The Effect of Time Delay to Surgical Debridement of Open Tibia Shaft Fractures on Infection Rate

Posted on November 11, 2008

By Krishna Tripuraneni, MD; Sarat Ganga, MD; Robert Quinn, MD; Rick Gehlert, MD
ORTHOPEDICS 2008; 31:1195

Historical practices have advocated emergent operative debridement for all open fractures. To date only studies in guinea pigs have demonstrated decreased infection with surgical intervention within 6 hours of injury. Recent studies have questioned this practice in humans. The purpose of this study was to determine if there was an increased infection rate based on time delay from presentation to initial operative debridement. A retrospective chart review was done from 1998 to 2004 to identify patients who presented to our level 1 trauma center with open tibia shaft fractures and had at least 2 years of follow-up. Two hundred fifteen open tibia shaft fractures in 206 patients were included in this study. A time delay of 0 to 6 hours revealed a 10.8% (7/65) infection rate, of 6 to 12 hours a 9.5% (9/95) infection rate, of 12 to 24 hours a 5.6% (2/36) infection rate, and no infections in a delay >24 hours (N=19). Using the Mantel-Haenszel chi-square test, P =.12; Fisher exact test P value was .53. Combining time intervals to 0 to 12 hours and >12 hours returned 10% (16/160) and 3.6% (2/55) infection rates, respectively. Fisher exact test P value was .17. Statistical analysis failed to show significant differences among the various time interval groups. Based on current evidence, we recommend that in the absence of gross contamination, early informal irrigation should be done on an urgent basis along with initiation of intravenous antibiotics, while a formal debridement combined with fixation, if indicated, can be done later in a timely manner.

Due to historically high infection rates, frequency, and limited soft tissue coverage, open tibia fractures have long been managed with emergent surgical irrigation and debridement. This time limit is based on historical literature of research done on guinea pigs by Friedrich in 1898, where he showed that intervention in soft tissue wounds had a time interval of effectiveness of <6 hours.1 Many lives were lost to infections from open fractures sustained in battles throughout the great wars. Alexander Fleming’s development of penicillin saved countless lives in World War II. Since the early 20th century, based in large part on these and similar discoveries, the management of open long-bone fractures has included urgent wound irrigation and debridement and antibiotic administration. Yet the management of open long-bone fractures is still controversial, as many of the best practice protocols are still created based on historical precedent rather than conclusive scientific evidence.2-4

The minimal soft tissue on the anteromedial aspect of the leg predisposes tibia shaft fractures to a high risk of skin penetration and makes it the most commonly fractured long bone to be associated with an open injury. Therefore, the open tibia fracture is more susceptible to infection, with rates documented up to 20 times higher than other areas.3

Gustilo and Anderson2 in 1976 considered early antibiotic therapy and formal surgical debridement necessary to prevent infection of open fractures. Their study included all types of open fractures but did not limit the intervention to just irrigation and debridement. They also included 3 other interventions: early treatment, no internal fixation of the fractures, and early antibiotics. While their surgical intervention was not independently assessed with regard to infection rates, their study remains one of the definitive studies in support of early irrigation and debridement for open fractures. In a later study, the same authors advocated immediate internal fixation to aid in soft tissue management.5

Recent studies have debated the effectiveness of early debridement for open fractures. Khatod et al6 advocated emergent treatment of open tibia fractures after discovering a 22.6% infection rate in 106 fractures; 5.7% of these fractures subsequently developed osteomyelitis. Patzakis and Wilkins4 suggested early surgical debridement after prospectively reviewing 1104 open fractures of all types (age, bone, type of open fracture) and finding a 7% infection rate. Meanwhile, Skaggs et al7 have recommended that there is no benefit in debridement performed < 6 hours after injury compared to > 7 hours after injury. They found similar rates of acute infection among different types of open fractures in 554 children. Eighty-two patients from Bednar and Parikh’s8 study also revealed no difference in early vs late debridement of open fractures.

Although it has been the practice at our busy level 1 trauma center to treat open fractures urgently, we frequently encounter treatment delays secondary to patient instability or system issues, such as operating room availability. The hypothesis of this study was that infection rates do not significantly increase in open tibia shaft fractures with time delay from presentation. The purpose of this study was to retrospectively review the effects of time delay on the infection rates of open tibia shaft fractures at our institution.

