|Year : 2022 | Volume
| Issue : 3 | Page : 3-15
Host factors and risk of pin site infection in external fixation: A systematic review examining age, body mass index, smoking, and comorbidities including diabetes
Marie Fridberg1, Mats Bue2, Jan Duedal Rölfing2, Søren Kold1
1 Department of Orthopedics, Aalborg University Hospital, Aalborg; Interdisciplinary Orthopedics, Aalborg University, Denmark
2 Department of Orthopedics, Aarhus University Hospital; Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark
|Date of Submission||20-Oct-2021|
|Date of Decision||27-May-2022|
|Date of Acceptance||09-Aug-2022|
|Date of Web Publication||12-Oct-2022|
Department of Interdisciplinary Orthopaedics, Aalborg University Hospital, Aalborg
Source of Support: None, Conflict of Interest: None
Introduction: Host factors affecting pin site infections were selected by The Pin site Consensus Group, using a modified Delphi approach, to be one of the top 10 priorities to investigate how to reduce rates of pin site infections, improve clinical management, and inform research. The aim of this study was to perform a systematic literature review of the association between host factors and pin site infection, focused on age, smoking, body mass index, and comorbidities, in particular diabetes. Materials and Methods: The literature search strategy was developed as advised in the Cochrane Handbook for Systematic Reviews of Interventions following the PRISMA guidelines with the help from a scientific librarian. The protocol was registered in the International Register of Systematic Reviews, PROSPERO (ID: CRD42021273305). The literature search was executed in three electronic bibliographic databases, including Embase MEDLINE (1111 hits) and CINAHL (2066 hits) through Ovid and Cochrane Library CENTRAL (387 hits). Results: A total of 3564 titles were found. 3162 records were excluded by title and abstract screening. 140 studies were assessed for full-text eligibility. All excluded studies were not reporting specific numbers of patients with pin site infection and the associations of interest. 11 studies were included for data extraction. The included studies were all designed retrospective, and the risk of bias assessment was done using Joanna Briggs Institute risk appraisal tool. The extracted data are presented as results in tabular summaries. This review reveals an increased risk of pin site infection associated with increased HbA1C level in diabetic patients and congestive heart failure in diabetic patients. An increased risk of pin site infection was associated with a lower ASA score. None of the included studies found any association between pin site infection and smoking, age, or body mass index. Conclusion: This systematic literature search identified a surprisingly low number of studies examining the association between pin site infection and the specific host factors. Thus, this review most of all serves to demonstrate a gap of evidence about the correlation between host factors and risk of pin site infection, and further studies are warranted.
Keywords: External fixation, host factors, pin site infection
|How to cite this article:|
Fridberg M, Bue M, Rölfing JD, Kold S. Host factors and risk of pin site infection in external fixation: A systematic review examining age, body mass index, smoking, and comorbidities including diabetes. J Limb Lengthen Reconstr 2022;8, Suppl S1:3-15
|How to cite this URL:|
Fridberg M, Bue M, Rölfing JD, Kold S. Host factors and risk of pin site infection in external fixation: A systematic review examining age, body mass index, smoking, and comorbidities including diabetes. J Limb Lengthen Reconstr [serial online] 2022 [cited 2022 Dec 9];8, Suppl S1:3-15. Available from: https://www.jlimblengthrecon.org/text.asp?2022/8/3/3/358261
| Introduction|| |
External fixation is widely used for initial and final treatment of complex fractures as well as for limb lengthening and reconstruction of bone deformities including infections. Advantages of external fixation include fracture fixation without interfering with the fracture site or the concomitant soft-tissue zone of injury. Furthermore, external fixation allows for gradual deformity correction even in the skeletally immature patient. External fixation provides good and reliable results., However, a major drawback is the risk of pin site infection occurring at the site where the external wires or pins penetrate the skin. In the literature, the incidence of pin site infection varies widely and depends on its classification and severity, and if expressed as the number of pin sites or the number of patients. A recent prospective study of 39 trauma, limb deformity, and bone infection patients treated with external fixation reports an infection rate of 30% of the included pin sites corresponding to 92.5% of the patients. Even though the most pin site infections are superficial, this complication often results in patient pain and need for increased pin site care or antibiotic treatment. If the infection proceeds to deep infection, the treatment might fail due to loosing of fixation or the development of osteomyelitis.
