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Ann Thorac Surg 1996;61:195-201
© 1996 The Society of Thoracic Surgeons


Original Articles: General Thoracic

Closed Drainage Using Redon Catheters for Local Treatment of Poststernotomy Mediastinitis

Sylvie Calvat, MD, Jean-Louis Trouillet, MD, Patrick Nataf, MD, Albert Vuagnat, MD, Jean Chastre, MD, Claude Gibert, MD

Réanimation Médicale, Hôpital Bichat, Paris, France

Accepted for publication September 13, 1995.


    Abstract
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 
Background. Continuous irrigation has been used worldwide for the treatment of acute poststernotomy mediastinitis. However, its high rate of failure led to the development of new methods, among them closed drainage with Redon catheters.

Methods. We evaluated the results obtained with Redon catheters in 70 patients, and compared them to those obtained in 38 patients treated with continuous irrigation.

Results. The two treatment groups were not different for age, type of cardiac operation, and initial severity of illness. Local failure of Redon catheter drainage occurred less frequently (20 of 38 versus 9 of 70 patients; p = 0.0001). This reduced failure rate was mainly attributable to a lower incidence of superinfections (10 of 38 versus 2 of 70 patients; p = 0.0002), but also to a lower incidence of primary failure (10 of 38 versus 7 of 70 patients; p = 0.026). Mortality was significantly decreased (15 of 38 versus 12 of 70 patients; p = 0.01). The other major advantage of this technique was the simplicity of its use.

Conclusions. The technique using Redon catheters should be considered an effective and convenient treatment of acute poststernotomy mediastinitis.


    Introduction
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 
Since its introduction in 1957, the median sternotomy incision has been universally adopted as the incision of choice for open heart operations. In such patients, severe infection of the wound results in mediastinitis and sternal involvement. The incidence of acute mediastinitis after cardiac operation has been reported to be 1% to 3% in major series involving patients treated in the 1980s [13]. Mortality ranges between 20% and 50%, and death may be caused by generalized sepsis, endocarditis, fatal hemorrhage, or secondary multiple organ dysfunction, as well as nosocomial superinfections. Finally, the severity of the underlying cardiac disease can be aggravated during the infectious process, leading to increased mortality. Moreover, deep sternal infections leave physical, cosmetic, and mental scars, and often require prolonged hospitalization. Accordingly, the ideal surgical treatment should be as conservative as possible, engender few side effects, and assure a low failure rate.

Open wound treatment is the most ``aggressive'' way to handle acute mediastinal infections. It is a conservative procedure that can be applied in virtually any situation by surgeons with almost any level of experience, but its disadvantages include persistence of the open wound with concomitant risks of superinfection or fatal hemorrhage and prolonged hospitalization, which can be as long as 6 to 10 months [4, 5]. Closed techniques, continuous irrigation (CD-CI), or flap reconstruction, therefore, whenever possible, are usually preferred. Continuous irrigation is a time-honored procedure that is both rapid and effective. It can be used for the majority of early infections. From its first description [6] until the 1980s, it was considered the standard therapy for mediastinitis at most of institutions. However, its reliability was in doubt because of a reported failure rate of up to 50% [710]. Consequently, during the past decade, reconstruction with vascular pedicle flaps gained significant attention, as it can be used initially or after a few days of open wound packing [1, 8, 11]. In the late 1980s, Lecompte's group (Porte de Choisy Clinic, Paris) proposed simple closed drainage using Redon catheters (CD-RC) (Fig 1Go) instead of CD-CI [12]. Redon catheter drainage seemed easier to perform than muscle flap closure and even less complex in maintenance than CD-CI. The purpose of the present study was to assess the efficacy of the CD-RC technique in a large number of patients in the treatment of acute mediastinal infections after cardiac operation, and to compare the therapeutic results with those obtained at the same institution with CD-CI.



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Fig 1. . The components of the Redon drainage device: collecting bottle, vacuum indicator, and Redon catheter. The Redon catheter is connected to a plastic tube with a clamp to avoid air entry when bottles are changed. The vacuum bottle is graduated. When inflated, a plastic device indicates the loss of negative pressure.

