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Three Part Question

Should [vacuum-assisted closure therapy] be routinely used for management of [deep sternal wound infection] after [cardiac surgery]?

Clinical Scenario

You are asked to see a patient with deep sternal wound infection following coronary artery bypass surgery. You feel that a wound debridement with closure will probably be the best approach. However, your consultant wants this patient's wound to be managed with vacuum-assisted closure (VAC) therapy. You manage the patient as desired by the consultant but decide to review the literature to see if there is any evidence to back up this strategy.

Search Strategy

Medline 1966 to November 2006 using OVID interface, EMBASE 1980 to 2006 Week 52.
[exp Vacuum-assisted closure therapy OR VAC.mp./] AND [exp Deep sternal wound infection OR Postoperative wound infection OR mediastinitis OR poststernotomy mediastinitis/] AND [exp Cardiopulmonary Bypass OR CABG.mp. OR exp Thoracic Surgery OR exp Cardiac surgical procedures OR Coronary art$ bypass.mp. OR Cardiopulmonary bypass.mp. OR exp Cardiovascular Surgical Procedures/OR exp Thoracic Surgical Procedures/OR exp Coronary Artery Bypass/OR cardiac transplantation.mp. OR exp Heart Transplantation/].

Search Outcome

A total of 198 papers were identified using the reported search. A further three relevant papers was identified by hand searching reference lists. Thirteen papers represented the best evidence on the subject and are summarised

