International Wound Journal ISSN 1742-4801

O R I G I N A L A R T I C L E

Successful treatment of complex traumatic and surgicalwounds with a foetal bovine dermal matrixErnesto Hayn

Plastic Surgery of Palm Beach, Wellington, FL, USA

Key words

Dermal repair; Plastic surgery;Reconstructive surgery; Trauma; Woundhealing

Correspondence to

E HaynPlastic Surgery of Palm Beach10115 W Forest Hill Blvd, #400Wellington, FL 33414USAE-mail: Docehayn@gmail.com

doi: 10.1111/iwj.12028

Hayn E. Successful treatment of complex traumatic and surgical wounds with a foetalbovine dermal matrix. Int Wound J 2014; 11:675–680

Abstract

A foetal bovine dermal repair scaffold (PriMatrix, TEI Biosciences) was used to treatcomplex surgical or traumatic wounds where the clinical need was to avoid skin flapsand to build new tissue in the wound that could be reepithelialised from the woundmargins or closed with a subsequent application of a split-thickness skin graft (STSG).Forty-three consecutive cases were reviewed having an average size of 79·3 cm2,50% of which had exposed tendon and/or bone. In a subset of wounds (44·7%),the implantation of the foetal dermal collagen scaffold was also augmented withnegative-pressure wound therapy (NPWT). Complete wound healing was documentedin over 80% of the wounds treated, whether the wound was treated with the foetalbovine dermal scaffold alone (95·2%) or when supplemented with NPWT (82·4%).The scaffold successfully incorporated into wounds with exposed tendon and/or boneto build vascularised, dermal-like tissue. The new tissue in the wound supportedSTSGs, however, in the majority of the cases (88·3%); wound closure was achievedthrough reepithelialisation of the incorporated dermal scaffold by endogenous woundkeratinocytes. The foetal bovine dermal repair scaffold was found to offer an effectivealternative treatment strategy for definitive closure of challenging traumatic or surgicalwounds on patients who were not suitable candidates for tissue flaps.

Introduction

Treatment options to close challenging skin wounds can varydepending on a number of factors including the size of thewound, tissue structures exposed, level of contamination andvascular perfusion of the site (1–3). The availability, condi-tion and desire to use rotational flaps, free flaps or skin graftsare also important considerations when developing an appro-priate treatment strategy. Moreover, growth factors, decel-lularised animal tissues, cadaveric human dermis, fabricatedcollagen foams, autogenous or allogenic living cells and nega-tive pressure wound therapy (NPWT) can be used to augmenttreatment protocols (2,4–8). While a variety of wound man-agement strategies have been reported successful, the clinicalindications, modes of action and whether the available treat-ment options are best to be used alone or in combination arenot always clearly defined.

This article reports on the author’s 4-year clinical expe-rience with decellularised foetal bovine dermis (PriMatrix

Key Messages

• complete wound healing was documented in over 80%of the wounds treated with PriMatrix, whether thewound was treated with the foetal bovine dermalscaffold alone (95·2%) or when supplemented withNPWT (82·4%)

• PriMatrix offers an alternative treatment strategy fordefinitive closure of traumatic or surgical wounds inpatients who are not suitable candidates for tissueflaps as well as in patients with poor integument,limited vasculature or require multiple orthopaedicsurgeries

• the data gathered from this study suggest the equiv-alence of PriMatrix with and without NPWT in thetreatment of partial-thickness wounds as well as in full-thickness wounds with exposed tendon and/or bone

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Complex traumatic and surgical wounds treated with a foetal bovine collagen matrix E. Hayn

Dermal Repair Scaffold, TEI Biosciences Inc, Boston,MA) to treat challenging skin wounds. Patients who havelarge traumatic skin wounds or wounds from surgicalsites that have failed conservative and/or advanced ther-apeutic treatments are routinely referred. These woundscan have poor surrounding integument, limited vascula-ture and exposed tendon and/or bone. The patients canalso have comorbidities making them poor candidatesfor successful skin grafts or rotational or free flaps.

A review of the literature on the clinical effectiveness ofthe foetal bovine dermal scaffold in traumatic and surgicalwounds is largely positive. Two case studies have beendetailed by Higgs (9,10). In a finger crush, degloving injury,the ventral aspect of fifth finger presented with significantsoft tissue loss exposing the underlying tendons and bones(9). The foetal dermal scaffold was placed in the woundand sutured to the wound margins. The scaffold was shownto assimilate into the wound and the wound fully reepithe-lialised. In a necrotising fasciitis case, PriMatrix was stackedto fill a significant tissue void created by the aggressivedebridement (10). In this case, the wound was also coveredwith a NPWT dressing. A vascularised tissue developed tofill the wound which went onto successfully support thesubsequent split-thickness skin graft (STSG).

