WOUNDS Management of Open Distal Lower Extremity Wounds ... · CASE SERIES 306 WOUNDS® Abstract: Open wounds of the distal third of the leg and foot with an exposed tendon present

Management of Open Distal Lower Extremity Wounds With Exposed Tendons Using Porcine Urinary Bladder Matrix

WOUNDS

Scott E. Geiger, MD; Olivier A. Deigni, MD; John Tracy Watson, MD; Bruce A. Kraemer, MD, FACS,

CASE SERIES

306 WOUNDS® www.woundsresearch.com

Abstract: Open wounds of the distal third of the leg and foot with an exposed tendon present a challenge in wound management and in at-taining stable, durable coverage. The mobility of the tendon often leads to chronic inflammation that impedes wound closure, while the desic-cation of the exposed tendon leads to progressive tendon necrosis. For the authors’ cases, the ability of extracellular matrix (ECM) products to modulate wound bed inflammation and facilitate constructive remodel-ing of a wound seemed a reasonable approach in treating these wounds, especially in patients who are often poor surgical candidates for more advanced reconstructive procedures. Methods. The authors reviewed 13 patients who had open wounds of the distal third of the leg and/or foot that had associated tendon involvement in the wound (Achilles, 6; tibialis anterior, 6; and peroneal, 1). Patients’ wounds were treated to total closure. The clinical course and patient management is reviewed herein. Results. The authors found newer ECM products can provide a more optimal method of management of patients with exposed ten-dons, as compared to prolonged negative pressure wound therapy. Conclusion. Furthermore, the authors conclude the use of newer ECM products yields a more stable, less scarred, reconstructed wound that more closely resembles normal foot and ankle appearance compared to other more complex reconstructive operative procedures.

Key words: lower extremity wounds, surgical wounds, porcine urinary bladder extracellular matrix, tissue repair

Wounds 2016;28(9):306-316

From the 1Division of Plastic and Reconstructive Surgery, Saint Louis University School of Medicine; and 2Department of Orthopaedic Surgery, Saint Louis University School of Medicine, St. Louis, MO

Address correspondence to:Bruce A. Kraemer, MD, FACSPandrangi Professor of Plastic SurgeryChief, Division of Plastic and Reconstructive SurgerySaint Louis University School of Medicine3635 Vista Ave3rd Floor Desloge TowersSt. Louis, MO [email protected]

Disclosure: Dr. Kraemer participates in the Key Opinion Leaders Bureau for ACell Inc, Columbia, MD and has received monies for presenting his clinical experience using the porcine urinary bladder matrix-extracellular matrix products described in this paper. Dr. Geiger received travel and hotel expenses from ACell Inc to present a poster including these clinical cases at the Orthopaedic Trauma Association 2014 Annual Meeting in Tampa, FL.

Management of Open Distal Lower Extremity Wounds With Exposed Tendons Using Porcine Urinary Bladder Matrix

Scott E. Geiger, MD1; Olivier A. Deigni, MD1; John Tracy Watson, MD2; and Bruce A. Kraemer, MD, FACS1

The ultimate goal of lower extremity limb reconstruction for wounds with exposed tendons is obtaining wound coverage that is stable and durable with normal tendon gliding and associated joint mobil-

ity. Ideally the patient should have a pain-free, normal-appearing leg and foot that can fit into regular footwear. The use of pedicle or free flaps in the management of these patients is frequently suggested as the optimal means of wound closure.1-10 However, the additional bulk of flaps to the foot and ankle region often limits the use of normal footwear and requires future re-visions. A collagen-glycosaminoglycan biodegradable matrix (Integra Bilayer Wound Matrix, Integra LifeSciences Corp, Plainsboro, NJ) has been report-edly used in managing wounds with exposed tendons.11-18 Utilizing negative

Licensed and used with permission from HMP Communications, LLC from September 16, 2016 through September 16, 2017.