Materials and Methods

After receiving approval from the institutional review board, a retrospective chart review was conducted of all patients who presented at our level 1 trauma center with open tibia shaft fractures from 1998 to 2004. Data was recorded on each fracture, to include their presentation time, time of first operative debridement, presence of infection at any point in the course of their treatment, and final follow-up. All patient charts were reviewed for a minimum of 2-year follow-up. No patients, including children, were excluded from this study.

The standard protocol at our institution has been emergent delivery of intravenous antibiotics along with an informal wound irrigation in the emergency department by the on-call orthopedic junior resident upon initial presentation. A formal operating room irrigation and debridement was attempted on an urgent basis within 6 hours of injury. In some cases this was not possible due to the nature of concomitant injuries or logistical operating room issues such as staffing, so various time delays were created between presentation time and time of first operative debridement. Since time of injury was not universally available, emergency room time of arrival was used to calculate the time delay. Cefazolin was administered in all cases; in addition, patients with grossly contaminated fractures received a 1-time dose of gentamicin as well. Patients received antibiotics from 24 to 48 hours postoperatively following their last operative debridement and/or wound closure.

Fractures were classified based on the Gustilo and Anderson system,2 including type III subtypes. The type of open fracture was determined by a review of the hospital chart, including the operative report, radiograph reports, and available teaching photographs. Infection was defined as the presence of a positive intraoperative tissue or fluid culture, or clinical evidence of purulence requiring operative debridement, even if intraoperative cultures did not demonstrate any growth.

Statistical Analysis

The data was first grouped based on Gustilo and Anderson’s types of open fractures and the time interval between patient presentation and surgery. The time intervals were divided into 4 groups: <6 hours, between 6 and 12 hours, between 12 and 24 hours, and >24 hours. Infection rates were then evaluated based on these time subgroups. Time interval groups were combined to see whether a difference in infection rate existed. Other studies have traditionally combined ≤6 hours and >6 hours as comparison groups.6,8-10 Groups of 6 to 12 hours, 12 to 24 hours, and >24 hours were established to determine if other time intervals would have a significant increase in infection compared to the traditional <6 hours group. Infections were also grouped by open fracture type to determine if the severity of the open fracture affected the infection rate. The effects of type and time to surgery were evaluated using logistic regression analysis. A Fisher exact test and Mantel-Haenszel chi-square test were done to determine if the rate of infection was affected by time to surgery.

A power analysis was done using the Statistical Analysis System (SAS Institute, Cary, North Carolina) to determine the number of patients needed to detect a 20% difference in the rate of infection with a P value of <.05 and a power of 80%.

Results

Our review returned 215 open tibia shaft fractures in 206 patients from 1998 to 2004, all of which were included in this study. Average age of the review group was 39.2 years (range, 8-73 years). The distribution of open tibia shaft fractures based on time delay is listed in Table 1. These fractures were separated based on type of open fracture. The number of infections per time group was also included. Average follow-up was 10.02 months (range, 2 weeks to 52 months). One hundred sixty-seven fractures were treated definitively with an intramedullary nail, 30 with an external fixator, 10 with a long-leg cast, and 3 with Steinmann pins and a long-leg cast. Five fractures initially treated with an external fixator were converted at a later date to a plate-and-screws construct (1) or to an intramedullary nail (4).

The number of fractures in the 0 to 6 hours group was 65 (30.2%), 95 (44.2%) in the 6 to 12 hours group, 36 (16.7%) in the 12 to 24 hours group, and 19 (8.8%) in the >24 hours group.

There were 62 type I fractures (28.8%), 98 type II (45.6%), 26 type IIIa (12.1%), 25 type IIIb (11.6%), and 4 type IIIc (1.9%). The total number of infections was 18 (8.4%).

The type of fracture was compared with the rate of infection (Table 2). There were 2 infections out of 62 type I fractures (3.2%), 8 infections out of 98 type II fractures (8.2%), 1 infection out of 26 type IIIa fractures (3.8%), 7 infections out of 25 type IIIb fractures (28%), and 0 infections out of 4 type IIIc fractures. The Mantel-Haenszel chi-square value was 6.88 (P=.009). The Fisher exact test P value was .013, showing a correlation between type of fracture and infection.

