Abstract
The aim of this study was to review the feasibility of using vacuum‐assisted closure (V.A.C.®) Therapy for the management of surgical and traumatic wounds in the home care settings in the Netherlands. De‐identified patient data were collected from a health insurance database in the Netherlands. All patients with complete records, including indication, age, duration of therapy and defined treatment goal between January and November 2006 were included. Data from 338 patients were analysed. On average, wounds had been present for 2 months before start of V.A.C. Therapy. Overall, 74% of patients reached the pre‐defined therapy goal (77% for dehisced wounds, 68% for abdominal wounds, 73% for traumatic wounds and 91% for sternal wounds) with approximately 1 month of V.A.C. Therapy. There was a negative association between the wound duration prior to V.A.C. Therapy and the treatment success rate (r = −0·162, P = 0·003). Wounds with shorter duration (≤4 weeks) prior to initiation of V.A.C. Therapy achieved an 82% success rate compared with 33% for wounds present for >6 months prior to V.A.C. Therapy. V.A.C. Therapy is a feasible and effective treatment for surgical and traumatic wounds in home care patients with over 70% of patients treated in this sample achieving pre‐defined treatment goals. The success rate of V.A.C. Therapy is negatively associated with the duration of the wound before V.A.C. Therapy is commenced.
Keywords: Home care, Surgical, Trauma, V.A.C, Wounds
Introduction
Surgical and traumatic wounds are, by far, the most common types of wounds managed in the home care settings (1). While the majority of surgical and traumatic wounds heal through primary closure without complications and in a predictable timeframe, some may be problematic, because of extensive tissue loss and/or complications (2). These problem wounds may be healed by secondary intention or may require extensive management prior to healing by delayed primary intention.
Two complications that can have a major impact on healing of surgical and traumatic wounds are dehiscence and infection.
The numerous risk factors associated with wound dehiscence include obesity, age, malnutrition and smoking 3, 4, 5. Dehiscence can range from opening of the skin layers to complete dehiscence of the muscle and fascia. In the worst cases, this can result in exposure of both internal organs and incisional hernias and necessitate additional surgery.
Delayed healing increases the risk of infection. Bacterial colonisation of the sutures or staples used to assist in closure is inevitable to some extent. Consequently, the longer sutures remain in place, the higher the risk of infection (6). Infections can usually be managed through the appropriate use of antibiotics; however, surgical intervention may sometimes be required.
Complicated surgical and traumatic wounds represent a burden to patients through avoidable morbidity as well as to health services through additional treatment costs. Delayed wound healing can extend the period of hospitalisation following a surgical procedure and lead to an increased risk of complications. Estimates from the United Kingdom suggest that the development of a surgical site infection adds approximately £400 to the cost of a hospital procedure (7). Studies from the US report estimated average added costs of approximately $2000 USD (8), with some infections adding as much as tens of thousands of dollars 9, 10. When infection leads to dehiscence, additional surgical procedures may be needed and that further increases the costs of care.
Wound therapies that can reduce the incidence of delayed healing or manage it when it does occur are vital to minimising both the human and financial burden.
V.A.C.® Therapy
Vacuum‐assisted closure (V.A.C.) Therapy (KCI, San Antonio, TX) involves the controlled uniform application of continuous or intermittent negative pressure to the wound bed transferred via an open‐pore foam (reticulated polyurethane or polyvinyl alcohol). V.A.C. Therapy has been shown to stimulate wound bed preparation and healing via a number of mechanisms [reviewed by Gustafsson et al. (11)]. In short, V.A.C. Therapy actively removes exudate and the inhibitory materials therein, thereby reducing oedema and improving the wound environment. V.A.C. Therapy stabilises the wound and results in a closed wound environment, potentially reducing complications such as dehiscence and infection. V.A.C. Therapy increases local blood perfusion. Foam tissue interactions under negative pressure result in macro‐and microdeformations that stimulate granulation tissue formation and neovascularisation.
