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Ann Thorac Surg 2003;76:2048-2053
© 2003 The Society of Thoracic Surgeons


Original article: cardiovascular

Deep sternal wound infection: a sternal-sparing technique with vacuum-assisted closure therapy

Ronny I. Gustafsson, MDa*, Johan Sjögren, MDa, Richard Ingemansson, MD, PhDa

a Department of Cardiothoracic Surgery Heart and Lung Division, Lund University Hospital, Lund, Sweden

Accepted for publication June 25, 2003.

* Address reprint requests to Dr Gustafsson, Department of Cardiothoracic Surgery, Heart and Lung Division, Lund University Hospital, SE-221 85 Lund, Sweden.
e-mail: ronny.gustafsson{at}thorax.lu.se


    Abstract
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 
BACKGROUND: Vacuum-assisted closure therapy is a novel treatment employed to aid wound healing in different areas of the body and recently also in sternotomy wounds. Aggressive vacuum-assisted closure treatment of the sternum in postoperative deep wound infection enhances sternal preservation and the rate of possible rewiring.

METHODS: The records of 40 consecutive patients with deep sternal wound infection were reviewed. Sternal bone sparing was achieved by using layers of paraffin gauze (Jelonet; Smith and Nephew Medical, Hull, UK) at the bottom of the wound in order to cover and protect visible parts of the right ventricle, lung tissue, and grafts from the sternal edges. Two separate layers of polyurethane foam (KCI, Copenhagen, Denmark) were placed so as to fit between the sternal edges and subcutaneously. A continuous negative pressure of 125 mm Hg was applied and subsequent revision was made exclusively in nongranulation areas.

RESULTS: There were no deaths during the 90 days of follow-up. Three late deaths unrelated to the infection and three subcutaneous fistulas occurred during the total follow-up period (3 to 41 months). The median duration of the vacuum-assisted closure therapy was 10 days (range, 3 to 34). The series represents a total of 474 days with the vacuum-assisted closure device without serious adverse events.

CONCLUSIONS: In our opinion this modified vacuum-assisted closure therapy is a safe and reproducible option to bridge patients with postoperative deep sternal wound infection to complete healing. Reconstruction of the sternum was achieved in all patients without the use of muscle or omental flap surgery.


    Introduction
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 
Deep sternal wound infection is a rare but devastating complication after open-heart surgery through a midline sternotomy. Most authors report an incidence of 1% to 4% of all sternotomy procedures [1, 2]. Morbidity and mortality have remained high over time despite advances in antibiotic and wound-healing strategies [35]. The modern standard treatment at most centers involves surgical debridement, drainage, irrigation, and reconstruction using pectoral muscle flap or omentum transposition [6, 7].

In recent years some authors have reported promising results with complex wound healing using the vacuum-assisted closure technique [811]. In cardiac surgery the vacuum-assisted closure system has been used as an adjunct to patients with deep sternal wound infection [1215]. In these cases mortality, morbidity, and hospital stay seem to be the same as or even lower than those resulting from standard, more invasive treatment procedures. In a previous study by our group a strategy for timing of wound closure and monitoring of vacuum-assisted closure therapy was proposed [16]. However, the surgical technique required to obtain a sternotomy in the appropriate condition for surgical refixation with vacuum-assisted closure therapy is not well defined. In the present paper we describe such a technique in 40 consecutive patients with postoperative deep sternal wound infection.


    Patients and methods
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 
All patients at our department who presented signs and symptoms of deep sternal wound infection between February 1999 and May 2002 were considered candidates for vacuum-assisted closure therapy. Deep sternal wound infection was defined according to the guidelines of the Centers for Disease Control and Prevention (CDC) [17]; diagnosis of deep sternal wound infection required at least one of the following criteria: (1) an organism was isolated from culture of mediastinal tissue or fluid; (2) evidence of mediastinitis was seen during operation; or (3) chest pain, sternal instability, or fever (> 38°C) was present and there was either purulent discharge from the mediastinum or an organism isolated from blood culture or culture of drainage of the mediastinal area.

During this period a total of 4,124 sternotomy procedures were performed. Nine patients were rewired as early sterile dehiscence and 3 patients with sternal instability received vacuum-assisted closure therapy but were closed at the first change of dressing as the tissue cultures were negative. Forty patients (26 men and 14 women) with deep sternal wound infection received vacuum-assisted closure therapy. The patient characteristics and surgical procedures are presented in Table 1. As soon as deep sternal wound infection was diagnosed clinically the patient was taken to the operating theater and the wound was explored. Classification of mediastinitis (Table 2) was based on the criteria proposed by El Oakley and associates [18]. Foreign material such as steel wires and sutures was debrided. Five tissue cultures were obtained from different substernal sites of the wound. Debridement of clearly necrotic and infected soft tissue was performed at once but no deep revision was made around the heart. Sternal edges were revised with a sharp spoon. Special attention was directed to the left hemisternum and underlying right ventricle by checking for adherences and sharp edges. That was followed by saline irrigation and thorough hemostasis.


