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| SYSTEMATIC REVIEW |
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| Year : 2022 | Volume
: 8
| Issue : 3 | Page : 59-68 |
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Current classifications of pin site infection and quality of reporting: A systematic review
Alexis Dimitris Iliadis1, David William Shields2, Bilal Jamal2, Nima Heidari3
1 Limb Reconstruction and Bone Infection Service, The Royal London Hospital, Barts Health NHS Trust, London, UK
2 Department of Trauma and Orthopaedics, Queen Elizabeth University Hospital, Glasgow, Scotland, UK
3 Limb Reconstruction and Bone Infection Service, The Royal London Hospital, Barts Health NHS Trust, London, UK; George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, Targu Mures, Romania
| Date of Submission | 18-Oct-2021 |
| Date of Decision | 23-Mar-2022 |
| Date of Acceptance | 01-Aug-2022 |
| Date of Web Publication | 12-Oct-2022 |
Correspondence Address:
Alexis Dimitris Iliadis
Limb Reconstruction and Bone Infection Service, The Royal London Hospital, Barts Health NHS Trust, London
UK
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/jllr.jllr_31_21
Introduction: Pin site infection is a commonly encountered complication. There is no universally accepted definition or classification system which impairs data interpretation and the development of evidence-based practice. The aim of this systematic review is to investigate the existing classification systems and the quality of reporting pin site infections in the current literature. Materials and Methods: The systematic review protocol was prospectively registered (PROSPERO; National Institute for Health Research and University of York, 2015) and conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. A comprehensive search strategy was executed. Data were extracted pertaining to clinical, radiological, microbiological, and mechanical elements alongside associated grading and demographics. The scope of the classification systems was considered. Results: Twelve reports of classifications were included in the synthesis. Four classifications provide information for guiding decision-making and management while the remainder are descriptive or informative in nature. There is no classification with prognostic inference. Four of the classifications can only be applied retrospectively as they are outcome derived. Staging relies on a single variable in six of the classifications. It relies on multiple variables (maximum of four) in the remainder. Conclusion: There is a lack of a clear definition of pin site infection and a lack of a universally accepted grading system. Existing classifications focus on different aspects and have a number of limitations. Establishing standard reporting guidelines will allow for future development of a meaningful and universally accepted definition and classification.
Keywords: Classification, definition, infection, Pin site, pin track, scoring, staging
How to cite this article:
Iliadis AD, Shields DW, Jamal B, Heidari N. Current classifications of pin site infection and quality of reporting: A systematic review. J Limb Lengthen Reconstr 2022;8, Suppl S1:59-68 |
How to cite this URL:
Iliadis AD, Shields DW, Jamal B, Heidari N. Current classifications of pin site infection and quality of reporting: A systematic review. J Limb Lengthen Reconstr [serial online] 2022 [cited 2023 Jan 29];8, Suppl S1:59-68. Available from: https://www.jlimblengthrecon.org/text.asp?2022/8/3/59/358260 |
| Introduction | |  |
Pin site infection is a common complication of external skeletal fixation devices and places a significant burden on the patient and health-care system.[1] There is a great discrepancy in reported incidence ranging from 1% to as high as 100%.[2],[3],[4] There has been extensive research on this commonly encountered complication, with different studies focusing on the pathophysiology,[5],[6] optimal pin design,[7] surgical techniques,[8],[9],[10] postoperative care protocols,[11],[12],[13],[14] and management strategies.[1],[3],[15],[16]
There is currently, however, no universally accepted definition for pin site infection.[1],[2],[3],[13] Authors have previously provided broad definitions such as signs and symptoms of infection around a pin or wire which required increasing the frequency of local cleansing, protecting the pin site with dressing, using an oral or intravenous antibiotic, removing the pin or wire, or performing surgical debridement.[5],[6] Others have adopted the criterion of the presence of purulent exudate for defining the presence of infection,[17] whereas others the presence of pain, redness, swelling, and culturing of a significant number of pathogenic bacteria.[18]
Many authors have developed classification systems,[11],[19],[20],[21],[22],[23],[24],[25],[26],[27],[28],[29] some of which have been used in subsequent literature. Their validity/reliability and reproducibility have not been established and as a result, none have become universally accepted.[3],[12],[30]
The lack of an established reporting system impairs data interpretation and poses further challenges in advancing our understanding and determining optimal management strategies for this commonly encountered complication. Inconsistencies in definition impair the ability to determine the true incidence of this complication as well as complicate the process of determining the accuracy of interventions.[4],[13]
The pin site consensus group,[31] has been working to determine and develop international standards in pin site management and to produce a consensus document to help improve clinical management and inform further research. Utilizing a modified Delphi approach, and following two surveys, the top ten priorities in pin site management have been identified and this systematic review has been invited to address one of them.