The use of the foetal bovine dermal repair scaffold toheal wounds without the need for surgical closure has beenreported on by Lullove when used in a podiatric settingand by Wanitphakdeedecha et al. when implanted followingMohs micrographic surgery. Lullove reported on a subset often non-healing traumatic wounds (average size, 21·8 cm2)that had been unresponsive to conventional wound-healingmodalities (11). Following one or two applications of meshedPriMatrix, these wounds healed on average in 75·4 days.Wanitphakdeedecha et al. reported an 80% healing rate inMohs surgery skin wounds (average size, 13·4 cm2) treatedwith a single application of solid, non-meshed pieces of thefoetal bovine dermal scaffold (12).

Neill et al. have presented a biopsy analysis of a seriesof PriMatrix-treated full-thickness skin wounds to build tis-sue that was successfully reepithelialised with STSGs (13).Biopsies taken from the meshed dermal repair scaffold imme-diately prior to grafting showed acellular foetal bovine dermisto be revascularised and repopulated with fibroblasts to gen-erate a tissue histologically similar to the dermis. The gapsin the meshed dermal scaffold had also been filled with gran-ulation tissue. This new tissue was found to develop withina week following application. The authors suggest that skingrafting onto a prepared wound bed consisting of dermis-likeand granulation tissue may improve long-term outcomes ofa grafting procedure, namely cosmesis, range-of-motion andreduction in subsequent wound contraction.

In this study, the foetal bovine dermal repair scaffoldwas used by the author in wounds where skin flaps wereto be avoided and the clinical goal was to close the woundeither through reepithelialisation from the wound margins orwith the subsequent application of an STSG. Some woundswere of full thickness with exposed bone and tendon. Ina subset of patients where insurance coverage permitted,the implantation of the foetal dermal collagen scaffold was

augmented with NPWT. NPWT was chosen as an ancillarywound dressing method as it is reported to facilitate theformation of granulation tissue and improve wound healingoutcomes. Thus, this retrospective study also permittedevaluation and comparison of outcomes when the treatmentstrategy consisted of PriMatrix alone and when the dermalrepair scaffold was supplemented with NPWT.

Methods

Patient and wound characteristics

Following Institutional Review Board approval, a retrospec-tive review of medical records was performed from January2006 to July 2010 for consecutive patients with woundstreated with PriMatrix (TEI Biosciences) or PriMatrix supple-mented with NPWT dressings (PriMatrix + NPWT). Patients’age, sex, weight and height were recorded. Wound aetiol-ogy, location and dimensions were recorded as well as deter-mined whether exposed tendon and/or bone were observed atthe treatment site. Additionally, it was doubted whether thewound had been previously treated using conservative modal-ities (sterile bandaging, antibiotics or topical medication) orthat an advanced wound therapy (recombinant platelet-derivedgrowth factor (PDGF), human acellular dermal matrix orimplants containing living cells) had been attempted.

Surgical techniques

In all cases, PriMatrix was prepared in accordance with themanufacturer’s guidelines. An aggressive surgical debride-ment was performed to ensure healthy bleeding wound edgesindicative of viable tissue. Exposed bone was also scored toencourage bleeding beneath the implanted foetal dermal col-lagen. PriMatrix was rehydrated in 0·9% sterile saline at roomtemperature and meshed prior to placement in the woundbed to allow for drainage of exudate as well as to enhancethe congruency of the implanted foetal dermal collagen withthe underlying wound bed. After application, PriMatrix wassecured to the wound bed and surrounding skin using suturesor staples. The wound was then covered with a porous,non-adherent dressing coated with Bacitracin in a petrola-tum/mineral oil ointment and either in sterile gauze wrap or in(wrap) self-adherent elastic wrap. When financially and clin-ically possible for the patient’s circumstances, NPWT wasadministered as an adjunct to the dermal repair scaffold.

Secondary dressings were changed as needed, typicallyat least once a day, with no disruption of the underlyingPriMatrix. The wound was inspected visually during dressingchanges to assess the degree of tissue development, vas-cularisation, reepithelialisation and the emergence of othercomplications, for example, infection or wound dehydration.A subset of patients with wound areas without completedermal/epidermal healing underwent a second debridementand received a second application of PriMatrix. Patients withdeep tissue voids also typically received two applications ofPriMatrix to build a thicker tissue bed.

