Abstract
Background
Controversy remains on the most effective method of treating open tibia shaft fractures. The timing of the different treatment variables remains at the heart of this dispute. This study aimed to investigate outcomes of open tibial shaft fractures. Specific objectives were to determine the association of time delay to antibiotic administration, surgical debridement, definitive skeletal stabilisation and soft tissue reconstruction, and the development of fracture-related infection (FRI).
Materials and methods
A total of 227 patients with 237 open tibia shaft fractures were included. The time from arrival to (1) antibiotic administration (<3 hours vs >3 hours); (2) primary debridement in theatre (<24 hours vs >24 hours); (3) definitive skeletal stabilization (<5 days vs >5 days); (4) definitive soft tissue reconstruction (<5 vs >5 days); and (5) time to union was recorded. The number of debridements and the length of hospital stay were also recorded.
Results
Patients who waited more than 5 days for definitive skeletal fixation or soft tissue reconstruction had a significant increase in FRI [odds ratio (OR) 4.7, 95% confidence intervals (CI): 2.0–10.9 and OR 4.7, 95% CI: 2.0–11.0, respectively]. Patients who underwent more than two formal debridements also had a higher risk of developing FRI than those who only had ≤2 debridements (OR 15.6, 95% CI: 5.8–41.6).
Conclusion
Time delays in managing open tibia shaft fractures are associated with an increased risk of FRI. Definitive soft tissue reconstruction and skeletal stabilisation should not be delayed for more than 5 days.
Clinical significance
Fracture-related infection following open tibia shaft fractures can be mitigated by reducing treatment delays, specific to definitive soft tissue reconstruction and skeletal stabilisation.
How to cite this article
Kock FM, Basson TR, Burger MC, et al. The Effect of Treatment Delays on Fracture-related Infection in Open Tibia Shaft Fractures: A Retrospective Cohort Study. Strategies Trauma Limb Reconstr 2025;20(1):25–30.
Keywords: Definitive skeletal stabilisation, Fracture-related infection, Tibial fractures, Time to antibiotic administration
Introduction
Open tibia fractures are long bone fractures frequently encountered by orthopaedic surgeons. These injuries have a high incidence (3.4 per 1,00,000), and the treatment of open tibial fractures remains challenging.1,2 The complications associated with these injuries include, but are not limited to, fracture-related infections (FRIs) and non-union. Despite an expanding body of research, controversy remains on the most effective method of treating open tibia shaft fractures.3,4 Antibiotic choice and timing, the timing of primary surgical debridement, the timing of definitive skeletal stabilisation and definitive soft tissue reconstruction, as well as the choice of skeletal stabilisation, are some of the most critical aspects that remain contentious.
One of the critical aspects associated with the decrease in infection rates in open fractures is the early initiation of appropriate antibiotic cover.5,6 In 1989, Patzakis and Wilkins demonstrated the importance of intravenous antibiotics being administered as early as possible following the injury.7 The most widely implemented protocol for administering antibiotics is governed by the AO and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) guidelines.8,9 The BAPRAS guidelines also emphasise the initiation of broad-spectrum antibiotics within three hours.8 More recent National Institute for Health and Care Excellence (NICE) 2016 guidelines recommend pre-hospital antibiotic administration where possible.10 In most settings, emergency services do not have the means to administer antibiotics at the scene, and the first opportunity for antibiotic administration is when the patient presents to a healthcare facility.
