wound literature compendium

WOUND LITERATURE COMPENDIUM

MicroMatrix® and Cytal® Wound Matrix in Clinical Practice

ACell’s proprietary platform technology – MatriStem UBM™ (Urinary Bladder Matrix) technology – is an extracellular matrix (ECM) derived from porcine urinary bladder and differentiated from other ECM products by its intact epithelial basement membrane. MatriStem UBM technology is the only commercially available form of Urinary Bladder Matrix (UBM), and is utilized in the manufacturing of Cytal Wound Matrix and MicroMatrix devices.

UBM has been found to facilitate a remodeling response by the body that leads to the formation of site-appropriate tissue. As a result, ACell’s wound management devices, including MicroMatrix devices and Cytal Wound Matrix devices, are often used in complex, slow-healing wounds where traditional treatments have not been effective.

UBM has a considerable breadth of research supporting its value in clinical settings. The extensive body of research includes more than 100 pre-clinical and 50 clinical peer-reviewed articles. Several of the most clinically relevant publications in the area of wound management are summarized in this compendium.

The publications presented in this compendium contain the opinions of and personal techniques practiced by the treating physician(s). The techniques presented herein are for informational purposes only. The decision of which techniques to use in a particular clinical application lies with the treating physician(s) based on patient profile, particular circumstances surrounding the procedure, and previous clinical experiences.

Cases presented involving Veterans Administration facilities or physicians do not reflect the opinion of the United States military or Veterans Affairs office.

Note: Cytal® Wound Matrix and MicroMatrix® were previously marketed under the brand name MatriStem.

The authors of certain publications presented in this compendium may make claims that are not made by ACell or its representatives. In these publications, the underlying use of the ACell wound devices to manage wounds falls within the current indications for use of these devices, and therefore these publications are summarized within this compendium.

§ Former ACell Employee | ¶ Consultant | ▲ ACell Sponsored Research Agreement | # ACell Employee


MicroMatrix® and Cytal® Wound Matrix in Clinical Practice

Regenerative medicine for soft tissue coverage of the hand and upper extremity. Lanier, et al. Page 1

Acellular micronized extracellular matrix and occlusive dressings for open fingertip injuries. Dreifuss, et al. Page 1

A value analysis of microsurgical lower extremity reconstruction vs. acellular urinary bladder matrix (UBM) for radiation wounds of the lower extremity.

Micallef, et al. Page 2

Complex wounds treated with MatriStem xenograft material: case series and cost analysis. Sasse¶, et al. Page 3

Porcine bladder extracellular matrix for closure of a large defect in a burn contracture release.

Mitchell, et al. Page 4

Urinary bladder matrix for the treatment of recalcitrant nonhealing radiation wounds. Rommer, et al.

Evaluation of tissue engineering products for the management of neuropathic diabetic foot ulcers: An interim analysis.

Frykberg, et al. Page 6

The clinical effectiveness in wound healing with extracellular matrix derived from porcine urinary bladder matrix: a case series on severe chronic wounds.

Kimmel, et al. Page 7

A comparative analysis of skin substitutes used in management of diabetic foot ulcers. Martinson, et al. Page 8

Modulation of inflammation in wounds of diabetic patients treated with porcine urinary bladder matrix.

Paige, et al. Page 9

Efficacy of a urinary bladder matrix for treating wound dehiscence with hardware exposure in a patient with rheumatoid arthritis.

Bui, et al. Page 10

Application of extracellular matrix product in limb salvage in a patient with history of lower extremity amputation.

Irwin, et al. Page 10

TABLE OF CONTENTS

1

Extensive tissue loss can add significant complications to the management of complex wounds. Authors of this review article focused on the role of extracellular matrices (ECMs) in providing reconstructive options to help mitigate the complexities inherent in the most common treatment modalities. The authors suggest that ECMs can provide an alternative to advanced procedures in the reconstructive ladder and present examples where various devices were used for complex wound management. In many cases, the complex wounds presented with exposed avascular structures. Multiple modalities, such as ECMs and Dermal Regenerative Templates (DRT), including Integra®, were used to support development of a healthy vascularized wound bed that could further be managed with autologous skin grafting.

