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Cosmetic injections have become increasingly popular in recent decades. According to the American Society of Plastic Surgeons (ASPS, 2016), out of over 15 million minimally-invasive cosmetic procedures performed in the United States in 2016, over 7 million involved injections of Botulinum Toxin Type A and over 2.5 million procedures included soft tissue fillers, such as collagen, hyaluronic acid, calcium hydroxylapatite, and others.
Since 2000, the number of minimally-invasive procedures performed annually has increased by 180 percent (ASPS, 2016). Cosmetic injections are widely perceived to be a safe alternative to plastic surgery. Indeed, if performed by a professional, the procedures yield satisfying results with virtually no consequences or side effects. However, some people still experience local side effects of different severity, such as inflammations, infections, asymmetries, allergic reactions, or even skin necrosis (Dumitrascu & Georgescu, 2013). According to recent studies, most of the side effects are not due to allergies, as previously believed, but due to the formation of biofilm (Dumitrascu & Georgescu, 2013).
Dumitrascu and Georgescu (2013) define biofilms as “groups of microorganisms in which cells stick to each other in a three-dimensional structure, on a given surface” (p. 192). Biofilms are usually resistant to antibiotic treatment due to their outer layer, which consists of a protective polymeric substance offering antibiotic resistance (Sadashivaiah & Mysore, 2010). Biofilms can consist of several different microorganisms, including bacteria, protozoa, and fungi, which means that they can cause different types of infections (Sadashivaiah & Mysore, 2010).
The concept of biofilm remains relatively new to dermatology, with few studies available on the formation of biofilm post-cosmetic injections; however, it is needed to explore the ways of preventing biofilm formation from reducing the occurrence of side effects and complications. According to Conrad, Alipasha, Thiru, and Kandasamy (2015), biofilms can cause delayed onset of sterile abscesses, as well as inflammatory responses similar to allergic reactions. Kim, Ahn, Jeong, and Suh (2014), on the other hand, argue for the involvement of biofilms in the formation of granuloma, which affects up to 1% of patients after cosmetic injections. Ozturk et al. (2013) add that “All fillers, especially longer-lasting products, are potential surfaces for biofilm formation” (p. 870), which is why it is crucial to generate an effective framework for the prevention of biofilm formation.
“The guidelines on the best infection control practices for intradermal, subcutaneous, and intramuscular needle injections” (Hutin et al., 2003) have been issued by the WHO in 2003. They are still applied to cosmetic injections in the U.S. and the rest of the world. The guidelines stress the use of sterile injection equipment, prevention of contamination, needle-stick injuries, and access to used needles, as well as the use of appropriate hygiene equipment and practices before, during, and after injection (Hutin et al., 2003). “Centers for Disease Control and Prevention guidelines for the prevention of surgical site infections” also provide some advice on the procedures (Berrios-Torres et al., 2017). However, neither of the guidelines addresses the formation of biofilm, specifically, which creates a gap in evidence-based prevention practices.
Moreover, as the prevention of bacterial infections by the current guidelines usually implies the use of preventive antibiotic therapy, and biofilms are usually insusceptible to antibiotics, there is also a need for supplementary preventive care with the use of efficient anti-biofilm agents. For instance, Borges, Saavedra, and Simoes (2012) describe the possible use of ferulic and gallic acids in biofilm prevention and control of pathogenic bacteria, whereas a subsequent study by Borges, Simoes, Saavedra, and Simoes (2014) suggests that selected isothiocyanates can act as preventive agents reducing the possibility of biofilm formation. Additional qualitative research studies were used to complement the evidence-based approach suggested in this paper.
Due to the scarcity of research on biofilm formation post-cosmetic injections, the search process for applicable articles was extensive. Scholarly journal databases were searched for articles regarding the formation of biofilm following cosmetic injections. The inclusion criteria applied to all articles found during the search process included both objective criteria, such as the date of publication and credibility of the source, and subjective criteria, such as validity and applicability to the research topic.
Only sources published within the last five years were admitted into the current study. The following databases were searched: National Center for Biotechnology Information (NCBI), Taylor and Francis, Elsevier, Science Direct. The search terms used in these databases included “biofilm formation post-cosmetic injections,” “prevention of biofilm formation,” “biofilm in dermatology,” and “biofilm prevention.” CDC and WHO websites were also searched to obtain information on the current guidelines. Some articles were found by examining the References sections of secondary research articles on the topic. To provide an introduction to the topic, the website of the American Society of Plastic Surgeons was searched for the latest reports on the prevalence of cosmetic injections in the United States.