Although early initiation of appropriate antibiotic cover is essential, surgical management should still be performed as soon as possible following the presentation of an open fracture.11 Wound debridement after an open fracture is considered one of the essential variables to reduce the risk of FRI.12 Traditionally, it was proposed that debridement of open fractures should be performed within six hours of presentation.12 A 1989 publication by Patzakis and Wilkins concluded that appropriate, prophylactic antibiotic treatment is more important than the initial surgical debridement of the injury.7 Recent literature supports Patzakis' findings that if the appropriate antibiotic cover is established immediately, the debridement of open fractures can be safely postponed to an urgent-elective theatre list without increasing the risk of infection.13–16 Additionally, outcomes are better when an experienced surgical team does the primary debridement on an urgent-elective slate compared to those treated as an emergency case by a junior surgeon.17,18
The optimal timing for definitive skeletal stabilisation and soft tissue closure is still contentious.17,18 From a biological perspective, stabilising the fracture and restoring alignment prevents further soft tissue injury, limits bacterial spread, improves blood flow and reduces oedema.19 The BAPRAS and the British Orthopaedic Association (BOA) guidance recommended that both procedures be completed at the time of primary surgery or within 72 hours of injury. In contrast, some authors have suggested that these procedures can be delayed up to 7 days after injury.20–23
This study aimed to investigate the outcomes of open tibial shaft fractures at a level one trauma centre in a developing world setting. Specific objectives were to determine the association of time delay to antibiotic administration, surgical debridement, definitive skeletal stabilisation and soft tissue reconstruction, and the development of FRI. Institutional ethics committee approval was obtained before the collection of data.
Materials and Methods
A retrospective cohort study included all adult patients with open tibia shaft fractures from July 2014 to June 2016 and January 2018 to December 2019. A pause in data collection occurred in 2018 due to a change in trauma personnel and the implementation of more precise treatment guidelines. Patients who were skeletally immature at the time of injury, those with pathological fractures and those who did not complete follow-up of at least three months following definitive management were excluded. Institutional ethics committee approval was obtained before the collection of data.
Patients were identified from hospital and theatre records, and demographic and essential clinical information was collected. Given that no reliable information about the time of injury could be obtained, the time of arrival at the hospital's emergency department was used as a starting point from which time was measured. The time from arrival to (1) antibiotic administration; (2) primary debridement in theatre; (3) definitive skeletal stabilisation; (4) definitive soft tissue reconstruction; and (5) time to union was recorded. The number of debridements as well as the total hospital stay were also recorded. At the time of primary debridement, the injury was classified according to the Gustilo and Anderson system.3 The most important outcome of interest was FRI, with non-union also recorded. The diagnosis of FRI was based on the criteria defined by Metsemakers et al. and Govaert et al.24,25 Fractures that did not unite within nine months following the injury, or did not illustrate any radiological progression to union within three consecutive months, were defined as “non-union”. Non-union was defined as fractures that failed to unite nine months after the injury or showed no radiological progression to union in three consecutive months.
Data was captured in Microsoft Excel and analysed using STATISTICA (v13.5, TIBCO Software). Data is described using frequencies and counts for categorical variables. Means and standard deviations are used to describe parametric, continuous variables, whilst medians and interquartile ranges are used to describe non-parametric, continuous variables. Differences in time delays (as continuous variables) between treatment time points for specific outcomes (such as osteomyelitis) were investigated using an independent t-test or a Mann–Whitney U test, depending on distribution. The cut-off time for antibiotic administration was set at three hours, as suggested by Patzakis and Wilkens.7 A cut-off value of 24 hours was used for time to surgical debridement.9,14,15,17,18 The cut-off value for definitive skeletal fixation utilised by Basson et al.26 of 5 days was used. Finally, patients were grouped into those who had soft tissue closure within or after 5 days.20–23 Patients were divided into two groups, differentiating between those who underwent two or fewer formal surgical debridement vs those who underwent more than two procedures. Whether there was a time delay between definitive fixation and soft tissue reconstruction, or whether the definitive fixation and soft tissue reconstruction were performed at the same setting, was also categorised as yes/no. A Chi-squared (or Fisher's Exact test, where appropriate) was used to detect significant differences between groups. Significance was accepted at the p = 0.05 level.
Results
General and Injury Characteristics
A total of 227 patients with 237 open tibia shaft fractures were included in this study. Ten patients presented with bilateral open tibia fractures. The mean age of the patients was 34.0 ± 11.1 years (95% CI: 32.6–35.4, range 15.0–63.0). Pedestrian-vehicle accidents (45.1%, n = 107), followed by motor-vehicle accidents (16.0%, n = 38) and gunshot injuries (13.9%, n = 33), were the most common mechanisms of injury observed in this study (Table 1). The majority of patients suffered from Gustilo–Anderson grade IIIA injuries (34.2%, n = 81), with most injuries located in the proximal third of the tibia (Table 2).