The infection rate for each time interval was calculated (Table 3). In the 0 to 6 hours group there were 7 infections out of 65 fractures (10.8%), in the 6 to 12 hours group there were 9 infections out of 95 fractures (9.5%), in the 12 to 24 hours group there were 2 infections out of 36 fractures (5.6%), in the >24 hours group there were 0 infections out of 19 fractures. The Mantel-Haenszel chi-square value was 2.423 (P=.12). The Fisher exact test P value was .53, showing no significant difference in the infection rate based on time interval.

The number of infections for combined time intervals was analyzed (Table 4). For time delays from 0 to 12 hours there were 16 infections in 160 total fractures (10%). For time delays >12 hours there were 2 infections in 55 total fractures (3.6%). The Fisher exact test P value was .17, showing no significant difference in the infection rate based on time interval.

Table V demonstrates the infection rate when combining time intervals >6 hours. Table VI provides a list of the bacterial species isolated from intraoperative cultures in infected tibia shaft fractures.

Discussion

The current paradigm in orthopedic treatment of open fractures is still emergent irrigation and debridement.11-14 The existing literature has yet to conclusively support that this long-standing protocol is critical in minimizing the risk of infection. Gustilo and Anderson2 were unable to distinguish which of their 4 interventions (delayed primary closure of type III wounds, prohibition of internal fixation, treatment of open fractures as emergencies, and use of antibiotics) resulted in their documented improvement of infection rates in their patients.

The importance of treating a potential bacterial infection is supported by Williams and Meynell’s15 data on the importance of contamination load and time for bacteria to multiply and their concomitant effects on infection. The load of bacteria and the rate of the cell reproductive cycle (birth, growth, and death) are important factors in contamination of wounds. Anglen’s16 review highlights the importance of wound irrigation as an integral part of treatment of open fractures. Bhandari et al17 showed no difference in ability to remove bacteria with low- or high-pressure irrigation within 3 hours of contamination. This supports the idea that diminishing bacterial load is important in the treatment of contaminated wounds, particularly open tibia shaft fractures, which have historically had a higher rate of infection.2,4,18,19 Data also shows that open fractures must be treated as infected wounds.20 While this is undisputed, it remains unclear whether the best treatment method is emergent irrigation and debridement, administration of early antibiotics, or both.

Patzakis and Wilkins4 showed that delay to irrigation and debridement is only a factor in cases where time to antibiotic therapy is >12 hours. Factors that increased risk of infection included not administering antibiotics, antibiotic-resistant organisms in wounds, increased time from injury to first dose of antibiotics, extent of soft tissue damage, open tibia fractures, positive post-debridement culture, and the presence of Clostridium perfringens. Of their group debrided within 12 hours, an infection rate of 6.8% was noted, whereas after 12 hours the infection rate was 7.1%.4 Their retrospective review combined with our data demonstrates—although without statistical significance—the minor infection rate in patients with debridement performed after 12 hours.

Although not statistically significant, the present study demonstrates a trend toward higher infection rate with higher type of fracture (P=.013). This is in agreement with previous studies done by Gustilo and Anderson2 and Khatod et al,6 which showed that the increasing type of open fracture directly correlates with an increased infection rate. A study by Harley et al21 also determined that the strongest predictors for the development of a deep infection were fracture type and a lower extremity fracture.

Our study was unable to determine conclusively that a time delay to irrigation and debridement resulted in a greater number of infections or increased infection rate.4,6,17 Skaggs et al22 found no statistical difference between open fractures treated after a delay of ≤6 hours vs ≥7 hours, with a P value of .43. A chi-square test demonstrated no difference in overall infectious outcome in open fractures treated within 6 hours vs those treated after 6 hours in the study by Khatod et al.6 Our Mantel-Haenszel chi-square value is 2.43 with P=.12 when comparing our 4 groups (Table 3). The P value when comparing irrigation and debridement within 6 hours vs >6 hours is .43. These values cannot be directly compared to other studies; however, our power is likely greater than other studies given our sample size, the largest to date in the literature for a specific fracture type.