Seven studies were found that fit the search criteria for recency, credibility, validity, and applicability to the topic. Four of the studies used descriptive qualitative methodology to summarize the previous findings and complement them with new information and suggestions. Two of these studies were used in the problem Identification section due to the fact that they provide an in-depth explanation of the process of biofilm formation and the difficulties in the treatment of biofilm-induced complications. Another study used case studies to illustrate the complications following cosmetic injections, their prevalence, and treatment methods (Conrad et al., 2015).
Two studies used quantitative methodology to illustrate the effects of particular substances in the prevention of biofilm formation (Borges et al., 2012; Borges et al., 2014). Overall, five of the nine studies that passed the search criteria were applied to the creation of the present evidence-based practice protocol.
The first study that was considered in this research is a qualitative descriptive research by De Boulle and Heydenrych (2015). In this study, the researchers focus on patient-specific factors that have to be addressed before cosmetic injections as they may be predictive of various complications, including biofilm formation. De Boulle and Heydenrych (2015) state, “Selecting appropriate patients, or perhaps, more importantly, not treating inappropriate patients, is the first and a crucial step in avoiding complications with dermal fillers” (p. 205). The research methodology included a convention of a round table meeting with physicians practicing cosmetic injections regularly in order to determine the prevalent correlation between patient factors and the onset of complications (De Boulle & Heydenrych, 2015).
A thorough literature review of the journal articles considering post-cosmetic injection complications was also conveyed to identify the common patterns (De Boulle & Heydenrych, 2015). Based on the information collected, the authors constructed a table representing the factors contradicting or warranting caution in the use of dermal fillers (De Boulle & Heydenrych, 2015).
For instance, active skin infection, hypersensitivity, active collagenous, as well as hemostatic or coagulation disorders are stated to be contradicting factors to the use of dermal fillers (De Boulle & Heydenrych, 2015), which means that patients with these conditions should not receive dermal fillers to avoid complications, particularly due to the possibility of biofilm formation. The authors also provide directions considering the timing of injections: for instance, “Botulinum toxin treatment should be planned two weeks before filler” (De Boulle & Heydenrych, 2015, p. 209). These recommendations should also be included in the evidence-based practice protocol, as the ignorance of the directions may create a risk of biofilm formation.
Another qualitative descriptive study by Kim et al. (2014) presents a treatment algorithm for complications following cosmetic filler injection. The article also explores the preventive procedures that can help to avoid general complications, including those resulting from biofilm formation (Kim et al., 2014). For example, the authors stress the importance of cleaning the injection area and avoiding injections of hydrophilic permanent filler materials through oral or nasal mucosa (Kim et al., 2014).
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The injections of fillers into the previous filler site or traumatized tissue is also not recommended (Kim et al., 2014). The authors also consider several injection techniques to be particularly harmful, including a fan-like injection pattern, rapid injection, rapid flow rates, and injection of higher volumes (Kim et al., 2014). Other methods to avoid complications, including the use of blunt or small-caliber needles, aspiration before injection, and delivery of material at different points, are also discussed (Kim et al., 2014). Overall, this article is useful as it provides supporting material that is needed to create a comprehensive practice protocol.
In their article “Abscess formation as a complication of injectable cosmetic fillers,” Conrad et al. (2015) present a series of cases gathered from the author’s clinical practice. The authors examine the factors that may have influenced the process of abscess formation in these patients, stating that three of the four patients were prone to inflammatory reactions that could have affected the abscess formation.
The relevance of the article to biofilm study is also evident, as the authors confirm that biofilms appear to be present in all of the four cases, although in a dormant state (Conrad et al., 2015). The authors explain the use of Peptide Nucleic Acid Fluorescent In Situ Hybridization test, a cytogenic technique that can help to identify the bacteria present in biofilms, even if they are in a dormant state (Conrad et al., 2015).
The article provides evidence of the usefulness of the FISH test in the treatment of biofilms, stating that “Fish test has the advantage that in addition to being as highly specific as ordinary culture, it is much more sensitive concerning identifying bacteria in biofilms; with one study of 44 cases showing FISH test identifying 58% of cases compared to none identified with two different culture methods” (Conrad et al., 2015, p. 17). Overall, the article is applicable to the topic in two separate ways. First, the authors identify the possible contraindications to the injection of cosmetic fillers based on the four cases reviewed. Furthermore, the authors justify the use of PNA FISH test for the detection of biofilm and the particular bacteria that it contains, which can be used to prevent the growth of biofilm at the beginning stages if there is a threat of bacterial infection.