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Vol. 28, No. 9 September 2016 307

pressure wound therapy (NPWT) with or without future skin grafting is helpful in managing patients with these wounds,19 but marked scarring and graft adherence can develop.20 Thus, the authors began utilizing newer extra-cellular matrix (ECM) treatment methods for the man-agement of complex full-thickness wounds including exposed tendon in challenging flap candidate patients.

This report summarizes the authors’ experience utiliz-ing porcine urinary bladder matrix ECM (UBM-ECM) products in the management of challenging distal lower extremity wounds with exposed tendons.

MethodsWith Institutional Review Board approval, from Feb-

Table 1. Patient characteristics and clinical data

Age (years)/ Sex Comorbidity Injury

Presence of Orthopedic Hardware

Wound Culture Organisms Identified BMI

Injury to Treat (days)

A1 79/M AFib, venous stasis Trauma and venous stasis

Absent Pseudomonas, Methicillin-sensitive Staphylococcus aureus

21 54

A2 59/F IDDM, CAD-MI, HTN, kidney-pan-creas transplant, immunosuppressed

Achilles rupture re-pair, ankle fracture

Screw, removed Coagulase-negative Staphylococci, Escherichia coli

22 85

A3 61/F IDDM, OSA, HTN, tendinitis

Achilles rupture repair

Tendon sutures, removed

Methicillin-sensitive S. aureus

44 85

A4 61/M HTN, IDDM, venous stasis

Posterior Achilles trauma



51 182

A5 68/M AFib, CAD Achilles rupture repair


No culture done 27 41

A6 30/F Smoking GSW calf Absent Negative 21 2

TA1 42/F Heroin addict, DM, hepatitis, schizo-phrenia

Intravenous drug injection

Absent Prevotella, Streptococcus anginosus

28 8

TA2 36/M Negative Ankle sprain, ankle bullae

External fixator present

Group A beta-hemolytic Streptococci

20 9

TA3 32/M Negative Open ankle fracture dislocation, wound breakdown

Plates and screws of ORIF bimalleolar fracture (not in wound)


32 55

TA4 51/M Smoker MVA, extensor ten-don avulsion

Absent Negative 32 1

TA5 21/M Smoker Degloving anterior tibial region

Absent Enterobacter cloacae, Enterococcus

26 16

TA6 57/M Tibial artery transection, venous stasis, DM, DVT-PE

Open ankle joint wound anteriorly

Absent Methicillin-sensitive S. aureus, Bacillis

30 13

Per 53/M Smoker Calcaneal fracture after falling down stairs, osteomyelitis

Screw in calcaneus

Methicillin-resistant S. aureus

26 305

BMI: body mass index; A1-6: Achilles tendon patients; TA1-6: tibialis anterior tendon patients; Per: peroneal tendons patient; M: male; F: female; AFib: atrial fibrillation; IDDM: insulin-dependent diabetes mellitus; CAD-MI: coronary artery disease-myocardial infarction; HTN: hypertension; OSA: obstructive sleep apnea; GSW: gunshot wound; DM: diabetes mellitus; ORIF: open reduction internal fixation; MVA: motor vehicle accident; DVT-PM: deep vein thrombosis and pulmonary embolism

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ruary 2012 through April 2014, a total of 13 patients with foot or lower third extremity wounds involving tendons were managed by the Plastic Surgery Service at St. Louis University (St. Louis, MO) utilizing porcine urinary bladder matrix-extracellular matrix (UBM-ECM) (MicroMatrix, MatriStem Multilayer Wound Matrix, and MatriStem Surgical Matrix RS, PSM, and PSMX, ACell Inc, Columbia, MD) as the primary wound management mo-dality. At the time of initial plastic surgery evaluation, these patients were not deemed suitable candidates for routine surgical management with standard local or free

flap techniques; therefore, none of these patients had a flap procedure. Multiple medical comorbidities and an inability to undergo extensive surgical procedures were the primary reasons for alternative wound man-agement. The medical comorbidities were as follows: culture positive wounds 77% (10/13); diabetes melli-tus 38% (5/13); smoking 31% (4/13); leg edema/venous stasis 23% (3/13); and a body mass index greater than 35 15% (2/13). Additional medical problems included 1 patient each with end-stage renal disease on hemodi-alysis, congestive heart failure, coronary artery disease

Table 2. Wounds characteristics and treatment

Size (cm)

No. of RX UBM-ECM Treatment Wound Management

STSG or Suture

Time to Healing (weeks)

Follow-up (mos.)