 

    Patients and Methods
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 
Study Population
To evaluate the respective effectiveness of closed drainage with CD-RC and CD-CI the medical files of patients treated with one of these two closed techniques during a 4-year period (November 1987 to December 1991) were reviewed. Patients were referred to Bichat hospital intensive care unit (ICU) from different local secondary or tertiary surgical centers. Most patients were discharged from the center of cardiovascular surgery of Pitié-Salpétriêre hospital. Diagnosis and surgical debridement were generally done just before the patient was transferred to our center. Patients treated for acute mediastinitis were excluded from analysis when one of the following criteria was present: initial treatment with open packing, wound infection occurred in immunocompromised patients (heart or heart--lung transplantation, high steroid doses, or patients with the human immunodeficiency virus), or death before or during surgical debridement. The study population was divided into two groups: group 1 included patients treated with CD-CI and group 2 underwent CD-RC. Age and sex of study patients, and the type of open-heart operation were recorded. The severity of mediastinal infection was assessed by four data: (1) the incubation period duration, defined as the interval between cardiac operation and debridement for mediastinitis; (2) concomitant bloodstream infection; (3) the simplified acute physiology score, which is a disease severity index based on physiologic variables recorded during the first 24-hour period in the ICU [13]; and (4) renal failure (serum creatinine level more than 300 µmol/L or urine output less than 500 mL/24 h) during the first 24 hours in the ICU. The causative organisms (ie, those isolated from surgically removed tissues or blood cultures) were also recorded.

Diagnosis and Treatment
Acute mediastinal infection was defined as the presence of pus or bacterial growth, or both, in mediastinal tissues sampled during surgical reexploration. The following debridement procedure was used throughout the study period: all necrotic and infected cancellous sternal bone and fibropurulent material were removed, and the wound was repeatedly irrigated with copious amounts of antiseptic solution. Once the wound had been cleaned, a closed technique was applied when surgeons judged local damage did not prevent skin closure. The subsequent choice of drainage technique was made by the operating teams according to their previous experience and technical skill.

Regarding CD-CI, the sternal edges were brought together over one or two infusion catheters and two or three large and multifenestrated drainage tubes. The sternum was usually rewired shut and the subcutaneous wound and skin were closed without a drain. Postoperatively, the mediastinum was irrigated continuously with 0.5% povidone-iodine solution, at a mean rate of 100 mL/hour, and the wound was simultaneously drained by gentle suction (-20 cm H2O). Irrigant input and output were calculated three times a day to prevent retention of fluid and insufficient irrigation. On day 10, the irrigation was systematically stopped and the drainage tubes were progressively removed over the next 48 hours.

The same surgical debridement procedure was performed when closed drainage was to be applied. Three to six Redon catheters (Braun Melsungen AG, Melsungen, Germany), which are small, multiperforated, rigid tubes, were placed in all infected areas, including the mediastinal cavity and the dissected subcutaneous chest wall area. Once the sternum had been rewired and the skin closed, each catheter was connected to a plastic bottle (Fig 1Go) in which a strong vacuum (negative pressure, 700 mm Hg) had been created (Redovac; Sterimed, Püttlingen, Germany). The number of Redon catheters used in the wound depended on the size of residual cavity, because one catheter--vacuum bottle device probably ensured the suction of a small area. The collecting bottles were changed daily. Subcutaneous tubes were progressively removed (2 cm daily) as of day 10 after debridement, and the mediastinal tubes as of day 15. Redon catheters were temporally clamped during drain removal to avoid the possibility of suction-induced tissue damage or bleeding due to strong migrating suction.

Twice a week, the mediastinal effluent in the CD-CI drains or in the CD-RC collecting bottles was sampled. The mediastinal effluents were examined by Gram stain and standard microbiological cultures were set up. Patients were discharged from ICU a few days after the drains or the catheters had been removed, when no life-threatening complication necessitated further intensive care. When one of the two closed techniques had been unable to cure local infection, the open-packing technique was used after surgical redebridement.

Antibiotic management did not change during the study period. Appropriate antibiotic treatment was systematically started before surgical debridement, based on available bacteriologic data. Initial treatment generally combined a ß-lactam or a glycopeptide antibiotic and an aminoglycoside. After this 2- to 5-day regimen, staphylococcal infection was treated with a combination of a ß-lactam or glycopeptide antibiotic and two other antimicrobial agents capable of providing high concentrations in bone tissue and cells (fluoroquinolone, rifampin, sodium fusidate, or fosfomycin). The parenteral route was used during the first 3 weeks. When the local evolution was judged to be satisfactory, the antibiotics were then administered orally as much as possible. Antibiotic treatment was prescribed for a total duration of 6 weeks [14]. Regarding non-staphylococcal infections, the antibiotic regimen was chosen according to results of bacterial susceptibility testing and to achieve the same tissular distribution.