The article detailed a case of a traumatic forearm wound with devitalized tendon and exposed muscle which was managed with MicroMatrix and Cytal Wound Matrix. In this case, skin grafting was not needed to achieve closure, and the wound remained closed six months following reconstructive procedures.

Images reprinted with permission from Walter Klowers Health, Inc.

A B

A) Traumatic forearm wound including the presence of devitalized tendon and exposed muscle. Wound was managed with MicroMatrix and Cytal Wound Matrix. B) Three weeks following salvage procedures. C) Six months following salvage procedures, wound demonstrates stable coverage without the use of skin grafting.

C

Lanier ST, Ruter DI, Valerio IL. Current Orthopaedic Practice. 2018; 29(2): 120-126. doi: 10.1097/BCO.0000000000000592.

Dreifuss SE, Wollstein R, Badylak SF‡, Rubin PJ. Acellular micronized extracellular matrix and occlusive dressings for open fingertip injuries. Plastic and Aesthetic Research. 2015;2:282-283. doi: 10.4103/2347-9264.156994.

Regenerative medicine for soft tissue coverage of the hand and upper extremity.

Acellular micronized extracellular matrix and occlusive dressings for open fingertip injuries.


In this retrospective case series, the authors reviewed wound management protocols and results of eight patients presenting with fingertip amputations. The extent of the injuries included fingertip pulp only, pulp and nail bed, or pulp, nailbed, and distal phalanx. MicroMatrix was applied to each injury, followed by non-adherent petroleum gauze and cotton gauze fingertip bandaging as a secondary dressing. The follow-up regimen included a gentle rinse with saline before application of MicroMatrix and the previously described dressing protocol. Prior to each re-application of MicroMatrix, the dressings were carefully removed and the wound was gently rinsed. Any remaining product on the wound was preserved. Average time to healing was seven weeks, and patients recorded a comfort score of five out of five in wounds that the authors noted to typically be reported as painful. Authors stated that patients reported satisfaction with the appearance and function, with all patients noting a subjective recovery of pressure sensation, light touch, and temperature sensation comparable to uninjured fingers.

2

In this retrospective case study, authors reviewed the management protocol and outcome of a 77-year-old male patient with a radiation wound treated with Cytal Wound Matrix and MicroMatrix. The patient was a smoker with bilateral squamous cell carcinoma of the lower extremities treated with external beam radiation. Radiation therapy often provides successful outcomes, but can result in recalcitrant chronic radiation wounds that can be difficult to manage. In this case, radiation therapy resulted in non-healing ulcers on both legs. The right leg had an exposed tibia and tibialis anterior tendon which was managed with a free latissimus dorsi muscle flap. The left leg had a chronic indolent medial mid-calf wound, which was unsuccessfully treated for two years with conservative wound treatment options including wet to dry dressings, alginate silver, and Integra Bilayer. The patient's wound was managed by applying weekly applications of Cytal Wound Matrix and MicroMatrix until the wound completely closed and re-epithelialized by week seven. Authors of the study found that using Cytal Wound Matrix and MicroMatrix provided a successful alternative to previously failed treatment options and negated the need for additional flap procedures, potentially avoiding complications and costs associated with such procedures.

A B C

Images reprinted with permission from Oxford University Press.

A 77-year old male patient with bilateral wounds resulting from external beam radiation. A) Right leg wound managed using free latissimus dorsi flap. B) Recalcitrant left leg wound following various wound treatment modalities including Integra Bilayer and hyperbaric treatment. C) Fully healed wound six months following wound management with Cytal Wound Matrix and MicroMatrix.

