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A Reprint from Surgical Technology International Volume 30 USE OF AN O VINE COLLAGEN DRESSING WITH INTACT EXTRACELLULAR MATRIX TO IMPROVE WOUND CLOSURE TIMES AND REDUCE EXPENDITURES IN A US MILITARY VETERAN HOSPITAL OUTPATIENT WOUND CENTER DANIEL T. FERRERAS, DPM, FAPWCA, AAWC CHIEF/LEAD PODIATRIST SURGICAL SERVICES CARL VINSON VA MEDICAL CENTER DUBLIN,GEORGIA SEAN CRAIG, RN, CWCN WOUND CARE NURSE NURSING ALEXANDRIA VA HEALTH CARE SYSTEM PINEVILLE,LOUISIANA REBECCA MALCOMB, RN RN CARE MANAGER FOR PRIMARY CARE NURSING ALEXANDRIA VA HEALTH CARE SYSTEM PINEVILLE,LOUISIANA

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Page 1: USE OF AN VINE OLLAGEN DRESSING WITH NTACT EXTRACELLULAR … · a reprint from surgical technology international volume 30 use of an ovine collagen dressing with intact extracellular

A Reprint from Surgical Technology International Volume 30

USE OF AN OVINE COLLAGEN DRESSING WITH INTACTEXTRACELLULAR MATRIX TO IMPROVE WOUND CLOSURETIMES AND REDUCE EXPENDITURES IN A US MILITARYVETERAN HOSPITAL OUTPATIENT WOUND CENTER

DANIEL T. FERRERAS, DPM, FAPWCA, AAWCCHIEF/LEAD PODIATRISTSURGICAL SERVICES

CARL VINSON VAMEDICAL CENTERDUBLIN, GEORGIA

SEAN CRAIG, RN, CWCNWOUND CARE NURSE

NURSINGALEXANDRIA VA HEALTH CARE SYSTEM

PINEVILLE, LOUISIANA

REBECCA MALCOMB, RNRN CARE MANAGER FOR PRIMARY CARE

NURSINGALEXANDRIA VA HEALTH CARE SYSTEM

PINEVILLE, LOUISIANA

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AAnovel, comprehensive decision-making and treatment algorithm was established within a US govern-

ment-run military veteran hospital in an attempt to standardize the process of outpatient wound care

and streamline costs. All patients were systematically evaluated and treated using the comprehensive

algorithm over a span of nine months. After three months of adherence to the algorithm, the algorithm was

modified to include ovine-based collagen extracellular matrix (CECM) dressings as a first-line conventional

treatment strategy for all appropriate wounds. The purpose of this retrospective analysis was to evaluate the

hospital’s change in cellular and/or tissue-based graft usage and cost, as well as wound healing outcomes fol-

lowing modification of the wound care standardization algorithm. Data from the first quarter (Q1; three

months) of protocol implementation were compared to the subsequent two quarters (six months), during

which time the first-line dressing modification of the protocol was implemented. Results showed that

between quarters 1 and 3, the percentage of wounds healed increased by 95.5% (24/64 to 80/109), and the

average time to heal each wound decreased by 22.6% (78.8 days to 61.0 days). Cellular and/or tissue-based

Use of an Ovine Collagen Dressing withIntact Extracellular Matrix to ImproveWound Closure Times and Reduce

