Timing of Surgical Debridement for Open Tibia Shaft Fractures: How Long Can We Wait?

Keywords

Surgical Debridement; Open Tibia Fracture; Infection; Implant Failure; Nonunion

Abstract

Purpose: The relationship between time to surgical debridement and complications for open tibia fractures remains debatable. The American College of Surgeons guidelines recommend debridement within 24 hours of presentation. However, there are various reasons that debridement may be delayed beyond this due to patient instability from life-threatening injuries. This study evaluates the safety of non emergent debridement of open tibia shaft fractures beyond 12 and 24 hours.

Methods: Patients with open tibia shaft fractures undergoing surgical debridement were retrospectively reviewed. Patient demographics, injury severity, type of fixation, time to antibiotics, Gustilo classification and time to debridement were recorded. Patients were grouped into < 12h, 12-24h, and > 24h cohorts, based on time to debridement. Primary outcomes included rates of infection, tibia nonunion, and implant failure. Univariate analysis and logistic regression were performed.

Results: 66 patients were included in our study, with a median follow-up of 7.5 months (IQR = 4.8-13.5). Mean time-to-debridement was 15 hours ± 11.7. 33 patients (50%) underwent debridement < 12h, 24 patients (36%) between 12-24h, and 9 patients (14%) > 24h. In total, 12 patients (18%) went on to nonunion, 6 patients (9%) had an implant failure, and 14 patients (21%) experienced an infection. Infection, nonunion and implant failure rates did not vary between patients who underwent debridement < 12h (p = 0.22), between 12-24h (p = 0.55), and > 24h (p= 0.89).

Conclusion: In this study, surgical debridement of open tibia fractures 24 hours following presentation was not associated with increased complications. These findings suggest a possibly favorable outcome even for patients who cannot undergo urgent debridement due to medical issues or other traumatic factors.

Citation

Saade A, Tse S, Simister S, Megerian M, Campbell ST, et al. (2024) Timing of Surgical Debridement for Open Tibia Shaft Fractures: How Long Can We Wait?. SM J Orthop 7: 8.

INTRODUCTION

Open fractures are considered orthopaedic emergencies requiring early operative debridement and stabilization, with a reported average infection rate for open tibia fractures of around 18% [1]. However, the relationship between time to operative debridement and complication rates for open tibia fractures remains unclear. Several factors, such as injury severity, antibiotic prophylaxis, promptness of initial management, and extent of debridement collectively influence the incidence of infection [2]. This complexity highlights the challenge of pinpointing an optimal timing for debridement.

Debridement of an open tibial fracture necessitates meticulous surgical exploration, removal of devitalized tissue, and copious irrigation for effective mechanical cleansing using pulsed lavage. Early and thorough debridement with complete excision of the injury zone is crucial in open fracture care. A systematic and judicious approach at each tissue layer is essential, aiming to retain viable tissues while removing contaminated elements and determining the appropriate extent of debridement [3].

The American College of Surgeons (ACS) guidelines recommend that patients with open fractures should undergo irrigation and debridement within 24 hours of presentation when possible [4]. However, there are various reasons that this may be delayed beyond the recommended time period, ranging from logistical factors and operating room availability to patient instability from life-threatening injuries [5]. Several publications have suggested that adequate debridement and the timely administration of antibiotics may be a more important factor than early debridement in mitigating infection risk [2,6].

The purpose of this study is to assess the safety of non-emergent debridement of open tibia fractures. The authors hypothesize that surgical debridement beyond 24 hours does not increase the risk of subsequent complications in open tibia shaft fractures.

MATERIALS AND METHODS

After Institutional Review Board approval, the authors conducted a retrospective review of consecutive patients with open tibia shaft fractures treated in a single academic Level-1 Trauma center between July 2014 and July 2022. The initial chart review yielded 418 tibia fractures. Patients who sustained open tibia shaft fractures with at least three months of clinical follow-up were included in the study. Patient demographics (age, sex, BMI), smoking status, substance use status, injury mechanism, Injury Severity Score (ISS), gross contamination at presentation, Gustilo-Anderson (GA) classification, time of initial antibiotic administration, time of presentation and surgical debridement were collected.

