From the Society for Vascular Surgery
Cost analysis of negative-pressure wound therapy with instillation for wound bed preparation preceding split-thickness skin grafts for massive (>100 cm2) chronic venous leg ulcers C. Kevin Yang, MD, Sean Alcantara, MD, Selena Goss, MD, and John C. Lantis II, MD, New York, NY Objective: Massive ($100 cm2) venous leg ulcers (VLUs) demonstrate very low closure rates with standard compression therapy and are costly to manage. Negative-pressure wound therapy (NPWT), followed by a split-thickness skin graft (STSG), can be a cost-effective alternative to this standard care. We performed a cost analysis of these two treatments. Methods: A retrospective review was performed of 10 ulcers treated with surgical debridement, 7 days of inpatient NPWT with topical antiseptic instillation (NPWTi), and STSG, with 4 additional days of inpatient NPWT bolster over the graft. Independent medical cost estimators were used to compare the cost of this treatment protocol with standard outpatient compression therapy. Results: The average length of time ulcers were present before patients entered the study was 38 months (range, 3-120 months). Eight of 10 patients had complete VLU closure by 6 months after NPWTi with STSG. The 6-month costs of the proposed treatment protocol and standard twice-weekly compression therapy were estimated to be $27,000 and $28,000, respectively. Conclusions: NPWTi with STSG treatment is more effective for closure of massive VLUs at 6 months than that reported for standard compression therapy. Further, the cost of the proposed treatment protocol is comparable with standard compression therapy. (J Vasc Surg 2015;61:995-9.)
Although much is written about chronic venous disease in the literature, very little is reported about venous leg ulcerations (VLUs) that measure >40 cm2, let alone massive VLUs of $100 cm2. Of the estimated 1% of the United States population with this chronic, disabling condition, w25% will have active open ulcerations.1-3 Such ulcerations, particularly large ones, are difficult to heal, taking months to obtain closure and, while open, severely affect the patient’s quality of life. The economic burden of the disease is significant. In the United Sates, direct costs are estimated at $1 billion annually.1 The direct costs of VLU treatment include medical and nursing staff, diagnostic imaging, hospitalization, medications, dressings, and interventional procedures. Indirect costs related to lost productivity are more difficult to measure but contribute significantly.
From the Mount Sinai St. Luke’s Hospital and Mount Sinai Roosevelt Hospital. Author conflict of interest: J.C.L. is a paid consultant for KCI (San Antonio, Tex). Presented as a poster at the 2014 Vascular Annual Meeting of the Society for Vascular Surgery, Boston, Mass; June 4-7, 2014. Reprint requests: John C. Lantis II, MD, Mount Sinai St. Luke’s Hospital and Mount Sinai Roosevelt Hospital, 1090 Amsterdam Ave, Ste 7A, New York, NY 10025 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2015 by the Society for Vascular Surgery. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jvs.2014.11.076
Compression therapy remains the current standard care from an efficacy and cost standpoint.4 However, massive VLUs are particularly challenging. They have very poor closure rates: one study showed only 50% of VLUs >20 cm2 closed after 21 weeks of multilayer compression therapy.5 Thus, because the cost of VLU treatment is directly related to time to achieve closure, massive VLUs are expensive, requiring more frequent dressing changes, office visits, and adjunctive therapy. Further, the tools used to close these ulcers are varied and poorly studied. The application of a split-thickness skin graft (STSG) is an option for achieving closure of a massive VLU. Although the body of literature is small, a few studies have shown STSGs for VLUs are superior to standard compression therapy in the rate of ulcer healing and pain reduction.6,7 Associated benefits include earlier time to mobilization, decreased outpatient visits, and reduced need for dressings. Potentially, this directly translates into health care dollar savings. Because VLU beds are characterized by chronic inflammation, tissue edema, decreased oxygen content, and bacterial colonization, there is concern regarding the viability of STSGs when placed directly into such wounds.8-10 Negative-pressure wound therapy (NPWT) with topical wound solution instillation (NPWTi) has shown promise as an adjunct to wound preparation before a STSG.11 In vitro work using a porcine model demonstrated increased granulation tissue, improved tissue oxygenation, and clearance of wound debris with the use of NPWTi.12,13 Furthermore, NPWT after STSG improved graft take through imbibitions and neovascularization by reducing shear forces and fluid collection.14 995
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Table I. Current Procedural Terminologya (CPT) codes used Code 11042 15100 29581 97606 99213
Description Debridement, skin and subcutaneous tissue STSG Multilayer compression therapy NPWT Office visit
NPWT, Negative-pressure wound therapy; STSG, split-thickness skin graft. a American Medical Association, Chicago, Ill.
