Clinical Index

Insights from your peers

Literature Review

Over the last 5 years there has been exponential growth of clinical investigations and evidence shown of NovoSorb BTM. A literature review of 172 publications, the vast majority independent of PolyNovo, was conducted to better understand the performance of NovoSorb BTM in the hands of numerous surgeons across the globe.

To assess performance, an analysis of all publications (released by 2022) was conducted with the following inclusion criteria: underwent peer-review, contained published data, did not overlap previously published data, included endpoints of BTM take, skin graft take, and/ or number of applications. 50 publications met the criteria (3 of 50 sponsored by PolyNovo) and all 241 NovoSorb BTM patients in the publications were included.

Table 1: NovoSorb BTM Publication Growth

New Standard Results:

Avg.94%

NovoSorb BTM Take

Avg.98%

Skin Graft Take

Within1

Application

Table 2: NovoSorb BTM Scar Assessment

  • Scaled 1-10, 1 representing best scar or sensation, 10 being worst

  • Scaled 1-10, 1 representing normal skin, 10 being very different to normal skin

NovoSorb BTM has been clinically evaluated by globally recognized scar assessment scales. Table 2 illustrates 5 publications (3 being prospective) where POSAS was used to assess the scar quality of NovoSorb BTM treated wounds (n=74) in 48 patients. Scoring was conducted 12 months post skin graft in all studies except Li et al. where follow-up time ranged from 3-18 months.27 Reported are the observers overall scores with an average of 2.80 out of 10.

Clinical Summary of Select Publications

Author/Year Description Wounds Evaluated

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

Author/Year

Wu et al. 202211

Description

Retrospective review of all patients treated with NovoSorb BTM (PolyNovo) or CCS bilayer (Integra Life Sciences) between January 31, 2015 through July 31st, 2020. 303 cases are reviewed and 206 are excluded based on inclusion criteria. <18 years of age (n=47), multiple types of dermal matrices used (n=128), no dermal matrix applied (n=14), or deceased within study period (n=17). Clinical outcomes are compared between BTM group (n=51) and CCS (n=46).

Wounds Evaluated

51

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

Statistically significant results include: skin graft loss (BTM 3.6% vs CCS 23.1%), skin graft complications (BTM 25% vs CCS 37.5%), mean number of secondary procedures (BTM 1.0 vs CCS 1.9), mean number of skin grafts applied (BTM 1.1 vs 1.5 CCS), use of NPWT (31.4% BTM vs 60.9% CCS), concomitant treatments at surgical site (41.2% BTM vs 67.4% CCS) and time to skin graft (BTM 37 days vs 16 days CCS); however, time to definitive closure is not statistically different (5.4 months BTM vs 6.4 months CCS).

Author/Year

Li et al. 202127

Description

Multcenter prospective study.

Wounds Evaluated

35

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

Average 97% BTM take and 88% skin graft take. POSAS scale evaluation demonstrated 3.63 ± 2.04 (1 being normal skin, 10 being very different to normal skin).

Author/Year

Patel et al. 202224

Description

Near total scalp avulsion (80%) missing pericranium following dog bite of pediatric patient. BTM applied following failed Integra Bilayer Wound Matrix.

Wounds Evaluated

1

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

Complete take of BTM and subsequent skin graft with no signs of infection and a “favorable aesthetic and sensory outcome” at 6 months.

Author/Year

Solanki et al. 202216

Description

72% of wounds include exposed bone or tendon.

Wounds Evaluated

25

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

Skin graft take is “excellent and complete in most cases.” Range of motion (ROM) is considered “excellent with no skin tethering.” Study limitations include lacking long term follow up.

Author/Year

Carrington-Windo et al. 202137

Description

Traumatic injury to chest at high risk of infection.

Wounds Evaluated

1

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

No infection despite contaminated wound. Excellent cosmetic and functional outcome. Includes patient perspective.

Author/Year

Schlottmann et al. 202238

Description

Single-centre retrospective analysis of patients with multiple co-morbidities.