Table 1.
Characteristics of all patients with open tibia shaft fractures between July 2014–June 2016 and January 2018–December 2019
| Patient characteristic | N = 227 patients |
|---|---|
| Age (years, mean ± SD) | 34.0 ± 11.1 |
| Sex (male/female) [% (n)] | 77.1 (175)/22.9 (52) |
| Smoker (yes/no/unknown) [% (n)] | 39.6 (90)/60.4 (137)/0 |
| Diabetic (yes/no/unknown) [% (n)] | 3.5 (8)/96.5 (219)/0 |
| HIV positive (yes/no/unknown) [% (n)] | 10.1 (23)/79.3 (180)/10.6 (24) |
| MOI | N = 237 fractures |
| PVA [% (n)] | 45.1 (107) |
| MVA [% (n)] | 16.0 (38) |
| GSW [% (n)] | 13.9 (33) |
| Blunt assault [% (n)] | 8.9 (21) |
| Fall from height (<2 meters) [% (n)] | 6.8 (16) |
| Sharp object [% (n)] | 5.5 (13) |
| Fall from height (>2 meters) [% (n)] | 1.7 (4) |
| Train track injury [% (n)] | 0.8 (2) |
| Sport injury [% (n)] | 0.4 (1) |
| Crush injury [% (n)] | 0.4 (1) |
| Farm injury [% (n)] | 0.4 (1) |
GSW, gunshot wounds; MOI, mechanism of injury; MVA, motor vehicle accident; PVA, pedestrian-vehicle accident; SD, standard deviation
Table 2.
Fracture classification and fracture site
| Injury characteristic | N = 237 [% (n)] |
|---|---|
| Gustilo–Anderson grade | |
| I | 32.9 (78) |
| II | 10.1 (24) |
| IIIA | 34.2 (81) |
| IIIB | 22.4 (53) |
| IIIC | 0.4 (1) |
| Fracture site | |
| Proximal third fractures | 46.0 (109) |
| Middle third fractures | 35.9 (85) |
| Distal third fractures | 16.0 (38) |
| Segmental fractures | 2.1 (5) |
Injury Management
The majority of patients received their first dose of antibiotics within three hours of presenting to the emergency unit (65.8%, n = 156), with the median time across all patients being 2.25 hours. Cephazolin was the prescribed antibiotic in the majority of cases (94.1%), with Augmentin (3%) and triple antibiotic cover (2.5%) used less frequently. Triple antibiotic cover consisted of Ampicillin, Gentamycin and Metronidazole (Table 3). The median duration of antibiotic administration was 3 days [interquartile range (IQR) 1–7 days]. A total of 89.9% of patients were taken to theatre for their primary debridement within the first 24 hours following presentation. Definitive skeletal fixation and definitive soft tissue reconstruction were performed at a median of 2.87 and 2.95 days after presentation, respectively (Table 4).
Table 3.
Intravenous antibiotics administered
| Antibiotic | N = 237[% (n)] |
|---|---|
| Kefzol | 94.1 (223) |
| Augmentin | 3.0 (7) |
| Triple antibiotics | 2.5 (6) |
| Clindamycin | 0.4 (1) |
Table 4.
Time delays and treatment variables of all patients
| Treatment variables | Median (IQR) |
|---|---|
| Time to 1st dose of antibiotics (hours) | 2.25 (1.17–3.67) |
| Duration of antibiotics (days) | 5.0 (3.0–9.0) |
| Time to primary debridement (days) | 2.32 (1.4–3.7) |
| Time to definitive fixation (days) | 2.87 (1.7–5.0) |
| Time to temporary stabilisation (days) | 1.90 (1.3–2.9) |
| Time to definitive soft tissue reconstruction (days) | 2.95 (1.9–5.9) |
| Time between soft tissue reconstruction and def fixation (days) | 0.0 (0.0–0.0) |
| Number of debridements | 1.0 (1.0–2.0) |
| Length of hospital stay | 8.0 (5.0–15.0) |
IQR, interquartile range
Intramedullary nailing was the most frequently employed definitive fixation (54.0%, n = 128) (Table 5). The median time to union was 16.3 weeks. Of the 237 open tibia shaft fractures included in this study, 11% (26) developed FRI and 10.1% (24) failed to unite (Table 5).
