Abstract
Objective:
This study aimed to evaluate the clinical characteristics and identify risk factors for surgical site infection (SSI) following abdominal wall reconstruction using biological mesh.
Methods:
A retrospective analysis was conducted on patients with open abdomen (OA) with fistula who underwent abdominal wall reconstruction with biological mesh at Jinling Hospital between January 2010 and August 2023. Patients were divided into SSI and non-SSI groups, and their perioperative data were compared to identify potential risk factors.
Results:
The SSI rate following abdominal wall reconstruction was 23.71% (23/97) in patients with OA with fistula. Significant differences (p < 0.05) were found between the SSI and non-SSI groups in body mass index (BMI), BMI classification, nutritional risk index (NRI) classification, abdominal wall defect partition, pre-operative day one neutrophil count (NEUT), post-perative day one white blood cells (WBCs) and NEUT, post-operative day three WBCs and NEUT, post-operative day seven procalcitonin (PCT) and NEUT, length of hospitalization, and total hospitalization cost. Multifactorial analysis identified normal BMI (odds ratio [OR]: 0.151, 95% confidence interval [CI]: 0.041–0.551, p = 0.004) and high BMI (OR: 0.072, 95% CI: 0.010–0.546, p = 0.011) as protective factors against SSI and moderate NRI (OR: 4.054, 95% CI: 1.069–15.376, p = 0.004), severe NRI (OR: 18.233, 95% CI: 2.971–111.897, p = 0.002), and abdominal wall defect partition (OR: 4.032, 95% CI: 1.218–13.349, p = 0.022) as independent risk factors for SSI.
Conclusions:
Normal BMI and high BMI act as protective factors against SSI, whereas moderate NRI, severe NRI, and abdominal wall defect partition are independent risk factors for SSI. Nutritional management and surgical care should be emphasized to reduce SSI incidence in patients with OA with fistula undergoing abdominal wall reconstruction.
Introduction
Open abdomen (OA) therapy, a significant advancement in damage control surgery, has emerged as a crucial measure for treating severe abdominal trauma and intra-abdominal infections.1–3 This approach has significantly improved the survival rate of patients.4–6 However, OA therapy often leads to intestinal exposure, intestinal leakage, significant fluid loss, and abdominal wall defects. In addition, patients with OA with fistula exhibit complex clinical features, including sepsis, body fluid imbalance, and electrolyte imbalance, and delayed wound healing.7,8 Therefore, timely and effective abdominal wall reconstruction is vital for restoring abdominal integrity and improving prognosis.
Although the prompt closure of the abdominal incision and restoration of gastrointestinal continuity are effective treatment strategies, achieving complete closure in a short period can be challenging because of multiple injuries and uncontrolled infections. In addition, if post-inflammatory edema adhesions forming on the abdominal wall are forcibly separated, it can lead to intestinal injury and fistula formation. Consequently, temporary abdominal closure strategies (TACs), such as abdominal wall grafting, skin-only closure, and negative pressure suction technology, are often employed, with definitive reconstructive procedures performed 3–6 months later, after patient recovery.9,10
The use of biological mesh is effective in abdominal wall reconstruction. 11 Numerous animal experiments and clinical studies, both domestic and international, have demonstrated that biological materials possess strong reparative capabilities for abdominal wall defects, particularly in the repair of contaminated and infected abdominal wall defects, with success rates exceeding 76%.12,13 However, site surgical infection (SSI) after abdominal wall reconstruction can significantly impact the normal post-operative recovery process of patients and also pose potentially life-threatening risks. 14 Moreover, because of SSI, patients may incur greater associated treatment costs, including wound care, antimicrobial drug usage, and prolonged hospitalization.1–8,15 Limited research has specifically addressed SSI in patients who underwent abdominal wall defect repair following OA with fistula. 16 Therefore, it is crucial to focus on this patient population to provide insights into the clinical characteristics and risk factors influencing SSI outcomes.
The Department of General Surgery, Jinling Hospital, is the largest center for fistula treatment in China, receiving referrals nationwide. 17 The study collected relevant clinical data of patients with OA with fistula who underwent abdominal wall reconstruction using biological mesh repair from January 2010 to August 2023 (Supplementary Fig. S1). The aim was to evaluate the clinical characteristics and identify risk factors for SSI, thereby guiding clinicians in optimizing patient management and enhancing surgical outcomes.
Material and Methods
Patient selection
A total of 280 patients with OA with fistula treated at Jinling Hospital from January 2010 to August 2023 were included in this retrospective study. The diagnosis of fistula in all patients was confirmed by imaging. The study was approved by the Ethics Committee of Jinling Hospital (Ethical Review Approval number: 2020NZKY-010–01).