Wounds Evaluated

27

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

Fastest integration is 13 days with a mean of 23.5 days. BTM shows high tolerance against infection with 18 of 20 patients having colonized wounds at time of BTM application.

Author/Year

Shah et al. 202229

Description

First report using sequential layering of BTM to improve resulting skin contour.

Wounds Evaluated

1

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

100% BTM and subsequent skin graft take at 14 days post BTM application. Includes patient perspective.

Author/Year

Teelucksingh et al. 2022

Description

Pediatric trauma with compound fractures and degloving where BTM used with free flaps

Wounds Evaluated

2

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

Very complex traumatic injuries. Demonstrates use of external fixator through integrated BTM. BTM used to supplement insufficient wound coverage by latissimus dorsi myocutaneous flap. Immediate BTM application was a useful adjunct to free tissue transfer and soft tissue reconstruction in a wound that traditionally would have been managed with autograft alone.

Author/Year

Wagstaff et al. 201512

Description

Prospective case series of free-flap (fibular and radial forearm) donor site reconstructions.

Wounds Evaluated

10

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

100% BTM and subsequent skin graft take for every patient who survived (1 died early for unrelated reasons). POSAS and MAPS scores are reported. Histology of punch biopsies showed degradation is virtually complete by 12 months, other than occasional microscopic remnants undergoing phagocytosis.

Author/Year

Damkat-Thomas et al. 20198

Description

First report of traumatic degloving case treated using BTM. 72-yearold diabetic man with hypertension and obesity.

Wounds Evaluated

1

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

Early signs of vascularization on Day 4 post BTM application. Ultrasound scan at 16 months demonstrated EHL and extensor tendons gliding freely under BTM without evidence of tethering. Mature pliable stable tissue with full ROM of toes extensors achieved.

Author/Year

Wagstaff et al. 201919

Description

First published case series of BTM for necrotizing fasciitis, including over extensive
exposed bone and tendon.

Wounds Evaluated

8

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

99% BTM take and 100% skin graft take within a single application. “BTM also has a beneficial role in necrotizing fasciitis defects.”

Author/Year

Sun et al. 202139

Description

Largest (15 cm) skin cancer (BCC) excision case reported to date.

Wounds Evaluated

1

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

100% BTM and skin graft take. Excellent cosmetic and functional outcome.

Author/Year

Kuang et al. 202233

Description

First prospective study evaluating the use of BTM for complex diabetic foot wounds.

Wounds Evaluated

18

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

Thirteen of 18 patients completed BTM treatment regime with patients achieving complete wound healing at a median time of 13 weeks. The rate of infection and reulceration are relatively low for this high-risk population at 15.4%. BTM demonstrates potential in healing diabetic foot wounds with exposed deep structures and chronic wounds subject to high shear stress.

Author/Year

Jennings et al. 202117

Description

First published case of severe meningococcal septicaemia.

Wounds Evaluated

8

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

100% BTM take and 98.33% skin graft take. “[BTM] may possess a higher degree of bacterial resistance than biological alternatives.”

Author/Year

Crowley et al. 202021

Description

9-year-old sustained extensive degloving injuries, in difficult anatomical wound
areas, following motor vehicle trauma.

Wounds Evaluated

7

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

100% BTM take with supple tissue and an acceptable cosmetic result.

Author/Year

Schmitt et al. 202126

Description

Early physical therapy (PT) exercises reported with BTM.

Wounds Evaluated

20

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

Establishes guidance on mobilization post BTM application. POSAS and MAPS indicated good cosmetic outcomes with relatively low levels of itch and minimal pain at 12 months after injury.

Author/Year

MacDiarmid et al. 2022

Description

Lower limb reconstruction following large circumferential resection of a giant Marjolin’s ulcer.

Wounds Evaluated

1

Trauma

Reconstruction

Soft Tissue Infection

Chronic Wounds

Cancer Resection

Pressure Wounds

Limb Salvage

Donor Site

Exposed Bone/Tendon

Upper Extremity

Lower Extremity

Head/Neck

Trunk

Key Findings

100% BTM take and 95% skin graft take. Authors record great cosmetic and functional outcome.