Evaluation Criteria
The end-point efficacy criteria of the two techniques were: (1) death during ICU stay and the time after admission at which it occurred, (2) length of ICU stay for survivors, and (3) treatment failure. Treatment failure was defined as the inability of the technique to resolve local infection resulting in surgical redebridement. Primary failure (persistence of the original infective agent) was differentiated from superinfection (wound infected by a different microorganism).

Other data were also analyzed, but were not considered end-point criteria: percentage of patients mechanically ventilated for more than 1 day and duration of ventilatory support, time to sterilization of mediastinal fluid, and occurrence of life-threatening complications. The time to sterilization of the mediastinal effluent was calculated as the interval between the time of debridement and the first day at which the recovered mediastinal fluid was sterile. It was not possible to evaluate the time to sterilization when initial cultures had been sterile, in the case of early death with positive cultures, or when redebridement was necessary due to primary failure. Recorded life-threatening complications were secondary prosthetic infective endocarditis, massive mediastinal hemorrhage caused by vascular or cardiac rupture, and development of multiple organ dysfunction. Because the blood urea nitrogen level and the time lapse until diagnosis had been shown to be predictive of CD-CI treatment failure [2, 8, 15], subgroup analyses taking these parameters into account were also performed.

Statistical Analyses
Quantitative values in the two groups were compared using the unpaired Student's t test and the Mann-Whitney U-test when modal distribution was not observed. Nominal variables were analyzed using {chi}2 analysis or Fisher's exact test when necessary. Survival curves were calculated using the Kaplan-Meier method and compared by a standard log-rank test. A p value of less than 0.05 was considered to be statistically significant.


    Results
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 
Between November 1987 and December 1991, 183 patients were referred for acute poststernotomy mediastinal infection in Bichat hospital ICU. Seven patients died before or during surgical debridement. Mediastinitis occurred in 9 heart transplant patients, but none in other immunocompromized patients. Therefore, 167 immunocompetent patients were treated for acute mediastinitis during this 4-year period. Fifty-nine patients were initially treated with open-wound packing.

Thus, 108 patients with a closed drainage technique were enrolled in the study: 38 patients were treated with CD-CI (group 1) and 70 patients underwent CD-RC (group 2). Figure 2Go illustrates the time distribution of the three treatment procedures (open-wound packing, continuous irrigation, and closed drainage). The use of CD-RC progressively drop at the expense of CD-CI. This time distribution was explained by the effectiveness of the new technique, which induced surgeon teams to use it in patients where CD-CI had been previously proposed.



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Fig 2. . Number of patients treated with open wound packing, continuous irrigation, and closed drainage using Redon catheters during the 4-year study period, which is divided into eight 6-month periods.

 
Characteristics of the two study groups are summarized in Table 1Gotab 1. Age, sex ratio and types of open-heart operation did not differ between groups 1 and 2. About half of the patients had undergone coronary artery bypass grafting and about a third underwent valve replacement. Other procedures were combined valve replacement and revascularization procedures (8 patients), intravascular aortic prosthesis insertion (5), myocardial repair (1), pulmonary artery prosthesis insertion (1), pulmonary embolectomy (1), and pericardiectomy (1 patient). Simplified acute physiology score values and the presence of renal failure were similar in the two groups. Incubation duration did not differ between groups. Wound infection developed in all patients within the first postoperative month, except 1 in group 1 and 3 in group 2. Bacteremic infections tended to be less frequent in group 1 than in group 2. Microbiological findings are summarize in Table 2Gotab 2. No difference was noted. The ratios of multimicrobial mediastinitis (6 of 38 versus 10 of 70 patients) were comparable.


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Table 1. . Baseline Clinical Characteristicsa
 

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Table 2. . Bacteria Isolated From Mediastinal Samples During Surgical Debridement
 
Table 3Go reports the three criteria used to evaluate the closed techniquestab 3. Mortality was high in both groups, but use of CD-RC rather than CD-CI associated with a significant diminution of ICU deaths. The Kaplan-Meier survival curves (Fig 3Go) show the significant influence of treatment choice on survival. Regarding treatment failure, 20 of the 38 patients treated with CD-CI required reintervention. In 4 patients, early reoperation was deemed necessary because of fluid leakage out of the incision with local uncontrolled infection. Another 16 patients were reoperated on after the drains were removed. On the other hand, failure of CD-RC, including primary failure and superinfection, occurred in only 9 patients. The length of stay in the ICU of surviving patients did not differ among groups (24.7 ± 19.5 days in group 1 and 29.2 ± 19.9 days in group 2).