Table 5.
Type of definitive fixation and treatment outcomes
| Treatment outcome | N = 237 | Time to union in weeks(mean ± SD) | Non-union[% (n)] | FRI[% (n)] |
|---|---|---|---|---|
| Type of definitive fixation | ||||
| Intramedullary nail | 128 | 16.4 ± 6.6 (127) | 0.8 (1) | 5.5 (7) |
| Hexapod | 50 | 32.4 ± 11.4 (39) | 22.0 (11) | 22.0 (11) |
| All wire ring fixator | 37 | 21.2 ± 8.1 (25) | 32.4 (12) | 21.6 (8) |
| Casting | 22 | 11.1 ± 3.7 (22) | 0.0 (0) | 0.0 (0) |
| All patients | 237 | 16.3 (12.3–24.4) | 10.1 (24) | 11.0 (26) |
FRI, fracture-related infection; SD, standard deviation
Definitive skeletal fixation was performed in the primary setting in 180 cases (75.9%), while 35 (14.8%) cases underwent definitive fixation at a secondary setting (Table 6); these patients were initially placed in a temporary mono-lateral external fixator and then converted to definitive fixation.
Table 6.
Type of definitive fixation after mono-lateral external fixation
| Definitive fixation after a temporary external fixator | N = 35[% (n)] |
|---|---|
| All wire external ring fixator | 57.1 (20) |
| Hexapod external fixator | 22.9 (8) |
| Intramedullary nail | 20.0 (7) |
Risk Factors for FRI
No association between age and sex with the presence of FRI was observed (Table 7). Fracture-related infection was more likely in patients with a distal third tibia fracture compared to proximal third and middle third fractures (p < 0.001). Segmental tibia fractures had the highest rate of FRI (60%), but in this group, there were only five fractures, and they did not have any statistical value. Fracture-related infection was most observed in patients with GA type IIIB injuries vs the other classifications (p < 0.001) (Table 7).
Table 7.
Associations between general and injury characteristics and FRI
| Patient- or injury-specific variable | FRI yesN = 26 | FRI no N = 211 | p-value |
|---|---|---|---|
| Age (years, mean ± SD) | 35.7 ± 14.4 | 33.8 ± 10.7 | 0.395 |
| Sex | |||
| Male [% (n)] | 12.6 (23) | 87.4 (160) | 0.111 |
| Female [% (n)] | 5.6 (3) | 94.4 (51) | |
| Injury site | |||
| Proximal 3rd [% (n)] | 2.6 (1) | 97.4 (37) | <0.001 |
| Middle 3rd [% (n)] | 8.3 (9) | 91.7 (100) | |
| Distal 3rd [% (n)] | 15.3 (13) | 84.7 (72) | |
| Segmental [% (n)] | 60.0 (3) | 40.0 (2) | |
| GA classification | |||
| I [% (n)] | 0 (0) | 100 (78) | <0.001 |
| II [% (n)] | 0 (0) | 100 (24) | |
| IIIA [% (n)] | 12.3 (10) | 87.7 (71) | |
| IIIB [% (n)] | 30.2 (16) | 69.8 (37) | |
| IIIC [% (n)] | 0 (0) | 100 (1) |
FRI, fracture-related infection; GA, Gustilo–Anderson grade
No association between FRI and antibiotic administration within three hours or after three hours of arrival at the emergency unit was observed (p = 0.625) (Table 8). Similarly, there was no association between patients who had primary debridement in theatre within 24 hours and the risk of FRI, compared to those who had primary debridement after 24 hours (p = 0.259) (Table 8). Definitive skeletal stabilisation after 5 days of presentation was associated with an increased risk of FRI compared to definitive skeletal stabilisation within 5 days of presentation (p < 0.001). Similarly, definitive soft tissue reconstruction after 5 days was associated with an increased risk of FRI compared to reconstruction performed within 5 days (p < 0.001). Patients who underwent more than two formal debridements had a higher risk of developing FRI than those who only had two or fewer debridements (p < 0.001). Finally, 9.14% of patients that had definitive soft tissue closure and definitive skeletal fixation at the same setting, or definitive soft tissue reconstruction followed by definitive fixation developed FRI compared to 28.57% of patients, first undergoing definitive fixation followed by soft tissue closure at another setting, developing FRI (p < 0.001) (Table 8).
