Surgical site infections (SSIs) are one of the most critical postoperative complications, presenting a significant clinical and economic burden to healthcare systems worldwide. Officially recognized in 1992, the term “surgical site infection” replaced the previous term “surgical wound infection” to offer a more precise and standardized classification of infections that occur within 30 days post-surgery, affecting the incision, deeper tissues, organs, or body cavities [2]. Despite significant advances in surgical techniques, aseptic practices, and infection control measures, SSIs remain prevalent, accounting for approximately 20% of hospital-acquired infections globally [3]. The consequences of SSIs are far-reaching, as they significantly increase patient morbidity and mortality, extend hospital stays, and drive-up healthcare costs. Studies have shown that patients with SSIs face a 2- to 11-fold higher risk of death, with nearly 77% of these deaths attributed directly to the infection itself [4-6].

The incidence of SSIs typically ranges from 2% to 5% following inpatient surgeries, though these figures are often underestimated due to challenges in tracking infections after patient discharge. In the United States alone, the annual number of SSIs is estimated to range from 160,000 to 300,000, contributing a staggering economic burden of $3.5 to $10 billion each year [7]. The additional healthcare expenses associated with SSIs, such as prolonged hospitalization, exceed $20,000 per patient, while readmissions account for more than $700 million in annual costs. Fortunately, up to 60% of SSIs are preventable through evidence-based practices, making it a high priority to reduce SSI rates in quality improvement, patient safety, and value-based care initiatives [8-10].

The Centers for Disease Control and Prevention (CDC) has established a widely accepted classification of SSIs based on the depth of tissue involvement. These classifications include superficial incisional SSIs, which affect the skin and subcutaneous tissue; deep incisional SSIs, which involve the fascia and muscle layers; and organ/space SSIs, which affect areas manipulated during surgery. Several intrinsic and extrinsic factors contribute to the risk of developing SSIs. Intrinsic (patient-related) factors such as diabetes, poor glycaemic control, smoking, obesity, malnutrition, and immunosuppression, as well as nonmodifiable factors such as age and prior radiation therapy, increase susceptibility. Extrinsic factors like inadequate sterilization, environmental conditions, improper antibiotic prophylaxis, and prolonged surgery duration further elevate the risk [12-15].

Surgical procedures themselves also play a role in the incidence of SSIs. Minimally invasive surgeries have been associated with lower SSI rates due to reduced incision sizes, less tissue trauma, and quicker recovery times. For example, laparoscopic cholecystectomy has a 1.1% SSI rate, compared to 4% for open surgery, while laparoscopic appendectomy demonstrates a 2% SSI rate versus 8% in open surgery [20-22]. These reductions are largely due to smaller incisions, reduced postoperative pain, and less immune suppression in patients.

The clinical impact of SSIs extends beyond patient outcomes, significantly influencing hospital readmissions, intensive care unit (ICU) admissions, and overall patient mortality. Studies show that SSIs increase the risk of ICU admission by 1.6 times, the risk of readmission by 5.5 times, and the risk of mortality by 2.2 times [23]. Moreover, SSIs often add an average of 6.5 to 9.8 days to the length of hospital stays, placing a substantial burden on both healthcare facilities and patients [24,25].

Microbiologically, most SSIs originate from the patient's own endogenous flora. Common pathogens include Staphylococcus aureus, coagulase-negative staphylococci, Enterococcus spp., and Escherichia coli. The rise of antibiotic-resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA) and Candida species, complicates treatment and underscores the importance of effective infection control measures, especially in immunocompromised patients. Colonization with organisms like nasal MRSA significantly elevates the risk of infection, especially in high-risk areas of the body, such as the axilla and groin, which are prone to Gram-negative organisms [26].