Utilizing a modified Delphi approach an international Pin Site Consensus Group has identified the topic of host factors affecting pin site infection to be one of the top 10 priorities in pin site management (personal communication). To prevent pin site infection, patient selection and optimization of modifiable host factors seem important to consider. Although previous reviews have provided recommendations for preventing pin site infection when using external fixation., the literature is limited in regards to reporting correlations between pin site infections and patient host factors. Therefore, we conducted a systematic literature search on the host factors affecting pin site infection.
| Materials and Methods|| |
This systematic literature search was performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis Protocols (PRISMA) guidelines 2020. The protocol was registered before data extraction in the International Register of Systematic Reviews, PROSPERO (ID: CRD42021273305). The intention was an etiological literature review, determining the association between specific host factors and the outcome pin site infection. A review of etiology is defined by Joanna Briggs Institute (JBI) as a review identifying and synthesizing the evidence of possible associations. Data were extracted if feasible, however, no meta-analysis was performed, and no narrative synthesis of data is presented. The aim was to report the frequency of studies reporting specific host factors to be associated with pin site infection. The host factors to be assessed were (a) age, (b) smoking, (c) BMI, (d) any comorbidity, and (e) diabetes.
The search string was based on the Population, Intervention or Exposure of interest, Comparison, Outcomes (PICO) criteria. P: Patients treated with external fixation. I/E: Host factors associated with the development of pin site infection. C: Patients who did not develop pin site infection. O: Patients who developed pin site infection.
Studies were included if they met the following criteria: Patients treated with external fixation, one or more patients who developed pin site infection, description of at least one host factor, and papers published in peer-reviewed journals only. Studies were excluded if they met the following exclusion criteria: Not written in English, German, Danish, Swedish, or Norwegian. Animal or cadaveric studies. Pin location at the cranium, face skeleton, spine, or thorax. Editorials or conference abstracts. The absence of numerical data on either the outcome (pin site infection) or the comparator group (no pin site infection). Absence of data on the specific host factors of interest (intervention/exposure).
Definition of pin site infection and outcome in search strategy
Several classification systems for pin site infections exist, but no international consensus/guideline is currently universally accepted. Terminology varies among the literature and standard terms that describe the content of our outcome is unique for every database. The logic grid [Table 1] shows how the search strategy was developed from the terminology.
The literature search was executed in three electronic bibliographic databases on the 16th of August 2021, including Embase MEDLINE (1111 hits) and CINAHL (2066 hits) through Ovid and Cochrane Library CENTRAL (387 hits) at its own website. The search included all peer-reviewed publications in the language; English, German, Danish, Swedish, and Norwegian from the year 1980 to 2021. A total of 3564 titles were found. We did not search for gray literature on Google scholar, and we did not hand search references or contact any specific authors.
The literature search strategy was developed using terms related to external fixator constructs, pin site infection, and the host factors of interest. From the PICO elements, a logic grid with key concepts, keywords, and index terms was made, and from that framework, a building block search strategy was designed. The search string was built with the help from a librarian from Aalborg University Hospital, Denmark. To achieve a high recall/sensitivity rate, we implemented a broad search with a low-precision rate, as advised in the Cochrane Handbook for Systematic Reviews of Interventions. We used both Medical Subject Headings (MeSH) and free-text words, combined with Boolean operators and truncations when suitable. No search limitations were added and the exact search strategy in each of the three databases can be found in [Appendix 1].
