complex wounds treated with matristem xenograft material ... · treating complex wounds is a...

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Case series

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For citation purposes: Sasse KC, Ackerman EM, Brandt JR. Complex wounds treated with MatriStem xenograft material: case series and cost analysis. OA Surgery 2013 Dec 01;1(1):3. Co

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Complex wounds treated with MatriStem xenograft material: case series and cost analysis

KC Sasse*, EM Ackerman, JR Brandt

AbstractIntroductionComplex wounds remain challenging to treat and heal, and those that in-volve additional risk factors such as immunosuppression, tobacco abuse, Crohn’s disease, diabetes and obesity pose increased risks of delayed heal-ing, non-healing, reoperation and reinfection. Treatment of wounds is often costly, involving materials, per-sonnel and procedures. MatriStem (Acell Inc., Columbia, MD) is a regen-erative extracellular matrix mate-rial derived from the porcine bladder that has shown efficacy in facilitat-ing the healing of complex wounds. In this analysis, 10 diverse cases of complex wounds treated with pe-riodic MatriStem application at a single institution are examined, and the materials costs of treatment are calculated. These costs are compared with comparable wound care ma-terials costs at the same institution using what has to date been the con-ventional wound treatment protocol: negative pressure wound therapy.Case seriesWe present 10 cases of complex wounds treated with MatriStem xenograft material in repeat applica-tions until the wound was maximally healed. In each case presented, the original surgery involved placement of a MatriStem graft, and the costs of this graft are represented based upon hospital contracted pricing. In subse-quent weeks, patients were treated with bedside or in-office additional

MatriStem material, either in the form of ground powder or in the form of single-layer wound sheets. The costs of these materials are also depicted, based upon the payment schedule from our facility. An analy-sis of the cost of care is provided and compared with weekly costs of care in the same institution when conven-tional methods using negative pres-sure wound therapy is utilised.ResultsUsing weekly MatriStem applications, each patient achieved healing of the wound without infection or complica-tion, and the median treatment time was 11 weeks. The average cost of materials per week for healing these wounds using MatriStem is $152 per week. The costs of materials for nega-tive pressure wound therapy calculat-ed from the same contracted pricing agreements by the same institution are $501 per week. MatriStem wound treatment is less costly for this diverse set of 10 wounds on a weekly basis than treatment with negative pres-sure wound therapy. This holds true even when the cost of the initial graft is included in the analysis. Further discussion illuminates why labour, transportation and miscellaneous supply costs are also lower for MatriS-tem treatment when compared with negative pressure wound therapyDiscussionTreating complex wounds is a chal-lenging and costly process. The use of MatriStem (Acell Corporation) has proven effective in achieving and ac-celerating wound healing in other studies. In this study, treatment of a diverse array of complex wounds re-sulted in successful clinical healing of the wounds without complications, re-infection or reoperation.

ConclusionPatients undergoing wound care with MatriStem report satisfaction with reduced need for visits, eliminating the need for wearing or carrying a negative pressure wound therapy device, elimination of the need for dressing changes and reduced in-teractions with both the medical personnel and the wound itself. The costs of materials for the treat-ment of these wounds are substan-tially less on a per-week basis than the costs at the same institution when negative pressure wound ther-apy is utilised.

Introduction Complex wounds remain challenging to treat and heal, and those that in-volve additional risk factors such as immunosuppression, tobacco abuse, Crohn’s disease, diabetes and obesity pose increased risks of delayed heal-ing, non-healing, reoperation and reinfection1. Treatment of wounds is often costly, involving materials, personnel and procedures2,3. Ma-triStem (Acell Inc., Columbia, MD) is a regenerative extracellular matrix (ECM) material derived from porcine bladder that has shown efficacy in at-tracting progenitor stem cells to the wound, promoting and accelerating the healing of complex wounds4–6. MatriStem material has been shown to exhibit anti-infective properties, and it is applied to complex open wounds with bedside or office week-ly or biweekly application7. Negative pressure wound therapy (NPWT) has grown from applications in ve-nous stasis ulcers to a wide array of complex wounds in our institution and elsewhere8,9. In this analysis, 10 diverse cases of complex wounds

* Corresponding author Email: [email protected]

Renown Regional Medical Center, 1155 Mill St, Reno, NV 89501, USA

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sacrococcygeal wound was left open. A three-layer MatriStem graft was placed at the time of the initial wide excision. Over the course of 9 weeks, seven additional applications of Ma-triStem powder or wound sheets were applied until total healing was achieved (Figures 4 and 5).

