A systematic review of the literature was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
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.
The ROBINS-I tool was used to assess the risk of bias in nonrandomized studies. 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. 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. 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.
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, of which two reported a reduced infection rate associated with pin site care. Three studies investigated the optimal frequency of care. 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, and one study reported retrospectively assessed results of a control group. 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.
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. 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.
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. In the present review, only one study was included comparing crust removal and crust retainment. Hereby, however, the removal resulted in lower infection rates.
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. 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.
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.
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Conflicts of interest
There are no conflicts of interest.
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