Micallef CJ, Johnson JN, Johnson MR. Journal of Surgical Case Reports. 2019; 3,1-3. doi: 10.1093/jscr/rjz051.

A value analysis of microsurgical lower extremity reconstruction vs. acellular urinary bladder matrix (UBM) for radiation wounds of the lower extremity.

3

This clinical, retrospective case series reviewed 10 cases of complex open wounds managed with MicroMatrix and/or Cytal Wound Matrix 1-Layer devices. Treatment costs with the UBM devices were compared to alternative wound treatment modalities at the same institution, including negative pressure wound therapy (NPWT). The cases were complex wounds ranging from recurrent, non-healing wounds to wounds in patients with compound comorbidities. Utilizing weekly applications of the UBM devices, authors achieved wound closure in all 10 cases without infection or complication by a median of 11 weeks. The authors concluded that ACell’s wound management devices allowed for healing of complex wounds at lower costs due to requiring less material and employee hours than NPWT with comparable healing times.

A) A 61-year-old male patient with stage IV sacral pressure ulcer. Patient treated with topical wound care treatments and seven weeks of NPWT without healing. B) Sacral wound after three, weekly treatments of MicroMatrix and Cytal Wound Matrix. C) Sacral wound closed at six weeks.

A) Colostomy closure wound. B) Colostomy closure wound healed four weeks following application of MicroMatrix and Cytal Wound Matrix.

A B C

A B

Images reprinted with permission from OA Surgery London.

Sasse KC¶, Ackerman EM, Brandt JR. OA Surgery. 2013 Dec 01;1(1):3.

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


4

This manuscript is a retrospective review of a complex case involving excision of a contracting scar from the patient’s anterior neck. Patient initially presented with a third-degree burn to the anterior neck and face. A skin graft was placed over the debrided neck burn; however, 17 months after surgery, the patient developed significant contracture and experienced sinus and fistulae formation. Upon excision and independent management of the fistula, the resulting wound edges retracted and an 8 cm x 14 cm wound remained. Patient was managed with MicroMatrix and Cytal Wound Matrix technology*, with bi-weekly dressing changes and additional applications of ACell wound management devices as necessary. At 16 weeks post-initial application, the wound was fully closed and the patient expressed great satisfaction with the functional and cosmetic outcome. The patient’s Vancouver Scar Scale score was reduced from a seven pre-operatively to a four before being discharged from physical therapy. There was no observed recurrence of the fistula or sinus formation at the time of submission of this manuscript.

Images reprinted with permission from MA Healthcare Limited.

Mitchell KB, Gallagher JJ. Journal of Wound Care. 2012 Sep;21(9):454-6. doi: 10.12968/jowc.2012.21.9.454. Retrieved from http://www.oapublishinglondon.com.

Porcine bladder extracellular matrix for closure of a large defect in a burn contracture release.

Patient with sinus tract and fistulae formation from a mature, hypertrophic scar across the neck. A,B) Initial presentation at the junction of the healed area of the anterior neck and the hypertrophic upper edge of the mature skin graft. C) Large tissue defect resulting from operative excision of the burn wound. D,E) Definitive closure achieved 16 weeks post-application of MicroMatrix and Cytal Wound Matrix.

A B

D E

C

* Actual device utilized in the case was a Gentrix® Surgical Matrix device. The base technology and process employed during the manufacturing of Gentrix Surgical Matrix devices is equivalent to the base technology and process employed during the manufacturing of Cytal Wound Matrix 3- and 6-layer devices. Cytal Wound Matrix devices are fenestrated while Gentrix Surgical Matrix devices are unfenestrated.

5

Rommer EA, Peric M, Wong A¶. Advances in Skin & Wound Care. 2013 Oct;26(10):450-5. doi: 10.1097/01.ASW.0000434617.57451.e6.