Case 3RB is a 67-year-old male with a his-tory of tobacco abuse and diabetes who developed acute superior mes-enteric artery (SMA) embolus and required open surgical SMA em-bolectomy. He required reoperation in the early postoperative period due to abdominal wall dehiscence and evisceration. The large open abdomi-nal wall wound was treated at this re-operation with MatriStem xenograft powder. Over the course of the next

for 3 months prior to consultation for advanced wound medicine. Dur-ing the 3 months, he had undergone both topical wound care treatments and 7 weeks of NPWT without suc-cess. He was taken to surgery for an outpatient wound debridement pro-cedure and placement of an initial three-layer MatriStem graft. In the course of 6 weeks, five additional treatments were performed in the office, with application of MatriStem powder (MicroMatrix), MatriStem Wound Matrix or both (Figures 1–3). The sacral wound healed completely in 6 weeks.

Case 2SV is a 27-year-old male with com-plex pilonidal disease and recur-rent abscesses. He underwent a wide excision procedure and the

treated with periodic MatriStem ap-plication at a single institution are examined, and the materials costs of treatment are calculated. These costs are compared with compara-ble wound care materials costs at the same institution using what has to date been the conventional wound treatment protocol: NPWT. Treat-ment of wounds is often costly in other ways, involving transportation costs, personnel and miscellaneous supplies. This analysis comments on how these additional costs are fur-ther affected by the use of MatriStem.

Case seriesCase 1FO is a 61-year-old male with dia-betes and coronary artery disease who had struggled with a non-heal-ing stage IV sacral decubitus ulcer

Figure 1: Sacral Wound.

Figure 3: Sacral wound healed. Figure 4: Pilonidal wound.

Figure 2: Sacral Wound after 3 weekly treatments.

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33 weeks, he returned for intermit-tent wound care and 14 additional MatriStem powder or wound sheet treatments, until the wound was completely healed (Figures 6 and 7).

Case 4TF is a 34-year-old-obese female who developed pain, redness and swelling at the lateral aspect of her low transverse hysterectomy scar. A CT scan demonstrated a fluid collec-tion, and at surgery, a deep subfas-cial abscess was drained. The open wound was treated with 500 mg of MatriStem powder and a 7 × 10 cm wound sheet. Five additional applica-tions of MatriStem powder or wound sheet xenograft material were ap-plied over the course of the next 7 weeks, at which point the wound was completely healed (Figures 8 and 9).

Case 5MH is a 67-year-old female with Crohn’s disease and multiple previous intestinal resections, incisional hernia repairs with mesh and an ileostomy. She developed purulent drainage from the midline scar and required abdominal wall excision of infected synthetic mesh and wound debride-ment for a complex abdominal wall abscess. Initial treatment included placement of MatriStem powder and a single-layer wound sheet. Fourteen treatments with powder or wound sheets and over the course of 27 weeks led to complete healing of the wound (Figures 10 and 11).

Case 6JS is a 51-year-old female with Crohn’s disease and previous colo-rectal surgery involving creation of a loop ileostomy that had devel-oped severe ulceration, drainage and dermatitis around it. She under-went resection and closure of the loop ileostomy with concomitant MatriStem xenograft placement in the form of 500 mg of MicroMatrix powder. Over the ensuing 10 weeks, she returned to the office for a total

of seven additional treatments with MatriStem powder until the wound was fully healed (Figures 12 and 13).

Case 7JZ is a 73-year-old female with a his-tory of an ascending colon carcinoma resected a year previously and who developed a right psoas and right flank soft tissue abscess stemming from an indolent anastomotic fistula. She underwent open resection of the anastomoses, debridement of the flank and abdominal wall abscesses, and placement of single-layer and powder MatriStem materials in the open right flank wound. Over the en-suing 12 weeks, she received eight additional treatments of MatriStem powder and/or single-layer wound sheets until the wound was com-pletely healed (Figures 14 and 15).

Case 8JP is a 68-year-old male with a history of tobacco abuse and severe hidrad-enitis suppurativa. After recurrent infections and procedures, a wide excision of the skin and affected soft tissue of the buttock, thigh and peri-rectal regions was performed with placement of single-layer MatriStem sheets and powder. A large, approxi-mately 30 × 20 cm irregular soft tissue wound remained. Over the ensuing 16 weeks, 10 additional applications of single-layer sheets and powder facili-tated complete healing of the wound.

Case 9ER is an 81–year-old female with a recurrent invasive leiomyosarcoma involving the right scapula and the subscapularis and intercostal mus-cles. After repeated wide resections and external beam radiation, she struggled with a 15 × 10 cm non-healing wound. It was treated with serial applications of MatriStem over the course of 12 weeks and healed to a superficial and non-tender area of 7 × 6 cm with lack of complete heal-ing due to the presence of persistent tumour.

