sumit presentation OF K WIRE FIXATION IN

K WIRE FIXATION

1. Title of Study: Study of comparison of outcomes of Antibiotics prophylaxis versus no antibiotics in K-Wire fixation used in Elective Orthopaedics Department: DEPARTMENT OF ORTHOPEDICS Name of PG student : DR.BHOSALE SUMIT Year of Admission: 2023 Name of PG Guide : DR. RAJENDRA ICCHARAM SARODE Names of other guiding faculty members: DR.DEEPAK AGRAWAL

2. Aim of Study : Does the insertion of K-wires in fracture reduction with antibiotics coverage lead to better outcomes compared to insertion without antibiotics coverage? What are the infection rates associated with K-wire insertion in fracture reduction with and without antibiotics coverage?

3. Objectives: 1 . To assess the impact of antibiotics coverage during K-wire insertion in fracture reduction on infection rates and overall outcomes. 2.To compare healing rates and functional outcomes between the group receiving antibiotics coverage and the group without antibiotics coverage. 3.To evaluate the incidence of complications such as nonunion, malunion, and hardware failure in both groups.

4. Background/ Introduction: Fractures represent a significant burden of musculoskeletal injuries worldwide, necessitating timely and effective management to facilitate optimal healing and functional recovery. Among the various modalities employed for fracture reduction, Kirschner wire (K wire) insertion remains a common technique utilized to stabilize and align fractured bone fragments, facilitating the restoration of anatomical alignment and promoting bone healing [1]. However, the optimal approach to K wire insertion, particularly regarding the use of antibiotic coverage, remains a subject of debate and clinical investigation.Antibiotics play a crucial role in fracture management, particularly in cases involving open fractures or surgical interventions where the risk of infection is heightened [2]. Prophylactic antibiotic coverage is routinely administered to mitigate the risk of surgical site infections (SSIs) and deep-seated infections, which can significantly compromise patient outcomes and necessitate additional interventions [3]. However, the necessity and efficacy of antibiotic coverage in conjunction with K wire insertion for fracture reduction remain contentious issues, with conflicting evidence regarding its impact on infection rates and clinical outcomes. This study aims to explore and compare the outcomes of K wire insertion in fracture reduction with and without antibiotic coverage, focusing on infection rates, healing outcomes, and complications. By critically evaluating the existing literature and analyzing clinical data, this study seeks to elucidate the role of antibiotics in the context of K wire fixation for fracture management and provide evidence-based recommendations for clinical practice.

5. Review of Literature : 1. Abul et al. (2023) conducted a systematic review and meta-analysis to compare the outcomes of antibiotic prophylaxis versus no antibiotic in Kirschner wire (K-wire) fixation, commonly used in trauma or elective orthopedics, to minimize the risk of surgical site infection (SSI). Following PRISMA guidelines, they searched electronic databases for randomized controlled trials (RCTs) and non-randomized studies. The analysis, including four retrospective cohort studies and one RCT with 2316 patients, revealed no significant difference in the incidence of SSI between the prophylactic antibiotic and no antibiotic groups (odds ratio [OR] = 0.72, P = 0.18). Consequently, the study suggests that administering peri-operative antibiotics for patients undergoing orthopedic surgery using K-wire fixation may not significantly impact outcomes

6. 2. Gillis et al. (2022) conducted a multicenter prospective analysis to compare infection rates in patients undergoing closed reduction and internal fixation (CRIF) of closed metacarpal and phalangeal fractures inside and outside the operating room (OR). The study included 1042 patients with a total of 2265 Kirschner-wires (K-wires). Results showed that infection rates were not statistically higher in patients who had CRIF outside of the OR compared to those in the OR group. Specifically, cellulitis occurred in 2.5% of patients in the outside OR group versus 3.4% in the OR group, and frank pus was observed in 1.4% versus 2.5%, respectively. Although the OR group had a longer time to operation and procedure time, they had a shorter time with the K-wires in place. The findings suggest that K-wire fixation of closed hand fractures outside of the OR is safe and does not increase infectious complications compared to CRIF performed in the main OR.

7. 3. Levy et al. (2021) conducted a retrospective study to evaluate the effectiveness of a novel approach to percutaneous Kirschner wire (Kwire) pinning aimed at reducing infection rates associated with hand and wrist fractures. The study included 90 patients who underwent K-wire fixation procedures following specific principles of their technique, which involved not burying or bending the wires and covering them with betadine-soaked alcohol pads as pin site dressings. Pins were removed in an outpatient setting within 12 weeks postoperatively, and patients were assessed for signs of infection. Remarkably, none of the patients exhibited any signs of infection or complications requiring antibiotics, early pin removal, or reoperation. This study highlights the efficacy of the proposed technique in preventing pin site infections, even in a population with prolonged fixation periods, and without the need for prophylactic antibiotics. The findings suggest that percutaneous K-wire fixation, following the outlined principles, can be a safe and costeffective approach without compromising patient safety.