In this study, the direct cost of treating massive VLUs $100 cm2 using an inpatient NPWTi and STSG protocol was compared with standard outpatient compression therapy over a 6-month period. METHODS An Institutional Review Board-approved retrospective review was conducted at a single institution. The need for informed consent was waived because of the retrospective nature of the study. Patient demographics and VLU characteristics were obtained from medical records. Patients were excluded if the VLU size was 20 cm2 demonstrate poor closure rates of only 50% at 21 weeks, massive VLUs are not likely to close with standard compression therapy alone in a reasonable time frame.5 However, by using STSG early in the treatment protocol, we demonstrated a considerable increase in ulcer-free days. The take rates for STSGs in VLUs are notoriously poor.21 This has been attributed to a hostile wound bed that has a large bacterial burden, poor perfusion, and increased edema and exudation. Our approach to this problem has been short-term NPWTi with a topical wound
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Table II. Wound characteristics and percentage of split-thickness skin graft (STSG) take Wound 1 2 3 4 5 6 7 8 9 10 Mean (SD)
Patient gender
Patient age, years
Wound size, cm2
Wound age, months
Hospital length of stay,days
STSG take at 30 days, %
STSG take at 180 days, %
Male Male Male Female Male Male Female Female Male Male
54 54 55 63 46 74 54 54 67 67 59.8 (8.5)
150 150 294 300 400 252 112 204 320 325 251 (94)
60 55 21 120 36 3 4 4 36 36 38 (36)
14 14 11 11 12 14 10 10 19 19 13.4 (3.3)
95 95 80 90 70 95 90 90 100 100 91 (9)
100 100 100 80 70 100 100 100 100 100 95 (11)
SD, Standard deviation.
Table III. Cost breakdown per wound over 6 months Description Operating room debridement STSG NPWT Hospital stay Office visit Multilayer compression therapy Additional wound dressing material Total
Compression, $
9552 16,800 1440 27,792
NPWTi and STSG, $ 519 4144 398 20,966 995 130 27,152
NPWT, Negative-pressure wound therapy; NPWTi, negative-pressure would therapy with instillation; STSG, split-thickness skin graft.
Fig. Progression of a venous leg ulcer (VLU) treated with negative-pressure wound therapy (NPWT) with instillation (NWPTi) and a split-thickness skin graft (STSG). A, Infected VLU before debridement. B, VLU after debridement and 7 days of NPWTi with Dakin solution before STSG. C, VLU at 30 days after STSG: complete take is seen.