Case 10CH is a 48-year-old male with se-vere faecal incontinence related to remote trauma and a permanent co-lostomy. He had developed a colos-tomy stricture with retraction and an obstructing parastomal hernia and underwent open laparotomy with colostomy takedown and reloca-tion. The old ostomy site was closed at the fascial level and treated with MatriStem wound sheet and powder, partially approximated at the sub-cutaneous level and covered with a vaseline gauze and dressing. Over the next 4 weeks the ostomy site wound healed completely with the applica-tion of one additional treatment in the office of MatriStem powder

ResultsThe mean time to healing for these complex wounds using weekly Ma-triStem xenograft material appli-cations was 13.6 weeks, and the median time to healing was 11 weeks. No patient required reopera-tion and none developed infection. No patient required visiting nurses, home wound care, visits to addi-tional wound Centres, or the need to wear or carry a device. The median cost for the material including the initial graft and subsequent office treatments was $2128. The cost of materials per week for the MatriStem wound protocol was $156(Table 1).

In the same centre, an analysis was undertaken to examine the costs of wound care materials using NPWT. Not including labour, the costs per week of material for the NPWT pro-tocol, utilising three-times-per-week changes, for the small, medium, large and extra-large systems are $410, $433, $782 and $932 respectively (Table 2).

Based on the aggregate size measurements and the exper-tise of the wound care nursing staff at our institution, the 10 cases represented here would re-quire initially two small NPWT systems, three large, one extra

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Figure 5: Pilonidal wound healed. Figure 8: Low transverse abdominal wound.

Figure 6: Midline wound. Figure 9: Low transverse wound partially healed.

Figure 7: Midline wound after partial healing. Figure 10: Midline wound near ostomy.

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Figure 11: Midline wound near ostomy healing. Figure 14: Flank wound.

Figure 12: Stomal and peristomal wound in Crohn’s disease. Figure 15: Flank wound healed.

Figure 13: Stomal and peristomal wounds healed. Figure 16: Colostomy closure wound.

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the same facility. Using the NPWT method, more visits and more per-sonnel costs increase the overall cost burden, as NPWT normally av-erages three times per week in our centre. Utilising MatriStem instead, a weekly or even biweekly dressing change is performed at the bedside, in the wound clinic or in the physi-cian’s office, usually by a mid-level practitioner. There appears to be little adverse consequence of less frequent treatment of the wounds when weekly MatriStem applica-tion is the intended treatment plan. Thus, less material and less man-power costs are utilised than with NPWT, with excellent wound heal-ing results. A randomised, prospec-tive, controlled trial comparing wound treatment protocols with NPWT versus MatriStem is the sub-ject of an ongoing investigation at our centre.

The use of MatriStem (ACell Inc.) has proven effective in achieving and accelerating wound healing across an array of complex clinical situations. The unique features of the porcine urinary bladder ECM include its po-tent chemotactic effect for host pro-genitor stem cells and macrophage M2 subtypes believed to be essen-tial for constructive remodelling of site-specific tissue10,11.

DiscussionIn this study, treatment of a di-verse array of complex wounds using MatriStem xenograft ap-plication resulted in success-ful clinical healing of the wounds without complications, re-infec-tion or reoperation. The median cost of materials per week using Ma-triStem is significantly less than that of the costs per week using NPWT, based on contracted pricing within

large and four medium systems. The mean weekly cost for NPWT at the onset would be $583 per week. Assuming that the size of the wound decreased over the weeks to the point at which six small systems and four medium systems were uti-lised, in the later weeks, the average cost per week would be $419. Us-ing a blended average, an estimated aggregate cost per week for NPWT materials is $501 per week.

Table 1 Wounds TreatedWound anatomy Duration to healing

(weeks)Cost of initial

graft ($)Number of

additional graftsCost of additional

grafts ($)Total

cost ($) 1. Sacrum 6 1480 5 1028 2508 2. Sacrococcygeal 9 640 7 1294 1934 3. Abdominal wall 33 2052 14 2101 4153 4. Abdominal wall 7 1364 5 855 2219 5. Abdominal wall 27 729 14 1308 2037 6. Peristomal 10 1121 7 814 1935 7. Flank 12 729 8 1135 1864 8. Buttoc 16 2538 10 3457 5995 9. Scapula 12 486 10 2280 276610. Ostomy closure 4 597 1 228 825

Figure 17: Colostomy closure wound healed.