A1 24 x 10 x 1 2 MMP/PSMX sheet NPWT, alginates, STSG STSG 78 19

A2 3.5 x 1 x 1.4 2 MMP/PSMX sheet Hydrogel - 42 24

A3 5 x 1 x 1 1 PSMX sheet Hydrogel - 32 25

A4 2.5 x 2.5 x 2 2 MMP/PSMX and MMP/burn matrix sheet

Hydrogel Suture 24 14*

A5 3.25 x 2.1 3 MMP and PSMX sheet (2 clinic PSMX applications)

Hydrogel - 15 16

A6 10 x 11 x 4 1 Burn matrix sheet NPWT (initial 3 weeks), then hydrogel

STSG 7 13

TA1 22 x 8 x 0.8 2 MMP and PSMX Hydrogel with polyurethane sheet dressing

STSG 18 19

TA2 18 x 18 x 0.8 1 MMP NPWT STSG 6 33

TA3 3.2 x 2.5 1 IBWM (by orthopedics), then MMP and PSMX

Hydrogel, polyurethane sheet dressing

- 15 21

TA4 4.2 x 3 x 0.6 2 MMP Hydrogel, polyurethane sheet dressing

- 9 22

TA5 18 x 12 x 0.8 1 MMP Hydrogel, polyurethane sheet dressing

STSG 7 22

TA6 25 x 13 x 3 7 MMP, PSMX x 2 MMP, burn matrix (4 applications), then MMP and FTSG

NPWT STSG & FTSG

19 20

Per1 3 x 1 x 0.6 1 MMP and burn matrix Wound closed, cadexomer dressing

Suture 14 16

*Reopened months 3-4 and now closed for 10 months A1–A6: Achilles tendon wound patients; TA1–TA6: tibialis anterior tendon wound patients; Per: peroneal tendon wound patient; RX: surgi-cal treatments; UBM-ECM: urinary bladdyer matrix-extracellular matrix; MMP: MicroMatrix micronized powder (ACell, Inc, Columbia, MD); Burn Matrix: UBM-ECM burn matrix sheet; PSMX: MatriStem Surgical Matrix PSMX (Acell, Inc) 6-layer, vacuum-pressed sheets; IBWM: Integra Bilayer Wound Matrix (Integra LifeSciences, Plainsboro, NJ) bovine tendon collagen and glycosaminoglycan matrix with a silicone layer; NPWT: negative pressure wound therapy; STSG: split-thickness skin graft; FTSG: full-thickness skin graft; polyurethane sheet dress-ing (Tegaderm, 3M, St. Paul, MN); cadexomer dressing: Iodosorb Gel (Smith & Nephew, Hull, UK)

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with prior myocardial infarction, and active atrial fibril-lation on anticoagulation. One patient with an Achilles tendon wound was on immunosuppression for a prior pancreas and kidney transplant.

There were 6 open Achilles tendon wounds, 6 open tibialis anterior tendon wounds, and 1 peroneus longus and brevis tendon wound. The time of initial UBM-ECM treatment relative to the date of injury varied depend-ing upon when the patient was referred and when the patient agreed to comply with the treatment regimen (no cigarette smoking and limited tendon motion with foot and ankle immobilization). All patients received parenteral prophylactic antibiotics preoperatively, and appropriate oral antibiotics were given as indicated by the wound bed cultures at the time of debridement and product placement (Table 1). These antibiotics were continued until the wound had healed to the point that the tendons were no longer exposed. Only 1 of the 4 patients who smoked maintained a nonsmok-ing status during treatment and during the follow-up period.