Wounds were typically allowed to progressively reepithe-lialise over weeks to months. Wounds that were slow to

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E. Hayn Complex traumatic and surgical wounds treated with a foetal bovine collagen matrix

reepithelialise or where more timely closure was desired weretreated with a delayed STSG. The harvested skin grafts wereapproximately 0·008 inch, meshed and placed directly ontothe vascularised tissue bed generated with PriMatrix or withthe PriMatrix + NPWT combination.

Results

From January 2006 to July 2010, 43 wounds were treatedwith PriMatrix or PriMatrix + NPWT to reconstruct dermaltissue in partial- or full-thickness wounds (Table 1). Ofthe 43 wounds evaluated, five wounds were excluded fromfurther analysis because of insufficient data or patient non-compliance. Anatomical location of the 38 wounds varied,and the majority were located on the leg 36·8%, chest 18·4%,arm 15·8% and back 10·5%. Stratified by aetiology, 60·5% ofthe wounds were surgical and 39·5% were of traumatic origin.

Of the 38 wounds analysed, 21 (55·3%) were treatedwith PriMatrix and the remaining 17 (44·7%) were treatedwith PriMatrix + NPWT (Table 1). PriMatrix- and PriMa-trix + NPWT-treated wounds had similar patient demograph-ics; average patient age was 66 ± 21·5 and 61·1 ± 11·7 yearsand average body mass index was 26·0 ± 5·1 and 26·2 ± 3·0,respectively. The wound sizes, on average, were comparablefor the PriMatrix-treated wounds (85·5 cm2) and the PriMa-trix + NPWT-treated wounds (71·9 cm2). A significant propor-tion of the wounds treated with both treatment regimens hadexposed tendon and/or bone: 38·1% of the wounds treatedwith PriMatrix and 64·7% of the wounds treated with PriMa-trix + NPWT. One difference found between the two groupswas that more wounds in the PriMatrix + NPWT treatmentgroup had previously failed prior therapies (58·8%) than thegroup of wounds treated with PriMatrix alone (19·0%).

Complete wound healing was documented, in over 80%of the wounds treated, whether the wound was treated withPriMatrix alone or with PriMatrix + NPWT (Figure 1). ThePriMatrix-treated wound closure rate was 95·2%, and Pri-Matrix + NPWT-treated wounds were closed in 82·4% of thecases. Wound healing was primarily a result of reepithelial-isation (Figure 1). The average number of applications ofPriMatrix in both groups was comparable, 1·1 ± 0·3 in thePriMatrix-alone group and 1·3 ± 0·5 applications when PriMa-trix was used in conjunction with NPWT. In the minority ofcases where PriMatrix or PriMatrix + NPWT treatment did notachieve closure, the wound neither deteriorated nor improvedas a result of the treatment, and other treatment modalitieswere attempted.

Time-to-healing was analysed for all patients who werecontinuously monitored throughout the duration of their treat-ment, which included 28 of the 34 wounds that healed. Thepatients who did not have timely follow-up and were seen aperiod of time after their wound had closed were not includedin this analysis, as the clinical record did not accuratelyreflect the actual closure time. The average time-to-healingwas found to be 91·4 ± 76·5 days (range, 27–237 days)for the PriMatrix treatment group and 140·3 ± 95·3 days(range, 15–346 days) for the PriMatrix + NPWT group. By16 weeks, it was found that 68·8% of the wounds treated

Table 1 PriMatrix-treated wound characteristics

PriMatrix PriMatrix + NPWT

Number of patients/wounds 21 17Age, mean ± SD 66·0 ± 21·5 61·1 ± 11·7BMI, mean ± SD 26·0 ± 5·1 26·2 ± 3·0Wound size area, mean ± SD (cm2) 85·5 ± 114·5 71·9 ± 83·8Wound size range, mean ± SD(cm2)

0·41–420·0 8·0–340·8

Wounds with exposed tendon/bone 8 (38·1%) 11 (64·7%)Wounds that failed priorconservative and/or advancedtherapies

4 (19·0%) 10 (58·8%)

BMI, body mass index; NPWT, negative pressure wound therapy.