solution before STSG.11 This single delivery system provides a bactericidal agent along with NPWT, which has been demonstrated to optimize blood flow and decrease local tissue edema.13,22 Admittedly, the literature regarding the optimal topical wound solution is lacking. The use of quarter-strength Dakin solution engenders some controversy.23 In vitro and in vivo data regarding use of Dakin solution in chronic wounds has revealed a narrow therapeutic window, exhibiting the fine balance between bactericidal effect and cytotoxicity.24,25 In light of this, short-term use for wound bed sterilization in conjunction with
negative pressure for wound bed preparation appears to be beneficial in our cohort. The direct cost of the two VLU treatment modalities is comparable. Clearly, the major cost in our cohort of patients is attributed to inpatient hospitalization. Because we practice in the highest cost region in the country, we chose to use a nationally adjudicated cost generator instead of a real charge capture technique. In addition, we used a nationalized cost calculator for NPWTi to eliminate preferential pricing. Further cost reduction in NPWTi and STSG treatment may be achieved in several areas. Our experience has been that NPWTi is best conducted in the inpatient setting because any problems with the device can be immediately addressed by the hospital staff. There may be a role for outpatient NPWTi before STSG by using visiting nurse services. Advantages of such a scenario include significantly reduced costs and avoiding complications associated with prolonged hospitalization such as deep vein thrombosis and nosocomial infections. However, at present, NPWTi remains beyond the scope of most home and nursing home care givers. It should be noted that we did not observe any of these proposed inpatient complications in our cohort of patients. All patients in this study received low-molecular-weight heparin prophylaxis. The optimal NPWTi time to adequate wound bed preparation is not known. Reducing NPWTi time, and
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therefore hospitalization, would clearly have an effect on overall cost. In a previous study with NPWTi, we found that 10 days was an adequate period before STSG in sterilization of wounds.11 We have since been able to reduce that preparation time to 7 days. However, further reductions in wound bed preparation time using current NPWTi methods have been suboptimal. Alternative adjuncts to surgical wound debridement, followed by immediate STSG, have been reported. Vanwijck et al26 described the use of hydrosurgery with the VersaJet (Smith & Nephew), followed by immediate STSG. They noted that the only graft failures in their cohort of 155 patients were in patients with chronic venous ulcers. Another study demonstrated only a 50% decrease in bacterial burden after hydrosurgery debridement.27 Thus far, NPWTi appears to be superior to hydrosurgery for adequate wound bed preparation. Other surgical algorithms for large recalcitrant VLUs exist. One approach with a high ulcer healing rate is free tissue transfer with perforating vein ablation.28 This technique is particularly useful when ulcerations involve exposed bone, tendon, or joints, a situation where STSGs would likely fail to take. Hospital costs of free tissue transfer, excluding major complications, are comparable with standard compression therapy.29 This study has several limitations. A matched comparison group with standard compression therapy was not part of the study design. Patients with massive VLUs often have accompanying symptoms of drainage, surrounding dermatitis, and secondary wound infections that require adjuvants to standard compression such as absorptive foams and topical corticosteroids, debriding agents (eg, collagenase), and antimicrobial agents (eg, iodine-based gels). There is high variability in which particular adjuvant or combination adjuvant treatment patients receive; therefore, a matched group with solely standard compression is not possible. In addition, a prospective two-arm study is needed to objectively demonstrate actual rates of ulcer-free days and associated costs in these massive VLUs. Until hospital charge data are completely transparent, it will be difficult to very accurately quantify these costs. Although we acknowledge that using cost estimators leads to an overestimation of true cost, applying costs to all components of the study allows for gross comparison. Further, it can be argued that instillation may be an unnecessary adjunct to wound bed preparation. This would necessitate comparative studies of the available topical wound solutions with NPWT without instillation. We have adopted this treatment algorithm at our institution in a stepwise fashion. Historically, our experience with STSG alone for large VLUs has been poor. With the advent of the NPWT bolster for STSG, significant gains were made in overall STSG take, as demonstrated by Llanos et al.30 Nevertheless, we found that simple debridement and washout of VLU before STSG was inadequate wound bed preparation. We subsequently applied our experience with Dakin NPWTi for treatment of chronically