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wounds: a major and snowballing threat to public health and the economy. Wound Re-pair Regen. 2009 Nov–Dec;17(6):763–71. 2. Carter MJ. Cost-effectiveness research in wound care: definitions, approaches, and limitations. Ostomy Wound Manage. 2010 Nov;56(11):48–59.3. Hankin CS, Knispel J, Lopes M, Bron-stone A, Maus E. Clinical and cost effi-cacy of advanced wound care matrices for venous ulcers. J Manag Care Pharm. 2012 Jun;18(5):375–84.4. Vineet A, Scott AJ, Janet R, Li Z, Stephen T, Gang W, et al. Epimorphic regeneration approach to tissue replacement in adult mammals. Proc Natl Acad Sci U S A. 2010 Feb;107(8):3351–5.5. Gilbert TW, Nieponice A, Spievack AR, Holcomb J, Gilbert S, Badylak SF. Repair of the thoracic wall with an extracellular matrix scaffold in a canine model. J Surg Res. 2008 Jan;147(1):61–7.6. Sasse KC, Brandt J, Lim DC, Ackerman E. Accelerated healing of complex open pilonidal wounds using MatriStem ex-tracellular matrix xenograft: nine cases. J Surg Case Rep. 2013 Apr;(4):rjt025.7. Brennan EP, Reing J, Chew D, Myers-Irvin JM, Young EJ, Badylak SF. Antibac-terial activity within degradation prod-ucts of biological scaffolds composed of extracellular matrix. Tissue Eng. 2006 Oct;12(10):2949–55.8. de Leon JM, Barnes S, Nagel M, Fudge M, Lucius A, Garcia B. Cost-effectiveness of negative pressure wound therapy for postsurgical patients in long-term acute care. Adv Skin Wound Care. 2009 Mar;22(3):122–7.9. Harding K, Posnett J, VowdenK. A new methodology for costing wound care. Int Wound J. 2012 Dec;10(6):623–9.10. Brown B, Lindberg K, Reing J, Stolz DB, Badylak SF. The basement membrane component of biologic scaffolds derived from extracellular matrix. Tissue Eng. 2006 Mar;12(3):519–26.11. Schultz GS. Extracellular matrix: review of its roles in acute and chron-ic wounds. www.worldwidewounds.com/2005/august/Schultz/Extrace-Matric-Acute-Chronic-Wounds.html [Accessed 1 Dec 2012].

heart disease, obesity and a refrac-tory stage IV sacral decubitus ulcer when the treatment strategy shifted to the use of MatriStem, instead of NPWT. If such historical compari-sons are representative measures, then wounds such as stage IV sacral decubitus wounds and sacrococcy-geal wounds may achieve a shorter time to total healing over conven-tional methods including NPWT, which would further reduce the costs involved. However, even if the total time to heal was equivalent, the costs on a weekly basis would be less and the burden to the patient lower when the wound is treated with MatriStem xenograft weekly applications.

Abbreviations listECM, extracellular matrix; NPWT: negative pressure wound therapy; SMA, superior mesenteric artery.

ConsentWritten informed consent was ob-tained from all patients for publication of this series study and accompany-ing images. A copy of the written con-sents is available for review by the Editor-in-Chief of this journal.

References1. Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, et al. Human skin

ConclusionIn this series, patients who have un-dergone treatment of their wounds using MatriStem xenograft material did not have to carry or wear cum-bersome negative pressure devices or tubing. None of the patients need-ed to perform dressing care at home. None of the patients were required to make daily or frequent trips to a wound care centre. Nor did they have visiting nurses. Although this paper examines costs of the materi-als involved, it is worth noting that patients experience a lower burden of travel, intrusions, physical encum-berments and visits when using Ma-triStem for wound healing than they would using NPWT at this institution.

It should also be noted that one of the cases presented herein describe the administration of MatriStem xenograft material after failed efforts with NPWT. In Case 1, a sacral stage IV decubitus ulcer had been treated for 3 months with conventional treat-ments, including 7 weeks of NPWT without success. The xenograft ap-plication and subsequent treatments resulted in a completely healed wound within 6 weeks. Although it is difficult to generalise on cost savings across many wounds, this case does imply a significant cost savings in at least this individual with diabetes,

Table 2 Medium dressing change average cost per week

Item number Description Amount/hours used Cost each Total cost

Cost for wound care to change dressing 6 $41.00 $246.0066800795 Medium kit w/port 3 $38.23 $114.6966800912 800 mL Cannister 2 $24.73 $49.4666800394 NPWT large drape 3 $7.84 $23.52

$433.67NPWT, negative pressure wound therapy.

complex wounds treated with matristem xenograft material ... · treating complex wounds is a...

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