Preventing SSIs requires a comprehensive, multidisciplinary approach across the preoperative, intraoperative, and postoperative phases. Preoperative strategies include minimizing hair removal, optimizing nutritional status, controlling blood glucose, screening for MRSA, and administering appropriate prophylactic antibiotics [27]. Intraoperative measures focus on strict aseptic technique, proper surgical hand hygiene, minimizing operating room traffic, and reducing operative times. Furthermore, immunosuppressive therapy must be carefully managed, as both discontinuation and continuation carry inherent risks [28-30]. Continued adherence to evidence-based practices is essential in mitigating the incidence and impact of SSIs in modern surgery [28].

Understanding the pathophysiology of biomarkers such as albumin, globulin, and the albumin-to-globulin (AG) ratio is also crucial in immune response regulation. Albumin is the most abundant soluble protein in the body and plays a significant role in maintaining fluid balance, supporting wound healing, and enhancing immune function. Globulin consists of a range of proteins, including carrier proteins and immunoglobulins (antibodies), which are essential for defending against pathogens such as bacteria, viruses, and fungi. Each immunoglobulin molecule is made of heavy and light chains, with different types such as IgG, IgA, IgM, IgE, and IgD, each playing a specific role in immune protection. A deficiency in immunoglobulins often leads to recurrent infections. The AG ratio measures the concentration of albumin relative to globulin in the blood. A high AG ratio indicates a higher albumin concentration, which can be linked to conditions such as liver disease, infections, obesity, and autoimmune disorders. In contrast, a low AG ratio, where globulin levels are elevated, is often associated with infections, cancers, and weakened immune responses. Monitoring the AG ratio can help assess infection risks and the body’s inflammatory status, providing valuable insight into patient health and recovery post-surgery.

Aims and Objectives

The present study was undertaken to evaluate the role of pre-operative biochemical markers in predicting the risk of postoperative surgical site infections. The primary research question guiding this investigation was: What is the predictive value of pre-operative Albumin, Globulin, and the Albumin/Globulin (AG) ratio in determining the occurrence of surgical site infection (SSI) following major orthopaedic surgeries involving implants in adult patients?

The central aim of the study was to determine the proportion of patients who developed SSI among those presenting with normal versus abnormal pre-operative levels of Albumin, Globulin, and the AG ratio. In line with this aim, the specific objective of the study was to assess the predictive significance of these pre-operative biochemical parameters in the development of SSI after major orthopaedic implant surgeries in adult individuals.