infected diabetic and venous ulcers to wound bed preparation, with promising results as described here. CONCLUSIONS The result of NPWTi with STSG treatment for closure of large complex VLUs is promising. The direct cost of this treatment method is comparable with standard compression therapy over a 6-month period. If additional indirect VLU costs, such as lost productivity, are factored and treatment time frame extended, NPWTi with STSG for massive VLU is clearly the more economical approach. AUTHOR CONTRIBUTIONS Conception and design: SA, JL Analysis and interpretation: KY, SA Data collection: SA, SG Writing the article: KY, SA Critical revision of the article: KY Final approval of the article: JL Statistical analysis: JL Obtained funding: SA, JL Overall responsibility: JL REFERENCES 1. de Araujo T, Valencia I, Federman DG, Kirsner RS. Managing the patient with venous ulcers. Ann Intern Med 2003;138:326-34. 2. Fowkes FG, Evans CJ, Lee AJ. Prevalence and risk factors of chronic venous insufficiency. Angiology 2001;52(Suppl 1):S5-15. 3. Shai A, Halevy S. Direct triggers for ulceration in patients with venous insufficiency. Int J Dermatol 2005;44:1006-9. 4. O’Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. Cochrane Database Syst Rev 2012;11: CD000265. 5. Marston WA, Carlin RE, Passman MA, Farber MA, Keagy BA. Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency. J Vasc Surg 1999;30:491-8. 6. Jankunas V, Bagdonas R, Samsanavicius D, Rimdeika R. The influence of surgical treatment for chronic leg ulcers on the quality dynamics of the patient’s life. Acta Chir Belg 2007;107:386-96. 7. Salome GM, de Almeida SA, Ferreira LM. Evaluation of pain in patients with venous ulcers after skin grafting. J Tissue Viability 2014;23: 115-20. 8. Smith PC. The causes of skin damage and leg ulceration in chronic venous disease. Int J Low Extrem Wounds 2006;5:160-8. 9. McDaniel JC, Roy S, Wilgus TA. Neutrophil activity in chronic venous leg ulcersda target for therapy? Wound Respair Regen 2013;21: 339-51. 10. Pascarella L, Schonbein GW, Bergan JJ. Microcirculation and venous ulcers: a review. Ann Vasc Surg 2005;19:921-7. 11. Raad W, Lantis JC 2nd, Tyrie L, Gendics C, Todd G. Vacuumassisted closure instill as a method of sterilizing massive venous stasis wounds prior to split thickness skin graft placement. Int Wound J 2010;7:81-5. 12. Rycerz AM, Allen D, Lessing MC. Science supporting negative pressure wound therapy with instillation. Int Wound J 2013;10(Suppl 1): 20-4. 13. Vuerstaek JD, Vainas T, Wuite J, Nelemans P, Neumann MH, Veraart JC. State-of-the-art treatment of chronic leg ulcers: a randomized controlled trial comparing vacuum-assisted closure (V.A.C.) with modern wound dressings. J Vasc Surg 2006;44:1029-37; discussion: 1038. 14. Azzopardi EA, Boyce DE, Dickson WA, Azzopardi E, Laing JH, Whitaker IS, et al. Application of topical negative pressure
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15. 16.
17.
18.
19. 20. 21. 22.
23.
(vacuum-assisted closure) to split-thickness skin grafts: a structured evidence-based review. Ann Plast Surg 2013;70:23-9. FAIR Health Consumer Cost Lookup. Available at: http://www. fairhealthconsumer.org. Accessed June 20, 2014. Jaimie O. Average cost per inpatient day across 50 states in 2010. Becker’s Hospital Review. Available at: http://www.beckershospital review.com/lists/average-cost-per-inpatient-day-across-50-states-in2010.html. Accessed June 10, 2014. Pappas PJ, You R, Rameshwar P, Gorti R, DeFouw DO, Phillips CK, et al. Dermal tissue fibrosis in patients with chronic venous insufficiency is associated with increased transforming growth factor-beta1 gene expression and protein production. J Vasc Surg 1999;30:1129-45. Thomas PR, Nash GB, Dormandy JA. White cell accumulation in dependent legs of patients with venous hypertension: a possible mechanism for trophic changes in the skin. Br Med J (Clin Res Ed) 1988;296:1693-5. Raffetto JD. Inflammation in chronic venous ulcers. Phlebology 2013;28(Suppl 1):61-7. Margolis DJ, Berlin JA, Strom BL. Which venous leg ulcers will heal with limb compression bandages? Am J Med 2000;109:15-9. Jones JE, Nelson EA, Al-Hity A. Skin grafting for venous leg ulcers. Cochrane Database Syst Rev 2013;(1):CD001737. Gabriel A, Shores J, Heinrich C, Baqai W, Kalina S, Sogioka N, et al. Negative pressure wound therapy with instillation: a pilot study describing a new method for treating infected wounds. Int Wound J 2008;5:399-413. Levine JM. Dakin’s solution: past, present, and future. Adv Skin Wound Care 2013;26:410-4.