All records were transferred to Endnote (Clarivate Analytics, Philadelphia, Pennsylvania, USA) and 302 duplicates were removed using the built-in software. A total of 3362 records were transferred for screening in the software Covidence (Veritas Health Innovation, Melbourne, Australia. Available at www.covidence.org). A pilot of 10 studies was conducted initially. All four authors screened the first 10 records that came up by alphabetic filtering only from title and abstract. They were discussed on a meeting in terms of inclusion and exclusion criteria to ensure consensus for the further selection process. All authors agreed on those 10 records without conflicts. Following all remaining records were screened from title and abstract independently by two authors (SK, MF, JR, or MB). Each author allocated all records to one of three groups (accept, maybe, and reject) based on the title and abstract. Records approved by two authors went into the full-text screening which was also done independently by two authors. The records labeled in the category “maybe” was discussed in a meeting by all four authors and the final decision of acceptance or rejection was agreed on. During the full-text screening a search for additional, supplementary, or appendix was done using the PDF word search tool searching for “Appen,” “Addi,” and “Suppl.” The folder with unsure records was finally scored and solved by a third author, and in case of doubt, the senior author (SK) was consulted and eventually the entire author group. During the data extraction process, 6 studies more were excluded, 3 studies were excluded because numerical data were not extractable, and 3 studies were excluded because 100% of the patients had diabetes without a comparator group and no data of any of the other specific host factors of interest (intervention/exposure) was available.
Data extraction was performed in collaboration between all authors, using a pre-designed excel spreadsheet. Discrepancies were reviewed, and disagreements were settled by discussion in the group or conferring with the senior author (SK). No authors were contacted in case of missing data but if additional material was available in online, it was looked up. Records were sought for the following variables, and the data items were noted in the data extraction spreadsheet tool: Title of the paper; Author; Journal; Publication Year; Study design; Number of patients included; Diagnosis/Reason for frame (e.g., Charcot, open tibia fracture); Location of frame (e.g., Femur/Tibia/Foot/Upper extremity); Number of patients with pin site infections; Number of patients without pin site infection; Pin site infection classification system used; Age; BMI; Smoking; Comorbidity; Diabetes; Conclusion.
The outcomes of this systematic literature search were of qualitative nature because we aimed to review the literature for primary research data on pin site infections and the association to the specific host factors. No data meta-analysis was performed. Instead, we report for each of the host factors mentioned above, the number of studies reporting on a possible association with pin site infection in a tabular summary as presented in [Table 2],[Table 3],[Table 4],[Table 5],[Table 6],[Table 7],[Table 8].
|Table 2: Overview of study design, aim and risk bias assessment [Appendix 2] of the 11 included studies|
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|Table 3: Alphabetic tabular summery, an overview of extracted data from the 11 included studies|
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|Table 5: Mean Body mass index (kg/m2) for groups with and without pin site infection (±standard deviation of body mass index)|
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|Table 6: Comorbidity score or absolute number/frequency of comorbidity for groups with and without pin site infection|
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|Table 7: Absolute number/frequency of diabetes for groups with and without pin site infection|
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|Table 8: Absolute number/frequency of smoking for groups with and without pin site infection|
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Risk of bias in the studies
Following the Joanna Briggs Institute (JBI) Manual for Evidence Synthesis, 2020 quality assessment of the included studies was done using JBI Critical Appraisal Tool. Since all studies were retrospective (cohort and case–control studies) the JBI critical appraisal checklists for case–control and cohort studies were used [Appendix 2]. The checklists consist of 10 and 11 questions, respectively, graded into four categories: Yes, No, Unclear, and Not applicable. All studies were assessed by two different authors, and conflicts were sorted at a meeting between the two. The assessments were based on the primary aim of each study, with pin site infections and host factors as secondary outcomes if necessary.
Effect measures and statistics
Pin site infections and host factors were assessed as a binary outcome. Analyses were carried out using Stata® 16 (StataCorp. 2019. Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC). When comparing different groups for pin site frequency, a risk of type I error below 0.05 was considered statistically significant.
| Results|| |
A total of 3302 records were included for screening, of which 11 studies were included,,,,,,,,,, in the review [Figure 1].
|Figure 1: PRISMA flow diagram for systematic reviews searches of databases and registrars only|
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The included studies were all designed retrospective [Table 2]. Three of the studies were case–control studies,, The studies included in total n = 1445 patients of which n = 276 patients had pin site infection [Table 3]. All studies were published within the year from 1995 to 2021 [Table 2]. One study included had online available supplementary data that were used to extract data on risk factors of pin site infection.