Expenditures in a US Military VeteranHospital Outpatient Wound Center

DANIEL T. FERRERAS, DPM, FAPWCA, AAWCCHIEF/LEAD PODIATRISTSURGICAL SERVICES

CARL VINSON VA MEDICAL CENTERDUBLIN, GEORGIA

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ABSTRACT

Advanced Wound HealingSURGICAL TECHNOLOGY INTERNATIONAL Volume 30

SEAN CRAIG, RN, CWCN WOUND CARE NURSE

NURSINGALEXANDRIA VA HEALTH CARE SYSTEM

PINEVILLE, LOUISIANA

REBECCA MALCOMB, RNRN CARE MANAGER FOR PRIMARY CARE

NURSINGALEXANDRIA VA HEALTH CARE SYSTEM

PINEVILLE, LOUISIANA

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Chronic ulcers affect more than 6.5million people in the US and are amajor growing health problem due toan aging population, increasing healthcare costs, and a steep rise in diabetesand obesity worldwide.1 The prevalenceof venous insufficiency ulcers in the USis approximately 600,000 annually,2 andvenous leg ulcers (VLU) account for atleast 70% of all chronic ulcers found onthe lower leg.2,3 In 2014, approximately22 million people in the US were livingwith diagnosed diabetes,4 and, of thesediabetics, an estimated 10–15% willdevelop a foot ulcer during their life-time.5 These foot ulcers represent asubstantial cost burden, estimated at aone-year cost of over $9 billion amongUS Medicare beneficiaries with dia-betes.6 In 2013, the average cost oftreating a diabetic foot ulcer (DFU)patient was approximately $49,209 forthe two-year period after diagnosis.5Compared to matched non-VLUpatients, a large database analysisshowed VLU patients incurred annualincremental medical costs of $6,391 inMedicare costs and $7,030 in privateinsurance costs, suggesting an annual USpayer burden of $14.9 billion forVLUs.7A focus on reductions in acute care

spending has transferred care to theoutpatient setting, and a growing num-ber of hospitals are offering outpatientwound services as part of this cost shift-ing. Currently, there are more than1,000 outpatient wound care centers inthe United States8 with alarming esti-mated annual expenditures on woundcare services of over $50 billion.9 Theseexpenditures have captured the atten-tion of US Centers for Medicare andMedicaid Services (CMS) administra-tors who have been moving to gain con-trol of the overwhelming costs ofoutpatient wound services. CMS intro-

duced several sweeping cost saving mea-sures in 2014, and there is a major shiftunderway toward value-based pay-ments, versus the present fee-for-ser-vice payments.10,11Along similar lines of quality

improvement and cost savings, withinthe US Veterans Affairs (VA) hospitalsystem, there has been a major pushtoward standardization since the August2001 launch of a Healthcare FailureMode and Effect Analysis (HFMEA)process.12 HFMEA is a five-step processthat uses an interdisciplinary team toproactively evaluate a health careprocess. It involves process flow dia-gramming, a hazard scoring matrix, anda decision tree to identify and assesspotential vulnerabilities. This standard-ization process was originally designedto assess and address prospective risk ofa health care process to enhance safety,but the process is now also used tostreamline cost.Basic tenets of HFMEA were used to

standardize the process of wound carewithin a US VA hospital in an attempt toimprove outcomes and reduce cost.Prior to standardizing the wound careprocess in this VA hospital, inpatientand outpatient wound care was per-formed on all floors and in all depart-ments by numerous physicians andclinicians with varying levels of woundcare training. A substantial proportionof hospital expenditures were spent onwound care, outcomes were nottracked, and patients were regularly lostto follow-up. Diabetic foot and venousleg ulcers were reported causes ofextended lengths of stay and increasedemergency department admissions. Fol-lowing committee analysis of the prob-lem, a wound healing center wasestablished within the hospital and atwo-part wound care standardizationalgorithm was developed and imple-mented. Goals of the wound healing center

and the algorithm were to standardize

wound care efforts and product usagethroughout the facility, to increase therate of wound resolution, and todecrease overall expenditures on woundcare. After three months of adherenceto the algorithm, the algorithm wasmodified to include an ovine-based col-lagen extracellular matrix dressing(CECM; Endoform® dermal template,Hollister Incorporated, Libertyville, Illi-nois) as a first-line treatment strategyfor all appropriate wounds based on itsunderstood effects in reducing elevatedmetalloproteinases (MMPs)13 and itsrelatively low cost. The purpose of thisretrospective analysis was to evaluatethe hospital’s change in cellular and/ortissue-based graft usage and cost, as wellas wound healing outcomes followingmodification of a wound care standard-ization algorithm to include CECMdressings as a first-line treatment strate-gy.

Materials and Methods

A 1,150 ft2 outpatient wound healingcenter was established within the VAhospital, and all ancillary departmentswere educated about the wound healingcenter services and how to referpatients to the center. A dual algorithmthat combined decision-making andwound treatment protocols was devel-oped and implemented by the woundhealing center program director (DanielT. Ferreras) (Fig. 1). Wound healingstaff members were educated about thesystematic use of the algorithm for eachpatient.