In this retrospective case series, the authors reviewed the management protocols and the results of three patients presenting with complex wounds years after receiving radiation therapy. Authors used MicroMatrix and Cytal Wound Matrix when skin grafting or tissue flaps were considered high risk due to the irradiated and aged tissue. The average patient age was 67.7 ± 3.5 years with the average time between radiation therapy and wound evaluation by the authors of 36.3 ± 17.8 years. Before the use of ACell wound management devices, patients had undergone hyperbaric oxygen treatment, Negative Pressure Wound Therapy (NPWT), or Regranex™ interventions without wound closure. All wounds closed after repeat applications of MicroMatrix and Cytal Wound Matrix.

A) A 71-year-old woman with previously irradiated scar tissue. B) Initial defect. C) Initial defect shown closely. D) Defect following debridement prior to coverage with posterior thigh fasciocutaneous flap. E) 2.5 cm x 1.5 cm wound breakdown, eight weeks following flap coverage. MicroMatrix applied biweekly, until wound closure at eight weeks. F) Wound remained closed 19 months after initial MicroMatrix application.

A

D

B

E

C

F

Images reprinted with permission from Wolters Kluwer Health.

Urinary bladder matrix for the treatment of recalcitrant nonhealing radiation wounds.


6

In this prospective, randomized, multi-center, clinical trial interim analysis, the concomitant use of MicroMatrix and Cytal Wound Matrix 1-Layer (“MicroMatrix and Cytal Wound Matrix group”) was compared to Dermagraft® (“Dermagraft group”) in the management of neuropathic DFUs. The study evaluated the incidence of complete ulcer closure, rate of ulcer healing, wound characteristics, patient quality of life (QoL), cost effectiveness, and reoccurrence. Ninety-five patients at 13 sites entered the study, from which the evaluable data of 56 patients at eight study facilities were analyzed. Patients were randomized between the MicroMatrix and Cytal Wound Matrix and Dermagraft groups. Twenty-seven MicroMatrix and Cytal Wound Matrix and 29 Dermagraft subjects had complete evaluable data at this interim analysis. These subjects were managed with weekly applications for up to eight weeks or until complete wound closure, whichever occurred first. A two-week period of Standard of Care (SOC) followed the treatment phase, and wound closure was assessed at the end of that period. Any wounds that completely healed were evaluated at six months after initial treatment for evaluation of reoccurrence. There were no statistically significant differences between the patient populations including gender, age, race, ethnicity, size of ulcer, ulcer location, diabetes type, and University of Texas Wound Classification System grade.

At the planned interim analysis, there was no statistical difference in incidence of complete wound closure or the rate of wound closure between the two groups; however, due to the small data set, direct clinical comparisons of safety and efficacy between the two groups could not be established. The MicroMatrix and Cytal Wound Matrix group showed statistically significant improvements in QoL measurements, although there was no correlation to any specific clinical variable, when compared to the Dermagraft group. Finally, the MicroMatrix and Cytal Wound Matrix group showed a statistically lower device cost per subject as compared to the Dermagraft group.

Average Diabetic Foot Ulcer Scale (DFS) Scores

MicroMatrix/Cytal Dermagraft P-Value

Time of Consent 181.56 (±53.04) 184.46 (±61.03) 0.851

Randomization 196.22 (±64.91) 193.897 (±64.85) 0.894

End of Treatment (8 weeks) 151.11 (±72.86) 195.73 (±81.59) 0.074

End of Post-treatment SOC (10 weeks) 134.15 (±74.35) 201.13 (±72.13) 0.023

The DFS is a validated QoL instrument that consists of 58 items grouped into eleven lifestyle domains. The scoring algorithm provides a health-related QoL response score, where a lower score correlates with a more positive subject assessment. DFS scores fall on a range of 58-290.*

Frykberg RG, Cazzell SM, Arroyo-Rivera J, Tallis A, Reyzelman AM, Saba F, Warren L, Stouch BC¶, Gilbert TW§. Journal of Wound Care. 2016 July;25 Suppl 7:S18-25. doi: 10.12968/jowc.2016.25.7.S18.�

Evaluation of tissue engineering products for the management of neuropathic diabetic foot ulcers: An interim analysis.