The aim of this systematic review is to investigate the existing classification systems and the quality of reporting pin site infections in the current literature. The intended applicability in clinical practice and the variables utilized by these systems will be examined.
| Materials and Methods | | |
Search Strategy and Electronic Resources
Following preliminary literature searches, relevant search terms were identified. These included “pin site,” “pin-site,” “pinsite,” “infection,” “staging,” “scoring,” and “classification.” A comprehensive search strategy, outlined in [Figure 1], was executed on the “MEDLINE® (1946 to September 29, 2021), Embase (1980–2021 Week 39), and “Cochrane Central Register of Controlled Trials” databases. The systematic review protocol was submitted for publication in advance on the International Prospective Register of Systematic Reviews (PROSPERO; National Institute for Health Research and University of York, 2015) and is open to access.[32]
A snowballing exercise was undertaken to identify additional studies through references and conference abstracts. We considered any publication from the inception of queried databases, through to the search date. The search results were restricted to the English language and deduplicated giving a finite body of literature which underwent title, abstract, and full paper screening by two authors (DS/AI).
Selection criteria
Manuscripts reporting on pin site infections in adult and pediatric patients undergoing treatment for orthopedic pathologies with external fixation devices were considered. In vitro and animal studies were excluded as were any reports solely involving treatment of deep infection.
Manuscripts proposing and/or evaluating a new or significantly modified classification system for pin site infection were included. Those that did not utilize a classification system to report were excluded, as were those utilizing a classification system that has been previously described. All levels of evidence were included with the exception of case reports.
Data extraction
Data were extracted using a prepilot method to ascertain information pertaining to the clinical, radiological, microbiological, and mechanical elements of each classification alongside associated grading and demographics. The scope of the classification systems (descriptive vs. prescriptive) was also considered.
| Results | | |
Study selection
Our study flow, utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses[33] is outlined in [Figure 2]. The search strategy returned 705 results, which after deduplication, language limitation, and additional resources resulted in 664 citations for review. Following the screening, 12 reports of classifications were identified and included in the synthesis and these are shown in [Table 1].
Study demographics
Eight of the studies[11],[20],[21],[22],[23],[27],[28],[29] describe the classification system in relation to a patient cohort with the mean number of patients being 55 (range 13–110). The rest of the studies describe a classification as part of a literature review,[25] a multisite survey,[24] or a specialist opinion.[26] Green[19] retrospectively applied their classification to a cohort of 1394 patients from the studies included in their review.
Purpose of classification
Four of the reviewed classifications[20],[23],[24],[26] provide information-guiding clinical decision-making and subsequent management. The rest are descriptive or informative in nature. There is no classification with prognostic inference. Four of the classifications[19],[22],[25],[26] rely on outcomes for determining the stage and therefore provide a retrospective classification for descriptive and communication purposes. Three of the classifications are aimed at monitoring pin site state and alerting patients, carers, and clinicians.[11],[28],[29]
Variables included
There are six classifications that rely on a single variable[19],[21],[22],[25],[28],[29] to determine the grading. Green[19] considered the need for hospitalization to classify into minor or major. Saleh and Scott[22] and Ward[25] graded infection based on response to treatment. Mahan et al.[21] and Clint et al.[28] relied on clinical signs and symptoms, whereas Santy-Tomlinson et al.[29] relied on patient-reported outcomes.
There are four classifications that rely on two variables.[11],[20],[23],[27] Three of these rely on clinical signs and symptoms as well as radiological signs.[20],[23],[27] Patterson[11] considered clinical and mechanical factors.
One classification system included three variables with the authors including clinical, radiological, and mechanical variables toward grading.[24]
The Checketts–Otterburn classification[26] relies on clinical signs and symptoms, radiological signs, mechanical factors, and outcomes and is, therefore, the only one to consider four variables.
Clinical signs and symptoms
Nine out of the eleven manuscripts[11],[19],[20],[21],[22],[23],[24],[26],[27],[28],[29] consider clinical signs and symptoms as the main variable for classification. Signs and symptoms of erythema, tenderness, swelling, and discharge (serous or purulent) are considered as representing the whole spectrum of manifestation of problems at the pin–soft tissue interface ranging from foreign body reaction to inflammation and infection. All of these classifications consider these with regard to clinician-derived observations, with the exception of Santy-Tomlinson et al.[29] which considers patient and carer observations.
Outcomes
Four of the classifications[19],[22],[25],[26] rely on established outcomes to determine the grading.
Radiological signs
Five classifications[20],[23],[24],[25],[26],[27] use radiological signs of osteolysis and ring sequestrum toward defining high grades of infection with bone involvement.