The time from injury to administration of antibiotics is also a critical time frame and has been examined. Patazakis and Wilkins4 examined 77 infections in 1104 open fracture wounds and looked at factors that reduced the infection rate. They found that for fractures treated with antibiotics within 3 hours of injury, 4.7% were infected, compared to a 7.4% infection rate in those that started antibiotic treatment after 3 hours. They concluded that the single most important factor in reducing infection rate was early administration of antibiotics.3,23 Our study did not specifically document the timing of antibiotic administration.

Our study was limited in various ways. First, we are limited by its retrospective nature. Second, we may have overlooked the possibility of β error. Despite having less infection with more time delay, our study is underpowered. In order to obtain 80% power with an odds ratio of 2.5, >575 patients were needed. Power is low in this analysis because the categorical variable analysis naturally has lower power than a continuous variable analysis, and because only about one-third of the patients are in the ≤6 hours category. Having only 65 of our study’s 215 open tibia shaft fractures in the ≤6 hours group does not fairly challenge historical time frames; an equal distribution of participants within time intervals would provide improved analysis.

It is unlikely that a randomized, prospective, controlled trial with sufficient power and distribution could be conducted in the near future. This is due in large part to ethical limitations of randomizing patients to urgent vs elective treatment. With more retrospective studies performed like this one and those previously reported,4,6,17 and with increasing data supporting a shift away from emergent operative debridement for lower type open fractures, future prospective, randomized, or longitudinal studies seem more likely to be approved by research review committees. We hope our data contributes to a larger meta-analysis in the future, and we do not expect this study alone to change daily and time-tested practices.

Some argue that early surgical debridement does not independently serve as a predictor of decreased infection risk and may even pose risks to patient safety.24 Our data suggests—although does not demonstrate a statistically significantly difference—a decreasing infection rate with increased time delay. One possible explanation for this is that the more severe type open fractures with severe soft tissue injury tended to go to surgery quicker than others, and a larger proportion of these were more prone to infection. However, our data clearly shows more patients with fractures underwent surgery in the 6 to 12 hours range compared to any other time interval group. This is likely attributable to staff or operating room availability.

There is no paucity of literature about open fractures and their relationship to infection. Our data and literature reviewed in this article attempt to improve our daily practices. Logistical issues (eg, nursing shortages, resident work restrictions, hospital financial constraints limiting availability of equipment and personnel) increasingly result in further delays in urgent treatment. Personnel shortages and constrained hospital finances, combined with concerns regarding patient safety in the environment of overworked, sleep-deprived on-call surgeons, make it incumbent on the medical community to provide scientific data to support emergent treatment modalities, such as in the case of open fractures.

The issue of separating the effects of antibiotics vs irrigation and debridement remains. There is clearly a need to more aggressively manage higher types of open fractures, but there is no conclusive evidence for the need for definitive surgical management within 6 hours.2,6,19 We support the conclusion by Spencer et al25: that the body of literature in which open fractures and their treatment are studied, while inconclusive by analysis of individual studies, still maintains value for addressing the question of proper treatment of open fractures. Based on current evidence, we feel that most open fractures can be treated with early informal irrigation in the emergency room along with initiation of intravenous antibiotics, while a formal debridement combined with fixation, if indicated, can be done later in a timely manner. High-energy injuries (eg, shotgun injuries, presence of severe comminution, crush injuries, or injuries with infiltrated air) and injuries with extensive soft tissue involvement and/or extensive contamination should still be debrided emergently.

This analysis is of patients injured in a civilian setting and is likely not pertinent to military or civilian injuries where extensive soft tissue injury occurs, such as experienced in blast injuries or with military-grade ballistics, and where debridement may have a greater role in infection prevention than in lower-energy fractures.

References

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Authors

Drs Tripuraneni, Quinn, and Gehlert are from the Department of Orthopedics, University of New Mexico, Albuquerque, New Mexico; and Dr Ganga is from the Department of Orthopedics, University of Miami, Florida.

Drs Tripuraneni, Ganga, Quinn, and Gehlert have no relevant financial relationships to disclose.

Correspondence should be addressed to: Robert Quinn, MD, UNM Department of Orthopedics, 2211 Lomas Blvd NE, Albuquerque, NM 87106.

Posted in Infection