Inclusion and exclusion criteria
Patients were eligible for inclusion if they met the following criteria: (a) their medical records were complete, including general information, demographic data, pre-operative data, surgery-related data, laboratory examination data, and post-operative data, and (b) they were patients with OA with fistula who had received TACs in the early stage and subsequently underwent abdominal wall reconstruction surgery using biological mesh.
Patients were excluded if they: (a) underwent abdominal wall reconstruction without the use of biological meshes, (b) died before surgery, (c) were still in the OA stage, (d) were in the TACs stage, or (e) had missing or incomplete data.
Data collection
A data collection sheet was designed to meet the purpose of this study based on our previous studies and experience. 18 Retrospective data collection was conducted using the electronic medical records of patients with OA admitted to Jinling Hospital from January 2010 to August 2023, encompassing patient demographics, pre-operative data, surgery-related data, laboratory examination data, and post-operative data.
The patient demographics collected included gender, age, BMI, nutritional risk index (NRI) 19 , history of smoking, history of drinking, and presence of comorbidities such as tumors, hypertension, chronic obstructive pulmonary disease (COPD), diabetes, renal dysfunction, and hepatic dysfunction. The primary diseases documented were trauma, tumors, gastrointestinal perforation, intestinal obstruction, acute pancreatitis, acute gangrenous appendicitis, and other conditions such as superior mesenteric artery embolism with intestinal necrosis, short bowel syndrome, jejunal volvulus, and colonic diverticulitis. The pre-operative data collected included the reasons for OA, the primary site of the fistula, the number of organs related to the fistula location, the number of fistulas, whether an ostomy was present, the number of previous abdominal operations before abdominal wall reconstruction, the types of TACs utilized (including skin grafting, skin-only, vacuum sealing drainage [VSD] negative pressure suction, and polypropylene mesh for tension reduction suture), the time interval between TACs and definitive abdominal wall reconstruction, the use of antibiotics, the size of the abdominal wall defect, the type of the abdominal wall defect, the grade of the abdominal wall defect, and the partition of the abdominal wall defect. 20 The key information collected regarding abdominal wall reconstruction surgery included the type of biological mesh used, the specific location where the biological mesh was placed, the surface area of the biological mesh utilized, and whether any additional antibacterial dressing was used. Laboratory examination data collected included measurements of procalcitonin (PCT), serum albumin (ALB), white blood cells (WBCs), C-reactive protein (CRP), and neutrophil (NEUT) on pre-operative day one, post-operative day one, post-operative day three, and post-operative day seven.
The post-operative data collected included the duration of intensive care unit (ICU) stay and the use of nutrition, as well as the occurrence and documentation of various complications. These complications encompassed bleeding, incisional infection, necrosis of the surrounding tissue, poor wound healing, incisional dehiscence, intra-abdominal abscess, recurrent enterocutaneous fistula, intestinal obstruction, mesh infection, and re-extraction of the mesh. In addition, the success rate of the treatment, hospital length of stay, associated hospitalization costs, readmission rate, and reoperation rate were also recorded.
Surgical techniques
This retrospective analysis was conducted at a single institution. Consequently, all patients underwent relatively standardized treatment protocols that included pre-operative optimization, surgical techniques, and post-operative care. 21 Fistula management options include using triple cannulae proximally to collect intestinal fluid and distally to return it or implanting a 3D-printed intestinal fistula scaffold to re-establish intestinal continuity.22–24 Temporary abdominal closure techniques include skin grafting, skin-only closure, gradual retraction using polypropylene mesh, and negative pressure suction. Abdominal wall reconstruction is primarily performed using the component separation technique (CST) with biological mesh to close the abdominal cavity (Supplementary Fig. S2).25–29 The mesh placement techniques used in the patient population included onlay, sublay, and underlay.30,31 In an onlay repair, the mesh is placed on the anterior fascia, which typically involves dissecting flaps and primarily closing the fascia below the mesh. In a sublay repair, the mesh is placed between the rectus abdominis muscle and the posterior rectus sheath. In an underlay repair, the mesh is placed in the intra-peritoneal position and secured to the anterior abdominal wall.
Outcomes
The primary outcome was the incidence of post-operative SSI. According to the diagnostic criteria established by the Centers for Disease Control and Prevention (CDC), an SSI is defined as an infection that occurs in the surgical site and can be further classified as superficial, deep, or organ space. 32 The secondary outcomes included the duration of post-operative hospital stay, length of ICU stay, number of readmissions, and total treatment cost.