The treatment protocol involved judicious excisional debridement of the wound bed and tendon with scal-pel, scissors, or hydrosurgical debridement (Versajet Hy-drosurgery System, Smith & Nephew, Hull, UK). All intra-tendinous sutures were also removed to rid the wound of foreign material. All wounds received a topical appli-cation of UBM-ECM micronized powder (MicroMatrix) to the wound bed, tendons, and remaining interstices. Earlier patients in the study had 2-, 3-, or 6-layer vacuum-pressed UBM-ECM sheets (MatriStem Surgical Matrix) used while later study patients also had the 2-layer ly-ophilized UBM-ECM multilayer sheets (MatriStem Mul-tilayer Wound Matrix) applied in place of or along with the vacuum-pressed sheets. Experience led to place-ment of more UBM-ECM product into the wound at the time of the initial surgery in the patients treated later in the study. The product was placed into the wound to fill it to skin level and, when possible, attempts were made to close the wound over the product. In all cases, the product was retained in the wound with sutures or staples and a polyurethane sheet dressing (Tegaderm, 3M, St. Paul, MN) placed over the wound to keep the product moist. After the UBM-ECM product placement, subsequent wound care was determined by the amount of wound drainage and the need to keep the tendon moist. Concomitant treatments included negative pres-sure wound therapy (NPWT) (for drainage over 20–50 cc/day), hydrogels, petroleum gauze, and additional

Figure 1. (A) Open anterior distal tibial wound after tis-sue necrosis due to local heroin injection; (B) healing of infected tendon wounds with 2 urinary bladder matrix-extracellular matrix (UBM-ECM) treatments and polyure-thane sheet dressings; (C) office treatment of residual tendon exposure with UBM-ECM 6-layer, vacuum-pressed sheets; and (D) wound healing after 3 months of topical hydrogel therapy just prior to skin grafting of the remain-ing open wound.

A

B

C

D

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polyurethane sheet covering. An absorptive pad outer dressing was then changed as needed for the draining fluid. Unlike standard moist wound therapy treatment, the wounds treated with UBM-ECM performed well in a more moist environment and needed less frequent dressing and wound manipulation. Earlier study patients were observed in the clinic more frequently due to con-cerns about potential complications, but as the authors’ experience increased, the patients treated later in the study were observed less frequently. Patients with an open Achilles tendon wound had their active tendon excursion limited by external pin fixation systems, an-kle immobilizers, or healing Ankle Foot Orthosis (AFO) boots as fitted by an orthotic specialist. Other patients simply needed posterior ankle splint immobilization. If primary skin closure was not possible, patients with larger wounds received a partial- or full-thickness skin graft to close the wound once the wound volume was filled and completely vascularized. The patient clinical data and care is summarized in Tables 1 and 2.

ResultsThe number of applications of UBM-ECM by tendon

group was as follows: tibialis anterior tendon wounds: 1-2 (average 1.2, median 1) (Figure 1); Achilles tendon wounds: 1-3 (average 1.83, median 2) (Figure 2, Figure 3); and peroneal longus and brevis tendons wound 7 treatments (Figure 4). The treatment of the one pa-tient with the largest complex open ankle joint with multiple exposed tendons that received 7 treatments (separated out from the tibialis anterior tendon group above) is shown in Figure 5. Primary skin closure was attempted in 4 wounds involving the Achilles tendon and in 1 wound involving the peroneal tendons. Split- or full-thickness skin grafts were used to achieve com-plete wound closure in 2 wounds involving the Achil-les tendon and 4 wounds involving the tibialis anterior tendon. Smaller wounds involving the tibialis anterior tendon closed with no need for skin grafting. The aver-age follow-up was 20 months with a minimal follow-up of 13 months.