Table 8.
The relationship between different treatment variables and the development of FRI
| Treatment variables | Number of fractures[% (n)] | FRI: Yes [% (n)] | FRI: No [% (n)] | OR (95% CI) | p-value |
|---|---|---|---|---|---|
| Time to antibiotics | |||||
| <3 hours | 65.8 (156) | 10.3 (16) | 89.7 (140) | 1.2 (0.5–2.9) | 0.625 |
| >3 hours | 34.2 (81) | 12.4 (10) | 87.7 (71) | ||
| Time to primary debridement | |||||
| <24 hours | 10.1 (23) | 4.4 (1) | 95.7 (22) | 3.1 (0.4–23.8) | 0.259 |
| >24 hours | 89.9 (204) | 12.3 (25) | 87.8 (179) | ||
| Time to definitive fixation | |||||
| <5 days | 76.4 (181) | 6.6 (12) | 93.4 (169) | 4.7 (2.0–10.9) | < 0.001 |
| >5 days | 23.6 (56) | 25.0 (14) | 75.0 (42) | ||
| Time to definitive soft tissue reconstruction | |||||
| <5 days | 73.6 (167) | 6.6 (11) | 93.4 (156) | 4.7 (2.0–11.0) | < 0.001 |
| >5 days | 26.4 (60) | 25.0 (15) | 75.0 (45) | ||
| Number of debridements | |||||
| ≤2 | 90.3 (214) | 6.5 (14) | 93.5 (200) | 15.6 (5.8–41.6) | < 0.001 |
| >2 | 9.7 (23) | 52.2 (12) | 47.8 (11) | ||
| Time delay between definitive fixation and soft tissue reconstruction | |||||
| Yes | 12.4 (28) | 28.6 (8) | 71.4 (20) | 4.0 (1.5–10.3) | < 0.001 |
| No | 87.6 (197) | 9.1 (18) | 90.9 (179) |
CI, confidence interval; FRI, fracture-related infection; OR, odds ratio
Among the 26 patients who developed an FRI, management involved surgical intervention in the majority of cases, including further debridement with or without implant exchange or removal. Discussion regarding the details of FRI management falls beyond the scope of this retrospective review.
Discussion
This study aimed to evaluate the association of timing from injury to antibiotic administration, surgical debridement, definitive skeletal stabilisation and soft tissue closure and the development of FRI in patients who sustained open fractures to the tibia shaft.
The most widely accepted antibiotic protocol following open fractures is proposed by the AO and BAPRAS guidelines.8 These guidelines state that antibiotics should be initiated within three hours of injury. More recent NICE 2016 guidelines recommend pre-hospital antibiotic administration where possible.10 The present study reports that the administration of antibiotics within 3 hours from presentation to the emergency unit had no impact on the development of FRI. It is important to consider that the timing of the first antibiotic dose in our study was recorded from arrival at the emergency centre and not from the time of injury, as the time of injury was not reliably available. As a result, the true time from injury to administration is, therefore, longer than reported and very likely more than three hours. Our findings, however, do corroborate those of Hull, Carver and Weber, who noted that, after adjusting for factors such as injury severity and time to surgical debridement, timing to antibiotic administration did not affect the rates of FRI.14,16,27,28
Urgent surgical debridement is essential to prevent FRI in open fracture management.3,4,29 Hull et al. reported that the risk of developing FRI in open tibia shaft fractures increased by three per cent for every hour delay after injury.27 The importance of urgent surgical debridement has, however, been questioned in recent literature, with authors arguing that the focus should instead fall on the quality of debridement and the experience of the surgical team.9,13,15–18,30 In the present study, the sample size of individuals who underwent debridement within 24 hours was small, and the study was not powered to detect true differences for this variable. Future studies with more balanced groups would be better suited to determine whether debridement within 24 hours reduces infection risk.