Patients were then categorized into three cohorts based on time-to debridement: (1) less than 12 hours, (2) between 12 and 24 hours, and (3) greater than 24 hours. Gross contamination was defined by the presence of gross debris at the wound site. The primary outcome measures for this study were rates of infection, fracture nonunion, and implant failure. These were defined as the following:

• Infection: any infection that required surgical intervention following the debridement surgery.

• Nonunion: delayed or incomplete bone healing evidence on imaging correlated with clinical findings such as persisting pain on ambulation

• Implant failure: Any implant that required removal due to hardware breakage or loosening following infection, nonunion or idiopathic cause.

Secondary outcomes included the possible relationship between the different primary outcomes and risk factors, including Gustilo classification, sex, BMI, ISS, the mechanism of injury, smoking status, Substance Use Disorder (SUD), gross contamination, timing of antibiotics administration and the method of fracture fixation during debridement.

For statistical analysis, the GA classifications were combined into three categories [type I, type (II +3A) and type (3A+3B)] based on the type of management for each type of fracture and to compensate for the poor inter-observer agreement when identifying fractures based on the GA classification [6]. Univariate analysis assessed variables using Chi-square and Fisher’s exact tests and one-way Analysis of Variance (ANOVA) tests. Multiple logistic regression was performed to control for confounders and identify independent risk factors for different primary outcomes. Due to the small sample size and low number of events, we employed a model selection procedure: (1) we tested for univariate associations between all risk factors and each primary outcome. (2) Those significant at the 0.2 level were included as covariates/potential confounders in a multiple logistic regression model. (3) Backward selection was implemented to sequentially remove the covariate with the largest non-significant p-value, where time to debridement was included in all models regardless of p-value. (4) This was repeated until all covariates were significant at the 0.05 level. All statistical analyses were conducted using SAS 9.4 (M8 Version, SAS institute, Cary NC) and statistical significance was determined at p <0.05.

RESULTS

66 patients met our inclusion criteria, with a median follow-up of 7.5 months (IQR = 4.8-13.5). The mean time-to-debridement was (Mean ± SD: 15 hours ± 11.7). 52 patients (79%) received definitive tibia fixation at the time of initial debridement, while 14 (21%) received staged fixation.

33 patients (50%) underwent debridement within 12 hours (7.9 ± 3.3), 24 patients (36%) between 12 to 24 hours (16.7 ± 3.0), and 9 patients (14%) after 24 hours (40 ± 12.3). The maximum time-to-debridement was 63 hours for an unstable polytrauma patient. These three cohorts were comparable regarding patient demographics, smoking status, SUD, injury mechanism, rate of gross contamination, GA classification, time to intravenous antibiotic administration, and follow-up time (Table 1). However, patients who underwent debridement after 24 hours had a higher ISS (p = 0.03). Stabilization of more life-threatening injuries requiring general surgery and/or neurosurgery clearance were the most common reasons for debridement occurring beyond 24 hours. According to GA classification, the fracture type distribution among patients was the following: 9 patients (13.6%) with type I, 24 patients (36.4%) with type II, 16 patients (24.3%) with type 3A, 8 patients (12.1%) with type 3B and 9 patients (13.6%) with type 3C. 12 patients (18%) went on to nonunion and 14 had an infection (21%).

Table 1: Descriptive Statistics of patient sample based on time to debridement windows.

SD, *. BMI, *. MVC, *. MCC, *.

Overall, 22 patients required a return to the operating room for additional surgery: 18 patients (27%) were treated for infection or nonunion, while 4 patients (6%) underwent surgery for elective or symptomatic removal of hardware. Two patients underwent below knee amputation (BKA): one was an early amputation 2 weeks after debridement for an unsalvageable limb due to vascular compromise, while the other had a late amputation 15 months after initial debridement due to chronic infections (Figure 1).