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24. Heggers JP, Sazy JA, Stenberg BD, Strock LL, McCauley RL, Herndon DN, et al. Bactericidal and wound-healing properties of sodium hypochlorite solutions: the 1991 Lindberg Award. J Burn Care Rehabil 1991;12:420-4. 25. Kozol RA, Gillies C, Elgebaly SA. Effects of sodium hypochlorite (solution) on cells of the wound module. Arch Surg 1988;123:420-3. 26. Vanwijck R, Kaba L, Boland S, Gonzales y Azero M, Delange A, Tourbach S. Immediate skin grafting of sub-acute and chronic wounds debrided by hydrosurgery. J Plast Reconstr Aesthet Surg 2010;63: 544-9. 27. Fraccalvieri M, Serra R, Ruka E, Zingarelli E, Antoniotti U, Robbiano F, et al. Surgical debridement with VERSAJET: an analysis of bacteria load of the wound bed pre- and post-treatment and skin graft taken. A preliminary pilot study. Int Wound J 2011;8: 155-61. 28. Weinzweig N, Schlechter B, Baraniewski H, Schuler J. Lower-limb salvage in a patient with recalcitrant venous ulcerations. J Reconstr Microsurg 1997;13:431-7. 29. Kumins NH, Weinzweig N, Schuler JJ. Free tissue transfer provides durable treatment for large nonhealing venous ulcers. J Vasc Surg 2000;32:848-54. 30. Llanos S, Danilla S, Barraza C, Armijo E, Pineros JL, Quintas M, et al. Effectiveness of negative pressure closure in the integration of split thickness skin grafts: a randomized, double-masked, controlled trial. Ann Surg 2006;244:700-5.
Submitted Aug 27, 2014; accepted Nov 18, 2014.
Cost analysis of negative-pressure wound therapy with instillation for wound bed preparation preceding split-thickness skin grafts for massive (>100 cm2) chronic venous leg ulcers C. Kevin Yang, MD, Sean Alcantara, MD, Selena Goss, MD, and John C. Lantis II, MD, New York, NY Objective: Massive ($100 cm2) venous leg ulcers (VLUs) demonstrate very low closure rates with standard compression therapy and are costly to manage. Negative-pressure wound therapy (NPWT), followed by a split-thickness skin graft (STSG), can be a cost-effective alternative to this standard care. We performed a cost analysis of these two treatments. Methods: A retrospective review was performed of 10 ulcers treated with surgical debridement, 7 days of inpatient NPWT with topical antiseptic instillation (NPWTi), and STSG, with 4 additional days of inpatient NPWT bolster over the graft. Independent medical cost estimators were used to compare the cost of this treatment protocol with standard outpatient compression therapy. Results: The average length of time ulcers were present before patients entered the study was 38 months (range, 3-120 months). Eight of 10 patients had complete VLU closure by 6 months after NPWTi with STSG. The 6-month costs of the proposed treatment protocol and standard twice-weekly compression therapy were estimated to be $27,000 and $28,000, respectively. Conclusions: NPWTi with STSG treatment is more effective for closure of massive VLUs at 6 months than that reported for standard compression therapy. Further, the cost of the proposed treatment protocol is comparable with standard compression therapy. (J Vasc Surg 2015;61:995-9.)
Although much is written about chronic venous disease in the literature, very little is reported about venous leg ulcerations (VLUs) that measure >40 cm2, let alone massive VLUs of $100 cm2. Of the estimated 1% of the United States population with this chronic, disabling condition, w25% will have active open ulcerations.1-3 Such ulcerations, particularly large ones, are difficult to heal, taking months to obtain closure and, while open, severely affect the patient’s quality of life. The economic burden of the disease is significant. In the United Sates, direct costs are estimated at $1 billion annually.1 The direct costs of VLU treatment include medical and nursing staff, diagnostic imaging, hospitalization, medications, dressings, and interventional procedures. Indirect costs related to lost productivity are more difficult to measure but contribute significantly.