One of the two quantitative studies used for the protocol is research by Borges et al. (2012) on the activity of ferulic (FA) and gallic acids (GA) in biofilm prevention. The research proved that the overall level and speed of biofilm formation were substantially reduced by the phenolic acids, which shows that there is a potential to use them in the prevention of biofilm formation after cosmetic filler injections. The proposed intervention was effective in reducing the bacteria’s adhesive capacity; however, this quality of biofilms also offers opportunities to explore alternative ways of preventing adhesion, such as light preventive massage of the area of injection. In conclusion, the authors suggest using GA and FA in conjunction with the prescribed antibiotic therapy, as they can adjust the resistance level of the bacteria forming the biofilms (Borges et al., 2014).
Borges et al. (2014) offer another quantitative study, focusing on the action of selected isothiocyanates, allylisothiocyanate (AITC), and 2-phenylethylisothiocyanate (PEITC), on bacterial biofilm prevention and control. The same four types of bacteria were studied as in the 2012 research: Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Listeria monocytogenes (Borges et al., 2014).
The two aspects of ITCs’ effect on biofilms were assessed: reduction of biofilm mass and bacteria mobility (Borges et al., 2014). The researchers also outline the potential of using phytochemicals in the treatment and prevention of biofilms. For instance, they explain that Glucosinolates (GLS) are an important group of phytochemicals that are present in foods such as cabbage, broccoli, cauliflower, horseradish, Brussels sprouts and kohlrabi (Borges et al., 2014).
These phytochemicals have proven antimicrobial effects (Borges et al., 2014) and thus can be used as a supplement to preventive therapy during the post-injection period. According to the result of the experiment, both types of isothiocyanates were useful in preventing and controlling the formation of biofilms (Borges et al., 2014). Overall, the study proves that isothiocyanates have potential use in biofilm prevention and treatment. However, further studies are needed to evaluate the effect of these phytochemicals on human and animal cells to ensure that it would be safe to use AITC and PEITC in high concentrations (Borges et al., 2014). However, the natural sources of isothiocyanates can still be used as part of the prevention efforts to control the development of biofilms following cosmetic injections.
Critical Analysis and Evaluation of Literature
A critical analysis and evaluation of the literature are reflected in Table 1. The most significant study that supports the proposed practice is a study by Berges et al. (2012), which proved the effectiveness of gallic acid (GA) and ferulic acid (FA) in the prevention and control of biofilm development. The findings suggest that complementing antibiotic therapy with GA and FA, as well as using these phytochemicals independently, will prevent the formation of biofilm. The remainder of the studies is displayed in Table 1.
Formulation of Intervention Protocol for Clinical Problem
The patient population for this protocol includes patients of any age or gender who are considering receiving treatment with cosmetic injections using soft tissue or dermal fillers.
- Identify any patient-specific factors that may serve as contraindications to cosmetic injections. According to De Boulle and Heydenrych (2015), there are several factors that may affect the onset of complications. The proposed protocol insists on not treating patients who are at a high risk of developing inflammatory complications.
- Examine the area and patient history for signs of inflammatory responses to past procedures. According to Conrad et al. (2015), the majority of patients who present with biofilm-induced complications are prone to developing inflammatory reactions.
- Clean the injection area thoroughly. As outlined in WHO’s injection guidelines (Hutin et al., 2003) and Kim et al. (2014), ensuring that the area is properly cleaned reduces the risk of infection.
- Avoid injecting of hydrophilic permanent filler materials through oral or nasal mucosa (Kim et al., 2014).
- Avoid harmful injection techniques (fan-like injection pattern, rapid injection, rapid flow rates, and injection of higher volumes), as these techniques can harm the surrounding area, thus facilitating inflammation (Kim et al., 2014).
- If possible, inject the material through small-caliber needles. According to Kim et al. (2014), delivering the material through small-caliber needles allows reducing the speed and volume of the injection, thus preventing damage to the surrounding area.
- Advise patient to use gallic acid (GA) and ferulic acid (FA) as part of the post-treatment preventive therapy. Borges et al. (2012) proved the effectiveness of GA and FA in the prevention of biofilm development.
- Encourage the patient to include isothiocyanate-rich foods into his or her diet during the post-treatment period. According to Borges et al. (2014), allylisothiocyanate (AITC) and 2-phenylethylisothiocyanate (PEITC) are effective in controlling the metabolic activity of bacteria and preventing the formation of biofilm. While the use of these phytochemicals in high concentrations has not been studied, foods rich in isothiocyanates can play a significant part in the prevention of biofilm formation.
- Advise the patient to report any tenderness, redness, or swelling in the area. If the patient experiences any signs of inflammation or infection, it is crucial to begin the antibiotic treatment in due time to avoid further complications.