Figure 1 Wound-healing percentage. The clinical outcomes of woundstreated with PriMatrix or PriMatrix + NPWT (negative-pressure woundtherapy) were compared. Bars represent averages and the number ofwounds that healed is indicated for each data subset.

with PriMatrix healed and 50% of the wounds treated withPriMatrix + NPWT healed (Figure 2).

Notably, when the presenting wound did not exhibit evi-dence of exposed tendon and/or bone, complete wound healingwas documented for all wounds whether treated with PriMa-trix or with PriMatrix + NPWT. For wounds with documentedexposed tendon and/or bone, a higher percentage of healingwas found in the PriMatrix-only group (87·5%) when com-pared with that of the PriMatrix + NPWT group (72·7%).Wounds with exposed tendon and/or bone healed by reep-ithelialisation except for one wound in each group wheresplit-thickness grafting was used (Figure 3).

Discussion

The use of decellularised foetal bovine dermis with or with-out NPWT provided an effective treatment option to restoreintegument in large or difficult skin and soft tissue defects.In this study, PriMatrix treatment has been successful in sal-vaging limbs marked for amputation due to the severity oftraumatic insult (Figure 4), has been used as an effective alter-native to a free flap to treat large skin defects with exposed

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Complex traumatic and surgical wounds treated with a foetal bovine collagen matrix E. Hayn

Figure 2 Time-to-healing. Time-to-healing was analysed for all patientswho were continually monitored throughout the duration of theirtreatment. By 16 weeks, it was found that 68·8% of the woundstreated with PriMatrix healed and 50% of the wounds treated withPriMatrix + NPWT (negative pressure wound therapy) healed. Barsrepresent averages and the number of wounds that healed by 16 weeksis indicated for each data subset.

Figure 3 Healing percentage for wounds with tendon and/or boneexposure. The clinical outcomes of wounds having tendon and/or boneexposure treated with PriMatrix or PriMatrix + NPWT (negative-pressurewound therapy) were compared. Bars represent averages, and thenumber of wounds healed with tendon and/or bone exposure is indicatedfor each data subset.

underlying bone (Figure 5) and has been proved as a success-ful treatment option for wounds that were poor candidates forskin grafts because of patient age, health conditions and poorsurrounding integument (Figure 6). Similar to other reports,this dermal repair scaffold was observed to take and becomesecured in the debrided wound bed within the first week ofapplication. The implanted acellular dermis became vascu-larised, building a new tissue that could be reepithelialised orsupport an STSG (Figures 4–6).

A

B

C

D

E

Figure 4 Limb salvage and reconstruction of a traumatic lowerextremity wound with PriMatrix and negative-pressure wound therapy(NPWT). (A) 67-year-old female was involved in a motor vehicle accident,suffering extensive bony and soft tissue injuries to her left lowerextremity, including fractures of the tibia, fibula, ankle and multiplemetatarsals. Additionally, the patient sustained circumferential loss ofdermal coverage extending from the knee distally to the ankle anddorsum of her left foot, with exposure of multiple pedal extensor tendonsand the Achilles heel tendon. Because of the extent of the injury, a below-knee amputation was recommended; however, PriMatrix was used asan alternative strategy. (B) Initial surgical intervention included externalfixation of the orthopaedic injuries and, wound debridement. PriMatrixwas placed in the wound defect, and NPWT was used. After 27 days,the patient underwent open reduction internal fixation of her fracturesand PriMatrix was reapplied to cover the extensor pedal and Achillestendons. (C) Forty-six days after initial injury, red granulation tissuecovering all exposed structures was present and the patient underwenta third debridement and (D) final application of meshed PriMatrix to theanterior aspect of the dorsum of the foot and posterior Achilles heel.Twenty-eight days after the final PriMatrix application, a clean bed ofgranulation tissue was generated covering the entire patient’s exposedtendon and bone. (E) A split-thickness skin graft (STSG) was placed onthe entire lower extremity and the patient progressed to walking withassistance after a total period of approximately 5 months.

