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Ann Thorac Surg 2005;79:526-531
© 2005 The Society of Thoracic Surgeons

Original article: Cardiovascular

Clinical Outcome of Patients With Deep Sternal Wound Infection Managed by Vacuum-Assisted Closure Compared to Conventional Therapy With Open Packing: A Retrospective Analysis

Uwe Fuchs, MDa,*, Armin Zittermann, PhDa, Benjamin Stuettgen, MDa, Arndt Groening, MDb, Kazutomo Minami, MDa, Reiner Koerfer, MDa

a Department of Cardiothoracic Surgery
b Department of Laboratory and Transfusion Medicine, Heart Center North-Rhine Westfalia, Ruhr University of Bochum, Bad Oeynhausen, Germany

Accepted for publication August 5, 2004.

* Address reprint requests to Dr Fuchs, Department of Cardiothoracic Surgery, Heart Center North-Rhine Westfalia, Ruhr University of Bochum, Georgstraße 11, D-32545 Bad Oeynhausen, Germany (E-mail: ufuchs{at}hdz-nrw.de).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 References
 
BACKGROUND: It is suggested that the vacuum technique is a promising new method for the therapy of mediastinitis, but reliable investigations are currently almost completely lacking. We therefore compared clinical outcome of patients whose sternal infection was managed with the vacuum-assisted closure system or with the conventional procedure of open packing.

METHODS: We performed a retrospective analysis in 68 cases of sternal wound infection that were identified at our Heart Center between September 1998 and September 2003. Thirty-five patients could be allocated to the vacuum group and 33 patients to the conventional group. We compared the time interval from sternal infection until freedom of microbiological cultures, in-hospital stay, the status at discharge (rewired or open sternum), the time interval until wound healing was achieved, and survival rates. Moreover, we compared serum levels of C-reactive protein and blood leukocyte counts on admission, at diagnosis of sternal infection, and at different points of time until discharge.

RESULTS: Baseline characteristics and blood factors did not differ between the two study groups at diagnosis of sternal infection. Moreover, the number of prescribed antibiotics was similar, and the C-reactive protein level and blood leukocyte counts at discharge were comparable in both groups. However, freedom from mediastinal microbiological cultures was achieved earlier (p < 0.01), C-reactive protein levels declined more rapidly (p < 0.025), in-hospital stay was shorter (p < 0.01), rewiring was earlier (p < 0.01), and survival tended to be higher (p < 0.15) in the vacuum group compared to the conventional group.

CONCLUSIONS: This retrospective analysis could demonstrate that the vacuum technique improves the medical outcome of patients with mediastinitis compared with the conventional technique of open packing.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 References
 
Deep sternal wound infection is a rare complication after median sternotomy. The reported incidence ranges from 0.15% to 5% [1]. The complication often results in a prolongation of the in-hospital stay, with a sometimes lethal outcome. Compared with the first decades of median sternotomy, the advent of novel antibiotics and more refined surgical techniques was able to decrease mortality of sternal infections considerably [2, 3]. Nevertheless, mortality remained constant during the last two decades at a rate of 10% to 20% [4–6].

Until recently, established treatment included aggressive surgical debridement, sternal wound drainage, antibiotics, open packing, and delayed closure of the sternal defect. For approximately five years, however, a novel technique using vacuum-assisted closure (VAC) has been increasingly used for the treatment of sternal infections instead of open packing [7–11].

It has been assumed that the negative pressure generation by the VAC device leads to arteriolar dilatation and decreases fluid excess and edema. As a result, microcirculation should be improved and bacterial colonization should be reduced [7]. Consequently, it has been hypothesized that the VAC technique leads to reduced intensive care stay, in-hospital stay, and also to a significant reduction in the overall costs per patient compared to conventional treatment of sternal infections [8]. However, the data basis for this suggestion is scanty and systematic studies on medical outcome are almost completely lacking. We have studied the literature and have found only one very small study demonstrating that in-hospital stay was shorter and that rate of treatment failure was lower in patients managed with the VAC system compared to the method with the open packing procedure [12]. One other study has shown that the VAC technique is associated with fewer complications compared with the technique of primary closure [13].