Decision protocolPart one of the algorithm (Decision

Protocol) is a decision tree honoring thefundamentals of wound care and wasused to determine that both the patientand wound bed were ready for treat-ment. The Decision Protocol was based

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Use of an Ovine Collagen Dressing with Intact Extracellular Matrix to Improve Wound Closure Times and Reduce Expenditures in a US Military VeteranHospital Outpatient Wound CenterFERRERAS/CRAIG/MALCOMB

INTRODUCTION

MATERIALS AND METHODS

graft unit usage decreased by 59.7% (144 units to 58 units), and expenditures on cellular and/or tissue-based

grafts decreased by 66.0% ($212,893 to $72,412). Results of this analysis displayed a trend toward decreased

expenditures, faster healing times, and a greater number of healed wounds following modification of an evi-

dence-based algorithm to incorporate CECM dressings as a first-line treatment strategy in managing chronic

wounds.

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Advanced Wound HealingSURGICAL TECHNOLOGY INTERNATIONAL Volume 30

Figure 1. Dual protocol algorithm.

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on five fundamental factors necessaryfor wound healing: optimized perfusion(compression when needed), offloadingproperly, control of infection/biobur-den, debridement of devitalized tissue,and balanced nutrition according to thespecific needs of the patient.14-18 Each ofthese fundamentals was addressed bythe wound healing team through sys-tematic use of the decision protocol.Once the fundamentals were addressed,

and if the patient did not have a first orsecond degree burn or exposedtendon,19 the patient could proceed tothe treatment protocol.

Treatment protocolPart two of the algorithm (Treat-

ment Protocol) was used to guidetreatment for each patient once thewound and patient were prepared. Forthe first three months after algorithm

implementation, oxidized regeneratedcellulose (ORC)/collagen dressingswere used as first-line conventionaltreatment for all appropriate chronicwounds. Based on the needs of ourchronic wound population and grow-ing evidence implicating MMP imbal-ances as a critical factor in stalledwounds,20 a decision was made toswitch to CECM dressings as a first-line conventional treatment strategyafter three months (beginning of quar-ter 2). Silicone fenestrated gauze or anantibacterial foam dressing bound withgentian violet and methylene blue(GV/MB) (Hydrofera Blue®; HollisterIncorporated, Libertyville, Illinois)was used as a cover over the CECMdressing, and paper tape was used tosecure the cover dressing. The areawas wrapped with a latex-free con-forming stretch bandage and a lightfour inch self-adherent elastic wrap asneeded.Compression stockings and appro-

priate off-loading strategies (controlledankle movement walker boot, offload-ing padding, and total contact cast)were used as needed. At weekly fol-low-up appointments, diet wasreviewed, and wounds were debridedand irrigated as necessary. Changes ingranulation tissue and wound dimen-sions were recorded, and wounds werephotographed using a 16 megapixeldigital camera system.21 Wounds werereassessed at four, eight, and 12 weeksfor progress. If the wound size continued to con-

tract after four to five weeks of con-ventional treatment, CECM dressingsremained the pr imary dressing. Ifwound contraction stalled or woundsize increased after four to five weeks,a cellular and/or tissue-based graft waschosen in lieu of CECM dressings toreach our resolution endpoint. Theselection of cellular and/or tissue-based products was varied and includ-ed cryopreserved placental membrane,dehydrated human amnion/chorionmembrane allograft, human fibroblast-derived skin substitute, living bi-lay-ered skin substitute, and fetal bovinedermal scaffold materials. Acceptable change in wound-base

quality was defined as beefy red granu-lation tissue, limited or no hypergranu-lation, and no wound edge epibole.The wound was considered resolvedwhen there was 100% re-epithelializa-tion and no drainage.

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Use of an Ovine Collagen Dressing with Intact Extracellular Matrix to Improve Wound Closure Times and Reduce Expenditures in a US Military VeteranHospital Outpatient Wound CenterFERRERAS/CRAIG/MALCOMB

Table IPatient demographics and outcomes

Q1 Sept-

Nov. 2014

Q2Dec. 2014-Feb. 2015

Q3Mar-

May 2015

Patients (n)Male, n (%)Female, n (%)

7976 (96.2)3 (3.8)

7876 (97.4)2 (2.6)

7371 (97.2)2 (2.7)

Average age (years) 66.5 64.5 65.4

Wounds treated (n)DFU, n (%)VLU, n (%)Heel PrU, n (%)

6435 (54.7)25 (39.1)4 (6.2)

8465 (77.4)17 (20.2)2 (2.4)

10982 (75.2)21 (19.3)6 (5.5)