Published articles

Storey K, Lalloz M, Choy K-T, McBride CA, McMillan C, Das Gupta R, Patel B, Choo K, Stefanutti G, Borzi P, Phua Y, Bade S, Griffin B, Kimble RM. 2023

The versatility of Biodegradable Temporising Matrix – A 63 paediatric case series with complex wounds.

Crowley K, Balaji S, Stalewski H, Carroll D, Mariyappa-Rathnamma B. 2020

Use of Biodegradable Temporizing Matrix (BTM) in large trauma induced soft tissue injury: A two stage repair.

Carrington-Windo E, Leong S, Ibrahim N, Pope-Jones S. 2021

Biodegradeable temporising matrix use in a traumatic chest wound.

Li H, Lim P, Stanley E, Lee G, Lin S, Neoh D, Liew J, Ng SK. 2021

Experience with NovoSorb® Biodegradable Temporising Matrix in reconstruction of complex wounds.

Teo TS, Crawford LC, Pilch WT, Carney B, Solanki N, Kidd SE, Warner MS. 2021

Mycetoma caused by Microsporum canis in a patient with renal transplant: A case report and review of the literature

Li H, Lim P, Stanley E, Lee G, Lin S, Neoh D, Liew J, Ng SK. 2021

Experience with NovoSorb® Biodegradable Temporising Matrix in reconstruction of complex wounds.

Frost SR, Deodhar A, Offer GJ. 2022

A novel use for the biodegradable temporizing matrix

Wu-Fienberg Y, Wu SS, Gatherwright J, Chepla KJ. 2021

An alternative dermal template for reconstruction of complex upper extremity wounds.

Pontell ME, Niklinska E, Bonfield CM, Golinko MS. 2022

Management of an open nasofrontal encephalocele during the first day of life.

Dastagir K, Obed D, Bucher F, Hofmann T, Koyro KI, Vogt PM. 2021

Non-invasive and surgical modalities for scar management: A clinical algorithm.

Storey K, Lalloz M, Choy K-T, McBride CA, McMillan C, Das Gupta R, Patel B, Choo K, Stefanutti G, Borzi P, Phua Y, Bade S, Griffin B, Kimble RM. 2023

The versatility of Biodegradable Temporising Matrix – A 63 paediatric case series with complex wounds.

Sreedharan S, Morrison E, Cleland H, Ricketts S, Bruscino-Raiola F. 2019

Biodegradable Temporising Matrix for necrotising soft tissue infections: a case report.

Ray K, Khajoueinejad N, Park S, Chan M, Lee J, Lantis JC. 2021

The evidence for antimicrobial and hard to infect regenerative matrices.

Li H, Lim P, Stanley E, Lee G, Lin S, Neoh D, Liew J, Ng SK. 2021

Experience with NovoSorb® Biodegradable Temporising Matrix in reconstruction of complex wounds.

Storey K, Lalloz M, Choy K-T, McBride CA, McMillan C, Das Gupta R, Patel B, Choo K, Stefanutti G, Borzi P, Phua Y, Bade S, Griffin B, Kimble RM. 2023

The versatility of Biodegradable Temporising Matrix – A 63 paediatric case series with complex wounds.

Kuang B, Pena G, Cowled P, Fitridge R, Greenwood J, Wagstaff M, Dawson J. 2022

Use of Biodegradable Temporising Matric (BTM) in the reconstruction of diabetic foot wounds: A pilot study.

Young CA, Semple HK, Kode GM. 2022

Complex wound healing in a complex patient.

Cao Y, Dominic W, Knezevich S, Kochubey M. 2022

Multiple leg wounds in an obese female with normal renal function.

Ray K, Khajoueinejad N, Park S, Chan M, Lee J, Lantis JC. 2021

The evidence for antimicrobial and hard to infect regenerative matrices.

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