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E. Hayn Complex traumatic and surgical wounds treated with a foetal bovine collagen matrix

A B

C D

E F

Figure 5 Traumatic scalp injury with tendon and/or bone exposuretreated with PriMatrix and negative-pressure wound therapy (NPWT). (A)63-year-old male suffered a significant electrical burn to the scalp whileworking at his home. The injury consisted of necrosis encompassingthe entire dermal and periosteal components of the apex of his scalp.Because of the extent of the injury, a free latissimus dorsi flap to thearea of injury with an accompanying split-thickness skin graft (STSG) forcoverage was recommended; however, the patient refused the use ofany muscle transfer because he felt that the loss of muscle functionwould be detrimental to his ability to work. (B) To avoid a free flap to theinjured site, the wound area was debrided and (C) PriMatrix was applied.(D) After 30 days, a majority of the wound regenerated a rich vasculargranulation tissue; however, an area without complete dermal healingwas present. (E) In this area, a second debridement was performedand a second application of meshed PriMatrix was secured followedby NPWT. After the regeneration of a rich vascular granulation tissue,a split-thickness skin graft (STSG) was placed for final coverage. (F)One hundred sixty-eight (approximately 6 months) days after injury, thepatient had complete dermal regeneration, complete wound closure andpositive aesthetic outcomes.

PriMatrix was used with and without NPWT dressing in acomparable number of wounds as well as in comparable typesof wounds. While NPWT was observed clinically to be anexcellent technique to anchor PriMatrix into the wound bed,control exudate and assist with patient compliance, healingoutcomes were found to be neither significantly improvednor diminished by its use. For wounds that did not have anytendons and/or bones exposed, healing was documented in allpatients whether conventional or NPWT dressings were usedwith PriMatrix. For the subset wounds where tendons and/orbones were exposed, a greater percentage of wounds healedwhen PriMatrix treatment was not supplemented with NPWT,87·5% versus 72·7%. The difference between the healingpercentages and time-to-healing may be more reflective of the

A

B

C

Figure 6 PriMatrix reconstruction of a traumatic injury of upperextremity with PriMatrix on elderly patient with poor health conditionsand poor surrounding integument with PriMatrix dermal repair scaffold.(A) A 78-year-old female with past medical history of diabetes andCOPD fell at home and suffered extensive soft tissue injuries with alaceration avulsion of her dermis from the proximal dorsal forearm to hercarpal area. The patient’s upper extremity had significant soft tissue lossthat typically requires a skin graft. (B) Initial surgical intervention withdebridement was performed, and PriMatrix was applied to the dorsumof the left distal forearm. (C) Approximately 2 months (63 days) afterapplication of PriMatrix, the wound had completely reepithelialised withminimal scarring without the need for a split-thickness skin graft (STSG).

higher number of challenging wounds in the NPWT treatmentgroup rather than indicating any diminution in healing fromNPWT.

The patients and wound characteristics treated with PriMa-trix in this study reflect the diversity of challenging woundsthat can arise and be effectively treated with a scaffold com-posed of decellularised foetal bovine dermis. Comparison ofthe clinical outcomes obtained with the use of PriMatrix with

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Complex traumatic and surgical wounds treated with a foetal bovine collagen matrix E. Hayn

other dermal scaffold technologies used to treat surgical andtrauma wounds is difficult as most studies report the frequencyof scaffold take and not the subsequent wound-healing out-comes as was reported in this study (14–16). A comparison ofthis study with other clinical reports is also limited by its retro-spective nature where patients and wounds did not meet anyspecific inclusion/exclusion criteria. To definitively identifyany clinical benefits, the PriMatrix wound-healing technologyoffers over other alternatives, formal prospective, randomisedclinical studies with long-term follow-up wound assessmentsare required.

The results obtained from this study of the use of PriMa-trix to treat difficult wounds support previously documentedclinical results with PriMatrix (6,9–13,19). The clinical obser-vations made over 4 years of use agree with other descriptionsof the ability of PriMatrix to assimilate into a wound and pro-mote the building of vascularised, viable tissue. Using meshedPriMatrix and scoring exposed bone surfaces prior to applica-tion appears to improve scaffold revascularisation, fibroblastrepopulation and healing when compared with solid sheets ofthe scaffold placed on non-debrided tissue. The dermal-liketissue that develops at the implant site is capable of supportingan STSG or reepithelialisation by local keratinocyte migrationand proliferation.

PriMatrix offers an alternative treatment strategy for defini-tive closure of traumatic or surgical wounds on patients whoare not suitable candidates for tissue flaps as well as forpatients with poor integument, limited vasculature or requiremultiple orthopaedic surgeries. The data gathered from thisstudy suggest the equivalence of PriMatrix with and with-out NPWT in the treatment of partial-thickness wounds aswell as of full-thickness wounds with exposed tendon and/orbone. These data also support the use of PriMatrix treatmentfor difficult wounds when NPWT may be preferred but isnot available because of patient circumstances such as woundlocation and lack of insurance coverage.

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