* Abetz L, Sutton M, Brady L, McNulty P, Gagnon DD. The Diabetic Foot Ulcer Scale (DFS): a quality of life instrument for use in clinical trials. Practical Diabetes Int. 2002; 19(6); 167-175.

7

A) Necrotic diabetic ulcer to the medial aspect of the patient’s right foot. B) Debridement in the operating room down to the joint capsule. C) Cytal Wound Matrix technology secured to wound bed with sutures. D) Full-thickness wound healed 13 weeks from the date of surgery.

A

A

D

B

B

C

C

A) Dehiscence to the lateral surgical wound that was present for six weeks and was not responsive to standard wound care. B) Initial application of MicroMatrix. C) Wound closure after four weeks of treatment.

Images reprinted with permission from Elsevier.


In this retrospective series of severe and complex wounds, the authors reviewed the cases of three patients managed with MicroMatrix and/or Cytal Wound Matrix technology*. Wounds included a dehiscence of a superior lateral surgical wound to the foot, a necrotic DFU, and a full-thickness DFU probed to bone of the fifth metatarsal head. These wounds previously underwent standard and advanced wound care modalities and had stalled. Authors observed management with MicroMatrix and/or Cytal Wound Matrix technology led to epithelialization of recalcitrant, complex, chronic wounds involving tunneling or exposed joint capsules. Repeated applications of ACell wound management devices led to epithelialization in all patients, including those with multiple comorbidities. Authors observed limited formation of scar tissue by 13 weeks post-first application.

Kimmel H, Rahn M, Gilbert TW§. The Journal of the American College of Certified Wound Specialists. 2010 Nov 30;2(3):55-9. doi: 10.1016/j.jcws.2010.11.002.

The clinical effectiveness in wound healing with extracellular matrix derived from porcine urinary bladder matrix: a case series on severe chronic wounds.

* Actual device utilized in the case was a Gentrix Surgical Matrix device. The base technology and process employed during the manufacturing of Gentrix Surgical Matrix devices is equivalent to the base technology and process employed during the manufacturing of Cytal Wound Matrix 3- and 6-layer devices. Cytal Wound Matrix devices are fenestrated while Gentrix Surgical Matrix devices are unfenestrated.

8

Medicare claims data from 2011-2014 were used to compare relative product cost and clinical advanced wound therapy for management of DFU outcomes for four products: Cytal Wound Matrix, OASIS® Wound Matrix, Apligraf®, and Dermagraft.

Data from the Centers for Medicare & Medicaid Services (CMS) Standard Analytical Files (SAF) were used for analysis. Data was gathered from patients diagnosed with a foot ulcer, diabetes, and who had not had any foot ulcer claims for 60 days or more prior. Each episode had to last 30 days or more to eliminate any wounds that were easily healed. Costs, episode length, amputation rate, and product utilization were compared.

A total of 13,193 skin substitute treatment cases from 814 hospitals were investigated. The authors observed from their analysis the Apligraf and Dermagraft groups had a statistically significant longer episode length. Authors also observed in episodes where two skin substitutes were used, the incidence of Cytal as the second treatment increased, suggesting it was used after a previous advanced wound care modality had failed. It was also noted that there was an increased incidence of Cytal use in patients with osteomyelitis and gangrene indicating Cytal was chosen for more complicated cases. In addition, the Cytal group had the lowest average cost per DFU episode.

Martinson M, Martinson N. Journal of Wound Care. 2016 Oct 1;25(Sup 10)S8-S17. doi: 10.12968/jowc.2016.25.Sup10.S8.

A comparative analysis of skin substitutes used in the management of diabetic foot ulcers.

• The MicroMatrix/Cytal treatment group had the lowest average cost per DFU episode.

• Apligraf and Dermagraft had significantly longer episode lengths.