Generally, infections and inflammations lead to a massive rise in plasma levels of C-reactive protein (CRP). Treatment of mediastinitis has recently been successfully guided by plasma CRP levels [9]. Therefore, circulating CRP concentrations can be used as an indicator of wound healing after sternal infection. The present retrospective study was thus aimed at comparing the course of plasma CRP levels, in-hospital stay, time interval from diagnosis of sternal infection until wound healing, and mortality rate in patients whose deep sternal infection was managed with the open packing procedure or with the VAC technique.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 References
 
Patients
Between September 1998 and September 2003, a total of 18,920 sternotomy procedures due to bypass operations and heart valve replacements were performed at the Heart Center North Rhine Westfalia. During this interval, 68 cases of deep sternal wound infections were identified in adult patients, giving an incidence of deep sternal wound infections of approximately 0.36%. Patients with sternal infections were aged 44 to 81 years, with a sex distribution of 79.5% males and 20.5% females. All patients were retrospectively allocated to either the group with conventional treatment (CON group; n = 33) or to the group treated with the vacuum-assisted closure system (VAC group; n = 35). Between September 1998 and October 2000, all deep sternal infections were managed with the conventional technique. Since November 2000, only 8 patients (3 in 2001, 3 in 2002, and 2 in 2003) were managed with this technique while the other patients were treated with the new VAC technique. All sternal infections met the criteria of the Centers for Disease Control and Prevention [14]. Thus, diagnosis was based on at least one of the following criteria: (1) a bacterium was isolated from culture of mediastinal tissue or fluid; (2) evidence of mediastinitis was seen during operation; (3) sternal instability, or fever was present and there was purulent discharge from the mediastinum.

Study Procedures
After diagnosis of sternal infection, patients of both study groups first underwent wound incision under aseptic conditions and removal of sternal wires. Then, aggressive debridement was done. Thereafter, the procedures in the CON group included irrigation with povidone-iodine solution, saline and H2O2. Moreover, wound drainage, open packing, and delayed closure were performed. In the VAC group, a vacuum-assisted closure system, consisting of polyurethane foam and a special, computer-controlled pump unit, was used. The polyurethane VAC sponge was fitted into the wound substernally. A second and third sponge was placed between the sternal edges and the subcutaneous layer, respectively. The wound was covered with an adhesive, semipermeable drape that was connected to the therapy unit. The therapy unit delivers a negative pressure in a continuous modus. As recommended in the clinical guidelines of the distributor (KCI Medical, Hannover, Germany), pressures of –125 to –150 mm Hg were usually used. However, if the patient suffered from severe pain, pressure was reduced down to –75 mm Hg. The VAC dressing was renewed every 3 to 7 days, at least until the wound was free from microbiological cultures. The guidelines for VAC removal were (1) negative bacterial cultures, (2) no fever, (3) falling CRP levels, and (4) a macroscopic infection-free wound. Patients of both study groups were only discharged if freedom of the sternal wound from microbiological cultures was proofed threefold. In both study groups, rewiring was done without the use of muscle flaps or omentoplasty and was only performed if granulation was satisfying. Both groups were treated with antibiotics according to the sensitivity of the organism and the clinical response of the patient.

Blood concentrations of leukocytes, hemoglobin, CRP, and creatinine were analyzed using routine laboratory methods. Biochemical factors were assessed on admission, at diagnosis of deep sternal infection (t0), at t1 (3 to 7 days after t0), at t2 (8 to 12 days after t0), at t3 (13 to 17 days after t0), and at discharge (td). We also assessed the time interval between thoracic surgery and the occurrence of the deep sternal wound infection, in-hospital stay from the beginning of mediastinitis until discharge, and the status at discharge (rewired or open sternum). We followed the patient at least until the sternum was rewired (primary wound healing), until wound healing was achieved without rewiring (secondary wound healing), or until the patient died with an open sternum. In those patients who were discharged with an open sternum, we contacted the family doctor to assess the time interval of open sternum. Classification of sternal infection was performed according to El Oakley and Wright [15].