The time from initial UBM-ECM product application to wound closure varied from 6–78 weeks, with the larger wounds requiring more time to heal. All wounds achieved closure despite a variety of positive cultures at the time of initial UBM-ECM application. In the exposed Achilles tendon wound group, healing times ranged from 7–78 weeks, with an average of 33 weeks to com-plete wound healing (median 28 weeks). In the exposed

Figure 2. (A) Immunosuppressed 59-year-old transplant patient with diabetes, Achilles rupture, and calcaneal fracture repair wound dehiscence; (B) debrided wound prior to urinary bladder matrix-extracellular matrix (UBM-ECM) treatment; (C) powder UBM-ECM formulation in the central wound and UBM-ECM 6-layer, vacuum-pressed sheets in the lower posterior heel wound; and (D) topi-cally healed wounds after 2 treatments with UBM-ECM.

A

B

C

D

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tibialis anterior tendon group, healing was achieved by 6–18 weeks (average 11 weeks; median 9 weeks). The 1 peroneal tendon exposed wound closed in 14 weeks. Time to skin graft application after initial UBM-ECM product application ranged from 3.5–16 weeks over-all (average 10.3 weeks; median 10.5 weeks). Two of 6 (33%) Achilles wounds were ultimately grafted at 5 and 16 weeks after UBM-ECM application. Three of 5 (60%) exposed tibialis anterior tendon wounds were grafted, 3.5–15 weeks after initial UBM-ECM product applica-tion (average 7.8 weeks; median 5 weeks). One patient with a posterior Achilles wound and bilateral venous stasis disease redeveloped a small wound during a leg ulcer flare that subsequently healed with compression and topical care.

A majority of patients had multiple treatments (7/13) of UBM-ECM, with most of these secondary product ap-plications occurring in the clinic (Figure 1, Figure 2, Figure 3, Figure 4). A notable exception was 1 of the patients treated early in the study who had a severe wound involving an open ankle joint with loss of all an-terior ankle tissues except for the tendons, and whose wound required multiple product applications in the operating room (Figure 5). Time to ambulation from initial UBM-ECM application was 8–33 weeks in the ex-posed Achilles wound group (average 20 weeks; medi-an 21 weeks) and 7–17 weeks (average 11.4 weeks; me-dian 10 weeks) in the exposed tibialis anterior tendon group. The patient with the exposed peroneal tendons was poorly compliant and ambulated throughout his postoperative treatment. No significant skin graft losses were noted, and all wounds were considered healed ap-proximately 3 weeks after skin grafting.

The UBM-ECM products appeared to perform well in an environment kept more moist than typically employed in classic moist wound therapy regimens. Therefore, the authors transitioned from more frequent NPWT use in patients treated earlier in the study to its seldom-prolonged use in the patients treated later (af-ter the first study year) in the study. The authors found a simple polyurethane sheet or a foam gauze dressing with daily application of several milliliters of saline or hydrogel on the wound typically provided an appropri-ate amount of moisture. With larger wounds, 1 to 2 lay-ers of a Drawtex (SteadMed, Fort Worth, TX) dressing was added over an Adaptic (Johnson & Johnson, New Brunswick, NJ), nonadherent layer to achieve a better moisture balance under the polyurethane sheets. These dressings were then changed every 2–3 weeks in the of-

fice, when additional products could also be added. The patient changed an outer absorptive dressing as needed in the management of any fluid leakage that occurred from under the polyurethane sheets.

In 4 wounds involving the Achilles tendon and the 1 wound involving the peroneal tendon, wound dehis-cence was observed after closure due to postopera-tive swelling or the patient ambulating against advice. Wound dehiscence did not lead to loss of product or compromise healing. The wound separation was man-aged by the application of a topical moist dressing. Of note, the hydrated UBM-ECM product can have the ap-pearance of standard wound slough and should be care-fully retained in the wound as its presence facilitates the ongoing tissue remodeling process.

Figure 3. (A) A 79-year-old male with a large posterior Achilles wound with combined venous stasis disease and arterial disease which failed negative pressure wound therapy and split-thickness skin grafting (STSG); and (B) healed posterior Achilles heel wound appearance after treatment with urinary bladder matrix-extracellular ma-trix, full-thickness skin grafting, and STSG.