From the Mount Sinai St. Luke’s Hospital and Mount Sinai Roosevelt Hospital. Author conflict of interest: J.C.L. is a paid consultant for KCI (San Antonio, Tex). Presented as a poster at the 2014 Vascular Annual Meeting of the Society for Vascular Surgery, Boston, Mass; June 4-7, 2014. Reprint requests: John C. Lantis II, MD, Mount Sinai St. Luke’s Hospital and Mount Sinai Roosevelt Hospital, 1090 Amsterdam Ave, Ste 7A, New York, NY 10025 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2015 by the Society for Vascular Surgery. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jvs.2014.11.076
Compression therapy remains the current standard care from an efficacy and cost standpoint.4 However, massive VLUs are particularly challenging. They have very poor closure rates: one study showed only 50% of VLUs >20 cm2 closed after 21 weeks of multilayer compression therapy.5 Thus, because the cost of VLU treatment is directly related to time to achieve closure, massive VLUs are expensive, requiring more frequent dressing changes, office visits, and adjunctive therapy. Further, the tools used to close these ulcers are varied and poorly studied. The application of a split-thickness skin graft (STSG) is an option for achieving closure of a massive VLU. Although the body of literature is small, a few studies have shown STSGs for VLUs are superior to standard compression therapy in the rate of ulcer healing and pain reduction.6,7 Associated benefits include earlier time to mobilization, decreased outpatient visits, and reduced need for dressings. Potentially, this directly translates into health care dollar savings. Because VLU beds are characterized by chronic inflammation, tissue edema, decreased oxygen content, and bacterial colonization, there is concern regarding the viability of STSGs when placed directly into such wounds.8-10 Negative-pressure wound therapy (NPWT) with topical wound solution instillation (NPWTi) has shown promise as an adjunct to wound preparation before a STSG.11 In vitro work using a porcine model demonstrated increased granulation tissue, improved tissue oxygenation, and clearance of wound debris with the use of NPWTi.12,13 Furthermore, NPWT after STSG improved graft take through imbibitions and neovascularization by reducing shear forces and fluid collection.14 995
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Table I. Current Procedural Terminologya (CPT) codes used Code 11042 15100 29581 97606 99213
Description Debridement, skin and subcutaneous tissue STSG Multilayer compression therapy NPWT Office visit
NPWT, Negative-pressure wound therapy; STSG, split-thickness skin graft. a American Medical Association, Chicago, Ill.
In this study, the direct cost of treating massive VLUs $100 cm2 using an inpatient NPWTi and STSG protocol was compared with standard outpatient compression therapy over a 6-month period. METHODS An Institutional Review Board-approved retrospective review was conducted at a single institution. The need for informed consent was waived because of the retrospective nature of the study. Patient demographics and VLU characteristics were obtained from medical records. Patients were excluded if the VLU size was 20 cm2 demonstrate poor closure rates of only 50% at 21 weeks, massive VLUs are not likely to close with standard compression therapy alone in a reasonable time frame.5 However, by using STSG early in the treatment protocol, we demonstrated a considerable increase in ulcer-free days. The take rates for STSGs in VLUs are notoriously poor.21 This has been attributed to a hostile wound bed that has a large bacterial burden, poor perfusion, and increased edema and exudation. Our approach to this problem has been short-term NPWTi with a topical wound
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Table II. Wound characteristics and percentage of split-thickness skin graft (STSG) take Wound 1 2 3 4 5 6 7 8 9 10 Mean (SD)
Patient gender
Patient age, years
Wound size, cm2
Wound age, months
Hospital length of stay,days
STSG take at 30 days, %
STSG take at 180 days, %
Male Male Male Female Male Male Female Female Male Male
54 54 55 63 46 74 54 54 67 67 59.8 (8.5)
150 150 294 300 400 252 112 204 320 325 251 (94)
60 55 21 120 36 3 4 4 36 36 38 (36)
14 14 11 11 12 14 10 10 19 19 13.4 (3.3)
95 95 80 90 70 95 90 90 100 100 91 (9)
100 100 100 80 70 100 100 100 100 100 95 (11)
SD, Standard deviation.