There is a significant body of evidence summarising the mechanism of action of V.A.C. Therapy and the clinical effectiveness in the treatment of various wound types, including traumatic and surgical wounds. In 2006, Stannard et al. published interim data from two randomised controlled trials (RCTs) studying the effect of V.A.C. Therapy versus pressure dressings on draining haematomas and that of V.A.C. Therapy versus standard postoperative dressings on high‐energy fractures. In the interim analysis of both study groups, V.A.C. Therapy significantly reduced drainage duration (12). An RCT by Joseph et al. studied V.A.C. Therapy in patients with chronic wounds, including traumatic and dehisced wounds. Wet‐to‐moist gauze dressings were used as control therapy. Forty‐two per cent of the patients were treated in home care. Main outcomes were decreased inflammation, increased vascularity and faster granulation tissue formation with V.A.C. Therapy (13).
Several retrospective controlled studies report greater wound size reduction (14), reduced wound bed preparation, faster healing 14, 15 and reduced complications 14, 16 when V.A.C. Therapy was used to treat traumatic wounds. Based on a case series of 75 patients, who were mainly treated on an outpatient basis, DeFranzo et al. suggested that it might be appropriate to use V.A.C. Therapy as first‐line treatment in lower extremity wounds with exposed bone because of the reduced number of required flap procedures and complications (17).
V.A.C. Therapy has also been used to treat surgical wounds. When compared with the use of closed drainage in the management of sternal wounds, V.A.C. Therapy has been shown to result in a significant reduction in hospital stays, higher survival rates, reduced intensive care unit stays, reduced rates of deep sternal wound infection following cardiac surgery, fewer therapy failures and reduced costs 18, 19, 20, 21, 22. Song et al. have shown that compared with a traditional twice‐a‐day dressing, V.A.C. Therapy reduces the number of dressing changes and requires a shorter time between initial debridement and definitive closure (23). Kaplan et al. (24) summarise the advantages and disadvantages of the dressings used to achieve temporary abdominal closure in patients with open abdomens. They report that V.A.C. Therapy is associated with 79% wall closure (compared with 12% for the control) and conclude that V.A.C. Therapy is the preferred method of managing the open abdomen.
The aim of this retrospective study was to investigate the feasibility of using V.A.C. Therapy among patients with surgical and traumatic wounds managed in a home care setting and to determine the effectiveness of V.A.C. Therapy in achieving pre‐defined treatment goals in these patients.
Methods
Patients
Patients were identified from an insurance claim database in the Netherlands. This database collects pre‐specified data from all patients treated with V.A.C. Therapy in home care settings in the Netherlands. De‐identified data from all patients with surgical or traumatic wounds treated with V.A.C. Therapy in the home care setting between January and November 2006 were suitable for inclusion. All patients with complete records, including indication, age, duration of therapy, defined treatment goal and outcome treated in the above period were included in the final study sample.
The treatment goal was selected by the health care professional who was responsible for managing the patient at the outset of their treatment with V.A.C. Therapy. Treatment goal options included palliative, cleaning of the wound, granulation tissue formation to skin level, wound closure with V.A.C. Therapy, closure via surgery, closure via transplant and combinations of these goals.
Analysis
Simple statistical approaches were used to analyse the data. Data were analysed in an aggregated fashion as well as in sub‐groups where applicable. Logistic regression analysis was undertaken to determine whether the achievement of treatment goals was dependent upon a particular factor or factors. Logistic regression analysis was chosen because of the binary nature of the outcome variable (i.e. pre‐defined treatment goal achieved or not achieved). Data analysis was conducted using SPPS® 15·0 for Windows (SPSS, Chicago, IL).
Results
The characteristics of the patients in the database are shown in Table 1, with the treatment duration and percentage that reach the therapy goal shown in Table 2. Of the 338 patients included in the study, 48% had dehisced surgical wounds, 27% had abdominal wounds, 22% had traumatic wounds and 3% had sternal wounds.
Table 1.