Statistics
All statistical evaluations were performed with the Statistical Package for Social Sciences (SPSS), version 11 (SPSS Inc,Chicago, IL). For comparative evaluations, the Fisher exact test, the unpaired t test (normal distributed data), the Friedman test (non-normal data, biochemical factors), and the Mann-Whitney U test (non-normal data; biochemical factors) were used. Normal distribution of the data was tested by the Kolmogorov-Smirnov test. Normal distribution was considered if p values were above 0.05. We calculated {Delta} values of biochemical factors (differences between the values at [t0] and at t1, t2, t3, and td), whereas a negative value indicates a decline and a positive value indicates an increase during the time interval. Time effects within the study groups were evaluated using the Friedman test. The Mann-Whitney U test was used in order to compare the {Delta} values of CRP and leukocyte counts between the two study groups at specific points of time. Survival rates were calculated with the Kaplan-Meier product-limit estimator. The log-rank test was used in order to test for potential differences in survival rates between the study groups. The pvalues less than 0.05 (two-tailed test) were considered statistically significant. The p values of Kaplan-Meier survival analysis greater than 0.05 and less than 0.15 were considered borderline significant [16]. Data are expressed as median with interquartile range (IQR).


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 References
 
Baseline characteristics of the CON group and the VAC group are presented in Table 1. On admission, both groups were comparable in age, sex distribution, anthropometric data, and preexisting diseases. Blood leukocyte counts were slightly lower and creatinine levels were slightly higher in the VAC group compared to the CON group. Hemoglobin and CRP values did not differ between the two groups on admission. Moreover, all measured biochemical factors were comparable in the two groups at diagnosis of deep sternal wound infection.


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  		Table 1. Baseline Characteristics and Biochemical Factors of Patients Managed With the Vacuum-Assisted Closure System or Conventional Surgical Therapy on Admission and at Diagnosis of Deep Sternal Infection (Median and Interquartile Range)
 
The median time interval between the initial cardiac operation and the diagnosis of deep sternal infection in the VAC group and the CON group was 16 days (IQR: 11 to 24 days) and 12 days (IQR: 7 to 23 days), respectively (p > 0.05). Wound classification and mediastinal cultures of the VAC group and the CON group are given in Table 2. The patients were treated with 24 different antibiotics from 17 different groups. The number of prescribed antibiotics did not differ between the two study groups (p > 0.05). In detail, in the VAC group 57.1% of the patients were treated with 1 antibiotic, 20.0% with 2 antibiotics, 11.4% with 3 antibiotics, 2.9% with 4 antibiotics, and 8.6% with 5 antibiotics. The corresponding values for the CON group were: 57.6% with 1 antibiotic, 27.3% with 2 antibiotics, 9.1% with 3 antibiotics, 6.1% with 4 antibiotics, and 0% with 5 antibiotics.


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  		Table 2. Wound Classification According to El Oakley and Wright [13], and Mediastinal Cultures in Patients With Sternal Incision Managed With the Vacuum-Assisted Closure System (VAC Group; n = 35) or With Conventional Surgical Therapy (CON Group; n = 33)
 
Compared with the CRP and leukocyte values at diagnosis of the sternal infection, median plasma CRP levels and blood leukocyte counts declined significantly until discharge in the CON group and the VAC group (Fig 1 A+B). The extent of the decline until discharge did not differ between the CON and the VAC groups (CRP: –11.4 mg/dL and –14.5 mg/dL, respectively, not significant (n.s.); leukocytes: –4.1 x 109/L and –3.1 x 109/L, respectively, n.s.). However, the decline in plasma CRP levels was more rapid in the VAC group compared to the CON group (median decline at t2: –10.4 mg/dL and –3.9 mg/dL, respectively), and the patients of the VAC group could be discharged earlier in comparison to the patients of the CON group (see below). The course of the blood leukocyte counts was similar in both study groups. Hemoglobin and serum creatinine levels remained constant between the time of diagnosis and discharge in both study groups (p > 0.05; data not shown).