Clinic visits (n) 274 343 336

Healed wounds (n;%)DFU, n (%)VLU, n (%)Heel PrU, n (%)

24 (37.5)18 (51.4)3 (12.0)3 (75.0)

55 (65.5)44 (67.7)9 (52.9)2 (100.0)

80 (73.3)61 (74.3)16 (76.2)3 (50.0)

Average time to heal, days(weeks)DFU, n (%) (weeks)VLU, n (%) (weeks)Heel PrU, n (%) (weeks)

78.8 (11.3)

74.2 (10.6)86.1 (12.3)73.5 (10.5)

77.2 (11.0)

67.9 (9.7)115 (16.5)57.4 (8.2)

61.0 (8.7)

52.5 (7.5)99 (14.2)44.1 (6.3)

Table IIDressing usage and expenditures

Q1 Sept-

Nov. 2014

Q2Dec. 2014-Feb. 2015

Q3Mar-

May 2015

Cellular and/or tissue-based graftunits used (n)

CECM units used (n)

Total cost of cellular and/or tis-sue-based grafts ($US)

Avg. cellular and/or tissue-basedgraft cost/treated ulcer ($US)

Total cost of CECM units ($US)

144

0

212,893

3,326

0

84

50

115,096

1,370

1,363

58

40

72,412

664

1,253

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Data analysisDemographic, dressing usage, and

outcomes data from September 15,2014 to May 31, 2015 were retrospec-tively extracted from the electronicmedical records, and entered into anExcel® (Microsoft Inc., Redmond,Washington) spreadsheet to calculatetotals and averages. Endpoints measuredwere number of healed wounds, time toheal, and cost and units used of cellularand/or tissue-based grafts and CECMdressings. Data from the first quarter(three months) of protocol implementa-tion were compared to the subsequenttwo quarters (six months) during whichtime the first-line dressing modificationof the protocol was implemented.

Results

Patient demographics and outcomesare listed by quarter in Table I. Thetotal number of patients treated andaverage age were similar during allthree quarters. The number of woundstreated increased by 70.3% (64 in Q1to 109 wounds in Q3) and the numberof clinic visits increased by 22.6% (274in Q1 to 336 visits in Q3) betweenquarter one and three. During this sametimeframe, the percentage of woundshealed increased by 95.5% (24/64[37.5%] in Q1 to 80/109 [73.3%] inQ3), and the average time to heal eachwound decreased by 22.6% (78.8 daysin Q1 and 61.0 days in Q3).Between quarters 1 and 3, cellular

and/or tissue-based graft unit usagedecreased by 59.7% (144 units in Q1 and58 units in Q3), and expenditures on cel-lular and/or tissue-based grafts decreasedby 66.0% ($212,893 in Q1 and $72,412in Q3) (Table II, Figs. 2 and 3).

Case Studies

Case Study 1: Diabetic foot ulcersin a patient with peripheralvascular diseaseA 60-year-old male presented with

diabetic foot ulcers on the hallux andsecond digit of his left foot (Figs. 4a and4b). The man had type 2 diabetes with amedical history of neuropathy, syncopalevents, sleep apnea, obesity, anemia,depression, peripheral vascular disease(PVD), coronary arteriosclerosis, acute

osteomyelitis of the lower extremity(left), monoclonal paraproteinemia, andretinal detachment (legally blind). Thewounds were ultrasonically debrided atinitial presentation to remove eschar.Patient and wound preparation includ-ed attention to daily diet, noninvasivevascular diagnostic testing (arterialduplex ultrasound, CT-angiography),vascular intervention with stents, andmental/spiritual counseling.After wound bed preparation, a

CECM dressing was applied with aGV/MB foam dressing as a cover dress-ing. The foot was offloaded with a post-operative surgical shoe, and wounds

were surgically debrided at each weeklydressing change. At week nine, a bi-lay-ered skin substitute was applied to thewound (Fig. 4c) in an attempt to speedresolution. CECM dressings were con-tinued after the bi-layered skin substi-tute, and a fetal bovine dermal repairscaffold (rich in type III collagen) wasplaced on week 12 to help speedrestoration of the collagen-rich woundbed after the patient sustained a deepinjury to the foot ulcers and set woundhealing backward several weeks. CECMdressings were continued (Figs. 4d and4e) until both ulcers were fully healedat 6 1/2 months (Fig. 4f).