Patient characteristics
| Acute wounds (≤4 weeks) | Chronic wounds (>4 weeks) | All wounds | |
|---|---|---|---|
| Number of patients (%) | |||
| Dehisced surgical | 100 (61) | 63 (39) | 163 |
| Open abdominal | 54 (60) | 36 (40) | 90 |
| Traumatic | 41 (55) | 33 (45) | 74 |
| Sternal | 8 (73) | 3 (27) | 11 |
| Total | 203 (61) | 135 (39) | 338 |
| Average patient age in years (±SD) | |||
| Dehisced surgical | 56 (±19) | 57 (±18) | 57 (±18) |
| Open abdominal | 56 (±15) | 60 (±13) | 58 (±14) |
| Traumatic | 51 (±23) | 59 (±19) | 54 (±22) |
| Sternal | 64 (±8) | 77 (±7) | 68 (±9) |
| Overall | 55 (±19) | 59 (±17) | 57 (±18) |
| Average wound size in cm (±SD)* | |||
| Dehisced surgical | 54 (±68) | 79 (±160) | 64 (±113) |
| Open abdominal | 74 (±65) | 120 (±134) | 93 (±100) |
| Traumatic | 42 (±47) | 37 (±53) | 40 (±50) |
| Sternal | 50 (±56) | 36 (±16) | 47 (±48) |
| Overall | 57 (±64) | 79 (±134) | 66 (±99) |
| Mean duration of wound before V.A.C.® Therapy in days (±SD) | |||
| Dehisced surgical | 14 (±8) | 152 (±324) | 67 (±212) |
| Open abdominal | 14 (±7) | 107 (±192) | 52 (±130) |
| Traumatic | 12 (±7) | 121 (±151) | 61 (±114) |
| Sternal | 13 (±7) | 61 (±21) | 26 (±25) |
| Overall | 14 (±8) | 130 (±253) | 60 (±170) |
Actual sizes measured were maximum length and width (in cm). For the sake of comparison, these values were multiplied to be able to compare single numbers. Values presented are rounded and rounding errors may occur.
Table 2.
Treatment duration and percentage that reach the therapy goal*
| Acute wounds | Chronic wounds | All wounds | |
|---|---|---|---|
| Average V.A.C.® Therapy duration in days (±SD) | |||
| Dehisced surgical | 31 (±20) | 33(±28) | 32 (±24) |
| Open abdominal | 25 (±15) | 25 (±18) | 25 (±16) |
| Traumatic | 24 (±15) | 30 (±24) | 27 (±19) |
| Sternal | 44 (±18) | 56 (±36) | 47 (±23) |
| Overall | 29 (±18) | 31 (±25) | 29 (±21) |
| Percentage of patients that reached the therapy goal | |||
| Dehisced surgical | 85 | 65 | 77 |
| Open abdominal | 77 | 53 | 68 |
| Traumatic | 80 | 64 | 73 |
| Sternal | 88 | 100 | 91 |
| Overall | 82 | 62 | 74 |
Values presented are rounded and rounding errors may occur.
Table 1 provides baseline data for patients with acute wounds, for those with chronic wounds and for all wounds. An acute wound was defined as a wound present for 28 days or less at the time V.A.C. Therapy was initiated. The majority of patients had acute wounds (acute, 61%; chronic, 39%). Age, wound size and wound duration were the main baseline differences. Patients with chronic wounds were slightly older than those with acute wounds (not significant). Chronic wounds were larger in size and, by definition, had a much longer duration prior to initiation of V.A.C. Therapy (mean duration: acute, 14 days; chronic, 130 days).
Treatment goals were defined at the outset of V.A.C. Therapy by the clinician with responsibility for the patient. The most frequently selected combined treatment goal was ‘cleaning of the wound and granulation tissue formation’ (58%), followed by ‘granulation tissue formation to skin level’ (25%). Overall granulation tissue formation to skin level was mentioned as (part of the) treatment goal in more than 86% of the patients. ‘Complete closure with V.A.C. Therapy’ and ‘pre‐treatment with V.A.C. Therapy with subsequent closure via surgery’ were mentioned as goals in only 12% of the patients. Achievement of treatment goals was measured subjectively by the clinician.