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  		Fig 1. Median changes in C-reactive protein levels (A) and in leukocyte blood counts (B) between the time interval of diagnosis of sternal infection (t0) and t1 (3 to 7 days after t0), t0 and t2 (8 to 12 days after t0), t0 and t3 (13 to 17 days after t0), and t0 and td (discharge) are presented in a box plot. The boxes express the upper and lower quartiles, and the central lines show the median. A significant time effect was observed in CRP levels and in leukocyte blood counts in both study groups (Friedman test; p values < 0.001). A significant difference was also observed in {Delta} CRP levels between the CON ({square}) and the VAC ({blacksquare}) groups at t2; **p < 0.025 (Mann-Whitney test). (CON = conventionally treated group; CRP = C-reactive protein; VAC = group treated with the vacuum-assisted closure system.)

 
The time interval from diagnosis of sternal infection until freedom from microbiological cultures was significantly shorter in the VAC group (16 days, IQR: 10 to 26 days) compared to the CON group (26 days, IQR: 19 to 51 days) (p < 0.01). Removal of the VAC system was done after 21 days (IQR: 15 to 32 days). Wound healing (primary or secondary) was achieved after 21 days (IQR: 15 to 26 days) in the VAC group and after 28 days (IQR: 18 to 54 days) in the CON group. This difference was not statistically significant (p > 0.05). Median in-hospital stay after diagnosis of mediastinitis was 25 days (IQR: 18 to 35 days) in the VAC group and was 34 days (IQR: 24 to 55 days) in the CON group (p < 0.01). Although at the time of discharge all patients were free from a sternum infection, 21 out of the 33 patients in the CON group (64%), but only 10 out of the 35 patients in the VAC group (29%), were discharged with an open sternum. This difference was also statistically significant (p < 0.01). Four patients of the CON group (12.1%) and 1 patient of the VAC group (2.9%) died before wound healing. Cumulative survival rates tended to be higher in the VAC group compared with the CON group (Fig 2). The patient in the VAC group was 80 years old. He died on day 8 after diagnosis of sternum infection. The vacuum pressure used was –125 mm Hg. The patient died due to extended diffuse thoracic bleeding following right ventricular rupture: Within 15 minutes the patient’s central vein pressure increased from 9 mm Hg to 25 mm Hg and the arterial blood pressure decreased from 125/90 to 30/20 mm Hg. Despite sudden cardiopulmonary intervention it was not possible to stabilize him. Autopsy showed a small incision in the right ventricle that was perhaps caused by the sternum, indicating vacuum-related perforation. In the CON group, 2 patients died because of bleedings on the second day after diagnosis of sternum infection. The other 2 patients of the CON group died because of septic shock on day 33 and day 57 after diagnosis of the sternal infection. At that time, CRP levels were 8 mg/dL and 13 mg/dL, respectively.



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  		Fig 2. Cumulative survival of patients with sternal incision managed with the vacuum-assisted closure system (VAC group) and of patients with conventional surgical therapy (CON group).

 

   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
References
 
Several recent publications suggest that the VAC technique is a very promising method in order to manage deep sternal infections [8–12]. However, with a few exceptions [12, 13], reliable studies supporting this assumption are currently almost lacking. We present a retrospective investigation that compares the VAC technique with the so far established conventional treatment of sternal infection. We could demonstrate that the VAC technique (1) results in a more rapid decline of plasma CRP levels, (2) shortens the time interval from diagnosis of sternal infection until freedom of microbiological cultures, (3) reduces in-hospital stay, and (4) reduces the percentage of patients discharged with an open sternum. Moreover, the VAC technique tends to decrease mortality associated with deep sternal infection. Since we performed a retrospective data analysis, it is important to mention that baseline characteristics and several biochemical factors at diagnosis of deep sternal infection, including CRP values, were similar in both study groups. Therefore, it is rather unlikely that our results are influenced by study bias favoring the VAC technique. Nevertheless, since this is a sequential retrospective series, we cannot definitively rule out the possibility that the time of treatment affected outcome.