Statistical analysis
Summary statistics for categorical variables are presented as frequencies and percentages. Numerical data are summarized and expressed as either mean and standard deviation (SD) or median and interquartile range [M (Q1, Q3)], depending on the distribution of the data. The normality was assessed by plotting a frequency distribution. Comparisons between the two groups were conducted using the independent t-test for continuous variables and the chi-square test for categorical variables. Variables with statistically significant differences from the univariate analysis were further analyzed using logistic regression with the enter method to identify independent risk factors for SSI. All analyses were performed using SPSS 26 and GraphPad Prism 8 software. The values were considered significantly different when p < 0.05.
Results
Patient demographics
On the basis of the specified inclusion and exclusion criteria, a total of 97 patients were enrolled in this study, comprising 83 males and 14 females; their ages ranged from 13 to 82 years, with a mean of 46.99 ± 15.67 years (Supplementary Fig. S1). The study population consisted of 74 (76.74%) patients in the non-SSI group and 23 (23.71%) patients in the SSI group. Patient demographics are compared and presented in Table 1.
Demographic and Clinical Characteristics of Patients with OA
Data are expressed as mean ± standard deviation or as n (%).
Other diseases such as superior mesenteric artery embolism with intestinal necrosis, short bowel syndrome, jejunal volvulus, and colonic diverticulitis including diverticulitis of the colon.
The results of correction for continuity.
The results of the likelihood ratio test.
The results of Fisher exact test, test.
BMI, body mass index; COPD, chronic obstructive pulmonary disease; NRI, nutritional risk index; SSI, surgical site infection.
Statistical analysis revealed no significant differences in age, gender, smoking history, alcohol consumption history, comorbidities (including tumors, hypertension, COPD, diabetes, renal dysfunction, and hepatic dysfunction), or primary diagnoses (trauma, tumors, gastrointestinal perforation, intestinal obstruction, acute pancreatitis, acute gangrenous appendicitis, and other conditions such as superior mesenteric artery embolism with intestinal necrosis, short bowel syndrome, jejunal volvulus, and colonic diverticulitis) between the SSI and non-SSI groups (p > 0.05). In contrast, BMI, BMI classification, and NRI classification were statistically different between the two groups (p < 0.05), as shown in Table 1.
Results of univariate logistic regression analyses about surgery-related data between the two groups
Univariate analysis revealed no statistically significant differences between the two groups in the number of prior abdominal surgeries, reasons for OA, primary fistula location, number of involved organs, number of fistulas, ostomy status, TACs used for abdominal closure, or the use of antibiotics (p > 0.05) (Table 2). Univariate analysis of procedural data found no statistically significant differences between the two groups in the time interval between temporary and definitive abdominal wall reconstruction, abdominal wall defect size, defect types, or defect grade (p > 0.05) (Table 3). In contrast, the two groups differed significantly in the partition of the defect (p < 0.05). Specifically, there was a statistically significant distinction in the difference between single-partition defects and multiple-partition defects. Furthermore, the type of biological mesh, mesh placement location, mesh surface area, and use of additional antibacterial dressings did not differ significantly between the two groups (p > 0.05) (Table 3).
Univariate Analysis of Preoperative Clinical Data Between the Two Groups
Descriptive data are n (%).
The results of correction for continuity.
OA, open abdomen; ACS, abdominal compartment syndrome; VSD, vacuum sealing drainage; SSI, surgical site infection.
Univariate Analysis of Clinical Data Related to Abdominal Wall Reconstruction Between the Two Groups
Data are expressed as mean ± standard deviation or as n (%) or as M (Q1, Q3).
Is on the basis of the Chinese expert consensus on adult ventral abdominal wall defect repair and reconstruction.
The results of correction for continuity.
The results of Fisher exact test, test.
SSI, surgical site infection.
Results of univariate logistic regression analyses about laboratory examination data between the two groups
The changes in laboratory examination data between the two groups are presented in Supplementary Figure S3. The results of the univariate analysis suggested that there were no statistically significant differences between the two groups in terms of PCT, WBCs, and CRP on pre-operative day one, PCT and CRP on post-operative day one, PCT and CRP on post-operative day three, and WBCs and CRP on post-operative day seven (p > 0.05). However, statistically significant differences were observed between the two groups in pre-operative day one NEUT, post-operative day one WBCs and NEUT, post-operative day three WBCs and NEUT, and post-operative day seven PCT and NEUT (p < 0.05).