Mechanical factors
Three classifications[11],[24],[26] consider pin loosening as a variable toward grading.
Other factors
None of the classification systems reviewed, considers microbiology results, host factors, and mechanical factors other than pin loosening (such as mode of treatment and stability of construct) in grading pin site infection. No classification system objectively considers the host status in estimating the presence or magnitude of pin site infection.
| Discussion | | |
This systematic review of the literature has identified 12 classification systems that have been described and utilized to report pin site infection in external fixation constructs. On reviewing these classification systems, it is evident that they have been developed by considering different variables and for different purposes.
Green[19] described a binary outcome-derived classification system where the only variable under consideration is the need for hospitalization for the resolution of infection. Following a literature review, the authors included 21 studies published over the previous four decades and retrospectively applied their classification on 1394 patients. They commented on the stable rates of infection reported over this extensive period. The authors recognized the potential limitation in this classification whereby minor infections can be significantly underreported. Furthermore, such an approach lacks a prescriptive component that allows clinicians to manage infection based on different grades. In a similar manner, Ward[25] proposed a dichotomous outcome-derived classification system based on the need for pin removal for the resolution of infection.
Saleh and Scott[22] also utilized an outcome-based approach toward the grading of infection. The authors do not take into consideration clinical signs and symptoms but focus on response to treatment to establish the grade. There has been previous criticism of such an approach as it may be useful for reporting outcomes but precludes a proactive clinician approach to managing infection.[24]
Paley in his landmark paper[30] provided a classification for all the difficulties that can potentially arise during the process of limb lengthening by the Ilizarov technique. Problems represent difficulties that resolve without surgical intervention, obstacles are those that require further surgical intervention and complications that persisted at the end of treatment. He describes how this system can be applied to classify pin site difficulties. Furthermore, Paley described a three-grade classification system for pin site difficulties taking into consideration soft tissue and bony involvement and providing recommendations as to the appropriate management of these. The author describes purulent discharge from the pin site as the distinguishing criterion between Grade 1 and Grade 2. A Grade 1 infection is therefore refers to an inflammatory process and this raises issues with regard to outcome reporting.
Mahan et al.[21] introduced a summary inflammation score based on the presence of signs and symptoms of tenderness, erythema, heat, and purulent discharge. This method has previously been criticized for not being validated in well-designed studies and for the potential effect of poor inter-rater reliability.[29] As in other systems, there is no clear distinction between the presence of infection and inflammation and thus the construct validity is questionable.
Dahl et al.[23] described a six-point classification system based on clinical and radiological criteria and provided recommendations for management based on each grade. There is limited discussion as to how these criteria were derived and previous authors have questioned the validity and reliability of these,[29] especially with regard to distinguishing between grades 1–3. Gordon et al.[15] subsequently published a modification of this system which was not considered separately in this review due to the significant overlap.
Sims and Saleh[24] following a survey of 68 hospital practices proposed a four-stage system taking into consideration clinical, radiological, and mechanical factors. The system considers different stages of the reactive–infective process and directs treatment plans accordingly.
The Checketts–Otterburn classification[26] is one of the most commonly employed in the literature. It describes six grades of infection based on clinical, radiological, and mechanical factors and taking into consideration response to treatment while at the same time providing management recommendations for each stage. The authors further differentiate between the first three stages as minor infections and the last three as major and resulting in the need for the removal of the external fixation device. The content validity of this tool is considered the reason for its common use but concerns have been raised with regard to its criterion validity.[30] An inflamed pin site would be classified as Grade 1 and this highlights the lack of clear definition for what constitutes a pin site infection. Finally, the authors have questioned the need for such an extensive grading system and the relevance of its applicability in clinical practice.[28]
Patterson[11] introduced the concept of a rating scale and for this adapted a preexisting tool from a children's hospital. The concept is unique in considering clinical features as experienced and observed by patients' carers and for providing a very thorough assessment of all clinical aspects of pin site infection. The tool however has not been assessed with regard to both its reliability and validity and the proposed relationship between scores, infection stages, and management options. It has not been subjected to testing and validation, questioning its applicability as a research outcome measure.
Saw et al.[27] in a prospective randomized trial comparing cleansing solutions, reported using a three-grade scale based on clinical and radiological findings. Their classification system has not been used in studies outside their institution and has not been validated. There is overlap between Grade 1 and Grade 2 and the grading relies on clinician observations introducing concerns for reliability. There is no discussion as to how the grading relates to treatment and outcomes.