Overall, 74% of all patients reached their pre‐defined treatment goal. This was highest in patients with sternal wounds (91%), followed by surgical dehisced wounds (77%), trauma wounds (73%) and open abdominal wounds (68%).
Wounds that were present for more than 6 months before starting V.A.C. Therapy had a success rate of only 33% compared with 82% for wounds with a duration of up to 4 weeks prior to initiation of V.A.C. Therapy.
Very few patients required treatment past 56 days and most patients reached their therapy goal between 11 and 45 days of V.A.C. Therapy (Figure 1). The mean duration of V.A.C. Therapy was 29 days. Patients with acute trauma wounds spent the shortest time on V.A.C. Therapy (mean of 24 days) and patients with chronic sternal wounds spent the longest time on V.A.C. Therapy (mean of 56 days) (Table 2).
Figure 1.
Length of V.A.C.® Therapy for patients achieving their therapy goal.
Logistic regression analysis was performed by including the following variables in the equation: wound type, age of the patient at the start of the treatment, classification of wound as chronic or acute (with cut‐off point of 28 days), the wound surface area, the duration between wound start date and the start of V.A.C. Therapy and the duration of V.A.C. Therapy in days.
The analysis showed that only the duration of the treatment in days, the classification of the wound as acute or chronic and the time duration from the wound start date until the start of V.A.C. Therapy were significant predictors of the outcome.
A second regression analysis was conducted, which omitted the non significant variables associated with achieving pre‐defined treatment goals. Wound duration prior to starting V.A.C. Therapy and duration of V.A.C. Therapy remained significant predictors of whether an individual achieved their pre‐defined treatment goal (P = 0·029 and 0·01 respectively). Acute wounds, defined as those less than 28 days old, were also significantly associated with an increased likelihood of treatment success (P = 0·02).
Discussion
This study has shown that a high proportion of patients with surgical and traumatic wounds treated in a home care setting achieved the pre‐defined therapy goals set by their clinician. Overall, granulation tissue formation to skin level was the predominant pre‐defined treatment goal in more than 86% of the patients. Complete closure via V.A.C. Therapy and/or surgery was the therapy goal for 41 (12%) patients; 26 (64%) of these patients achieved that goal. The achievement of therapy goals was found to be negatively associated with the duration of the wound prior to initiating V.A.C. Therapy.
The heterogeneous nature of these wound types and the variability in endpoints selected complicate comparison with other studies of home care patients with surgical and traumatic wounds. Therefore, while the study findings indicate that V.A.C. Therapy is a feasible intervention for this population, it is not possible to draw conclusions relating to the relative effectiveness of the therapy in comparison with other wound care therapies. The use of V.A.C. Therapy in the management of traumatic and surgical wounds in home care settings has been reported in previous studies. DeFranzo et al. described the use of V.A.C. Therapy to treat 75 patients, many of whom were treated in home care settings, with lower extremity wounds with exposed bone, tendon and/or hardware (17). Profuse granulation tissue rapidly covered bone and hardware. The wounds were closed primarily and covered with split‐thickness skin grafts, or regional flaps were rotated into the granulating bed to fill the defect. Successful coverage was obtained without complication in 71 of 75 patients.
Joseph et al. conducted an RCT studying 24 patients with 36 chronic wounds, including traumatic and surgical wounds, that were treated with either V.A.C. Therapy (18 wounds) or saline dressings that were changed three times per day (18 wounds). While the majority of these wounds were pressure ulcers, traumatic and surgical wounds were included in the sample. In this study, V.A.C. Therapy resulted in a significantly faster wound size reduction (78% versus 30% after 6 weeks of therapy, P = 0·038) (13).
A large, retrospective analysis of data from US home care patients who suffered from pressure ulcers and were treated with V.A.C. Therapy and other therapies reported significantly reduced hospitalisation rates and significantly reduced emergent care for wound problems when V.A.C. Therapy was used (25).