Results of univariate logistic regression analyses about post-operative clinical data between the two groups
The univariate results in Supplementary Table S1 revealed that there was a statistically significant difference between the two groups in terms of length of hospital stay and cost of hospitalization (p < 0.05), although there was no statistically significant difference in terms of days of hospitalization in the ICU, the use of nutrition, and the number of readmissions (p > 0.05).
Results of multivariate logistic regression analyses
Statistically significant differences between the two groups, as determined by one-way analysis of the general and laboratory examination data, were then analyzed using multifactorial regression analysis with the enter method. The results identified normal BMI (odds ratio [OR]: 0.151, 95% confidence interval [CI]: 0.041–0.551, p = 0.004) and high BMI (OR: 0.072, 95% CI: 0.010–0.546, p = 0.011) as protective factors against SSI, whereas moderate NRI (OR: 4.054, 95% CI: 1.069–15.376, p = 0.004), severe NRI (OR: 18.233, 95% CI: 2.971–111.897, p = 0.002) and abdominal wall defect partition (OR: 4.032, 95% CI: 1.218–13.349, p = 0.022) as independent risk factors for SSI. (Table 4)
Multivariate Logistic Regression Analysis of SSI in Patients with OA
SSI, surgical site infection; BMI, body mass index; NRI, nutritional risk index.
Discussion
This study aims to explore the factors influencing SSI by retrospectively analyzing the clinical characteristics and occurrence of SSI in 97 patients who underwent abdominal wall reconstruction following an OA and concurrent fistula at the Department of General Surgery, Jinling Hospital. Through comprehensive univariate and multivariate analyses, we identified normal BMI (OR: 0.151, 95% CI: 0.041–0.551, p = 0.004) and high BMI (OR: 0.072, 95% CI: 0.010–0.546, p = 0.011) as protective factors against SSI and moderate NRI (OR: 4.054, 95% CI: 1.069–15.376, p = 0.004), severe NRI (OR: 18.233, 95% CI: 2.971–111.897, p = 0.002), and abdominal wall defect partition (OR: 4.032, 95% CI: 1.218–13.349, p = 0.022) as independent risk factors for SSI.
Patients with OA with fistula often have complex abdominal wall defects because of multiple prior operations, drainage procedures, muscle atrophy, and prolonged immobilization. Our center has developed standardized treatment techniques to achieve complete reconstruction of the abdominal wall through CST combined with biological mesh while reconstructing the digestive tract. 33 However, these patients remain at a high risk of developing SSI and other infections (Supplementary Fig. S4). To improve patient outcomes, it is important to investigate the clinical characteristics, risk factors, and predictive indicators of SSI.
Common pathogens including Escherichia coli, Enterococcus faecalis, and Klebsiella pneumoniae, have been previously identified by our center, along with risk factors including chronic liver disease, open surgery, colonic surgery, and contaminated and infected incisions, as contributing to SSI. 34 This study further found that normal BMI and high BMI are protective factors for SSI, whereas moderate NRI and severe NRI are independent risk factors for SSI. Maintaining a healthy nutritional status is crucial for patient recovery, particularly in terms of wound healing. 35 It was found that low BMI, moderate NRI, and severe NRI were prevalent among patients in the SSI group, suggesting that malnourished individuals have difficulty achieving a positive nitrogen balance after the stress of surgical trauma. A deficiency in nitrogen balance can impede the fundamental components required for wound healing, undermine immune function, disrupt hormonal balance, and ultimately increase the risk of SSI. Furthermore, the endocrine and metabolic changes, coupled with stress responses, that are associated with abdominal wall reconstruction surgery involving the abdominal organs may result in varying degrees of short-term nutritional depletion. 36 According to the principles of accelerated recovery surgery, timely nutritional supplementation during the perioperative period of open abdominal surgery can help increase nutrient reserves and enable the body to rapidly achieve a positive nitrogen balance under the demands of high-energy metabolism.37–39 Such an approach is beneficial for wound healing and can reduce the risk of SSI. 40 Therefore, providing appropriate nutritional support and intervention both before and after surgery is crucial for the prevention of SSI.
This study also revealed that the partition of abdominal wall defects has an impact on SSI, with multiple defects being more likely to result in SSI compared with single defects. Insufficient blood supply was identified as one of the contributing factors, as multiple defects often involve larger areas that may not receive adequate blood flow. Adequate blood supply is crucial for promoting tissue repair and regeneration, as it provides the oxygen and nutrients necessary for optimal wound healing. 41 Another factor is the lack of supportive structures, as multiple defects can lead to the absence or disruption of supporting structures.42,43 Insufficient support can place the wound under tension, which can increase the burden on the wound and impede the healing process. In addition, multiple defects can increase the risk of SSI because of the larger affected area, making the wound more susceptible to bacterial and microbial invasion. Infection can disrupt the normal healing process, delay healing time, and potentially result in poor wound healing outcomes. Therefore, healthcare professionals should prioritize monitoring the blood supply to the wound, repairing any disrupted supporting structures, and preventing and managing infections in cases of multiple abdominal wall defects to facilitate optimal wound healing outcomes.