A B

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DiscussionThis retrospective study showed UBM-ECM products

can facilitate wound healing in open, traumatic, lower extremity wounds involving exposed tendon and posi-tive cultures. All treated wounds showed satisfactory filling of the tissue deficit around the exposed tendons. Wound closure was observed in all patients with either primary reepithelialization, development of granulation tissue to support a skin graft, or primary reapproxi-

mation of the wound margins. Wounds managed with UBM-ECM had a noticeable decrease in periwound edema and drainage similar to wounds managed with NPWT. Wounds that had positive bacterial cultures but were not grossly infected responded well to UBM-ECM wound therapy. Patients reported reduced pain and ac-cepted the more prolonged time course of the UBM-ECM wound healing process. The healed wounds have fairly normal appearance and allow the patients to wear

Figure 4. (A) Peroneus longus and brevis open wound; (B) wound debrided and burn matrix sheet placed in wound; (C) wound closure with urinary bladder matrix-extracellular matrix powder and burn matrix; (D) wound dehiscence man-aged with daily hydrogel; and (E) final wound closure after 14 weeks.

A

B

C

D

E

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regular footwear and ambulate without assistive devic-es. After achieving wound closure, patients had mini-mally associated wound pain and no patient required medications for chronic pain.

The challenges in managing lower extremity wounds with exposed tendons include frequent tendon desic-cation, marked peritenon inflammation, and drainage induced by tendon motion. Given these obstacles to healing, a wide variety of tendon wound treatments

have been attempted.1-10,15-17 The use of the collagen-glycosaminoglycan biodegradable matrix in managing open wounds with exposed tendons has shown great promise as it may allow coverage of a wound that oth-erwise would not have supported a skin graft.18,20-24 Its use, however, requires a noninfected wound bed and at least a 2-stage procedure requiring secondary skin grafting. A recent review of free-tissue reconstruc-tions of open wounds with exposed Achilles tendons

Figure 5. (A) Open total dislocated talus degloved ankle wound in an unstable polytrauma patient with diabetes, an-ticoagulated after a major pulmonary embolism; (B) initial wound debridement using hydrosurgical device; (C) urinary bladder matrix-extracellular matrix (UBM-ECM) powder and 6-layer, vacuum-pressed sheets were applied; (D) serial healing observed after 4 UBM-ECM treatments; and (E) fi-nal appearance after split-thickness and full-thickness skin grafts. All tendons were able to be saved and were func-tional; however, the patient had an ankle fusion to treat avascular necrosis of the talus. The ankle fusion healed well in the constructively remodeled wound.

A

B

C

D

E

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advocated for anterolateral thigh flap reconstruction due to the limited success with other means of recon-struction of these wounds.14 Other authors16 have sup-ported the use of local flaps in the absence of signifi-cant vascular disease for wounds up to 2.5 cm x 2.5 cm, while some17 have tried autologous dermal graft-ing with vacuum-assisted closure of 4 cm x 4 cm and more shallow wounds. In contrast, UBM-ECM products, which contain an exposed epithelial basement mem-brane layer, facilitate peripheral reepithelialization so that secondary grafting of smaller wounds is not need-ed. An in-depth study25 of these wound devices via ad-vanced mass spectrometry methodology showed 129 distinct proteins comprise the product. The healing ef-fect is the result of all these proteins interacting with the wound bed.

For larger wounds, the intrinsic blood supply of the tendon is initially unable to support a skin graft. After UBM-ECM placement and tendon immobilization, en-hanced healing of the wound bed is noted as more exu-berant granulation begins forming that subsequently en-gulfs the tendon and allows secondary skin grafting on a newly, constructively remodeled tissue base and tendon.