This prospective hospital-based cross-sectional study was conducted in the Department of Orthopaedics, Assam Medical College and Hospital, Dibrugarh, Assam. The study spanned a period of twelve months, beginning in November 2023 and concluding in October 2024. The study population consisted of adult patients who underwent major orthopaedic surgeries involving fixation with implants in the Department of Orthopaedics during the study period. The sample size was calculated based on the reported sensitivity of the Albumin–Globulin (AG) Ratio in diagnosing surgical site infection (SSI) as 64.15% and the prevalence of SSI as 16.21%. With a 95% confidence interval, an absolute precision of 20%, and a non-response rate of 10%, the final sample size was determined and rounded to 160 participants. Patients aged 18–65 years of both genders who provided written informed consent and underwent major orthopaedic surgeries with implants (plates, nails, or prostheses) were included. Patients with systemic inflammatory diseases such as rheumatoid arthritis, psoriasis, systemic lupus erythematosus, polymyalgia, inflammatory bowel disease, myelodysplastic syndromes, sarcoidosis, lymphocytic leukemia, and multiple myeloma were excluded. Additional exclusion criteria included chronic liver disease, chronic kidney disease, type 2 diabetes mellitus, pre-existing infections, open fractures, polytrauma cases, and refusal to provide informed consent. Ethical approval for the study was obtained from the Institutional Ethics Committee (Human), Assam Medical College and Hospital, prior to the commencement of research activities. Data Collection Data were collected using a predesigned and pretested proforma after obtaining written informed consent from each participant. All eligible patients admitted for major orthopaedic surgeries with implants during the study period were identified. A detailed clinical history was recorded, with specific inquiry regarding recent fever, cough, urinary symptoms, fractures, prior orthopaedic interventions, and chronic infectious or inflammatory illnesses. A comprehensive general examination was performed to identify signs of infection such as fever, lymphadenopathy, pallor, clubbing, and edema. Systemic examination of the respiratory, cardiovascular, and abdominal systems was conducted to detect comorbid infectious or inflammatory conditions. Local examination of the affected limb was carried out, including evaluation of distal neurovascular status. Patients fulfilling the inclusion criteria were enrolled following institutional ethical approval. After explaining the study purpose, written informed consent was obtained. Demographic details such as age, gender, and duration of injury were documented. All patients underwent a detailed clinical evaluation and standard preoperative investigations as per hospital protocol. Routine preoperative laboratory and radiological investigations included complete blood count (CBC), liver function test (LFT), renal function test (RFT), serum electrolytes, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). The levels of serum albumin, globulin, and AG ratio were obtained from the LFT report. Laboratory analysis was performed in the Department of Biochemistry, Assam Medical College, Dibrugarh. Normal reference ranges included: • Serum Albumin: 3.50–5.00 g/dL • Serum Globulin: 2.80–3.20 g/dL • AG Ratio: 1.30–1.50 Follow-up Following discharge, patients were reviewed on postoperative day 10 for suture removal or in the outpatient department if sutures had already been removed in the ward. Subsequent follow-up visits were conducted at four weeks, monthly thereafter, and later every three months. Wound condition was assessed at each visit. Patients presenting with symptoms suggestive of SSI were evaluated immediately. Investigations included CRP, ESR, AG ratio, wound swab for Gram and fungal staining, culture and sensitivity, and radiological imaging to assess implant stability and rule out osteomyelitis. Statistical Analysis All collected data were organized into tables and graphical representations. Descriptive statistics were used to calculate percentages for categorical variables. Appropriate statistical tests were applied depending on data characteristics. Qualitative variables were analyzed using the chi-square test, while quantitative variables were assessed using the Z-test or Student’s t-test. Statistical analysis was performed using standard analytical tools.

The age group distribution of fractures, with a breakdown of SSI (Surgical Site Infection) and Non-SSI cases. The total number of fractures is 160, with the highest frequency of fractures occurring in the 31-40 age group (40 cases, 25%). The 18-30 age group follows closely with 29 cases (18.10%). Among the 18-30 age group, 4 cases are SSI and 25 are non-SSI, while the 31-40 group has 2 SSI cases and 38 non-SSI cases. The 41-50 and 51-60 age groups have 37 and 35 cases, respectively, representing 23.10% and 21.90% of the total, with 4 and 5 cases of SSI respectively. The 60-65 age group has the fewest fractures, with 19 cases (11.90%). Across all age groups, there are 19 SSI cases and 141 non-SSI cases. The gender distribution of fractures, broken down into SSI (Surgical Site Infection) and Non-SSI cases.

Among the 160 total fractures, 42 are female (26.3%) and 118 are male (73.8%). Of the females, 9 (21.43%) cases are associated with SSI, and 33 are non-SSI. In contrast, 10 (8.47%) male cases are related to SSI, while 108 are non-SSI. In total, there are 19 cases of SSI and 141 cases of non-SSI, accounting for 100% of the data. Among the fractures, the most common is the Proximal Femur Fracture, with 30 cases (18.75%), followed by the Neck of Femur Fracture with 26 cases (16.25%). Other notable fractures include the Shaft of Femur Fracture with 16 cases (10%) and the Forearm Fractures (single and both bone) and Both Bone Leg Fracture, each with 16 cases (10%). Less frequent fractures include the Vertebra Fracture (3.13%) and the Clavicle Fracture, Scapula Fracture, and Avascular Necrosis (0.63%). A few fractures like the Vertebra, Proximal Femur, and Malleolar fractures also have associated SSI (Surgical Site Infection) percentages, such as 40% for Vertebra Fracture and 23.33% for Proximal Femur Fracture. The total count of fractures is 160, summing to 100%.