Figure 1 A. Preoperative AP X-ray of right tibia fracture.

B. 8 months postoperative X-ray demonstrating nonunion and hardware failure.

C. 9 months postoperative X-ray demonstrating radiographic of osteomyelitis with antibiotic spacer placed after intramedullary nail removal.

D. Postoperative X-ray of the same extremity following below knee amputation due to unresolved chronic infection.

Univariate analysis

Univariate analysis revealed that patients who had subsequent infection were more likely to be older (p = 0.016), have a higher BMI (p = 0.008), and have a substance use disorder (p = 0.002). As for implant failure, patients with higher BMI (p = 0.009) and substance use disorder (p = 0.03) were at increased risk. Patients with SUD were at higher risk for infection (p = 0.002) and nonunion (p = 0.03). Due to lack of patients with diabetes, this variable was collected but excluded from the analysis. There was no difference in the rates of any complications between patients in the three different time-to-debridement cohorts (p = 0.19/0.25/0.50) (Table 2).

Table 2: Univariate analysis for primary outcomes

^*Wilcoxon rank sum p-value. ^**Fisher Exact p value. Variables with p <0.20 were included in the multiple logistic regression analysis using the backward selection procedure.

^a: Time to debridement analyzed as a continuous variable and used the multiple logistic regression.

^b: Time to debridement analyzed as a categorical variable using different time windows was not used in regression analysis.

Multiple Logistic Regression Analysis

For infection, smoking status was removed in the first step of backward elimination (p = 0.81), age in the second step (p = 0.20), and time to antibiotics in the 3rd step (p = 0.17). BMI and substance abuse remained significant (p = 0.009 and 0.005, respectively). Time to debridement was not statistically associated with infection alone (p = 0.40) or after controlling for significant covariates (p = 0.22). For nonunion, the injury mechanism was removed in the first step (p = 0.84), GA classification (p = 0.22) in the second step, and gross contamination in the third step (p = 0.10). BMI (p = 0.02) and fixation at the time of debridement (p = 0.02) remained significant.

Time to debridement was not statistically associated with nonunion alone (p = 0.26) or after controlling for significant covariates (p = 0.55). For implant failure, smoking status was removed in the first step (p = 0.49), time to antibiotics in the second step (p = 0.29) and age in the third step (p = 0.25). BMI (p = 0.02) and substance abuse (p = 0.06) remained significant. Time to debridement was not statistically associated with implant failure alone (p = 0.66) or after controlling for significant covariates (p = 0.89).

DISCUSSION

ACS has pushed for the time to debridement of open tibia shaft fractures to decrease to 8 hours (anecdotally a request mentioned at our institution’s last ACS review) [4]. This study investigated the impact of the timing of surgical intervention on complications in patients with open tibia shaft fractures. The study results suggest that the timing of debridement does not significantly impact rates of complications, including infections, tibia nonunion, and implant failures to a certain extent.