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Advanced Wound HealingSURGICAL TECHNOLOGY INTERNATIONAL Volume 30

Figure 2. Cellular and/or tissue-based graft/CECM unit usage and wounds healed over time.

Figure 3. Cellular and/or tissue-based graft and CECM unit expenditures over time.

RESULTS

CASE STUDIES

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Case Study 2: Bilateral diabeticfoot ulcers in a patient on anti-coagulant therapyA 64-year-old diabetic male present-

ed with three diabetic foot ulcers underthe metatarsal heads on the plantaraspects of both feet (Figs. 5a and 5b).Wounds had been present for four to fiveweeks. The patient was diabetic with ahistory of neuropathy, multiple typehyperlipidemia, PVD, hypertension,nicotine dependence, non-complianceissues, vitamin B-12 deficiency, coagula-tion therapy (treated with warfarin),depressive disorder, iron deficiency,coronary artery disease, pes cavus feet,varicose veins, and sleeplessness.

Wounds were mechanically andultrasonically debrided. CECM dress-ings (2 x 2 cm) were sized and placed inall ulcers and GV/MB dressings (2.5 x2.5 cm) were used as cover dressings.Both feet were offloaded with wedgeoffloading shoes. CECM dressings wereapplied once per week with weekly pro-gression measured at each dressingchange (Figs. 5c–5g). At each monthlyevaluation, all ulcers achieved adequatewound healing progression (40 to 50%smaller) to continue with CECM dress-ings for the duration of therapy. Theright foot ulcer was fully healed at eightweeks and the left foot ulcers werehealed at six weeks.

Case Study 3: Post-amputationwound dehiscence in a diabeticpatientA 78-year-old male presented with a

dehisced incision (Fig. 6a) following lefthallux amputation 10 weeks prior. Thepatient was type 2 diabetic with a histo-ry of chronic congestive heart failure,atr ial fibrillation, obesity, chronicobstructive pulmonary disease, hyper-lipidemia, anemia, PVD, hypothy-roidism, hypertension, age-relatedmacular degeneration, benign prostatichyperplasia, and insomnia. The woundhad been treated with negative pressurewound therapy (NPWT) for two weeksprior to presentation. The patient wore

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Use of an Ovine Collagen Dressing with Intact Extracellular Matrix to Improve Wound Closure Times and Reduce Expenditures in a US Military VeteranHospital Outpatient Wound CenterFERRERAS/CRAIG/MALCOMB

Figure 4. a) and b) At presentation, eschar-covered ulcers on the left hallux and second digit measured 9.5 x 2.0 cm and 4.5 x 3.5 cm, respectively. CECM dress-ings were initiated with a GV/MB foam cover dressing. c) Bi-layered skin substitute applied at nine weeks. CECM dressings were continued subsequently. d) DFUsafter three months of CECM dressings and two skin substitute applications. e) Ulcers nearly re-epithelialized at five months. f) At 6 1/2 months, ulcers are com-pletely healed.

Figure 5. a) and b). Diabetic foot ulcers on right and left foot at presentation. c) Right foot ulcer edges are flattened after three weeks of CECM dressings. d) Atseven weeks, right foot ulcer is nearly re-epithelialized. e) At eight weeks, right foot ulcer is healed. f) CECM dressing shown in left foot ulcer. g) Both left foot dia-betic ulcers are 100% re-epithelialized after six weeks of CECM dressings.

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a post-surgical shoe and ambulated in awheelchair. Excisional and ultrasonic debride-

ment were performed, (Fig. 6b) andCECM dressings with a polyvinyl alco-hol GV/MB foam dressing cover wereinitiated in tandem with NPWT, under-neath the NPWT foam dressing. CECMdressings were applied once per weekthroughout treatment. Fig. 6c shows thewound after two weeks. Cryopreservedplacental membrane grafts were placedwith NPWT at weeks four and five.CECM dressings were continued andthe wound volume was markedlydecreased at weeks eight (Fig. 6d) and12 (Fig. 6e). At week 16, a humanamniotic membrane allograft wasplaced over the remaining wound areas,and CECM dressings were continued(Fig. 6f) until complete closure at 22weeks (Fig. 6g).