The findings of the retrospective analysis reported herein have a number of limitations. The data were derived from an observational health insurance database, applying broad inclusion criteria. While the uncontrolled, observational nature of the study means that the results are open to bias, the findings from this population should be more reflective of general treatment pathways than those of many clinical trials. The subjective assessment of treatment ‘success’ is a further limitation of this study. While the success criteria were defined at the outset of the study, the fact that the assessments were subjective and carried out by the treating physician means that the results are subject to some degree of bias.
The database did not contain information on the reasons for discontinuing V.A.C. Therapy in patients who did not reach the pre‐defined treatment goal. It is not known whether this was because of the lack of effectiveness or whether other reasons, such as lack of reimbursement after a specific period, were limiting factors.
While the evidence suggests that V.A.C. Therapy is a feasible intervention in surgical and traumatic wounds, there remains a need for further, more robust studies to determine the extent of the clinical and economic benefits relative to alternative treatment options. While RCTs would be the preferred method to determine the clinical efficacy of V.A.C. Therapy, the implementation of RCTs in this group of patients is often difficult. Recruitment and randomisation of patients with surgical wounds is challenging, and the heterogeneous nature of surgical and traumatic wounds means that matching of patients can also present problems. However, further research is recommended to better understand the relative effectiveness of V.A.C. Therapy in this population of patients.
Conclusions
V.A.C. Therapy is a feasible therapy for treating surgical and traumatic wounds in home care settings. The success rate of V.A.C. Therapy in achieving pre‐defined treatment objectives in surgical and traumatic wounds was in excess of 70% in the population considered in this study. Average treatment duration with V.A.C. therapy was 29 days. The achievement of therapy goals is negatively associated with the duration of the wound prior to commencing V.A.C. Therapy.
Acknowledgements
This research was supported by funding from KCI Medical. PT has received institutional funding from KCI Medical to support previous research. The remaining authors have no potential conflicts to declare.
References
- 1. Pieper B, Templin TN, Dobal M, Jacox A. Wound prevalence, types, and treatments in home care. Adv Skin Wound Care 1999;12:117–26. [PubMed] [Google Scholar]
- 2. Baxter H. Management of surgical wounds. Nurs Times 2003;99:66–8. [PubMed] [Google Scholar]
- 3. Poole GV Jr. Mechanical factors in abdominal wound closure: the prevention of fascial dehiscence. Surgery 1985;97:631–40. [PubMed] [Google Scholar]
- 4. Sorensen LT, Hemmingsen U, Kallehave F, Wille‐Jorgensen P, Kjaergaard J, Moller LN, Jorgensen T. Risk factors for tissue and wound complications in gastrointestinal surgery. Ann Surg 2005;241:654–58. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5. Armstrong M. Obesity as an intrinsic factor affecting wound healing. J Wound Care 1998;7:220–21. [DOI] [PubMed] [Google Scholar]
- 6. Reilly J. Evidence‐based surgical wound care on surgical wound infection. Br J Nurs 2002;11(16 Suppl):S4, S6, S8, S10, S12. [DOI] [PubMed] [Google Scholar]
- 7. National Institute for Health and Clinical Excellence . Draft scope: surgical wounds – prevention and treatment of surgical site infection [WWW document]. URL http://www.nice.org.uk. 2004. [accessed on 26 February 2007].