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Table 3. . Outcome of Patients According to the Type of Closed Drainage Applied
 


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Fig 3. . Kaplan-Meier survival curves for patients treated with continuous irrigation and closed drainage with Redon catheters. Log-rank (Mantel-Cox) test: {chi}2 = 6.39; p = 0.01.

 
Prolonged mechanical ventilation was required in 26 of 38 (68%) group 1 patients and in 36 of 70 (51%) group 2 patients (p = not significant) and the duration of ventilatory support did not differ between groups (20 ± 17 versus 16 ± 18 days, respectively). Time to sterilization could be calculated in 85 patients. In group 1, 12 patients were excluded from this analysis (4 negative samples, 5 early deaths, 3 redebridements before sterilization). In group 2, 11 patients presented these exclusion factors (3 negative samples, 3 early deaths, and 5 redebridements before sterilization). Time to sterilization of the effluent was significantly longer for samples taken from collecting bottles of CD-RC than from CD-CI drains (7.9 ± 3.4 versus 1.9 ± 1.5 days, respectively). In all patients in both groups, mediastinal fluid samples were sterile at the time of drains removal.

The incidence of life-threatening complications was similar in the two groups. Regarding patients in whom mediastinitis developed after valve replacement, prosthetic valve infective endocarditis occurred in 4 patients: 1 in the CD-CI group and 3 in the CD-RC group (p = not significant). In our entire series, mediastinal massive hemorrhage was never observed during treatment with a closed technique. It only occurred when reintervention was deemed necessary and open wound packing was used: 3 patients in group 1 and 1 patient in group 2. Finally, multiple organ dysfunction complicated mediastinal infection equally in both groups (9 of 38 versus 12 of 70 patients).

When considering the subgroup of patients in whom infections developed more than 2 weeks after operation, 9 were treated using CD-CI and 29 using CD-RC. The failure rate was higher when CD-CI was applied (8 of 9 versus 4 of 29; p < 0.01). Regarding infections developing during the first 15 days, the failure rate was also higher in the closed irrigation group (12 of 27 versus 5 of 41, respectively; p < 0.05). In the 19 patients suffering from renal failure at the time of admission, no difference in the success rate was observed between groups 1 and 2 (4 of 8 versus 2 of 11, p = not significant). Finally, failure rate was not associated with bacterial type.


    Comment
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 
The present study allowed us to confirm that closed drainage with Redon catheters is an effective, simple, and comfortable closed treatment for poststernotomy mediastinal infection. The major advantage of this technique is its low rate of local failure, which was the major problem encountered with continuous irrigation. Simultaneously, the mortality rate decreased. These results led us to propose CD-RC as a very convenient closed treatment for poststernotomy deep wound infection.

Historically, CD-CI had been the first-line treatment for acute mediastinitis. However, the type and duration of irrigation have always been empirical, depending on individual practices, as shown in Table 4Go [13, 711, 1520]tab 4. During the first decade of its application, the irrigation liquid was saline solution with diluted antibiotics, but toxic side effects and superinfection with these regimens were reported rapidly [5]. The use of povidone-iodine (0.5% solution) as the irrigant was proposed by Thurer and colleagues in 1974 [17]. Its superiority over antibiotic solutions has not been demonstrated, but few side effects have been reported. Regarding duration of irrigation, studies have also reported varying regimens: most authorities ordered removal of the drains at preestablished times. We chose a 10-day regimen, which is the most commonly used (Table 4Go). Others preferred to adapt the time of drain withdrawal to the time of sterilization of the mediastinal effluent.


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Table 4. . Characteristics of Published Continuous Irrigation Regimens
 
Regardless of the modality chosen for CD-CI, most researchers agree that the technique results in a high rate of failure (Table 4Go), although the successful outcome of 90% to 95% had been reported in pioneer studies [6, 15, 17]. In the present series, a high rate of failure was also observed, which necessitated frequent surgical redebridment required to treat primary failure as well as superinfection. Superinfection of the mediastinal space during CD-CI has been noted previously [15], but not thoroughly evaluated. It is considered to be the consequence of exogenous contamination due to repeated disruptions of the system. Regarding primary failure, we often observed a scenario that had been described frequently: blood or fibrinous materials occlude catheters, resulting in insufficient irrigation or unsatisfactory drainage; a loculate cavity would then be created and an infectious process would develop within. Independently of these mechanical factors, two underlying conditions had been reported to be predictive of CD-CI failure: the presence of renal failure at the time of mediastinal infection [2, 13], and an incubation duration longer than 2 weeks [2, 8, 21].