8. 4. Bhatt et al. (2021) conducted a retrospective review to assess the impact of preoperative antibiotic use on the incidence of infection in children with supracondylar humerus fractures treated with closed reduction and percutaneous Kirschner wire (K-wire) fixation. They reviewed data from 1053 patients across three institutions between 2006 and 2016, focusing on patient demographics, antibiotic administration, and followup. Out of 905 patients included in the analysis, 755 received preoperative antibiotics, while 150 did not. The overall incidence of infection was 2.4%, with 2.5% of patients in the antibiotic group and 2.0% in the non-antibiotic group experiencing infections. This difference was not statistically significant. Most infections were managed with oral antibiotics, with or without early pin removal, while a small number of patients required surgical debridement and intravenous antibiotics, all of whom were in the preoperative antibiotic group. The study concluded that there was no significant difference in infection rates between patients who received preoperative antibiotics and those who did not, suggesting that preoperative antibiotic administration may not affect the incidence of infection following this procedure.

9. 5. Hussein et al. (2021) conducted a study to evaluate the occurrence of infections following elective surgeries of the forefoot that were fixed using Kirschner wires (K-wires) and to suggest effective treatment options for resolving the infection. The study spanned three years and focused on the surgical history of a single surgeon. The inclusion criteria for the study included patients without any diseases except for diabetes, with an age range of 18 to 44 years. A total of 50 patients were included in the final sample, who were prescribed prophylactic antibiotics or early removal of K-wires as necessary. Demographic and biological data such as age, BMI, and smoking status were recorded for each patient. The researchers conducted a Univariate analysis using a Chi-square test to analyze the data from 50 patients, accounting for 82 K-wires. The results of the study indicated that surgery type, BMI, and smoking were three variables that significantly affected the growth of infection following forefoot surgeries fixed with K-wires. Additionally, diabetes and the type of cleaning disinfectant used had marginal effects on infection growth. The study concluded that further research is necessary to elucidate the most effective treatments in this area, as treatment options such as antibiotics yielded similar results.

10. Methodology Type of Study : Prospective cohort study Place of Study : DUPMCH, JALGAON Study Duration and period: 3YEARS

11. Minimum Sample size: 60 Sampling Method : Randomization Calculation of sample size: Sample size: Estimation of Population Proportion with absolute precision P Your guess of Population P (any value < 1) 0.19 1-α Confidence level set by you 0.95 Z Z value associated with confidence 1.959963985 d Absolute precision (Value less than P) 0.1 N Minimum sample size 60

12. Data collection/Measurements: Baseline data including demographics, medical history, and fracture characteristics will be collected at the time of enrollment. Antibiotic regimens administered, including type, dosage, and duration, will be documented for Group A. Post-operative outcomes such as infection rates, healing progress, complications, and functional outcomes will be assessed at scheduled follow-up appointments. Standardized assessment tools such as imaging studies, clinical examinations, and patient-reported outcome measures will be utilized for data collection. Data will be recorded in a secure electronic database with strict adherence to patient confidentiality and privacy regulations.

13. Data processing: All the data collection will be entered in a Microsoft excel spreadsheet. Plan for data analysis/Statistics calculations planned/Tests of significance (if Any) : Quantitative parameters will be expressed as the mean ± standard deviation. Qualitative variables will be presented as frequency distribution tables in terms of percentages and proportions. Graphical presentations will be also done for qualitative data. Associations between qualitative variables will be studied with chi square test. A value of P < 0.05 will be used to define statistical significance

14. Written Informed consent INFORMED CONSENT FORM (ICF) Title of the research project: “K wire insertion in fracture reduction with antibiotics coverage and without antibiotics coverage” I, _________________________________resident of___________ Aged________ years _____________(GENDER), have read this consent or following consent has been read to me. The nature, purpose, duration, and risks of the study have been explained to me. My questions have been answered satisfactorily. I understand that my participation in the study is voluntary and that I may refuse to participate or may withdraw from the study at any time, without penalty or loss of benefits to which am otherwise entitled. I also give my consent to the use of radiographs, photographs/video recordings of the procedure for the study, and also for the publication of the results of this study for the public interest. I shall cooperate with doctors and paramedical staff in all respects. I shall inform the doctors of any adverse effects or unusual symptoms noticed by me. I agree to take part in the above study. ______________ _____________ ______________ Patient’s name Signature/thumbprint Date and Time

15. Inclusion criteria: Patients with fractures requiring K-wire insertion for reduction Patients undergoing K-wire insertion with or without antibiotics coverage Patients of all age groups and genders Exclusion criteria: Patients with contraindications to antibiotics or K-wire insertion Patients with pre-existing infections at the fracture site Patients with known allergies to antibiotics used in the study Patients with incomplete medical records or missing data

16. Results anticipated: The use of antibiotics coverage during K-wire insertion in fracture reduction will result in lower infection rates and better overall outcomes compared to procedures performed without antibiotics coverage. Fracture reduction with antibiotics coverage will demonstrate faster healing times compared to procedures without antibiotics coverage

17. Limitations of this study: Patients with allergy to antibiotics cannot be included in study. Patients with pre-existing infections at the fracture site cannot be included in study. Patients with known allergies to antibiotics cannot be used in the study .

18. How your research study will be useful for academic purposes/ patient care/ welfare of community? Study will give idea about the use of antibiotics in surgical interventions and also the outcomes of fracture healing due to the antibiotics used for the coverage.