Discussion

This retrospective analysis displayeda clear trend toward decreased expendi-tures, faster healing times, and a greaternumber of healed wounds followingimplementation and modification of analgorithm to incorporate CECM dress-ings as first-line treatment of chronicwounds. While there were substantialincreases from quarter to quarter in thenumber of wounds treated, as well asclinic visits and percent of woundsclosed, expenditures on cellular and/ortissue-based grafts decreased by$140,481 between the first and thirdquarter.Although the incremental effect of

each of the implemented changes is

unknown, these authors propose multi-ple factors that likely contributed toimproved outcomes and lower costs.During the first quarter of operation,the number of patients was greater thanthe number of wounds treated becauseseveral patients who did not have awound were consulted by primary-carephysicians to be seen by the wound cen-ter for general podiatry services likepartial nail avulsions. After the woundhealing center sent out a specialreminder delineating the scope of prac-tice, services offered, and days/hours ofoperation, staff members began to bet-ter direct appropriate patients to thecenter.Also, once a dedicated wound center

staff was assembled and educatedregarding the algorithm for decision-making and treatment, wound manage-ment became consistent and could betracked. The two-part algorithm wasdeveloped to incorporate pivotalwound healing concepts that have beenshown over the past 13 years to con-tribute positively to wound manage-ment from dermal defect to completeclosure. Evidence-based modalities,such as offloading boots, were consis-tently incorporated into the manage-ment strategies and appeared toinfluence outcomes over time. Establishing a target healing timeline

may have improved results as well. Forvenous leg ulcers, a 20–40% reductionin wound area within two to four weekshas been found to be predictive of heal-ing,22 whereas for diabetic foot ulcers, areduction of >50% by week four is pre-dictive of healing.23-25 We added oneweek to our algorithm, making it a fourto five week timeframe before switch-ing to a new dressing/therapy, to allow

for real world uncontrollable factorslike patient compliance, missed appoint-ments, or other random events. Settingsuch quality measures will be a necessi-ty for wound center survival in thefuture scenario of value-based reim-bursement. CECM dressing characteristics may

also have contributed to the improvedoutcomes and lower costs observed inQ2 and Q3. The dressings are madefrom propria submucosa of ovineforestomach tissue using proprietaryprocesses to delaminate and decellular-ize the tissue.13,26 They consist of natur-al, intact collagen, including types I, III,and IV, as well as secondary ECM com-ponents such as elastin, fibronectin,laminin, and glycosaminoglycans.27 Thematr ix dressing retains the three-dimensional architecture present in tis-sue ECM27 and has demonstrated broadspectrum matrix MMP reduction.13The new CECM/GV-MB dressing

combination was less expensive perdressing than previously used dressings,but the primary reason for the switchwas that we observed faster healingrates with the use of CECM dressingscompared to our experience withC/ORC dressings. Our outcomes mayalso have been influenced by theantibacterial effects of the GV/MBfoam cover dressings, but the incremen-tal effect of the cover dressings isunknown. In our experience, CECMprovided the strength of a dermal tem-plate but was simple to apply like a stan-dard collagen-based dressing. CECMdressings could be applied as little asonce per week and remained in thewound bed until they were no longervisible, which could save costs com-pared to other collagen dressings that

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Advanced Wound HealingSURGICAL TECHNOLOGY INTERNATIONAL Volume 30

Figure 6. a) and b). Post-amputation wound at presentation and after debridement. c) After two weeks of combined CECM dressings and NPWT. d) After eightweeks of CECM dressings and NPWT and two applications of cryopreserved placental membrane grafts. e) At 12 weeks with CECM dressings. f) At 16 weeks withCECM dressings. g) Wound is fully re-epithelialized at 22 weeks.

DISCUSSION

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require applications up to three timesper week.These authors know of just two case

series that have evaluated the use ofCECM in chronic wounds. Bohn et al.(2014) reported, in a retrospectiveanalysis, that 23 of 23 venous stasisulcers healed in an average of 7.3 weeks(range: 2 to 15 weeks) with the use ofCECM dressings.28 This is considerablyfaster than the average time to healVLUs in our study (14.2 weeks). Inanother series of 19 participants with24 ulcers of various etiologies, themean wound area decrease at 12 weekswith the use of CECM dressings was73.4%.31 Of the 24 wounds, eight(33%) were closed after eight weeks oftreatment and 12 (50%) were closed at12 weeks. Of wounds that closed, meantime to complete closure was 6.8weeks, which is similar to our closurerate for DFUs and faster than our clo-sure rate for VLUs.29 Reasons forlonger and inconsistent times to closurefor VLUs in our study could be due tothe comparatively advanced age of ourpatient population, as well as a historiclack of a specific process to identifyVLUs within the VA system and thetendency for patients with VLUs to bereferred to a VA wound clinic late in thedisease course.30This analysis contains all the inherent