Limiting time to definitive fracture stabilisation and soft tissue reconstruction is are important aspect to consider in preventing FRI in open tibia shaft fractures.8 In lower-grade injuries, definitive soft tissue closure and skeletal stabilisation of the fracture are usually completed during the initial theatre visit as recommended by the BAPRAS and BOA guidance standards.8,10,31 In treating more severe injuries, definitive management is not always possible during the initial theatre visit, and temporary skeletal stabilisation and wound dressings are often utilised.8,31 The optimal timing for conversion to definitive skeletal stabilisation and soft tissue closure remains controversial. Godina reported an infection rate of 1.5% in 134 patients, where soft tissue reconstruction was performed within 72 hours of the injury.32 Despite these findings, the authors recommended that definitive soft tissue coverage not be delayed more than 7 days.32 Hertel et al.,33 Gopal et al.18 and Naique et al.15 support these findings with their “fix and flap” protocol. They reported lower infection rates in patients who were treated using definitive soft tissue reconstruction within 7 days (8 vs 59%).15 In our study, the odds of developing FRI in patients who received definitive fracture stabilisation after 5 days increased by 4.7 times compared to those who had definitive fixation within 5 days. Similarly, patients who underwent definitive soft tissue reconstruction after 5 days also had 4.7 times greater odds of developing FRI than those who had definitive soft tissue reconstruction within 5 days. These findings highlight the importance of definitive fixation at the same time as soft tissue cover whenever possible.
Multiple surgical debridement (more than two) showed an increased risk of developing FRI with an OR of 15.6 (95% CI: 5.8–41.6). Although an expected finding, it was surprising to note the extent to which the risk of developing FRI increased when patients had to undergo more than two debridements. Despite being confounded by injury severity and degree of contamination, this finding again underlines the significance of adequate primary debridement and the importance of achieving definitive soft tissue reconstruction and skeletal stabilisation within 5 days of the injury to minimise the risk of FRI in open tibia shaft fractures.
Certain subgroup analyses, particularly those examining the circular frame fixation group, segmental fractures and patients undergoing late debridement, were limited by small numbers. As such, these findings should be carefully interpreted, and definitive conclusions regarding these subgroups cannot be made.
The study was limited by its retrospective nature. Missing data and inadequate clinical notes were encountered, but this was not found to be problematic, as the exact time for all relevant events was noted meticulously. Calculations were based on the time of presentation to the emergency department, seeing that the actual time of injury was never noted; as such, the findings related to “time to antibiotic administration” should be interpreted with caution, as the time from injury to antibiotic administration was likely to exceed 3 hours. In certain subgroups, the sample size was small, and no definitive conclusion could be made for these groups.
Conclusion
In conclusion, our findings emphasise the importance of adequate initial debridement and that definitive skeletal stabilisation and soft tissue reconstruction should not be delayed more than 5 days, ideally being performed at the same time.
Clinical Significance
Fracture-related infection following open tibia shaft fractures can be mitigated by reducing treatment delays, specific to definitive soft tissue reconstruction and skeletal stabilisation.
Orcid
Frans W Kock https://orcid.org/0000-0003-3943-1994
Tinus R Basson https://orcid.org/0000-0003-1686-9862
Marilize C Burger https://orcid.org/0000-0003-2831-4960
Nando Ferreira https://orcid.org/0000-0002-0567-3373
Footnotes
Source of support: Nil
Conflict of interest: None
Data Availability Statement
The datasets generated during and analysed during the current study are available from the corresponding author on reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets generated during and analysed during the current study are available from the corresponding author on reasonable request.