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Table 1. Characteristics of 40 Consecutive Patients With Vacuum-Assisted Closure (VAC) Therapy of Poststernotomy Mediastinitis

 

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Table 2. Classification of 40 Patients With Vacuum-Assisted Closure Treated Poststernotomy Mediastinitis

 
Three or four layers of paraffin gauze dressing (Jelonet; Smith and Nephew Medical, Hull, UK) were placed at the bottom of the wound covering and isolating visible parts of the right ventricle, lung tissue, and grafts from the sternal edges (Fig 1, A). Sterile polyurethane foam dressing, with an open pore structure of 400 to 600 µm (KCI, Copenhagen, Denmark) was trimmed to fit between the sternal edges. It was cut as a strip, 1.5 times broader than the sternal diastase to allow volume reduction when the vacuum was applied. This layer was used to seal the gap between the bone edges and was not placed below the level of the sternum. A separate noncollapsible evacuation tube (KCI, Copenhagen, Denmark) was inserted into the sternal foam layer (Fig 1, B) and fixed with a suture (Dermalon 2-0; Davis and Geck, St. Louis, MO). The second layer of polyurethane foam was placed subcutaneously, covering the wound completely. In a relaxed state the foam should protrude 1 to 2 cm over the edge of skin to allow volume reduction during vacuum therapy. This layer was then secured subcutaneously with a running suture (Dermalon 2-0) to the surrounding skin edge. A second tube was inserted into the middle of this foam layer and sutured with Dermalon 2-0. A skin barrier protector (Cavilon; 3M HealthCare, St. Paul, MN) was applied (Fig 1, C) and the open wound was sealed with a transparent adhesive drape (KCI, Copenhagen, Denmark). The drape overlapped the wound margins by 5 cm. The two drainage tubes were positioned 5 cm apart to facilitate application of the draping (Fig 1, D).



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Fig 1. (A) Three or four layers of Jelonet cover the heart and grafts. (B) A tube is inserted into the center of the sternal foam layer and sutured in place. (C) The superficial foam layer is sutured to the surrounding subcutaneous tissue and a skin protector is applied. (D) The tubes are positioned 5 cm apart to facilitate application of the draping around the tubes.

 
The two drainage tubes from the closed wound were connected to a purpose-built vacuum source (VAC-pump unit; KCI, Copenhagen, Denmark). This unit delivers continuous or intermittent negative pressure of 50 to 250 mm Hg. Initially 50 mm Hg was applied as it allows adjustment of the foam as the air is evacuated. If the wound geometry and foam contraction were considered satisfactory the pump unit was programed to deliver 125-mm Hg continuous negative pressure. At this pressure there can be no further adjustment since the compressed foam will be firm. A canister in the pump unit collects exudate from the wound. All patients were secured with a stabilizing sternum harness (Anita Med GmbH, Brannenburg, Germany) during the whole vacuum-assisted closure therapy period.

The polyurethane foam and Jelonet layers were changed at least three times a week depending on the C-reactive protein levels [16] under aseptic conditions and under general anesthesia. During vacuum-assisted closure therapy bone and soft tissue necrosis is demarked by lack of granulation tissue on the sternal edges and complementary revisions were made only in these areas during foam changes.

Most of the patients were extubated immediately after vacuum-assisted closure application and left the intensive care unit after 2 to 3 hours. A routine chest roentgenogram was performed to reveal any pleural effusion. The patients were able to move around on the ward with the vacuum-assisted closure system in place and received physiotherapy.

The wound was considered to be free of infection when the C-reactive protein level had declined to 30 to 70 mg/L without confounding factors such as the presence of tissue injury or infection elsewhere [16]. In such cases cultures were taken from the stenum before closure. Furthermore visual inspection should demonstrate a well-vascularized wound covered with granulation tissue (Fig 2). Finally the sternotomy was rewired with interrupted steel wires (Stahldraht; Johnson and Johnson, Brussels, Belgium). By using partial Robiseck wires to secure fractures, reinforced rewiring was performed without compromising sternal blood flow. The presternal fascia was carefully mobilized to cover the wires and sutured with interrupted stitches (Vicryl; Johnson and Johnson, Brussels, Belgium). The skin was closed with interrupted stitches (Dermalon 2-0). An Argyle Ch28 tube (Sherwood Medical, Tullamore, Ireland) was placed behind the sternum and a negative pressure of 20 cm H2O was applied. In addition two passive drainage tubes (Exudrain Mini Ch10; Astratech, Mölndal, Sweden) were located subcutaneously to avoid seroma. These tubes were kept in place until the drained volume was less than 20 mL in 24 hours.



