Clinical Index
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.
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/YearWu et al. 202211 |
DescriptionRetrospective 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 Evaluated51 |
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 FindingsStatistically 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/YearLi et al. 202127 |
DescriptionMultcenter prospective study. |
Wounds Evaluated35 |
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 FindingsAverage 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/YearPatel et al. 202224 |
DescriptionNear total scalp avulsion (80%) missing pericranium following dog bite of pediatric patient. BTM applied following failed Integra Bilayer Wound Matrix. |
Wounds Evaluated1 |
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 FindingsComplete take of BTM and subsequent skin graft with no signs of infection and a “favorable aesthetic and sensory outcome” at 6 months. |
Author/YearSolanki et al. 202216 |
Description72% of wounds include exposed bone or tendon. |
Wounds Evaluated25 |
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 FindingsSkin 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/YearCarrington-Windo et al. 202137 |
DescriptionTraumatic injury to chest at high risk of infection. |
Wounds Evaluated1 |
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 FindingsNo infection despite contaminated wound. Excellent cosmetic and functional outcome. Includes patient perspective. |
Author/YearSchlottmann et al. 202238 |
DescriptionSingle-centre retrospective analysis of patients with multiple co-morbidities. |
Wounds Evaluated27 |
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 FindingsFastest 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/YearShah et al. 202229 |
DescriptionFirst report using sequential layering of BTM to improve resulting skin contour. |
Wounds Evaluated1 |
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 Findings100% BTM and subsequent skin graft take at 14 days post BTM application. Includes patient perspective. |
Author/YearTeelucksingh et al. 2022 |
DescriptionPediatric trauma with compound fractures and degloving where BTM used with free flaps |
Wounds Evaluated2 |
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 FindingsVery 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/YearWagstaff et al. 201512 |
DescriptionProspective case series of free-flap (fibular and radial forearm) donor site reconstructions. |
Wounds Evaluated10 |
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 Findings100% 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/YearDamkat-Thomas et al. 20198 |
DescriptionFirst report of traumatic degloving case treated using BTM. 72-yearold diabetic man with hypertension and obesity. |
Wounds Evaluated1 |
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 FindingsEarly 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/YearWagstaff et al. 201919 |
DescriptionFirst published case series of BTM for necrotizing fasciitis, including over extensive |
Wounds Evaluated8 |
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 Findings99% BTM take and 100% skin graft take within a single application. “BTM also has a beneficial role in necrotizing fasciitis defects.” |
Author/YearSun et al. 202139 |
DescriptionLargest (15 cm) skin cancer (BCC) excision case reported to date. |
Wounds Evaluated1 |
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 Findings100% BTM and skin graft take. Excellent cosmetic and functional outcome. |
Author/YearKuang et al. 202233 |
DescriptionFirst prospective study evaluating the use of BTM for complex diabetic foot wounds. |
Wounds Evaluated18 |
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 FindingsThirteen 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/YearJennings et al. 202117 |
DescriptionFirst published case of severe meningococcal septicaemia. |
Wounds Evaluated8 |
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 Findings100% BTM take and 98.33% skin graft take. “[BTM] may possess a higher degree of bacterial resistance than biological alternatives.” |
Author/YearCrowley et al. 202021 |
Description9-year-old sustained extensive degloving injuries, in difficult anatomical wound |
Wounds Evaluated7 |
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 Findings100% BTM take with supple tissue and an acceptable cosmetic result. |
Author/YearSchmitt et al. 202126 |
DescriptionEarly physical therapy (PT) exercises reported with BTM. |
Wounds Evaluated20 |
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 FindingsEstablishes 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/YearMacDiarmid et al. 2022 |
DescriptionLower limb reconstruction following large circumferential resection of a giant Marjolin’s ulcer. |
Wounds Evaluated1 |
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 Findings100% BTM take and 95% skin graft take. Authors record great cosmetic and functional outcome. |
Published articles
- Trauma
- Reconstruction
- Soft Tissue Infection
- Limb Salvage
- Cancer Research
- Chronic Wounds
Carrington-Windo E, Leong S, Ibrahim N, Pope-Jones S. 2021
Biodegradeable temporising matrix use in a traumatic chest wound.