Clint et al.[28] recognized the absence of a valid and reliable classification system and devised a three-point scale based on clinical signs and symptoms of erythema, pain, and discharge. The authors tested their system for intra and inter-observer reproducibility. Regarding the absence of derived management strategies, the authors comment on the lack of available evidence for guiding this and for the need to primarily develop systems that will allow accurate data collection. Toward this purpose, they also propose a system for reliably labeling pin sites in different locations. This system is simple, relevant, and reproducible but its nature introduces a potential for observational variability.[34]
Finally, Santy-Tomlinson et al.[29] developed a system by focusing on patient experience and conceptualizing this in describing the dimensions of inflammatory pin states as calm, irritated, and infected. This approach emphasizes the importance of patient perceptions and involvement in addition to clinical observations. For the purposes of a classification system, however, it introduces significant observational bias.
Hargreaves et al.[35] have introduced a modified Oppenheim classification system for grading infection at the skin–pin interface. Their system has not been considered for the purposes of this review as it was not applied to external fixation constructs but percutaneous Kirschner wires in distal radius fractures. The system shares many similarities with the Checketts–Otterburn classification system but has not been utilized in subsequent literature by other authors.
From reviewing the existing classification systems, it is evident that certain limitations are universally encountered. The majority of systems have been developed without addressing fundamental steps along the process such as the face and content validity of the criteria involved and the construct validity of the tool. This results in significant concerns regarding their diagnostic accuracy. Few systems have been subjected to a rigorous process of determining their reliability and reproducibility. With regard to their practical value, some systems may be useful for outcome recording purposes but provide little guidance as to when and how management should be instigated.
None of the current classification systems utilizes microbiology results as a grading criterion. The role of microbiological samples from a foreign body skin external interface has been questioned.[36] Studies have reported positive cultures from up to 75% of retrieved pins.[21] The most common bacterial etiology is Gram-positive cocci[5],[21] and therefore first-line antibiotics are directed toward these organisms. It should be noted however that resistant organisms, Gram-negative bacteria, and mixed flora have been reported.[21] Further consideration of this important variable is required in view of the increasing antibiotic-resistant organisms and polymicrobial infections.
None of the current systems considered host factors as a variable toward grading. In view of the scope of pin site infections to develop into chronic osteomyelitis,[19] this is an important aspect for consideration in future classifications. In osteomyelitis, patient comorbidity is thought to play a role in both guiding appropriate surgical strategies and giving an indication of prognosis to patients.[37]
There is no system that considers the effect of the infected pin site toward the mechanical stability of the construct and the implications toward successful treatment and the need for further procedures following pin removal.
The lack of established definition and classification systems has been a major obstacle toward efforts in advancing our understanding and optimizing our management of pin site infections. This has been further hampered by the inconsistencies in reporting methods whereby authors may report the incidences as per patients or as per pins affected without often offering clarifications.[38] The need for clearly documenting affected pins by means of a universal labeling system has long been identified.[28] Recent efforts have been made toward developing prospective registration tools for reporting, evaluating, and monitoring pin site infections in patients treated with external ring fixation utilizing classification systems and anatomical descriptors.[39],[40]
It is crucial that clinicians are able to recognize the spectrum of pin site infections and be able to communicate findings and outcomes in a comprehensive and reliable manner. Relating clinical findings to individual hosts to determine optimal management strategies from an early stage, to prevent more serious complications such as bone infection is important.
Toward this purpose, we recommend the development of a standardized reporting tool for all clinicians dealing with pin site infections. This should be completed at each patient encounter from diagnosis to resolution. Reporting should document the mode of frame application and stage of treatment and should be based on individual pin sites utilizing an agreed universal labeling system such as the one proposed by the Oxford group.[40] All variables considered under the existing classification systems such as clinical signs and symptoms, radiological signs, treatment modalities employed, and outcomes should be included. Reporting should also include microbiology results, host factors, and mechanical factors (pin loosening) as well as other adverse effects. A proposed reporting tool has been developed by the authors [Table 2] that should serve as an initial template for further review by the pin site consensus group.
| Conclusion | | |
This review highlights the lack of a clear definition and a universally accepted classification system for pin site infections. Existing classifications have offered valuable insight into various aspects of managing this commonly encountered complication. They are, however, subjective, demonstrate varying degrees of reproducibility, and fail to offer any prognostic inference. They are often outcome-derived and of retrospective nature. Furthermore, no single classification can account for all the variable aspects relating to care and outcomes.
The establishment of standard reporting guidelines is needed to ensure comprehensive and consistent reporting from all authors publishing on pin site infections. Through analysis of the existing reporting systems, we make recommendations toward this purpose. This process will create comprehensive datasets that will inform on the relative effect of various aspects and will allow for the subsequent development of a meaningful and universally accepted definition and classification system. These would not only serve to improve communication between clinicians but would assist toward high-quality research evaluating preventive measures and care protocols.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]
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