Risk of bias assessment
Only 2, out of the 11 included studies had the primary aim to investigate an association between host factors and pin site infection in external fixation [Table 2]. Results of the risk of bias assessment using the JBI Critical Appraisal Tool are presented in [Table 2].
Results of individual studies
A tabular summary of the included studies is provided in [Table 3]. Out of the 11 studies, a possible correlation between host factors and pin site infection was reported as follows: age: 7 studies [Table 4], BMI: 5 studies [Table 5], different comorbidities: 6 studies [Table 6], diabetes mellitus: 4 studies [Table 7], and smoking: 3 studies [Table 8].
None of the five studies found that age was a significant risk factor for pin site infection [Table 4].
Body mass index
None of the five studies found that BMI was a significant risk factor for pin site infection [Table 5]. In the pediatric study by Fedorak et al. differences were found for pin site infection between the three groups: normal weight (31.2% pin site infection), overweight (42.9% pin site infection), and obese (38.3% pin site infection). However, these differences were not statistically significant (P = 0.46). Finkler et al. found that patients with pin site infection had a mean BMI of 35 kg/m (2) compared with patients without infection with a mean BMI of 38 kg/m (2). There was not a statistically significant difference in BMI between the two groups (P = 0.3).
McDonald et al. found a significant association between lower American Society of Anesthesiology (ASA) score and higher risk of pin site infection. No significant correlation to preoperative osteomyelitis, Gross Motor Function Classification System (GMCFS) grade, injury severity score, hypertension, and alcoholism chronic obstructive pulmonary disease was found in the included studies.
None of the studies found that diabetes was a statistically significant risk factor for pin site infection. Wukich et al. demonstrated a higher risk of minor wire complications in the diabetes group (P = 0.01) but “wire complications” was not defined as pin site infection alone. Finkler et al. found a statistically significant increased rate of pin site infection in patients with higher hemoglobin A1C levels (P < 0.05). Lyons et al. investigated a patient population treated for Charcot foot deformity and found in these diabetic patients a higher rate of pin site infection for patients with congestive heart failure.
None of the studies included found that smoking was a significant risk factor for pin site infection.
| Discussion|| |
To the best of our knowledge, this is the first review based on a systematic literature search examining the association between host factors and pin site infections. A total of 11 studies met the inclusion criteria making it possible to extract data regarding pin site infection and the predefined specific host factors: age, BMI, smoking, and comorbidity including diabetes. The majority of included studies did not demonstrate a significant association between pin site infections and the examined host factors. Significant associations between pin site infection were found for the following host factors: (a) increased HbA1C level in diabetic patients, (b) congestive heart failure in diabetic patients (15), and (c) lower ASA score, representative of lower comorbidity.
Pin site infection is a frequent complication and was in some of the studies found to be as high as 100%.,, Therefore, it is surprising that the literature is scarce of studies examining host factors and their association with pin site infection. The risk of bias is generally high for all included studies as they all are retrospective studies with small numbers of patients and infected pin sites. However, the risk assessment demonstrated that most of the included studies followed best practice for retrospective studies. Only two studies, had the primary aim of investigating the correlation between host risk factors and pin site infection. As no standardized assessment tool to clinically evaluate or report pin site infection exists, there is a potential risk of bias in this work. No studies were excluded from the systematic literature search based on their methodological quality or bias potential. None of the included studies used a clinical pin site infection grading system when reporting on pin site infection. The inconsistency on how to report on pin site infections and how to define a pin site is a major clinical challenge. Wukich et al. found a higher risk of minor complications in diabetic patients and defined a minor complication as an event in which a change was not required in the treatment plan. These included fine wire irritation, drainage, pin loosening not resulting in return to the operating room, minor skin traction/necrosis, or superficial infections that resolved with topical or oral antibiotics. None of the four studies investigating the association to diabetes found that diabetes was an isolated risk factor for pin site infection. However, Finkler et al. found a statistically significant increased rate of pin site infection in patients with higher hemoglobin A1C levels (P < 0.05). Lyons et al. investigated a patient population treated for Charcot foot deformity and found in these diabetic patients, a higher rate of pin site infection for patients with congestive heart failure. This might indicate that dysregulated diabetic patients should be preoperative optimized before treatment with an external frame. Further, the evidence on the association with comorbidity can be discussed. McDonald et al. found a significant association between lower ASA scores and the risk of pin site infection, but after logistic regression for possible confounding variables, the correlation was no longer significant.