Concannon E, Damkat-Thomas L, Rose E, Coghlan P, Solanki N, Wagstaff M. 2023
Use of a synthetic dermal matrix for reconstruction of 55 patients with non-graftable wounds and management of complications.
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.
Damkat-Thomas L, Greenwood JE, Wagstaff MJD. 2019
A synthetic Biodegradable Temporising Matrix in degloving lower extremity trauma reconstruction: A case report.
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.
Patel NK, Tipps JA, Graham EM, Taylor JA, Mendenhal SD. 2022
Reconstruction of a near-total scalp avulsion with NovoSorb Biodegradable Temporizing Matrix: Pediatric case report.
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.
Teelucksingh S, Chang C, Henton J, Lewis CJ. 2022
Immediate application of Biodegradable Temporizing Matrix to a muscle free flap for complex soft tissue reconstruction.
Schlottmann F, Obed D, Bingöl AS, März V, Vogt PM, Krezdorn N. 2022
Treatment of complex wounds with NovoSorb® Biodegradable Temporising Matrix (BTM) — A retrospective analysis of clinical outcomes.
Solanki NS, York B, Gao Y, Baker P, Wong She RB. 2020
A consecutive case series of defects reconstructed using NovoSorb® Biodegradable Temporising Matrix: Initial experience and early results.
Wu SS, Wells M, Ascha M, Gatherwright J, Chepla K. 2022
Performance of Biodegradable Temporizing Matrix vs collagen-chondroitin silicone bilayer dermal regeneration substitutes in soft tissue wound healing: a retrospective analysis.
MacDiarmid S, Butler D. 2022
Biodegradable Temporising Matrix for lower limb reconstruction following the resection of giant Marjolin’s ulcer.
Schlottmann F, Obed D, Bingöl AS, März V, Vogt PM, Krezdorn N. 2022
Treatment of complex wounds with NovoSorb® Biodegradable Temporising Matrix (BTM) — A retrospective analysis of clinical outcomes
Wu SS, Wells M, Ascha M, Gatherwright J, Chepla K. 2022
Performance of Biodegradable Temporizing Matrix vs collagen-chondroitin silicone bilayer dermal regeneration substitutes in soft tissue wound healing: a retrospective analysis.
Wu SS, Wells M, Ascha M, Gatherwright J, Chepla KJ. 2022
Upper extremity wounds treated with Biodegradable Temporizing Matrix vs collagen-chondroitin silicone bilayer
Shah R, Kiely A, McKirdy S. 2022
Double-layer biodegradable temporising matrix reconstruction for abdominal skin and soft-tissue reconstruction.
Wu S, Wells M, Ascha M, Duggal R, Gatherwright J, Chepla K. 2022
Head and neck wound reconstruction using Biodegradable Temporizing Matrix versus collagen-chondroitin silicone bilayer.
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.
Wagstaff MJD, Schmitt B, Caplash Y, Greenwood JE. 2015
Free flap donor site reconstruction: A prospective case series using an optimized polyurethane Biodegradable Temporizing Matrix.
Concannon E, Damkat-Thomas L, Rose E, Coghlan P, Solanki N, Wagstaff M. 2023
Use of a synthetic dermal matrix for reconstruction of 55 patients with non-graftable wounds and management of complications.
Wagstaff MJD, Salna IM, Caplash Y, Greenwood JE. 2019
Biodegradable Temporising Matrix (BTM) for the reconstruction of defects following serial debridement for necrotising fasciitis: A case series.
ALNafisee D, Casey MC, Kelly JL. 2022
Use of a synthetic biodegradable temporising matrix after necrotising fasciitis infection of the thigh.