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Cowan et al, 2005, Canada	22 patients treated with VAC for post-cardiac surgery wound complications	Retrospective cohort (Level 3b)	Morbidity & mortality	Vacuum-assisted closure induced granulation of 71% of the sternal wound area by 7 days, with a daily drainage of approximately 84 mL. By 14 days, there was a 54% reduction in wound size, and patients were discharged after approximately 19.5 days and placed on home therapy. Vacuum-assisted closure was discontinued at approximately 36.7 days with an average reduction in sternal wound size of 80%. Extensive secondary surgical closure, requiring muscle flaps, was avoided in 64% of patients, whereas 28% of patients required no surgical reconstruction for wound closure. No complications were related to VAC use.	Small sample size. No control group. Retrospective chart review.
Agarwal et al., 2005, USA	103 patients treated with VAC for post-cardiac surgery wound complications	Retrospective cohort (Level 3b)	Morbidity and mortality	VAC was utilized for an average period of 11 days per patient. 68% of the patients (70 of 103) had definitive chest closure with open reduction internal fixation and/or flap closure. The remaining 32 percent had no definitive closure method. The overall mortality rate was 28 percent (29 of 103 patients), although no deaths were directly related to use of the therapy, and only four deaths resulted from sepsis as a consequence of mediastinitis.	Largest series to date. Sixty-four percent of the patients had a diagnosis of mediastinitis; 36 percent had either superficial infections or a sterile wound. No control group. Retrospective review.
Sjogren et al 1, 2005, Sweden	46 patients treated with VAC for post-cardiac surgery mediastinitis and 4,781 patients who underwent isolated CABG without mediastinitis	Case-control study (Level 3b)	Long-term survival	There was no difference in early or late survival between the mediastinitis group treated with vacuum-assisted closure and the control group (p = not significant). The survival at 1, 3, and 5 years was 92.9% +/- 4.0%, 89.2% +/- 5.2%, and 89.2% +/- 5.2%, respectively, in the vacuum-assisted closure group; and 96.5% +/- 0.3%, 92.1% +/- 0.5%, and 86.9% +/- 0.8%, respectively, in the control group.	Small sample size. Retrospective analysis
Sjogren et al 2, 2005, Sweden	61 patients treated with VAC for post-cardiac surgery mediastinitis and 40 patients treated with conventional treatment for post-cardiac surgery mediastinitis	Cohort study (Level 3b)	Morbidity, mortality & survival	The 90-days mortality was 0% in the vacuum-assisted closure group and 15% in the conventional treatment group (p < 0.01). The failure rate to first-line treatment with vacuum-assisted closure and conventional treatment were 0% and 37.5%, respectively (p < 0.001). There was no statistically significant difference in the recurrence of sternal fistulas after vacuum-assisted closure therapy or conventional treatment: 6.6% versus 5.0%, respectively. Overall survival in the vacuum-assisted closure group was significantly better (p < 0.05) than in the conventional treatment group: 97% versus 84% (6 months), 93% versus 82% (1 year), and 83% versus 59% (5 years).	The cohorts were from different time periods. Nonrandomized retrospective analysis.
Scholl et al, 2004, USA	13 patients treated with VAC for post-cardiac surgery wound complications	Retrospective case series (Level 4)	Morbidity & mortality	Of the 13 patients, the VAC device was used prior to flap closure in six patients, and after flap closure in two patients. Sternal debridement with bilateral pectoralis muscle flaps was used to reconstruct 12 patients, and one patient underwent debridement only with VAC placement. All 13 patients (100%) had complete closure of their complex wounds at an average of follow-up of 14 months.	Small sample size. Retrospective case series.
Gustafsson et al, 2003, Sweden	40 patients treated with VAC for post-cardiac surgery deep sternal wound infection	Retrospective cohort study (Level 3b)	Morbidity & mortality	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.	Retrospective series
Domkowski et al, 2003, USA	102 patients treated with VAC for post-cardiac surgery wound complications. Ninety-six of the 102 patients received vacuum-assisted therapy while the remaining 6 underwent daily multiple dressing changes without vacuum-assisted therapy.	Retrospective cohort study (Level 3b)	Mortality and morbidity	Fifty-three of the 96 patients required only sternal debridement, followed by wound vacuum therapy and closure by secondary intention, while the remaining 43 had an additional procedure. Of these, 33 patients underwent omental transposition and 10 patients had a pectoralis flap. The length of stay for all patients was 27 +/- 12 days. This was related in part to intravenous antibiotics. Hospital mortality for all patients was 3.7% (4 patients).	Large case series. Retrospective analysis.
Luckraz et al, 2003, UK	27 patients treated with VAC for post-cardiac surgery wound complications. Group A (n = 14) had vacuum-assisted closure as the final treatment modality, whereas in group B (n = 13) vacuum-assisted closure was followed by either a myocutaneous flap (n = 8) or primary (n = 5) wound closure.	Small cohort study (Level 3b)	Morbidity & mortality	In group A, 4 patients died and a satisfactorily healed scar was achieved in 64% of cases. Median durations of vacuum-assisted closure and hospital stay in group A were 13.5 days (interquartile range 8.8-32.2 days) and 20 days (interquartile range 16.7-25.2 days), respectively. Mortality was 7.7% in group B, with a treatment failure rate of 15%. Median duration of vacuum-assisted closure in group B was 8 days (interquartile range 5.5-18 days), and median hospital stay was 29 days (interquartile range 25.8-38.2 days). During the year before institution of vacuum-assisted closure, poststernotomy infection (n = 13) was managed with rewiring and closed irrigation system. Treatment during this year failed in 30.7% of cases (n = 4/13), and mortality was also 30.7%. The total cost (hospitalization and treatment) per patient for vacuum-assisted closure was 16,400 dollars, compared with 20,000 dollars for the closed irrigation system treatment.	Retrospective analysis. Small sample size.
Song et al, 2003, UK	17 patients treated with VAC alone for post-cardiac surgery wound complications & 18 patients treated with traditional twice-a-day dressing changes	Small cohort study (Level 3b)	Comparison of number of days between initial debridement and closure, number of dressing changes, number and types of flaps needed for reconstruction, and complications	The V.A.C. therapy group had a trend toward a shorter interval between debridement and closure, with a mean of 6.2 days, whereas the dressing change group had mean of 8.5 days. The V.A.C. therapy group had a significantly lower number of dressing changes, with a mean of three, whereas the twice-a-day dressing change group had a mean of 17 (p < 0.05). Reconstruction required an average of 1.5 soft-tissue flaps per patient treated with traditional dressing changes versus 0.9 soft-tissue flaps per patient for those treated with V.A.C. therapy (p < 0.05). Before closure, there was one death among patients undergoing dressing changes and three in the V.A.C. therapy group, all of which were unrelated to the management of the sternal wound. Patients with sternal wounds who have benefited from V.A.C. therapy alone had a significant decrease in the number of dressing changes and number of soft-tissue flaps needed for closure. The V.A.C. therapy group had a trend towards a decreased number of days between debridement and closure.	Small sample size. Retrospective analysis.
Doss et al, 2002, Germany	22 patients treated with VAC alone for post-sternotomy osteomyelitis & 22 patients treated by conventional wound management	Small cohort study (Level 3b)	Morbidity & mortality	The patients treated by VASD had a significantly reduced treatment duration (mean 17.2+/-5.8 vs. 22.9+/-10.8 days, P=0.009) and total hospital stay (mean 27.2+/-6.5 vs. 33.0+/-11.0 days, P=0.03). Perioperative mortality was similar, with one early death in each group.	Small sample size. Retrospective analysis.
Gustafsson et al, 2002, Sweden	16 patients treated with VAC for post-sternotomy deep sternal wound infection followed by direct surgical closure	Small cohort study (Level 3b)	Morbidity & mortality	All patients were alive and free from deep sternal wound infection 3 months after the operation. The median vacuum-assisted closure treatment time until surgical closure was 9 days (range, 3-34 days), and the median C-reactive protein level at closure was 45 mg/L (range, 20-173 mg/L). The median hospital stay was 22 days (range, 12-120 days).	Small sample size. Retrospective case series.
Hersh et al, 2001, USA	16 patients treated with VAC for post-sternotomy deep sternal wound infection after initial wound debridement	Small cohort study (Level 3b)	Mortality and morbidity	Fifteen of the 16 patients survived and went on to complete wound healing and discharge from the hospital (average length of stay, 16.7 days). One patient sustained a cardiac dysrhythmia during the muscle flap procedure and died. There were no complications related directly to the use of the V.A.C.	Small sample size. Retrospective case series.