From the scientific point of view our results should be confirmed by randomized, prospective studies. However, it is worthy to note that the total number of sternal infections and of surgeries such as heart valve replacements and bypass operations at our heart center were 68 and 18,920, respectively, within the time interval from September 1998 until September 2003. The incidence of sternal infections of 0.36% is at the lower range of reported values in the literature [2]. Data indicate that for heart centers with good surgical practice it is unrealistic to prospectively and monocentrically evaluate the benefit of the VAC technique compared to the conventional technique. It should also be considered in future studies that other techniques such as omentoplasty, use of muscle flaps, and sternal reclosure after mediastinal irrigation have been used to treat mediastinitis. Especially, delayed primary closure with pectoralis muscle flaps seems to be another efficient method to improve clinical outcome after mediastinitis [13].

In our study, median duration of the VAC therapy (21 days) was higher than the duration reported in earlier studies (9.0 to 13.5 days) [8–11]. The VAC technique has been used in the management of sternal infections for only a few years. Consequently, there is little empirical experience concerning medical outcome in patients managed with this technique in thoracic surgery. Because of our high security standard, we have chosen a relatively long duration of the VAC therapy. This decision may have increased in-hospital stay of the VAC patients. On the other hand, good wound healing allowed us to perform a relatively simple wound closure without using muscle flaps or omentoplasty. Nevertheless, it may well be that the time interval of VAC therapy can be shortened in the future without changing the procedure of wound closure.

Obviously, antibiotic therapy in combination with the surgical procedures resulted in a successful treatment of sternal infections in the majority of patients in both study groups. This suggestion is confirmed by the similar decline in blood leukocyte counts and CRP levels of both study groups until discharge. Nevertheless, it is obvious that the CRP levels declined more rapidly in the VAC group compared to the CON group. Data confirm earlier assumptions that the VAC technique may be able to shorten the process of wound healing [7]. The course of the CRP levels in the two study groups is in line with their different durations of in-hospital stay. The decline in white blood cell counts was less pronounced compared to the decline in plasma CRP levels during treatment of mediastinitis (median decline in CRP levels: 77% to 79%; median decline in leukocyte counts: 30% to 33%). In line with earlier results, demonstrating that white blood cell count is not a useful guide for monitoring the therapy of sternal infection [9], leukocyte counts did not differ between the VAC group and the CON group at specific points of time during treatment.

In our study, 4 patients in the CON group but only 1 patient in the VAC group died of causes related to sternal wound infection. Data indicate that the VAC technique may prevent complications associated with the open packing procedure such as severe bleeding and septic shock. The mortality rate of 12.1% in the CON group is in line with results of earlier studies that have demonstrated a lethality of 10% to 20% [5–7]. It is encouraging that mortality rate was only 2.9% in the VAC group. However, because the death of the one patient who died was related to the VAC technique itself, this complication needs further consideration. The risk of right ventricular rupture during use of high-pressure suction drainage has also been described by others [17]. To reduce or prevent the risk of tissue irritation, a silicone gaze is now used as a layer between the VAC dressing and the tissue in all cases of mediastinitis at our clinic. In addition, the manufacturer of the VAC systems performs an intensive theoretical and practical training course for the management of the VAC system unit. This training course lasts 8 hours and is usually performed in groups of no more than two persons. In line with the suggestions of others [18], it is also mentioned in the training course that a negative pressure of –125 mm Hg or –150 mm Hg should usually be used to achieve optimal stabilization of the sternum.