limitations of a retrospective, uncon-trolled, nonrandomized study. Datawere extracted from the first ninemonths of operation, which was asomewhat erratic period as the woundcenter was becoming fully functional.Small “settling in” adjustments weremade throughout the study period thatwere undocumented and could haveinfluenced outcomes. CECM dressingswere introduced into the algorithm inQ2, and it is not possible from the datato know if there was a carryover effectfrom other treatment strategies. Coverdressing use and cost were also not con-sidered in the analysis. Additionally,“wound closure” was tracked over timein quar terly increments, and thepatients treated during each quarterwere not mutually exclusive; therefore,the number of wounds treated in Q1that were resolved in Q2 or Q3 was notdetermined. Clinician bias also mayhave skewed data results with respect toselection for, or timing of, a cellularand/or tissue-based graft. Long-termcontrolled studies are needed to deter-mine the actual incremental effect on

clinical outcome and cost of each of thevariables within the systematic algo-rithm.

Conclusion

This publication describes the firstattempt at implementing an evidence-based wound management algorithmwithin our VA hospital, or any VA facili-ty within our Veterans Integrated Ser-vice Network. Algorithm modificationsincorporating an MMP-modulatingCECM dressing showed improved clini-cal outcomes and reduced advancedgraft expenditures in this VA popula-tion. Our aim in developing a compre-hensive algorithm is that it could serveas a roadmap for other wound care cen-ter directors in and outside of the VAsystem who are looking to decrease theuse of more expensive modalities whileimproving quality of care. Healing wounds more efficiently on

the front-end—through the use of pro-gressive algorithms—to reduce overallcosts on the back-end fits with the cur-rent health care emphasis on evidence-based, outcome driven health caredelivery systems. This pilot study/algo-r ithm is novel in the VA systembecause, compared to non-VA hospital-based outpatient wound care depart-ments in the US, there remains greataccess to advanced wound dressings andtherapies, and administrators have notyet been forced to think of cost contain-ment at every level. The benefits of thisapproach are broad reaching andinclude saving US taxpayer dollars andenhancing military veteran quality ofcare.

Authors’ Disclosures

Daniel Ferreras is a consultant forHollister Incorporated.All other authors have no conflicts of

interest to disclose.

References

1. Sen CK, Gordillo GM, Roy S, et al.Human skin wounds: a major and snowballingthreat to public health and the economy.Wound Repair Regen 2009;17(6):763–71.2. Abbade LP, Lastória S. Venous ulcer: epi-

demiology, physiopathology, diagnosis andtreatment. Int J Dermatol 2005;44(6):449–56.3. Fife C, Walker D, Thomson B, et al. Lim-itations of daily living activities in patientswith venous stasis ulcers undergoing compres-sion bandaging: problems with the concept ofself-bandaging. Wounds 2007;19(10):255–7.4. Center for Disease and Prevention. Dia-betes Public Health Resource [Internet].(Atlanta (GA)]; c 1980-2014 [RevisedDecember 1, 2015]. Available from: http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm.5. Motley TA, Gilligan AM, Lange DL, et al.Cost-effectiveness of clostridial collagenaseointment on wound closure in patients withdiabetic foot ulcers: economic analysis ofresults from a multicenter, randomized,open-label trial. J Foot Ankle Res 2015;8:7. 6. Rice JB, Desai U, Cumming AK, et al.Burden of diabetic foot ulcers for Medicareand private insurers. Diabetes Care 2014;37(3):651–8.7. Rice JB, Desai U, Cummings AK, et al.Burden of venous leg ulcers in the UnitedStates. J Med Econ 2014;17(5):347–56. 8. Shah JB. The history of wound care. J AmCol Certif Wound Spec 2011;3(3):65–6.9. Fife CE, Carter MJ. Wound care out-comes and associated cost among patientstreated in US outpatient wound centers: Datafrom the US Wound Registry. Wounds2012;24:10–7. 10.Fife CE. Reassessing your outpatientwound clinic: Building tomorrow’s woundcare facility today. Today’s Wound Clinic2014;8:12–14,16.11.Fife C. Preparing for a quality-based pay-ment system. Today’s Wound Clinic [serialonline] 2015; Accessed June 16, 2016.12.DeRosier J, Stalhandske E, Bagian JP, etal. Using health care Failure Mode and EffectAnalysis: the VA National Center for PatientSafety’s prospective risk analysis system. JtComm J Qual Improv 2002;28(5):248–67,209.13.Negron L, Lun S, May BC. Ovineforestomach matrix biomaterial is a broadspectrum inhibitor of matrix metallopro-teinases and neutrophil elastase. Int Wound J2014;11:392–7.14.Ennis WJ, Meneses P. Wound Healing.Boca Raton, FL, USA: Taylor and Francis;2005. Comprehensive wound assessment andtreatment system; 59–68.15.Martin, LK, Drosou, A, Kirsner, RS.Wound Healing. Boca Raton, FL, USA: Tay-lor and Francis; 2005. Wound microbiologyand the use of antibacterial agents; 86–8. 16.Biggs, KL, Sykes, MT. Wound Care Prac-tice. (1st edition). Flagstaff, AZ, USA: BestPublishing Co; 2004. Arterial InsufficiencyUlcers; 225. 17.Lavery LA, Armstrong DG, WunderlichRP et al. Risk factors of foot infections in indi-viduals with diabetes. Diabetes Care2006;29(6):1288–93.18.Wauters, AD. Wound Care Practice. (1stedition). Flagstaff, AZ, USA: Best PublishingCo; 2004. Nutrition and Hydration;471–500.

