride

pin$ infection.ti, ab.

((pin-site or pinsite or pin-tract or pintract or half pin or half-pin or wire-site or wire site) adj2 (infection or care)).ti, ab.

1 and 13

2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11

14 and 15



 
  References Top

1.
Fragomen AT, Rozbruch SR. The mechanics of external fixation. HSS J 2007;3:13-29.  Back to cited text no. 1
    
2.
Ferreira N, Marais LC. Prevention and management of external fixator pin track sepsis. Strategies Trauma Limb Reconstr 2012;7:67-72.  Back to cited text no. 2
    
3.
Ktistakis I, Guerado E, Giannoudis PV. Pin-site care: Can we reduce the incidence of infections? Injury 2015;46 Suppl 3:S35-9.  Back to cited text no. 3
    
4.
Obremskey WT, Metsemakers WJ, Schlatterer DR, Tetsworth K, Egol K, Kates S, et al. Musculoskeletal infection in orthopaedic trauma: Assessment of the 2018 international consensus meeting on musculoskeletal infection. J Bone Joint Surg Am 2020;102:e44.  Back to cited text no. 4
    
5.
Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. PLoS Med 2009;6:e1000097.  Back to cited text no. 5
    
6.
Schardt C, Adams MB, Owens T, Keitz S, Fontelo P. Utilization of the PICO framework to improve searching PubMed for clinical questions. BMC Med Inform Decis Mak 2007;7:16.  Back to cited text no. 6
    
7.
Sterne JA, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: A revised tool for assessing risk of bias in randomised trials. BMJ 2019;366:l4898.  Back to cited text no. 7
    
8.
Clark HD, Wells GA, Huët C, McAlister FA, Salmi LR, Fergusson D, et al. Assessing the quality of randomized trials: Reliability of the Jadad scale. Control Clin Trials 1999;20:448-52.  Back to cited text no. 8
    
9.
Sáenz-Jalón M, Sarabia-Cobo CM, Roscales Bartolome E, Santiago Fernández M, Vélez B, Escudero M, et al. A randomized clinical trial on the use of antiseptic solutions for the Pin-Site Care of External Fixators: Chlorhexidine-alcohol versus povidone-iodine. J Trauma Nurs 2020;27:146-50.  Back to cited text no. 9
    
10.
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-B: 279-85.  Back to cited text no. 10
    
11.
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.  Back to cited text no. 11
    
12.
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.  Back to cited text no. 12
    
13.
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.  Back to cited text no. 13
    
14.
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.  Back to cited text no. 14
[PUBMED]  [Full text]  
15.
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.  Back to cited text no. 15
    
16.
Jansen MP, van Egmond N, Kester EC, Mastbergen SC, Lafeber FP, Custers RJ. Reduction of pin tract infections during external fixation using cadexomer iodine. J Exp Orthop 2020;7:88.  Back to cited text no. 16
    
17.
Cam R, Demir Korkmaz F, Oner Şavk S. Effects of two different solutions used in pin site care on the development of infection. Acta Orthop Traumatol Turc 2014;48:80-5.  Back to cited text no. 17
    
18.
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.  Back to cited text no. 18
    
19.
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.  Back to cited text no. 19
    
20.
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.  Back to cited text no. 20
    
21.
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.  Back to cited text no. 21
    
22.
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.  Back to cited text no. 22
    
23.
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.  Back to cited text no. 23
    
24.
Checketts RG, Maceachem AG, Otterbum M. Pin track infection and the principles of pin site care. In: Orthofix External Fixation in Trauma and Orthopaedics. London: Springer; 2000. p. 97-103.  Back to cited text no. 24
    


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