The diagnostic performance of serum proteins among the study participants reveals that the mean albumin level is 3.87 g/dL with a standard deviation of 0.53 g/dL, while the mean globulin level is 3.17 g/dL with a standard deviation of 0.49 g/dL. The albumin-to-globulin (AG) ratio has a mean value of 1.24 with a standard deviation of 0.2. These values provide insights into the balance between albumin and globulin levels, which may play a role in assessing nutritional status, inflammation, or disease prognosis in the study population.

Among the 160 total cases, 141 did not develop SSI, while 19 experienced infections. Plates were the most commonly used implant (56 cases) with only 2 infections, whereas nails had a relatively higher incidence of SSI (8 out of 49 cases). Hip replacement arthroplasty (HRA) had 4 infections among 19 cases, while tension band wiring (TBW), Cannulated Cancellous screw (CCS), and dynamic hip Screw (DHS) each had 1 infection. Pedicle screws showed a higher infection rate (2 out of 5 cases). Total knee replacement (TKR) and total hip replacement (THR) had no infections. These findings highlight variations in infection risk based on implant type.

Biochemical Parameters

The comparison of laboratory indicators between the infection and non- infection groups reveals significant differences in serum protein levels. The mean albumin (pALB) level was significantly lower in the infection group (3.08 ± 0.51 g/dL) compared to the non-infection group (3.61 ± 0.65g/dL), with a P-value of 0.009. Conversely, globulin (GLO) levels were markedly higher in the infection group (4.60 ± 0.53 g/dL) compared to the non-infection group (3.37 ± 0.52 g/dL), with P < 0.001. Consequently, the albumin-to-globulin ratio (AGR) was significantly lower in the infection group (0.79 ± 0.31) than in the non-infection group (1.29 ± 0.44), with a highly significant P-value (P < 0.001). These findings suggest that lower albumin and AGR, along with higher globulin levels, may be associated with infection risk in the study population.

Surgical outcomes of study participants

The comparison of incision size between patients with and without surgical site infections (SSIs) indicates that medium-sized incisions (7–14 cm) are the most common in both groups, accounting for 71.9% of the total cases. However, patients with SSIs had a higher proportion of large incisions (30.0%) compared to those without SSIs (21.4%). Small incisions (≤6 cm) were the least common overall, but the proportion was higher in the SSI group (10.0%) compared to the non-SSI group (5.0%). The significant p-value (<0.001) suggests a strong association between incision size and the risk of SSIs, with larger incisions potentially contributing to an increased likelihood of infection

Among the 160 total cases, 141 patients did not develop SSI, while 19 experienced infections. The majority of surgeries lasted less than 60 minutes (103 cases), with 11 developing SSI. In procedures lasting 60–90 minutes, 7 out of 52 patients had SSI. For surgeries exceeding 90 minutes, 1 out of 5 patients developed an infection. The p-value of 0.032 indicates a statistically significant association between surgical duration and the risk of SSI, suggesting that longer procedures may contribute to a higher infection rate. . Among the non-SSI group, 125 individuals have normal values for albumin, globulin, and the A:G ratio, while 16 individuals show abnormal values. In contrast, the SSI group has only 1 individual with normal values, while 18 individuals exhibit abnormal values. Overall, 126 individuals across both groups have normal values, while 34 individuals have abnormal values.

Our study covered cases undergoing major orthopedic surgeries involving implants or prosthesis in adult population who fulfills inclusion and exclusion criteria in the department of Orthopedics, Assam Medical College & Hospital, Dibrugarh (Assam).The preoperative values of Albumin, Globulin and the Albumin to Globulin (AG) ratio for all the cases are recorded and then they were followed up in their post operative period for detecting surgical site infection(SSI).There were total 160 patients included in the study and out of them 19 patients developed surgical site infection(SSI). Out of these, 18 patients with surgical site infection had altered pre-operative values of albumin, globulin, and albumin to globulin (AG) ratio, and only 1 patient had a normal preoperative value for the same. The results and observation of the study were compared and analyzed with other relevant studies. Age, gender, fracture patterns, implant selection, biochemical markers, incision size, and surgical duration are well-established determinants of postoperative surgical site infection (SSI).