The UBM-ECM products are available in several for-mulations: a micronized powder, a lyophilized single to multilayer sheet, or a multilaminate vacuum-pressed sheet of varying thicknesses. These products are tissue-derived scaffolds with a complex biochemical com-position that have not been fully characterized, but include collagens, glycosaminoglycans, and growth fac-tors.11-14 The micronized powder tends to remain in the wound for the shortest period of time as the body rap-idly integrates the product. The lyophilized multilayer sheet remains in the wound bed for a longer duration, while the vacuum-pressed sheet takes the longest pe-riod of time to fully remodel into the wound bed. The UBM-ECM product has shown efficacy in both acute and chronic wound healing by facilitating the body’s ability to produce site-specific, constructively remod-eled tissue.11-14

This product use requires an appreciation of the dif-ferences in the appearance of the wound and wound bed. As the matrix constructively remodels the wound, it becomes incorporated into the healing wound surface and may have the appearance of wound slough or adher-ent exudate. Classical wound management experience would suggest this apparent wound slough or adherent exudate should be removed as it will limit wound bed granulation formation and promote bacterial coloni-

zation. The authors’ experience shows the desired ad-herent matrix that builds up with UBM-ECM therapy facilitates the formation of an exuberant, firm, healthy, vascular granulation tissue. It is important that ancillary care providers appreciate that these wounds do not need debridement but instead need to be kept moist and undisturbed.

The management of wounds with UBM-ECM has proven to be less complex than traditional wound care or long-term NPWT. The authors recommend product application as soon after the injury as feasible, since wounds tend to respond more favorably the earlier they receive treatment with UBM-ECM products. In the early management period when there is more copious drain-age, NPWT is often employed. After 1-3 weeks when the amount of drainage decreases, alternative manage-ment regimens can be designed to allow for simple daily home wound care. With layered UBM-ECM products on the wound bed and a moisture-retentive primary dress-ing, the patient experiences much less wound care pain, because the actual wound bed can be left untouched for several weeks at a time. The periodic addition of mois-ture to the wound via hydrogel or tubing placed into the dressing is easily performed and well tolerated. When concerns about infection arise, silver releasing dressings such as an antimicrobial barrier silver dressing (Acticoat, Smith & Nephew, Hull, UK) or silver-plated nylon tech-nology dressing (Silverlon, Argentum Medical, Geneva, IL) have been added to the topical dressing layer with success. An ongoing remodeling and softening of the wound is noted with progressive skin mobility after final closure. When healed, the normal appearance and con-tour of the leg allows for more optimal edema control.

Additional benefits of this wound management meth-od include shortened physician operative time and postoperative care requirements so patients with these wounds can be easily added into an already busy sur-gical schedule. The total cost of care is potentially de-creased by a greater ability for these wounds to be cared for at home or at a stepdown facility with monitoring of wound progress in the clinic every second to third week, instead of complex inpatient hospital care.

A criticism of the present series is the time required to achieve wound closure, which was more prolonged than traditional pedicle or free-flap procedures or simi-lar to that achievable with NPWT alone. However, the use of UBM-ECM avoids donor site morbidity and surgi-cal complexity associated with traditional flap therapy, and it is less cumbersome than NPWT. The ability of the

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UBM-ECM product to manage large complex wounds makes the management of these wounds possible in less sophisticated medical settings and could prove to be a great benefit in many medically under-resourced regions of the world. The results of this case series suggest fur-ther evaluation be conducted to compare the time and quality of healing for traumatic open wounds involving exposed tendons managed with UBM-ECM versus other treatment modalities.

ConclusionWhile flap closure of major distal lower extremity

and foot wounds is the currently accepted standard of care, the present case series showed that wound treat-ment with UBM-ECM may provide a reasonable alterna-tive to these more complex surgical procedures. Ease of application and minimal operative time allows for easier management of patients with multilevel leg trau-ma wounds, patients who are committed smokers, or patients with other comorbidities such as cardiopulmo-nary compromise. While wounds managed with UBM-ECM may require a longer time for wound closure as compared to flaps, and may require several applications, the avoidance of significant donor site morbidity and complex, lengthy operative procedures is often favored by patients when provided a choice. These wound man-agement techniques can be easily performed at outlying facilities, and patients do not need to be referred to a larger treatment center for advanced care. The authors’ experience has shown that UBM-ECM wound care needs are much simpler, there are few complications, and the patient heals with a limb with a normal appearance that permits use of regular footwear. No post-healing wound revisions were required in this series, in contrast to the contour revisions often necessary in flap-based recon-struction of these difficult areas. The UBM-ECM can be utilized in wounds that are culture positive (but not grossly infected), and their use allows for more opti-mal timing of care for patients with these limb-critical wounds. The authors believe UBM-ECM products have utility whether they are used as the primary reconstruc-tive modality or as an adjunct to standard reconstructive techniques.