Our recent clinical practice has shown that xanthan gum hydrogel dressings play a critical role in the repair of abdominal wall defects following OA. As illustrated in Supplementary Figure S5, during the OA stage, the application of the xanthan gum hydrogel dressing resulted in two primary benefits. First, the excellent hydration properties of the dressing enabled it to effectively cover the damaged abdominal wall surface, forming a protective barrier that prevents the invasion of external bacteria and mitigates mechanical damage caused by direct contact of the mesh with the intestinal wall. Moreover, the chitosan present in the dressing exhibits strong antibacterial properties, further inhibiting bacterial growth and reducing the risk of infection. Second, the dressing demonstrates excellent biocompatibility and effectively promotes tissue regeneration, thereby reducing the incidence of post-operative complications.44,45 In addition, the xanthan gum hydrogel dressings positively influence angiogenesis and collagen synthesis, which facilitates the filling of granulation tissue between the intestinal loops, accelerates the formation of a frozen abdomen, and expedites the transition to the skin grafting stage. This ultimately shortens the time required for subsequent digestive tract and abdominal wall reconstruction, enhancing surgical efficacy. We believe that the widespread application of xanthan gum hydrogel dressings will bring breakthroughs in the management of OA procedures.
This study has several limitations. First, the diverse range of patients with OA with fistulas and the relatively small sample size may have precluded the identification of other potential risk factors for SSI. Second, the analysis of SSI risk factors did not include a detailed classification of the SSI cases. Furthermore, the lack of bacterial identification and antimicrobial susceptibility testing of wound and intra-abdominal drainage fluid samples limited the investigation into the impact of specific pathogens on SSI. The absence of systematic data collection and analysis on high-output and low-output fistulas may have underestimated the impact of fistula output on SSI. Moreover, the retrospective design of this study inherently limits the scope of the findings, necessitating prospective studies to further validate the conclusions. Lastly, the study focused excessively on SSI risk factors while inadequately addressing subsequent treatment approaches. These limitations should be addressed in future research.
Conclusions
This study identified normal BMI (OR: 0.151, 95% CI: 0.041–0.551, p = 0.004) and high BMI (OR: 0.072, 95% CI: 0.010–0.546, p = 0.011) as protective factors against SSI and moderate NRI (OR: 4.054, 95% CI: 1.069–15.376, p = 0.004), severe NRI (OR: 18.233, 95% CI: 2.971–111.897, p = 0.002), and abdominal wall defect partition (OR: 4.032, 95% CI: 1.218–13.349, p = 0.022) as independent risk factors for SSI. These findings can aid clinicians in enhancing awareness and formulating appropriate preventive measures, including diagnostic and treatment precautions, to mitigate SSI risk. Specifically, providing nutritional support and meticulous surgical care before and after surgery plays a crucial for preventing SSI and promoting effective wound healing. However, this study was a single-center retrospective analysis with a relatively small sample size. Therefore, further multicenter, large-sample prospective studies are needed to validate these findings.
Ethical Approval
The study was approved by the Ethics Committee of Jinling Hospital (Ethical Review Approval number: 2020NZKY-010–01).
Research Registration Unique Identifying Number
This clinical trial has been registered in the Chinese Clinical Trial Registry under registration number: ChiCTR2100043706.
Guarantor
Jianan Ren, Research Institute General Surgery, Affiliated Jinling Hospital, Medical School of Nanjing University, 305 East Zhongshan Road, Nanjing, 210002, China. e-mail:
Footnotes
Data Availability
The dataset analyzed for this study is available upon request to the corresponding author.
Authors’ Contributions
Y.L., X.W., and J.R.: study concept, design, and writing the article; Y.L., S.L., Y.T., J.Z., J.H., L.W., Z.Z.: data collection; Y.L., S.L., X.Z., X.L.: data analysis; Z.H., H.R.: data interpretation; Y.L., S.L., J.H., Y.T., L.W., J.Z., X.Z., X.L., Z.Z., Z.H., H.R., X.W., and J.R.: read and approved the final article.
Funding Information
This study was supported by: The
Author Disclosure Statement
No competing financial interests exist.
References
Supplementary Material
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