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Fig 2. The wound is ready for refixation after high negative pressure treatment.

 
The tissue cultures from the first revision show the significance of the infection and provide the cornerstone for the choice of antibiotics [19]. Our standard perioperative antibiotic regime is isoxazolylpenicillin 1 g three doses during the day of operation and the first postoperative day. When mediastinitis was detected antibiotic therapy commenced with vancomycin intravenously in all patients. The dose was adjusted according to the renal status of the patient. This treatment continues until the tissue cultures arrive, which were dominated by coagulase-negative staphylococci (Table 3).


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Table 3. Infectious Characteristics and Management Data

 
The regimen was then changed according to sensitivity and strains. The intravenous therapy continued for at least 7 days after sternal closure. Thereafter an oral regimen was continued for 4 weeks as a combined therapy according to the sensitivity of the strains.


    Results
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 
During follow-up 3 late deaths unrelated to mediastinitis occurred at 4, 6, and 16 months after vacuum-assisted closure treatment. Autopsy showed hemorrhagic pancreatitis, right heart failure secondary to congenital pulmonary stenosis, and disseminated pharyngeal carcinoma with ischemic bowel disease as the causes. There was no procedure-related mortality and no postmediastinitis mortality during the follow-up period. A stable sternotomy and primary wound healing were achieved in all cases.

A subcutaneous presternal fistula developed in 2 patients, 2 and 5 weeks postoperatively. The fistulas were excised under general anesthesia. One patient developed chronic fistulation and a revision with debridement of the fistulas and removal of all wires was carried out after 7 months. These fistulas obliterated completely after removal of the wires but represent a recurrence rate of 7.5%.

Minor bleeding problems occurred in 3 patients. The first patient had subcutaneous bleeding due to coughing. The vacuum-assisted closure device was temporarily removed, presternal subcutaneous bleeding was cauterized, and inhalation therapy was intensified. The second patient developed oliguria after coronary artery bypass grafting. During vacuum-assisted closure therapy a bolus of heparin was administered intravenously when dialysis was initiated. Bleeding was observed and the vacuum-assisted closure device was temporarily removed. Additional hemostasis was applied to a periostal bleeder, the negative pressure therapy was resumed, and heparin-free dialysis was initiated. The third patient received warfarin treatment after aortic valve replacement. The international normalized ratio (INR) was 3.5 at the time of foam change and bleeding occurred. The foam collected the clots and the pump unit displayed an alarm indicating that the canister was full (300 mL). A new surgical revision was performed and fresh frozen plasma was administered. The vacuum-assisted closure therapy was applied without further problems.

Minor air leakage was observed in 4 patients requiring complementary draping.

One patient with septicemia developed right-sided pleural effusion with empyema, which was decorticated and separately drained during vacuum-assisted closure therapy. The diagnosis was made from a computed tomography scan during treatment owing to a rising C-reactive protein level.


    Comment
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 
During the 3-year period of this study we have used vacuum-assisted closure therapy in all patients with deep sternal wound infection. This method is now the treatment of choice at our department. However there are several technical aspects that need to be considered before applying high negative pressure to an open sternotomy wound. An important issue is how the foam interacts with underlying vital structures.

In the literature the risk of right ventricular laceration when the sternum is left open for debridement and packing is associated with high mortality rates [1]. The potential etiology of this complication still needs to be addressed; therefore special attention should be directed to the left hemisternum and the relationship to the right ventricle. Adherences below the sternal edges are released and three or four layers of Jelonet are used as a buffer, separating underlying structures from the sternal edge. The Jelonet reduces the formation of adherences between the sternum and the right heart and the paraffin content facilitates movement. This maneuver enables the force of the vacuum to be applied in the horizontal plane thereby acting on the sternotomy and not vertical to the underlying vital structures.

When the dressing is applied the sternum support harness will stabilize and release the tension from the tissue around the contracted foam. This is particularly important in patients with postoperative coughing, obesity and chronic obstructive lung disease. It will also protect the dressing and the tubing during the entire period of treatment. During treatment patients were able to mobilize on the ward and received physiotherapy. No wound care was needed on the ward except for changing of canisters in the vacuum source.