$0

$3,000

$6,000

$9,000

$12,000

$15,000

Average Cost of Materials

MicroMatrix/Cytaln=279

Apligrafn=4926

Dermagraftn=5530

OASISn=2458

$1,500$1,800

$5,700

$14,700

Average Cost of Materials

Patient Population Characteristics

Characteristics All Patients Diabetic (n=9) Nondiabetic (n=9)

Age (y) 51.8 (±2.6) 55.8 (±1.3) 46.8 (±4.7)

BMI (lb/in2) 35.1 (±1.8) 37.6 (±2.6) 32.5 (±2.4)

Initial wound area (cm2) 6.5 (±1.7) 8.3 (±2.9) 3.8 (±1.2)

Smoker 13.0 (72%) 6 (33%) 7 (39%)

9

In this prospective case-control study, the authors intended to determine whether the macrophage phenotype related gene expression after management with MatriStem UBM would differ in diabetic patients compared to nondiabetic patients. The study reviewed 18 patients (9 diabetic and 9 nondiabetic) with open wounds that had not previously been treated with a biologic scaffold. More than 70% of the patients were smokers with a mean patient age of 51.8 and a mean BMI of 35.1. A sample of the initial debridement was saved for each patient prior to management with MicroMatrix and/or Cytal Wound Matrix 1-Layer wound management devices. Another wound debridement sample was taken 7-14 days post device-application. Using the pre- and post-treatment samples, the relative gene expression of M1 (pro inflammatory) and M2 (pro-remodeling) macrophages was measured from both the diabetic and nondiabetic patients and the M1:M2 ratio was calculated. Diabetic patients in this study exhibited a significantly higher M1:M2 score pre-treatment compared to post-treatment. The M1:M2 score was reduced to similar levels in both diabetic and nondiabetic patients following UBM wound management. Application of UBM was associated with statistically significant wound size reduction in both patient groups with a 35% ± 14 percent reduction in the diabetic and a 43% ± 18 percent reduction in the non-diabetic patients (p<0.05), with all but one diabetic patient exhibiting some magnitude of wound closure. The magnitude of the decrease in the M1:M2 score correlated with the rate of wound area reduction. Authors conclude that UBM has the potential to restore a normal inflammatory response in diabetic patients, suggesting that management with UBM in diabetic patients may result in healing rates similar to nondiabetic patients.

Paige JT, Kremer M, Landry J, Hatfield SA, Wathieu D, Brug A, Lightell DJ, Spiller KL, Woods TC. Regenerative Medicine. 2019 May;14(4):269-277. doi: 10.2217/rme-2019-0009. Epub 2019 Apr 25.

Modulation of inflammation in wounds of diabetic patients treated with porcine urinary bladder matrix.

M1:M2 scores pre and post management with MatriStem UBM devices for diabetic and nondiabetic patients.

Pre-Management M1:M2 Score Post-Management M1:M2 Score Decrease in M1:M2 Score

Diabetic 4.42 (±0.58) 2.075 (±0.94) 2.89 (±0.68)

Nondiabetic 2.06 (±0.74) 1.67 (±0.75) 0.66 (±0.53)


Note: Per the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Section 814.3, the FDA defines pediatric patients as persons aged 21 years or younger at the time of their diagnosis or treatment. The utilization of this article in promotional materials is not meant to infer or imply that ACell medical devices are cleared or approved for use in individuals younger than 22 years of age. This article contains scientific information relevant to the adult population (≥22 years) where urinary bladder matrix (UBM) may assist in restoring a host tissue immune response seen in diabetic patients to one similar to that of nondiabetic patients.

10

A B

A) Dehisced right hallux with hardware exposure. B) At 3-month follow-up, wound closure achieved with Cytal Wound Matrix.

A) Previous partial foot amputation with failure to heal. B) Status post revision of the partial foot amputation after endovascular intervention and application of Cytal Wound Matrix.