Redon catheter drainage was first described in 1972 by Letournel and associates [22], who used this technique to treat postoperative osteomyelitis of long bones after extensive resection of infected tissues. They claimed that it was better able to remove infected serous fluids because of the strong negative pressure applied over an infected area. Strong suction probably drained infected exudate through tissues, and the size of the drained area was proportional to the number and the location of the Redon catheters. Furthermore, the small diameter of the tubes was thought to avoid the persistence of a cavity after they had been removed, thereby possibly decreasing the risk of a recurrent loculate infectious process. This method was used by our group to treat mediastinal infections as secondary closure in patients who underwent primary open-wound packing [23]. In 1989, Durandy and colleagues [12] reported on the successful use of this technique as the first-line treatment in 10 patients, who experienced no local failure or death. They emphasized in their report the simplicity of the technique and the good cosmetic results. However, the smallness of the studied sample did not allow them to evaluate thoroughly the effectiveness of this technique. The population size and the varying ranges of disease severity reported in the present series allowed us to confirm their preliminary results. We were also able to confirm the excellent treatment acceptance by nurses and patients, which is a major advantage and probably an important factor in the efficacy to this therapy. Redon catheter drainage necessitated only daily changing of the collection bottle. Nursing care was thus facilitated as compared with CD-CI, which required frequent assessments of the system and repeated changes of the irrigation solution. The system was painless and comfortable for the patient, who was permitted to walk carrying a bag full of bottles as soon as the medical condition warranted. Finally, cosmetic results were judged particularly good by physicians and patients. No complication was observed.

The decreased mortality and treatment failure rate of CD-RC as compared with CD-CI may be related to the lowering of local superinfection, whatever acute infection manifests within 2 weeks after initial sternotomy or later. Moreover, in more chronic wounds, CD-RC, inducing more potent suction, might be able to obliterate any potential space, eliminating any residual cavity of undrained purulence, even if local tissues are indurated and poorly compliant. Obviously the decreased mortality and treatment failure rates observed with CD-RC must be tempered by some drawbacks of the present study. In particular, any improvement of the results might be due to better medical management, or improved quality of nursing care throughout the study period. However, it must be pointed out that during the study period our management of CD-CI was well established. In fact, at the beginning of the study period, this technique had been routinely used for more than 7 years at our institution. Conversely, clinical and nursing staffs were quite inexperienced in the management of CD-RC. Random assignment to CD-CI or CD-RC would have been a better study design to ensure that our findings did not result from time-dependent factors. However, in this study, the enthusiasm for CD-RC by the surgeons rendered randomization practically impossible. Moreover, it became ethically difficult to propose CD-CI when CD-RC appeared likely to be more effective and convenient.

Despite the fact that it was not an evaluation criterion, the time to sterilization of the mediastinal effluent during CD-RC was a meaningful piece of data. It was indeed surprising that the time necessary to sterilize mediastinal samples was longer during CD-RC than during CD-CI, despite the better efficacy of the former technique. This apparent contradiction might result from the fact that the mediastinal fluid collected during CD-CI was diluted in an antiseptic irrigant, with a consequent decrease in the bacterial concentration and partial inhibition of bacterial growth. On the other hand, fluid sampled from the collecting bottles of CD-RC consisted of ``pure'' mediastinal serous fluids collected over a 24-hour period at room temperature. The important consequence of this finding is that persistent growth in the mediastinal exudate of bacteria does not lead to the conclusion that CD-RC fails when local and systemic signs are satisfactory.

Closed drainage with Redon catheters seems to be the most simple and accurate closed technique for the treatment of acute mediastinal infection. Like continuous irrigation, it can be easily used by any surgeon and in any compromised patient. Unlike CD-CI, closed drainage, however, appears to be safe, reliable, and simple. Since 1992 we have used this technique routinely in most patients, including those in very poor condition for whom we had previously preferred open-wound packing with secondary closure. No evidence was found to suggest that this practice jeopardized patient prognosis. All these findings lead us to propose the use of Redon catheters on a large scale, despite the need for additional studies to compare this simple device to more sophisticated surgical procedures such as flap reconstruction.


    Footnotes
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 
Address reprint requests to Dr Calvat, Service de Réanimation Médicale, Hôpital Bichat, 46, rue Henri-Huchard, 75877 Paris Cedex 18, France.


    References
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 

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  21. Culliford AT, Rosenfeld K. Role of antibiotic lavage and radical debridement in the treatment of acute mediastinal wound infections following sternotomy. In: Vander Salm TJ, ed. Mediastinal and sternal infections: cardiac surgery: state of the art review. Philadelphia: Hanley & Belfus, 1988: 459--73.
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