Comment(s)

Poststernotomy mediastinitis, also commonly called deep sternal wound infection, is one of the most feared complications in patients undergoing cardiac surgery. The overall incidence of poststernotomy mediastinitis is relatively low, between 1% and 3%, however, this complication is associated with a significant mortality, usually reported to vary between 10% and 25% [Sjogren, 2006]. The Lund University Hospital group have published several series suggesting that vacuum-assisted closure therapy is a safe and reliable option in poststernotomy mediastinitis with excellent short as well as long-term survival and a very low failure rate compared with conventional treatment [Sjogren, 2005]. According to this group reconstruction of the sternum can be achieved in all patients without the use of muscle or omental flap surgery [Gustafsson, 2002, 2003]. Agarwal et al reported similar success rates for VAC as the first-line therapy in the management of sternal wounds. This is the largest retrospective series to date reporting VAC use in 103 patients. An earlier series by the same group [Song, 2003] also showed that VAC therapy alone leads to a significant decrease in the number of dressing changes and number of soft-tissue flaps needed for closure. In addition, patients treated with VAC therapy had a trend towards a decreased number of days between debridement and closure. Domkowski et al in their retrospective analysis of 102 patients also found VAC as an effective therapy for mediastinitis following debridement or before placement of a vascularized tissue flap. Similar conclusion was drawn by Cowan et. al, Scholl et al and Hersch et al. Five studies specifically comparing VAC therapy with conventional therapy have shown that freedom from mediastinal microbiological cultures was achieved earlier, C-reactive protein levels declined more rapidly, in-hospital stay was shorter, rewiring was earlier, and survival tended to be higher in the VAC group compared to the conventional group [ Sjogren 2005, Fuchs, Luckraz, Song, Doss]. Currently the evidence to endorse routine use for management of deep sternal wound infection after cardiac surgery is weak. A randomised controlled trial comparing VAC therapy with the conventional treatment involving surgical revision, closed irrigation, or reconstruction with omentum or pectoral muscle flaps is mandatory to validate its safety, efficacy, and cost effectiveness as a routine first-line therapy for management of deep sternal wound infection after cardiac surgery

Clinical Bottom Line

VAC is an effective and safe adjunctive strategy to manage post cardiac surgery deep sternal wound infection. It is especially useful for managing sternal osteomyelitis in high-risk patients and is an attractive option as a first-line therapy in this group of patients.