Table III. Cost breakdown per wound over 6 months Description Operating room debridement STSG NPWT Hospital stay Office visit Multilayer compression therapy Additional wound dressing material Total
Compression, $
9552 16,800 1440 27,792
NPWTi and STSG, $ 519 4144 398 20,966 995 130 27,152
NPWT, Negative-pressure wound therapy; NPWTi, negative-pressure would therapy with instillation; STSG, split-thickness skin graft.
Fig. Progression of a venous leg ulcer (VLU) treated with negative-pressure wound therapy (NPWT) with instillation (NWPTi) and a split-thickness skin graft (STSG). A, Infected VLU before debridement. B, VLU after debridement and 7 days of NPWTi with Dakin solution before STSG. C, VLU at 30 days after STSG: complete take is seen.
solution before STSG.11 This single delivery system provides a bactericidal agent along with NPWT, which has been demonstrated to optimize blood flow and decrease local tissue edema.13,22 Admittedly, the literature regarding the optimal topical wound solution is lacking. The use of quarter-strength Dakin solution engenders some controversy.23 In vitro and in vivo data regarding use of Dakin solution in chronic wounds has revealed a narrow therapeutic window, exhibiting the fine balance between bactericidal effect and cytotoxicity.24,25 In light of this, short-term use for wound bed sterilization in conjunction with
negative pressure for wound bed preparation appears to be beneficial in our cohort. The direct cost of the two VLU treatment modalities is comparable. Clearly, the major cost in our cohort of patients is attributed to inpatient hospitalization. Because we practice in the highest cost region in the country, we chose to use a nationally adjudicated cost generator instead of a real charge capture technique. In addition, we used a nationalized cost calculator for NPWTi to eliminate preferential pricing. Further cost reduction in NPWTi and STSG treatment may be achieved in several areas. Our experience has been that NPWTi is best conducted in the inpatient setting because any problems with the device can be immediately addressed by the hospital staff. There may be a role for outpatient NPWTi before STSG by using visiting nurse services. Advantages of such a scenario include significantly reduced costs and avoiding complications associated with prolonged hospitalization such as deep vein thrombosis and nosocomial infections. However, at present, NPWTi remains beyond the scope of most home and nursing home care givers. It should be noted that we did not observe any of these proposed inpatient complications in our cohort of patients. All patients in this study received low-molecular-weight heparin prophylaxis. The optimal NPWTi time to adequate wound bed preparation is not known. Reducing NPWTi time, and
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therefore hospitalization, would clearly have an effect on overall cost. In a previous study with NPWTi, we found that 10 days was an adequate period before STSG in sterilization of wounds.11 We have since been able to reduce that preparation time to 7 days. However, further reductions in wound bed preparation time using current NPWTi methods have been suboptimal. Alternative adjuncts to surgical wound debridement, followed by immediate STSG, have been reported. Vanwijck et al26 described the use of hydrosurgery with the VersaJet (Smith & Nephew), followed by immediate STSG. They noted that the only graft failures in their cohort of 155 patients were in patients with chronic venous ulcers. Another study demonstrated only a 50% decrease in bacterial burden after hydrosurgery debridement.27 Thus far, NPWTi appears to be superior to hydrosurgery for adequate wound bed preparation. Other surgical algorithms for large recalcitrant VLUs exist. One approach with a high ulcer healing rate is free tissue transfer with perforating vein ablation.28 This technique is particularly useful when ulcerations involve exposed bone, tendon, or joints, a situation where STSGs would likely fail to take. Hospital costs of free tissue transfer, excluding major complications, are comparable with standard compression therapy.29 This study has several limitations. A matched comparison group with standard compression therapy was not part of the study design. Patients with massive VLUs often have accompanying symptoms of drainage, surrounding dermatitis, and secondary wound infections that require adjuvants to standard compression