02

Application of Extracellular Matrix Product in Limb Salvage in A Patient with History of Lower Extremity Amputation

Citation: Jillian Irwin and Roger Kilfoil. “Application of Extracellular Matrix Product in Limb Salvage in A Patient with History of

Lower Extremity Amputation”. EC Orthopaedics RCO.01 (2019): 01-03.

foot wound (Figure 1). Her surgical history includes left be-low-knee amputation, carotid endarterectomy and AV fistu-la creation. In order for this patient to continue to ambulate with left prosthetic device or even transfer to a wheelchair, a right lower extremity salvage was imperative. It is also well known that the life expectancy of diabetics with am-putations is decreased (4). In addition, the patient experi-enced significant pain and tenderness to the right foot. The patient was treated by a hospitalist who managed her insu-lin while in the hospital, however the patient’s diabetes is primarily managed outpatient by an endocrinologist. Her most recent hemoglobin A1C is 6.8%. She was also seen by a nephrologist and received hemodialysis treatment while in the hospital. A vascular surgeon performed a right lower extremity angiogram with balloon angioplasty of the pero-neal and superficial femoral arteries, increasing the ability for wound healing upon revision of the partial foot ampu-tation. A revision transmetatarsal amputation was then performed. The surgical site was confirmed to be void of necrosis and infection and UBM was applied to the surgical amputation site. Three weeks following graft application and the wound base had a viable, granular, non-infected tissue covering the remaining metatarsal bone (Figure 2). The patient had significant improvement in tenderness at the surgical site as well, which may be attributed to the in-creased blood flow to the area due to the angioplasty. Take-home points:

1. Interdisciplinary approach to diabetic care can avoid future amputations

2. Proper treatment of underlying comorbid health problems such as peripheral vascular disease enhanc-es wound healing

3. Advanced wound products such as ECM products can enhance or augment wound healing

The above case is an example of a patient now receiving standard of care treatment of her underlying conditions. Previous doctors likely attempted limb salvage of her left lower extremity prior to amputation. There is speculation that she may not have received adequate care at the time due to any number of factors: patient noncompliance, fail-ures in patient education, or poor overall management of her underlying comorbidities and wound car. Once present-Figure 1: Previous partial foot amputation with failure to heal.

Figure 2: Status post revision of the partial foot amputation after endovascular intervention and application of ECM.

02

Application of Extracellular Matrix Product in Limb Salvage in A Patient with History of Lower Extremity Amputation

Citation: Jillian Irwin and Roger Kilfoil. “Application of Extracellular Matrix Product in Limb Salvage in A Patient with History of

Lower Extremity Amputation”. EC Orthopaedics RCO.01 (2019): 01-03.

foot wound (Figure 1). Her surgical history includes left be-low-knee amputation, carotid endarterectomy and AV fistu-la creation. In order for this patient to continue to ambulate with left prosthetic device or even transfer to a wheelchair, a right lower extremity salvage was imperative. It is also well known that the life expectancy of diabetics with am-putations is decreased (4). In addition, the patient experi-enced significant pain and tenderness to the right foot. The patient was treated by a hospitalist who managed her insu-lin while in the hospital, however the patient’s diabetes is primarily managed outpatient by an endocrinologist. Her most recent hemoglobin A1C is 6.8%. She was also seen by a nephrologist and received hemodialysis treatment while in the hospital. A vascular surgeon performed a right lower extremity angiogram with balloon angioplasty of the pero-neal and superficial femoral arteries, increasing the ability for wound healing upon revision of the partial foot ampu-tation. A revision transmetatarsal amputation was then performed. The surgical site was confirmed to be void of necrosis and infection and UBM was applied to the surgical amputation site. Three weeks following graft application and the wound base had a viable, granular, non-infected tissue covering the remaining metatarsal bone (Figure 2). The patient had significant improvement in tenderness at the surgical site as well, which may be attributed to the in-creased blood flow to the area due to the angioplasty. Take-home points:

1. Interdisciplinary approach to diabetic care can avoid future amputations

2. Proper treatment of underlying comorbid health problems such as peripheral vascular disease enhanc-es wound healing

3. Advanced wound products such as ECM products can enhance or augment wound healing

The above case is an example of a patient now receiving standard of care treatment of her underlying conditions. Previous doctors likely attempted limb salvage of her left lower extremity prior to amputation. There is speculation that she may not have received adequate care at the time due to any number of factors: patient noncompliance, fail-ures in patient education, or poor overall management of her underlying comorbidities and wound car. Once present-Figure 1: Previous partial foot amputation with failure to heal.

Figure 2: Status post revision of the partial foot amputation after endovascular intervention and application of ECM.

A B

Images published by EC Orthopaedics, licensed under CC BY 4.0

In this case study review, a 73-year-old patient presented with gangrene to her transmetatarsal amputation foot stump and failure to heal foot wound. The patient has a history of diabetes type II, peripheral vascular disease, arrhythmia, carotid stenosis, hypertension, end stage renal disease, and a left below-knee amputation. A vascular surgeon performed a right lower extremity angiogram with balloon angioplasty of the peroneal and superficial femoral arteries. Cytal Wound Matrix was applied to the surgical site once it was void of necrosis and infection. At the three week follow-up, the wound bed had viable, granular tissue covering the metatarsal bone. The patient also experienced improvement in tenderness at the surgical site.

Bui RD, Lam K, Panchbhavi VK. Efficacy of a urinary bladder matrix for treating wound dehiscence with hardware exposure in a patient with rheumatoid arthritis. Wounds. 2020 Apr;32(4):E27-E30; pmid: 32335519.

Irwin J, Kilfoil R. Application of extracellular matrix product in limb salvage in a patient with history of lower extremity amputation. EC Orthopaedics Researcher’s Column. 2019;01-03.

Efficacy of a urinary bladder matrix for treating wound dehiscence with hardware exposure in a patient with rheumatoid arthritis

Application of extracellular matrix product in limb salvage in a patient with history of lower extremity amputation.

This publication reviews a case study involving a patient, with a past history of hypothyroidism, osteoporoses, and rheumatoid arthritis, who experienced wound dehiscence of the right great toe and exposure of surgical hardware complicated by infection. The patient, who two weeks prior, had undergone right great toe arthrodesis, metatarsal neck osteotomies, extensor tendon lengthening, and capsulotomy of the second, third, fourth, and fifth toes, presented with suture pull out at the surgical incision site. Intravenous vancomycin was given to manage the patient's infection. Negative pressure wound therapy was used for 10 days, but discontinued due to poor suction caused by the location and irregular contour of the wound. Cytal Wound Matrix 1-layer was then applied to the wound. The Cytal was in place for 7 days before the patient was discharged. The patient was told to keep the wound and dressing dry and intact for 2 weeks and then to change the dressing every other day. The wound was closed at the 3-month follow-up without any drainage or infection. No further follow-up was needed.

ACell, Inc.6640 Eli Whitney Drive Columbia, MD 21046 800-826-2926

www.acell.com

MK-0267.06 | 20201822307-1-EN

Rx ONLY Refer to IFU supplied with each device for indications, contraindications, and precautions. US Toll-Free 800-826-2926 • www.acell.com © 2020 ACell, Inc. All Rights Reserved.

Integra® is a registered trademark of Integra LifeSciences CorporationREGRANEX™ is a trademark of Smith & Nephew, Inc.OASIS® is a registered trademark of Cook Biotech, Inc.Apligraf® is a registered trademark of NovartisDermagraft® is a registered trademark of Organogenesis, Inc.

MatriStem UBM™ is a trademark of ACell, Inc.Cytal® is a registered trademark of ACell, Inc.MicroMatrix® is a registered trademark of ACell, Inc.

wound literature compendium

Documents