It is important to ensure efficient immobilization of the sternal bone tissue to avoid pain. Therefore it is of value to place one tube in the sternal foam layer to secure an adequate drainage at this level. Since the foam layers and the tubing are sutured to the patient the application of the drape is facilitated and the risk of accidental removal of the device is minimized. In two obese patients the foam was sucked down into the wound, which caused discomfort. We increased the size of the subcutaneous foam layer, reducing the tension on the wound margins and solving the pain problem.

The plastic draping is essential for proper functioning of the device. Air leakage must be prevented as it will dry out the wound or stop the pump. The most common site for air leakage is around the tubing and from protruding sutures. Careful application of the plastic drape around the tubes is essential. Air leakage may also be treated with additional draping but as the drape is semipermeable, multiple layers over the skin are not recommended. The subcutaneous sutures keeping the foam in place are located deeply thereby not interfering with the drape.

Postoperative bleeding may cause the pump to stop and clots will be trapped in the foam, which must then be changed immediately to identify the cause of hemorrhage. Meticulous hemostasis is mandatory especially in patients on anticoagulant medication such as warfarin or low-molecular-weight heparin. Our initial bleeding problems were treated by additional diathermy as they were superficial and related to the anticoagulant state of the patient. By keeping the INR level between 2 and 2.5 vacuum-assisted closure therapy may well be maintained without further bleeding.

We have modified the vacuum-assisted closure technique so that it can be safely applied in patients with poststernotomy mediastintis after open-heart surgery, performed through a midline incision. Our goal is the complete restoration of the thoracic cage after treatment of the infected sternotomy. By saving the bone in deep sternal wound infection the possibility for reapproximation is high. This can be achieved when the vacuum-assisted closure system is applied by the first intention to treat. Sternal sparing was possible while the periostal surface was granulating owing to the high negative pressure applied. Areas of necrosis are visible as nongranulating areas, which can be successively debrided when changing dressings. The vacuum-assisted closure system may also increase the penetration of antibiotics to sternal and mediastinal tissues, which will decrease the bacterial counts in the wound. The sternotomy wound was treated to optimal granulation and to minimal signs of systemic inflammation. Bone tissue was cultured if systemic C-reactive protein levels did not decrease to values less than 70 mg/L [16]. At this point the sternum was closed with reinforced rewiring. By releasing the right hemisternum and moving it over to the left thereby covering the sternal diastasis, interference with the right ventricle was minimized. Refixation of the sternotomy was achieved in all cases leaving a stable sternotomy without the use of muscle or omental flaps.

In this consecutive study, which represents a total of 474 days with vacuum-assisted closure, there was no 90-day mortality and no recurrence of mediastinitis. This finding supports the theory that the use of the vacuum-assisted closure technique in combination with systemic antibiotics controls the infection and is well tolerated by the postoperative cardiac patient. In other series without the use of vacuum-assisted closure recurrent infection is reported to occur in 22% to 52% of cases after debridement, sternal rewiring, and catheter irrigation [6, 20]. With debridement, sternal refixation, and muscle flap coverage the reinfection rate is reported to be 3% to 26% and the mortality rate, 2% to 11% [3]. Early mortality is largely determined by the control of sternal infection and therefore some authors advocate radical sternectomy to control infection. However despite good results some of these patients without stable sternotomies experience complications such as paradoxic chest wall movement, painful rubbing and clicking of bony edges, and the added burden of an estheticically unattractive skin paddle [21].

This study has some limitations. It is retrospective and comprises an evolving surgical technique with an evolving technology. The results are encouraging but the numbers of treated patents are still low. Nevertheless vacuum-assisted closure represents an emerging safe new alternative treatment modality for expeditious wound healing in patients with deep sternal wound infection. The surgical technique for applying and changing the system in sternotomy wounds after a variety of primary cardiac procedures described here includes the concept of a sternal and a subcutaneous foam layer, incorporation of Jelonet layers to protect and separate underlying structures from the sternal edge (Fig 1, A), and a sternum support harness throughout the vacuum-assisted closure therapy.

The unique combination of high localized negative pressure with stepwise surgical debridement and systemic antibiotics enables sternal bone sparing and the advantage of a high rate of sternal refixation in the treatment of postoperative deep sternal wound infection.


    References
 Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 

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Blood Flow Responses in the Peristernal Thoracic Wall During Vacuum-Assisted Closure Therapy
Ann. Thorac. Surg., May 1, 2005; 79(5): 1724 - 1730.
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Ann. Thorac. Surg., May 1, 2005; 79(5): 1730 - 1731.
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J. Sjogren, R. Gustafsson, A. Wackenfors, M. Malmsjo, L. Algotsson, and R. Ingemansson
Effects of vacuum-assisted closure on central hemodynamics in a sternotomy wound model
Interactive CardioVascular and Thoracic Surgery, December 1, 2004; 3(4): 666 - 671.
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