Expected Outcomes and Associated Evaluation Criteria
If the proposed intervention is effective, the rate of complications following the cosmetic injection will decrease dramatically. However, given that the rate of complications for this type of treatment is already very low, it would be difficult to evaluate the impact of the protocol objectively. One of the possible ways of evaluation is by performing the PNA FISH test on the patients 4-6 months after the date of injection, given that no signs of infection are present. The test will help to determine if the formation of biofilm has occurred; a negative test result in the vast majority of the patients who adhered to the recommendations will be the ultimate reflection of the effectiveness of the protocol.
Table 1: Critical Analysis of Quantitative Research Articles.
| || || || || || |
|1. Patient factors influencing dermal filler |
complications: prevention, assessment,
2. Koenraad De Boulle
|5. Patients who presented with complications post-cosmetic filler injections.||7. Non-treatment of patients with high-risk levels. |
8. Observation, retrospective review of cases.
10. To gather a list of patient factors serving as contraindications to cosmetic filler injections.
|13. A list of patient factors that may facilitate the development of complications. |
14. The researchers do not advise physicians to treat patients with high-risk factors as indicated in the table.
|15. The study defines risk factors that affect the results of the treatment. The research team consisted of an international panel of professional physicians who reviewed cases of post-filler complications from their practice. |
16. The study provides no quantitative information on the sample size, the occurrence of complications, and the rate of risk factors. Only subjective evidence is available to confirm the validity of the study.
|1. Treatment algorithm of complications after filler injection: |
Based on the wound healing process.
2. Joo Hyun Kim
|5. Patients who presented with complications post-cosmetic filler injections.||8. Observation, description of patient cases, secondary research. |
10. To outline the types of complications and primary treatment schemes.
|14. The authors examined the possible complications, causes, and treatment, and provided guidelines for reducing the risk of complications.||15. Based on clinical evidence from past patients. Summarized past findings and illustrated with practical examples. |
16. No information regarding the sample size and validity of the results. The authors did not consider the patient factors affecting the development of complications.
|1. Abscess formation as a complication of |
2. K. Conrad
|5. Patients who presented with complications post-cosmetic filler injections. |
6. 4 female patients.
|8. Observation, description of patient cases, secondary research. |
10. To obtain high-risk patterns and to identify the optimal treatment of abscesses.
|13. The authors outline the presentation and treatment schemes for abscesses, as well as to describe the process of biofilm testing and its benefit |
14. Previous application of polyacrylamide gel or existing inflammatory disorders in the same part of the face is high-risk factors for cosmetic injections. PNA FISH test is effective in examining biofilm formation.
|15. The authors examine patient cases and patterns. Provide evidence from the previous literature to support their suggestions. |
16. The patient size is too small to be indicative of a larger patient population. The information presented in the article is highly subjective, as there is no statistical data to support the suggestions and patterns found.
|1. The activity of ferulic and gallic acids in biofilm prevention and control of pathogenic bacteria. |
2. Anabela Borges
|6. 200 ml of bacterial suspension with a density of 1×10^8 cells ml^-1. Bacteria types: Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Listeria monocytogenes.||7. Treatment and control of biofilm formation using GA and FA. |
8. Experiment, quantitative
10. To determine the effectiveness of the intervention on the listed groups of bacteria.
|12. The reduction of biofilm growth due to GA and FA exposure. |
13. GA and FA promoted reductions in biofilm activity by 70% for all the biofilms tested.
14. GA and PA should be used independently to prevent biofilm development and in conjunction with antibiotic treatment to undermine the levels of antibiotic resistance in the target bacteria.
|15. The study offers significant theoretical background. |
The results of the experiment are presented in quantitative figures.
Statistical analysis was performed to determine the significance of the effect.
16. No control group was used to compare the results. The authors do not offer information on the validity and reliability of the study.
|1. The action of selected isothiocyanates on bacterial biofilm prevention and control. |
2. Anabela Borges
|6. Two Gram-negative bacteria, E. coli CECT 434, P. aeruginosa ATCC 10145, two Gram-positive bacteria, S. aureus CECT 976, and L. monocytogenes ATCC 15313.||7. Treatment and control of biofilm formation using AITC and PEITC. |
8. Experiment, quantitative
9. To determine the effectiveness of the intervention on the listed groups of bacteria.
|12. The reduction of bacteria mobility, viability, and adhesion due to the exposure to AITC and PEITC. |
13. AITC and PEITC caused 60+% reductions in biofilm activity for all the bacteria types tested.
14. Further studies on mammalian cells are needed to ensure the safety of using AITC and PEITC in high concentrations.
|15. The study offers some theoretical background on the study of biofilms and their treatment. The authors provide information on the ITC and its sources. |
The results of the experiment are presented in quantitative figures and supported by
Control groups are used to ensure the validity of the experiment.
16. The authors do not offer a comprehensive conclusion on the use of ITCs for the treatment of biofilms. Other groups of bacteria were not examined.
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