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MatriStem® Wound Matrix and MatriStem® Multilayer Wound Matrix have been rebranded as Cytal™ Wound Matrix 1-Layer and Cytal™ Wound Matrix 2-Layer.

This paper by Geiger et al., published in the journal Wounds, is a retrospective study that evaluated clinical outcomes of thirteen (13) patients with open distal lower extremity wounds that were managed with the use of MicroMatrix®, MatriStem®

Burn Matrix, and/or MatriStem® Surgical Matrix PSMX, all of which are manufactured by ACell®, Inc. (“ACell”). The base technology and process employed during the manufacturing of MatriStem Surgical Matrix PSMX is equivalent to the base technology and process employed during the manufacturing of Cytal™ Wound Matrix 6-Layer devices.

The paper reported on the utility of commercially available urinary bladder matrix (i.e., MatriStem/Cytal technology) in facilitating the formation of a vascularized bed on large full thickness traumatic wounds to support subsequent skin grafting or primary re-epithelialization. The study was an investigator-initiated study that was performed independent of financial or scientific input from ACell. Scientific personnel from ACell provided only a superficial review of the manuscript prior to the authors’ submission of the manuscript to Wounds.

The United States Food and Drug Administration (“FDA”) cleared indications under which ACell currently markets MicroMatrix® and Cytal™ Wound Matrix are listed below. Any claims or indications outside of the cleared indications listed below are not endorsed or promoted by ACell.

• MicroMatrix is intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

• Cytal Wound Matrix (1-Layer, 2-Layer, 3-Layer, and 6-Layer) are intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/ undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

• Cytal Burn Matrix is intended for the management of wounds including: second-degree burns, partial and full- thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, and skin tears), and draining wounds. The device is intended for one-time use.

The ACell wound devices referenced above are not currently indicated for: pain management; treatment of infection; or tendon repair/reinforcement. ACell devices are not promoted to highlight any potential for bioactivity with host tissue.

ACell is not aware of any significant risks or safety concerns associated with the use of the ACell wound devices as described in this paper, beyond those potentially outlined in the paper itself. ACell is not aware of any published scientific or clinical data that is contradictory to the results of this study.

ACell’s distribution of this published Wounds article to members of the medical community should not be interpreted as and does not represent an endorsement by the authors of such distribution or any ACell product.

Dr. Kraemer serves as a consultant for ACell, and in that capacity he has received compensation from ACell for educating his peers by presenting his clinical experience using the ACell products/technology described in this paper. Dr. Geiger received travel and hotel expenses from ACell to present a poster including these clinical cases at the Orthopedic Trauma Association 2014 Annual Meeting in Tampa, FL. ACell is not aware of any other potential conflicts of interest concerning any of the other authors, nor is it aware of the funding source for this study.

ACell had no scientific oversight with respect to this study. ACell did, however, provide certain devices used in this study at no cost.

Rx ONLY Refer to IFU supplied with each device for indications, contraindications, and precautions. US Toll-Free 800-826-2926 • www.acell.com © 2017 ACell, Inc. All Rights Reserved. MK-0275.1 03/2017

ACell, Inc.6640 Eli Whitney Drive Columbia, MD 21046

www.acell.com800-826-2926

Documents

WOUNDS Management of Open Distal Lower Extremity Wounds ... · CASE SERIES 306 WOUNDS® Abstract: Open wounds of the distal third of the leg and foot with an exposed tendon present