In the present study of 160 fracture cases, these variables were analyzed comprehensively to understand their association with infection risk. The distribution of fractures revealed that the majority occurred among younger to middle-aged adults, with the highest frequency in the 31–40-year age group (25%), followed by the 18–30-year group (18.10%). Despite fractures being more common among younger individuals, SSIs were predominantly observed in older patients, particularly in the 51–60-year group, which recorded five cases of infection. This trend aligns with the well-documented study by Owens & Stoessel (2008) [30] influence of age on postoperative immune response and wound healing, where advancing age corresponds with higher susceptibility to infection. Gender distribution also demonstrated notable differences. Among the 160 cases, males constituted 73.8%, and females 26.3%. While fractures were more common in males, the overall SSI distribution—10 in males and 9 in females—suggests that infection risk is not exclusively related to fracture prevalence but may be influenced by immunological and hormonal differences. Previous study by Laupland et al. (2008) [31] have similarly reported marginally higher infection risk among males, attributed to behavioral and physiological factors affecting wound healing and microbial exposure.

Analysis of fracture types showed that Proximal Femur Fractures (18.75%) and Neck of Femur Fractures (16.25%) were the most common. However, Vertebral Fractures demonstrated the highest infection proportion, with 4 SSI cases out of 5 (40%). Proximal Femur Fractures also showed a comparatively high SSI rate (23.33%). The anatomical location of fractures, extent of soft-tissue damage, and surgical exposure required for fixation likely contributed to these elevated infection rates. Implant-associated infection patterns supported this observation; pedicle screw fixation showed the highest SSI rate (40%), followed by intramedullary nailing (16.33%) and hip arthroplasty (21.05%).

These findings mirror published results by Mangram et al., (1999) [32] highlighting that extensive exposure, soft-tissue stripping, and hematoma formation contribute significantly to implant-related SSIs. Biochemical parameters revealed a strong association between serum protein alterations and infection. Patients with SSI demonstrated significantly lower albumin levels, higher globulin levels, and a markedly reduced albumin-to-globulin (AG) ratio compared to those without infection. Since albumin reflects nutritional status and globulin reflects inflammatory response, a diminished AG ratio indicates systemic inflammation and compromised healing capacity. This pattern corresponds with previous report by Hennessey et al., (2010) [33] demonstrating the prognostic utility of albumin and AG ratio in identifying postoperative infectious complications.

Overall, the study highlights that advancing age, high-risk fracture types, implant selection, abnormal biochemical markers, larger incisions, and prolonged surgical duration significantly increase the likelihood of SSI. Strengthening aseptic measures, improving nutritional optimization, and minimizing operative time may substantially reduce postoperative infection rates.

The findings of the present study indicate that surgical site infection (SSI) remains a significant postoperative complication following open reduction and internal fixation of long bone fractures at Assam Medical College, Dibrugarh. Higher rates of SSIs were observed in cases involving pedicle screw fixation for vertebral fractures and nailing procedures for proximal femur fractures, with lower limb long bone fractures showing greater susceptibility compared to upper limb cases. Preoperative abnormalities in serum albumin, globulin, and the albumin–globulin ratio were found to be significantly associated with the occurrence of SSIs, underscoring their potential value as economical, objective, and convenient biomarkers for early identification of high-risk patients. Incorporating these parameters into routine preoperative screening may enhance the ability to predict and prevent SSIs in adult patients undergoing implant-based orthopaedic interventions. Given the substantial resource burden associated with managing SSIs, there is an ongoing need for effective screening protocols and innovative preventive strategies to mitigate their impact on both patients and healthcare providers.

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