In summary, this retrospective analysis demonstrates that the VAC therapy can improve medical outcome of patients with sternal infections in comparison to the conventional therapy with open packing.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

  1. Baskett RJ, NmacDougall CE, Ross DB. Is mediastinitis a preventable complication? A 10-year review Ann Thorac Surg 1999;67:462-467.[Abstract/Free Full Text]
  2. Schumaker Jr HB, Mandelbaum I. Continuous antibiotic irrigation in the treatment of infection Arch Surg 1963;86:384-387.
  3. Jurkiewicz MJ, Bostwick J, Hester TR, et al. Infected median sternotomy wound: successful treatment by muscle flaps Ann Surg 1980;191:738-744.[Medline]
  4. Loop FD, Lytle BW, Cosgrove DM, et al. Sternal wound complications after isolated coronary artery bypass grafting: early and late mortality, morbidity, and cost care Ann Thorac Surg 1990;49:179-187.[Abstract]
  5. De Feo M, Renzulli A, Ismeno G, et al. Variables predicting adverse outcome in patients with deep sternal wound infection Ann Thorac Surg 2001;71:324-331.[Abstract/Free Full Text]
  6. Francel TJ, Kouchoukos NT. A rational approach to wound difficulties after sternotomy: reconstruction and long term results Ann Thorac Surg 2001;72:1419-1429.[Abstract/Free Full Text]
  7. Fleck TM, Fleck M, Moidl R, et al. The vacuum-assisted closure system for the treatment of deep sternal wound infections after cardiac surgery Ann Thorac Surg 2002;74:1596-1600.[Abstract/Free Full Text]
  8. Luckraz H, Murphy F, Bryant S, et al. Vacuum-assisted closure as a treatment modality for infections after cardiac surgery J Thorac Cardiovasc Surg 2003;125:301-305.[Abstract/Free Full Text]
  9. Gustafsson R, Johnsson P, Algotsson L, et al. Vacuum-assisted closure therapy guided by C-reactive protein level in patients with deep sternal wound infection J Thorac Cardiovasc Surg 2002;123:895-900.[Abstract/Free Full Text]
  10. Gustafsson RI, Sjörgren J, Ingemansson. Deep sternal wound infection: a sternal-sparing technique with vacuum-assisted closure therapy. Ann Thorac Surg 2003;76:2048–53..
  11. Hersh RE, Kaza AK, Long SM, et al. A technique for the treatment of sternal infections using vacuum assisted closure device Heart Surg Forum 2001;4:211-215.[Medline]
  12. Catarino PA, Chamberlain MH, Wright NC, et al. High-pressure suction drainage via a polyurethane foam in the management of poststernotomy mediastinitis Ann Thoracic Surg 2000;70:1891-1895.[Abstract/Free Full Text]
  13. Fleck TM, Koller R, Giovanoli P, et al. Primary or delayed closure for the treatment of poststernotomy wound infections? Ann Plast Surg 2004;52:310-314.[Medline]
  14. Garner J, Jarvis W, Emori T, et al. CDC definitions for nosocomial infections 1988 Am J Infect Control 1988;16:128-140.[Medline]
  15. El Oakley RM, Wright JE. Postoperative mediastinitis: classification and management Ann Thorac Surg 1996;61:1030-1036.[Abstract/Free Full Text]
  16. Kaplan E, Meier P. Nonparametric estimation from incomplete observation J Am Stat Assoc 1958;53:457-463.
  17. Abu-Omar Y, Naik MJ, Catarino PA, Ratnatunga C. Right ventricular rupture during use of high-pressure suction drainage in the management of poststernotomy mediastinitisTo the editor. Ann Thorac Surg 2003;76:974.[Free Full Text]
  18. Fleck TM, Grabenwoger M. Right ventricular rupture during use of high-pressure suction drainage in the management of poststernotomy mediastinitisAuthor reply. Ann Thorac Surg 2003;76:974-975.[Free Full Text]



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