Lim P, Li H, Ng S. 2023
NovoSorb® Biodegradable Temporising Matrix (BTM) and its applications
Jennings M, Willet J, Coghlan P, Solanki NS. 2021
Biodegradable temporising matrix in severe meningococcal septicaemia: a case report.
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.
Concannon E, Damkat-Thomas L, Rose E, Coghlan P, Solanki N, Wagstaff M. 2023
Use of a synthetic dermal matrix for reconstruction of 55 patients with non-graftable wounds and management of complications.
Barker T, Wagstaff M, Ricketts S, Bruscino-Raiola F. 2022
Use of a bilayer biodegradable synthetic dermal matrix for the management of defects arising from necrotising fasciitis.
Ray K, Khajoueinejad N, Park S, Chan M, Lee J, Lantis JC. 2021
The evidence for antimicrobial and hard to infect regenerative matrices.
Wagstaff MJD, Caplash Y, Greenwood JE. 2017
Reconstruction of an anterior cervical necrotizing fasciitis defect using a biodegradable polyurethane dermal substitute.
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.
Malkoc A, Wong DT, Woodward B. 2022
Single staged treatment of a complex full thickness debridement for Hidradenitis Suppurativa using NovoSorb Biodegradable Temporizing Matrix.
Solanki NS, York B, Gao Y, Baker P, Wong She RB. 2020
A consecutive case series of defects reconstructed using NovoSorb® Biodegradable Temporising Matrix: Initial experience and early results.
Guerriero FP, Clark RA, Miller M, Delaney CL. 2023
Overcoming barriers to wound healing in a neuropathic and neuro-ischaemic diabetic foot cohort using a novel bilayer biodegradable synthetic matrix.
Ray K, Khajoueinejad N, Park S, Chan M, Lee J, Lantis JC. 2021
The evidence for antimicrobial and hard to infect regenerative matrices.
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.
Cheng C, Kwiecien GJ, Rowe DJ, Gatherwright JR, Chepla KJ. 2021
Reconstruction of chronic wounds secondary to injectable drug use with a Biodegradable Temporizing Matrix.
Cao Y, Dominic W, Knezevich S, Kochubey M. 2022
Multiple leg wounds in an obese female with normal renal function.
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.
Jennings M, Willet J, Coghlan P, Solanki NS, Greenwood JE. 2021
Biodegradable temporising matrix in severe meningococcal septicaemia: a case report. Australasian Journal of Plastic Surgery.
Sun L, Cox S, Tan EK. 2021
Radiotherapy for wound treated with BTM: A case report and review of literature.
Concannon E, Damkat-Thomas L, Rose E, Coghlan P, Solanki N, Wagstaff M. 2023
Use of a synthetic dermal matrix for reconstruction of 55 patients with non-graftable wounds and management of complications.
Wu SS, Wells M, Ascha M, Gatherwright J, Chepla K. 2022
Performance of Biodegradable Temporizing Matrix vs collagen-chondroitin silicone bilayer dermal regeneration substitutes in soft tissue wound healing: a retrospective analysis.
Shah R, Kiely A, McKirdy S. 2022
Double-layer biodegradable temporising matrix reconstruction for abdominal skin and soft-tissue reconstruction.
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.
MacDiarmid S, Butler D. 2022
Biodegradable Temporising Matrix for lower limb reconstruction following the resection of giant Marjolin’s ulcer.
Solanki NS, York B, Gao Y, Baker P, Wong She RB. 2020
A consecutive case series of defects reconstructed using NovoSorb® Biodegradable Temporising Matrix: Initial experience and early results.
Guerriero FP, Clark RA, Miller M, Delaney CL. 2023
Overcoming barriers to wound healing in a neuropathic and neuro-ischaemic diabetic foot cohort using a novel bilayer biodegradable synthetic matrix.
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.
Cheng C, Kwiecien GJ, Rowe DJ, Gatherwright JR, Chepla KJ. 2021