References

1. Sjogren J, Malmsjo M, Gustafsson R, Ingemansson R. Poststernotomy mediastinitis: a review of conventional surgical treatments, vacuum-assisted closure therapy and presentation of the Lund University Hospital mediastinitis algorithm. Eur J Cardiothorac Surg. 2006 Dec;30(6):898-905.
2. Cowan KN, Teague L, Sue SC, Mahoney JL. Vacuum-assisted wound closure of deep sternal infections in high-risk patients after cardiac surgery. Ann Thorac Surg 2005;80:2205-12.
3. Agarwal JP, Ogilvie M, Wu LC, Lohman RF, Gottlieb LJ, Franczyk M, Song DH. Vacuum-assisted closure for sternal wounds: a first-line therapeutic management approach. Plast Reconstr Surg 2005;116:1035-40.
4. Sjogren J, Nilsson J, Gustafsson R, Malmsjo M, Ingemansson R. (1) The impact of vacuum-assisted closure on long-term survival after post-sternotomy mediastinitis. Ann Thorac Surg 2005;80:1270-5.
5. Sjogren J, Gustafsson R, Nilsson J, Malmsjo M, Ingemansson R. (2). Clinical outcome after poststernotomy mediastinitis: vacuum-assisted closure versus conventional treatment. Ann Thorac Surg 2005;79:2049-55.
6. Fuchs U, Zittermann A, Stuettgen B, Groening A, Minami K, Koerfer R. Clinical outcome of patients with deep sternal wound infection managed by vacuum-assisted closure compared to conventional therapy with open packing: a retrospective analysis. Ann Thorac Surg 2005;79:526-31.
7. Scholl L, Chang E, Reitz B, Chang J. Sternal osteomyelitis: use of vacuum-assisted closure device as an adjunct to definitive closure with sternectomy and muscle flap reconstruction. J Card Surg 2004;19:453-61.
8. Gustafsson RI, Sjogren J, Ingemansson R. Deep sternal wound infection: a sternal-sparing technique with vacuum-assisted closure therapy. Ann Thorac Surg 2003;76:2048-53.
9. Domkowski PW, Smith ML, Gonyon DL Jr, Drye C, Wooten MK, Levin LS, Wolfe WG. Evaluation of vacuum-assisted closure in the treatment of poststernotomy mediastinitis. J Thorac Cardiovasc Surg. 2003;126:386-90.
10. Luckraz H, Murphy F, Bryant S, Charman SC, Ritchie AJ. Vacuum-assisted closure as a treatment modality for infections after cardiac surgery. J Thorac Cardiovasc Surg. 2003;125:301-5.
11. Song DH, Wu LC, Lohman RF, Gottlieb LJ, Franczyk M. Vacuum assisted closure for the treatment of sternal wounds: the bridge between debridement and definitive closure. Plast Reconstr Surg 2003;111:92-7.
12. Doss M, Martens S, Wood JP, Wolff JD, Baier C, Moritz A. Vacuum-assisted suction drainage versus conventional treatment in the management of poststernotomy osteomyelitis. Eur J Cardiothorac Surg 2002;22:934-8.
13. Gustafsson R, Johnsson P, Algotsson L, Blomquist S, Ingemansson R. 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.
14. Hersh RE, Jack JM, Dahman MI, Morgan RF, Drake DB. The vacuum-assisted closure device as a bridge to sternal wound closure. Ann Plast Surg 2001;46:250-4.