The strength of this study is that the results are presented as tabular summaries of the extracted numeric data, the literature search strategy was constructed evidence-based, and the eligibility process is well documented. This approach introduces no reporting bias. Concerning limitations introduced by our eligibility criteria, we have included only studies reporting on the specific number of patients who developed pin site infection and the association to the specific host factors of interest. Host factor data are in most studies reported as an appendix or as a figure presenting the demographics because the primary aim of the studies was not to examine for a correlation between pin site infection and host factors. We only included papers from peer-reviewed journals which might be a limitation; however, it might also increase the quality of the included studies.
A systematic literature search is always limited by the design of the search strategy and the applied eligibility criteria. We used the methodological systematic approach suggested by Cochrane by constructing a block search strategy based on the PICO criteria.
Throughout the process of producing this manuscript, two RCT studies comparing different pin care regimes with the risk of pin site infection were suggested to be included. The studies were not revealed by this systematic review block search strategy because neither the title nor the abstract included words or mesh terms related to the intervention/exposure block. The first study by Egol et al. prospectively randomized 120 wrists with pins to receive two different pin care regimes. In this study, the age of the patient was found to have a significant (P = 0.04) increased risk of pin site complications with an average age of 51 years (no complications) versus 64 years (complications). No validated pin site infection classification system was applied; instead, erythema, cellulitis, drainage, pin loosening, and radiological loosening were assessed. Moderate correlations between cellulitis around the pin and both ASA score (P = 0.03) and number of comorbidities (P = 0.02) were found. The second study by Fergusson et al. prospectively enrolled 116 patients with external frames on the lower extremity comparing traditional versus emollient pin care regimes. Forty-eight patients (41%) developed a pin site infection, assessed by the “Good, Bad Ugly approach” and no difference was found between the two regimes. Furthermore, no statistically significant association between age, BMI, sex, ethnicity, smoking and comorbidity and pin site infection was found.
The host factors to be examined in this systematic literature search were chosen based on the clinical experience from the authors. Thus, the authors thought that the host factors age, comorbidity, and in particular, the modifiable host factors: smoking and diabetes might increase the risk of pin site infection. In addition, it was expected that these host factors had a sufficiently high prevalence in the studies to allow for association assessments. The current literature demonstrates a gap in evidence that the host factors smoking, diabetes, increased age, and increased BMI are associated with increased risk of pin site infection. However, this lack of evidence should be interpreted with caution due to the small sample sizes and the high risk of bias in the retrospective studies. Thus, this review most of all serves to demonstrate a gap in evidence, and further studies are warranted. Future studies should be designed to prospectively examine associations between host factors and pin site infection and include a sufficient number of patients to make a sound conclusion about the absence of risk factors. Furthermore, it is of paramount importance that a universally accepted definition of pin site infection is developed and applied in all future studies. A stringent definition of pin site infection is needed to allow for accurate estimates of pin site infection and to allow for comparison between different studies.
This systematic literature search identified a surprisingly low number of studies examining for risk of pin site infection and host factors. The included studies did not demonstrate a significant association between pin site infections and the examined host factors: age, BMI, smoking, and diabetes. Individual retrospective studies reported a significant association between pin site infection and increased HbA1C level in diabetic patients; congestive heart failure in diabetic patients; and lower ASA score, representative of lower comorbidity.
We would like to thank the librarians from Aalborg University Hospital for the help building the search string.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]