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Use of an Ovine Collagen Dressing with Intact Extracellular Matrix to Improve Wound Closure Times and Reduce Expenditures in a US Military VeteranHospital Outpatient Wound CenterFERRERAS/CRAIG/MALCOMB

REFERENCES

STI

CONCLUSION

AUTHORS’ DISCLOSURES

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19.Ikeda C, Slade B. Wound Care Practice.(1st edition). Flagstaff, AZ, USA: Best Pub-lishing Co; 2004. Thermal Injury; 356–7.20.Schultz GS, Davidson JM, Kirsner RS, etal. Dynamic reciprocity in the woundmicroenvironment. Wound Repair Regen2011;19(2):134–48.21.Romanelli M, Magliaro A. Wound Heal-ing. Boca Raton, FL, USA: Taylor and Fran-cis; 2005. Objective assessment in woundhealing; 672. 22.Flanagan M. Improving accuracy of woundmeasurement in clinical practice. OstomyWound Manage 2003;49(10):28–40.23.Sheehan P, Jones P, Caselli D, et al. Per-cent change in wound area of diabetic footulcers over a 4-week period is a robust predic-

tor of complete healing in a 12-week prospec-tive trial. Diabetes Care 2003;26:1879–82.24.Snyder RJ, Cardinal M, Dauphinée DM, etal. A post-hoc analysis of reduction in diabeticfoot ulcer size at 4 weeks as a predictor ofhealing by 12 weeks. Ostomy Wound Manage2010;56(3):44–50. 25.Lavery L, Seaman JW, Barnes SA, et al.Prediction of healing for postoperative diabet-ic foot wounds based on early wound areaprogression. Diabetes Care 2008;31(1):26–9.26.Irvine SM, Cayzer J, Todd EM, et al.Quantification of in vitro and in vivo angio-genesis stimulated by ovine forestomachmatrix biomaterial. Biomaterials 2011;32(27):6351–61.27.Lun S, Irvine SM, Johnson KD, et al. A

functional extracellular matrix biomaterialderived from ovine forestomach. Biomaterials2010;31(16):4517–29.28.Bohn GA, Gass K. Leg ulcer treatmentoutcomes with new ovine collagen extracellu-lar matrix dressing: a retrospective caseseries. Adv Skin Wound Care 2014;27(10):448–54.29.Liden BA, May BC. Clinical outcomes fol-lowing the use of ovine forestomach matrix(Endoform dermal template) to treat chronicwounds. Adv Skin Wound Care 2013;26(4):164–7.30.Andersen CA, Aung BJ, Doucette M, etal. Improving the standard of care for treatingvenous leg ulcers within the Veterans Admin-istration. Wounds 2012;(Suppl):1–8.

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Advanced Wound HealingSURGICAL TECHNOLOGY INTERNATIONAL Volume 30

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