Our findings are consistent with several previous studies [7,8] in the literature, that challenges the shorter debridement time precedent [9]. The overall infection and nonunion rates observed in this study remain consistent with the existing literature [10-15], even for patients who had debridement surgery beyond 24 hours [27.8-63 hrs] [16]. Defining the ideal timing for surgical intervention in open tibia shaft fractures and perhaps open fractures in general remains inconclusive, as evidenced by much debate in the field [17]. For example, we found a trend in increased infections in surgeries performed within 12 hours is of clinical interest, even though statistical significance was not reached. This may suggest that the decision for urgent operative intervention may be affected by other clinical factors as patients with the most severe fractures tend to undergo debridement earlier. Paradoxically, despite prompter debridement, these patients still exhibit high infection rates likely due to the increased injury severity grade [7,8,18]. When stratifying fractures based on GA classification, this study revealed a significant difference between different GA fracture types and nonunion (p = 0.02) (Table 2). However, this wasn’t the case with the remaining primary outcomes, and when controlling for different confounders, no association was found between GA fracture type and nonunion (Table 3). This finding is consistent with one meta-analysis [7] but not with other studies that have shown an association between high-grade GA fractures and infection rates [18-20]. On the other hand, different studies revealed an increased infection rate for open tibia fractures with delayed debridement [27-29]. When controlling for time of debridement, Enninghorst, et al. compared patients with and without infections or nonunion following debridement. They found that injury severity, a non-modifiable predictor, resulted in poorer outcomes [21]. Upon closer analysis, some studies, including a meta-analysis controlled for confounding factors and identified that the severity of the injury, presence of contamination, and high GA grade fractures were among the significant predictors of poor outcomes that could exacerbate the infection rates when debridement is delayed [11,28,29]. BMI and SUD association with higher rates of tibial nonunion was confirmed with other studies that highlighted these patient factors [22,23]. Similarly, BMI, and SUD were associated with infection [24-26]. In this study, BMI was the only factor to influence the incidence of implant failure (Table 2,3). It is noteworthy to mention that the occurrence of implant/hardware failure is unrelated to the timing of the debridement, while other factors seem to have more influence such as having an open fracture [30].

Table 3: Multiple logistic regression analysis using backward selection elimination.

Variables not listed in the table were not included due to being non-significant (1) in the univariate analysis (p > 0.2) or (2) eliminated in the backward selection process.

In this study, the well-balanced groups, in terms of characteristics distribution such as demographics and patient factors, provided an equivalent comparison (Table 1). As most studies looked at the rate of infection and nonunion relative to the timing of debridement, this study looked at implant failure as an additional outcome and found no impact on its rate when comparing different timing of debridement. The results of this study suggest that while timing remains an essential factor, it might not be the most critical determinant of postoperative complications unlike patient factors such as BMI and SUD which has been demonstrated in this study (Table 3). Early antibiotic administration, adopted in this study (Table 1) is another critical determinant for postoperative infection [2]. Nevertheless, the authors recommend that timely debridement is scheduled promptly, however delays past 24 hours may be allowed when unavoidable. Although patients with higher ISS had delayed debridement beyond 24 hours due to concurrent life-threatening injuries, there was no difference in primary outcomes compared to patients who underwent debridement in varying time windows (Table 1,2). Surgeons may consider factors such as the patient’s hemodynamic stability, the presence of life threatening injury, and the availability of resources when planning the timing of surgical intervention [31]. Most patients in this study (n = 57, 86.3%) received debridement within 24 hours. The maximum time-to debridement was 63 hours for a patient who first required an exploratory laparotomy to stabilize hemorrhagic shock, followed by occipital cervical fusion for an atlantooccipital dissociation injury. This patient did not experience complications or reoperation related to their tibia injury. This study has limitations due to its retrospective nature. The small sample size affected the inability to examine different variables, particularly in the greater than 24-hour group and might have affected the finding of any association between different GA classifications and complications. The authors used a 3-month cutoff to identify nonunion in patients who did not display signs of bone healing [32]. Despite a mean post operative follow-up of 12 months, the lack of long-term monitoring beyond the initial 3 months for certain patients limits the assessment of delayed complications, potentially leading to an underestimation of their occurrence. Additionally, the involvement of multiple surgeons in treating this patient cohort can create discrepancies in management, thereby impacting outcomes. The timing of injury to ED admission, which was found to influence the incidence of infection, could not be retrieved [5].

CONCLUSION

This study found that performing surgical debridement beyond 24 hours following presentation was not associated with increased complications. It also contributes to the increasing evidence indicating that the timing of surgical intervention alone may not exclusively predict postoperative complications in open tibia fractures. Although the authors still advocate for prompt surgical debridement, ideally under 24 hours, for a more holistic approach in clinical decision-making, integrating patient demographics, comorbidities, and fracture characteristics is needed to best predict and improve patient outcomes. Future research endeavors could gain better insights from larger sample sizes, longer follow-up periods, and a prospective design to establish a higher level of evidence.

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