such as absorptive foams and topical corticosteroids, debriding agents (eg, collagenase), and antimicrobial agents (eg, iodine-based gels). There is high variability in which particular adjuvant or combination adjuvant treatment patients receive; therefore, a matched group with solely standard compression is not possible. In addition, a prospective two-arm study is needed to objectively demonstrate actual rates of ulcer-free days and associated costs in these massive VLUs. Until hospital charge data are completely transparent, it will be difficult to very accurately quantify these costs. Although we acknowledge that using cost estimators leads to an overestimation of true cost, applying costs to all components of the study allows for gross comparison. Further, it can be argued that instillation may be an unnecessary adjunct to wound bed preparation. This would necessitate comparative studies of the available topical wound solutions with NPWT without instillation. We have adopted this treatment algorithm at our institution in a stepwise fashion. Historically, our experience with STSG alone for large VLUs has been poor. With the advent of the NPWT bolster for STSG, significant gains were made in overall STSG take, as demonstrated by Llanos et al.30 Nevertheless, we found that simple debridement and washout of VLU before STSG was inadequate wound bed preparation. We subsequently applied our experience with Dakin NPWTi for treatment of chronically
infected diabetic and venous ulcers to wound bed preparation, with promising results as described here. CONCLUSIONS The result of NPWTi with STSG treatment for closure of large complex VLUs is promising. The direct cost of this treatment method is comparable with standard compression therapy over a 6-month period. If additional indirect VLU costs, such as lost productivity, are factored and treatment time frame extended, NPWTi with STSG for massive VLU is clearly the more economical approach. AUTHOR CONTRIBUTIONS Conception and design: SA, JL Analysis and interpretation: KY, SA Data collection: SA, SG Writing the article: KY, SA Critical revision of the article: KY Final approval of the article: JL Statistical analysis: JL Obtained funding: SA, JL Overall responsibility: JL REFERENCES 1. de Araujo T, Valencia I, Federman DG, Kirsner RS. Managing the patient with venous ulcers. Ann Intern Med 2003;138:326-34. 2. Fowkes FG, Evans CJ, Lee AJ. Prevalence and risk factors of chronic venous insufficiency. Angiology 2001;52(Suppl 1):S5-15. 3. Shai A, Halevy S. Direct triggers for ulceration in patients with venous insufficiency. Int J Dermatol 2005;44:1006-9. 4. O’Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. Cochrane Database Syst Rev 2012;11: CD000265. 5. Marston WA, Carlin RE, Passman MA, Farber MA, Keagy BA. Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency. J Vasc Surg 1999;30:491-8. 6. Jankunas V, Bagdonas R, Samsanavicius D, Rimdeika R. The influence of surgical treatment for chronic leg ulcers on the quality dynamics of the patient’s life. Acta Chir Belg 2007;107:386-96. 7. Salome GM, de Almeida SA, Ferreira LM. Evaluation of pain in patients with venous ulcers after skin grafting. J Tissue Viability 2014;23: 115-20. 8. Smith PC. The causes of skin damage and leg ulceration in chronic venous disease. Int J Low Extrem Wounds 2006;5:160-8. 9. McDaniel JC, Roy S, Wilgus TA. Neutrophil activity in chronic venous leg ulcersda target for therapy? Wound Respair Regen 2013;21: 339-51. 10. Pascarella L, Schonbein GW, Bergan JJ. Microcirculation and venous ulcers: a review. Ann Vasc Surg 2005;19:921-7. 11. Raad W, Lantis JC 2nd, Tyrie L, Gendics C, Todd G. Vacuumassisted closure instill as a method of sterilizing massive venous stasis wounds prior to split thickness skin graft placement. Int Wound J 2010;7:81-5. 12. Rycerz AM, Allen D, Lessing MC. Science supporting negative pressure wound therapy with instillation. Int Wound J 2013;10(Suppl 1): 20-4. 13. Vuerstaek JD, Vainas T, Wuite J, Nelemans P, Neumann MH, Veraart JC. State-of-the-art treatment of chronic leg ulcers: a randomized controlled trial comparing vacuum-assisted closure (V.A.C.) with modern wound dressings. J Vasc Surg 2006;44:1029-37; discussion: 1038. 14. Azzopardi EA, Boyce DE, Dickson WA, Azzopardi E, Laing JH, Whitaker IS, et al. Application of topical negative pressure
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Submitted Aug 27, 2014; accepted Nov 18, 2014.