- 8. Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical‐site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol 1999;20:725–30. [DOI] [PubMed] [Google Scholar]
- 9. Nettleman M. Cost and cost benefit of infection control. In: Wenzel RP, editor. Prevention and control of nosocomial infections. Baltimore: Lippincott Williams & Wilkins, 2003:33–41. [Google Scholar]
- 10. Chu VH, Crosslin DR, Friedman JY, Reed SD, Cabell CH, Griffiths RI, Masselink LE, Kaye KS, Corey GR, Reller LB, Stryjewski ME, Schulman KA, and Fowler VG, Jr . Staphylococcus aureus bacteremia in patients with prosthetic devices: costs and outcomes. Am J Med 2005;118:1416. [DOI] [PubMed] [Google Scholar]
- 11. Gustafsson R. Understanding topical negative pressure therapy. European Wound Management Association (EWMA). Position Document: Topical negative pressure in wound management. London: MEP Ltd, 2007. http://www.ewma.org/pdf/may07/EWMA%20Eng%2007%20final.pdf (accessed 26 February 2007). [Google Scholar]
- 12. Stannard JP, Robinson JT, Anderson ER, McGwin G Jr, Volgas DA, Alonso JE. Negative pressure wound therapy to treat hematomas and surgical incisions following high‐energy trauma. J Trauma 2006;60:1301–06. [DOI] [PubMed] [Google Scholar]
- 13. Joseph E, Hamori C, Bergman S, Roaf E, Swann NF, Anastasi GW. A prospective randomized trial of vacuum assisted closure versus standard therapy of chronic nonhealing wounds. Wounds 2000;12:60–7. [Google Scholar]
- 14. Page JC, Newswander B, Schwenke DC, Hansen M, Ferguson J. Negative pressure wound therapy in open foot wounds with significant soft tissue defects. Ostomy Wound Manage 2005;51(2A Suppl):9–14S. [PubMed] [Google Scholar]
- 15. Yang CC, Chang DS, Webb LX. Vacuum‐assisted closure for fasciotomy wounds following compartment syndrome of the leg. J Surg Orthop Adv 2006;15:19–23. [PubMed] [Google Scholar]
- 16. Labler L, Keel M, Trentz O. Vacuum assisted closure for temporary coverage of soft tissue injury in Type III open fracture of lower extremities. Eur J Trauma 2004;30:305–12. [Google Scholar]
- 17. DeFranzo AJ, Argenta LC, Marks MW, Molnar JA, David LR, Webb LX, Ward WG, Teasdall RG. The use of vacuum‐assisted closure therapy for the treatment of lower‐extremity wounds with exposed bone. Plast Reconstr Surg 2001;108:1184–91. [DOI] [PubMed] [Google Scholar]
- 18. Catarino PA, Chamberlain MH, Wright NC, Black E, Campbell K, Robson D, Pillai RG. High‐pressure suction drainage via a polyurethane foam in the management of poststernotomy mediastinitis. Ann Thorac Surg 2000;70:1891–5. [DOI] [PubMed] [Google Scholar]
- 19. 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. [DOI] [PubMed] [Google Scholar]
- 20. Fleck TM, Fleck M, Moidl R, Czerny M, Koller R, Giovanoli P, Hiesmayer MJ, Zimpfer D, Wolner E, Grabenwoger M. The vacuum‐assisted closure system for the treatment of deep sternal wound infections after cardiac surgery. Ann Thorac Surg 2002;74:1596–1600. [DOI] [PubMed] [Google Scholar]
- 21. Sjogren J, Nilsson J, Gustafsson R, Malmsjo M, Ingemansson R. The impact of vacuum‐assisted closure on long‐term survival after post‐sternotomy mediastinitis. Ann Thorac Surg 2005;80:1270–5. [DOI] [PubMed] [Google Scholar]
- 22. Sjogren J, Gustafsson R, Nilsson J, Malmsjo M, Ingemansson R. Clinical outcome after poststernotomy mediastinitis: vacuum‐assisted closure versus conventional treatment. Ann Thorac Surg 2005;79:2049–55. [DOI] [PubMed] [Google Scholar]
- 23. 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. [DOI] [PubMed] [Google Scholar]
- 24. Kaplan M, Banwell P, Orgill D, Ivatury R, Demetriades D, Moore F, et al. Guidelines for the management of the open abdomen. Recommendation from a multidisciplinary expert advisory panel. Ostomy Wound Manage 2005. (Supplement to Wounds: A Compendium of Clinical Research and Practice). [Google Scholar]
- 25. Schwien T, Gilbert J, Lang C. Pressure ulcer prevalence and the role of negative pressure wound therapy in home health quality outcomes. Ostomy Wound Manage 2005;51:47–60. [PubMed] [Google Scholar]