NovoSorb® BTM

Clinical Findings

Over 25 independent peer-reviewed manuscripts published in the last 12 months

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Highlighted Paper

Performance of Biodegradable Temporizing Matrix vs Collagen-chondroitin Silicone

Wu SS, Wells M, Ascha M, Gatherwright J, Chepla K. A multi center retrospective analysis for Plastic Surgery, Cleveland, OH, USA. Wounds. 2022.

  • This is one of the few studies of BTM cases reported to date to directly compare wound healing and complication rates using NovoSorb BTM against Integra DRT (referred to as CCS bilayer graft).
  • The authors analysed data for 97 adult patients (51 BTM and 46 Integra DRT) with a range of wound etiologies including: trauma, iatrogenic, compartment syndrome, skin cancer and osteomyelitis.
  • Although a cost-effectiveness analysis was not performed, the reported costs at this institution for BTM were dramatically lower than for Integra DRT.
  • They concluded: Compared with CCS bilayer graft, BTM has comparable closure rates, time to healing, and complication rates. Wounds managed with BTM required fewer secondary procedures, including skin grafting, and had significantly lower rates of graft failure than those treated with CCS. These findings support consideration of BTM as an alternative to CCS when dermal templates are indicated for soft tissue reconstruction.
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Meet the Authors

clinical-finding-author
Dr Kyle J. Chepla, Plastic Surgeon

MetroHealth Medical Center, Cleveland, OH, USA

Dr Kyle Chepla is an Assistant Professor in the Division of Plastic Surgery at MetroHealth Medical Center and a staff physician at the Louis Stokes VA Medical center in Cleveland, Ohio. He also serves as a staff member of the Cleveland Combined Hand Fellowship. He attended The Ohio State University College of Medicine and Public Health where he graduated magna cum laude in 2007. He then completed the integrated Plastic surgery residency at University Hospitals / Case Western Reserve University in 2013 and the Hand and Upper Extremity fellowship at The University of Pittsburgh Medical Center in 2014.

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clinical-finding-author
Dr. James Gatherwright, Plastic Surgeon

Cleveland Clinic Akron General, Cleveland, OH, USA

Dr. Gatherwright specializes in plastic and reconstructive microsurgery, including upper and lower extremity injuries. He completed his medical education at Case Western Reserve University School of Medicine, including an Integrated Plastic Surgery Residency. He also completed a microsurgery fellowship at the Cleveland Clinic. He is board certified by the American Board of Plastic Surgery. Dr Gatherwright is active in both the American Society of Plastic Surgeons and the American Society of Reconstructive Microsurgery.

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Discover the versatility of NovoSorb BTM

  • Trauma
  • Infectious
    Disease
  • Chronic
    Wound
  • Cancer
    Excision
  • Donor
    Site
An alternative dermal template for reconstruction of complex upper extremity wounds

  • Case series consists of 6 patients (4 males, 2 females) between the ages of 35-60 years old who sustained upper extremity wounds with exposed bone/tendon
  • All wounds were thoroughly debrided before application of BTM, and patients were retrospectively reviewed over a 1-year period.
  • 3 patients re-epithelialized spontaneously and did not need further treatment; the other three patients received split-thickness skin grafts. None of the patients incurred infections, loss of the matrix, or loss of the skin graft. There were no complications post-graft and no further surgical treatments necessary.
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Tissue engineered successful reconstruction of a complex traumatized lower extremity

  • Healthy male in his 30s presented with complex knee and thigh injuries from a car accident. He had severe skin degloving, progressive skin necrosis, multiple infections, and exposed joints. The patient requested maximum salvage of injured soft tissue.
  • Conservative debridement and PRP injections were performed to salvage muscles and tendon. Specially carved reticulated foam wrapping around the ischemic muscles and NPWT were utilized before muscle/tendon reconstruction. BTM was placed over the open wound and exposed tendons.
  • After removal of the sealing membrane, the study indicates there were healthy granulations over most of the wound. Thin split-skin grafts were applied, and all skin grafts took well.
  • Surgeons observed fibrogenesis and vascular growth into the BTM matrix In this large tissue defects.
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Experience with NovoSorb® Biodegradable Temporizing Matrix (BTM) in the reconstruction of complex wounds

  • 27 patients, ranging from 47- to 95 years old (19 males, 8 females), with a total of 35 wounds (14 lower limbs, 7 upper limbs, 12 head/neck, 1 abdominal, 1 breast) were treated with BTM.
  • Before application of BTM, the study’s inclusion criteria was comprised of: exposure of a critical structure (e.g., tendon, bone), previous skin graft failure, and a wound bed where the surgeon did not expect a traditional split skin graft (SSG) to take. Exclusion criteria included active infection or residual malignancy.
  • Initial debridement was performed to remove all devitalized and infected tissue before BTM application. In cases of malignancies, oncological clearance was obtained prior to BTM reconstruction. BTM was secured using gauze, crepe bandages, and negative pressure wound therapy (NPWT). Outer dressings were changed 1–2 times per week. In wounds involving the limbs or joints, a splint was applied for the first week after BTM application.
  • Follow-up ranged from 3 to 18 months. There was 100% BTM integration achieved in 33/35 (94%) of wounds. In 2 cases, the wound was completely re-epithelialized without the need for a skin graft.
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A synthetic Biodegradable Temporizing Matrix (BTM) in degloving lower extremity trauma reconstruction: case report

  • 72-year-old obese male with diabetes and hypertension presented with a dorsal foot degloving injury. The injury was sustained when his foot was crushed and sheared between a car door and a metal cupboard in his garage.
  • Initial surgery involved extensive soft-tissue debridement to remove avulsed tissues not suitable for replantation. The resultant wound had exposed deep structures including bone and extensor tendons.
  • BTM was applied and secured with staples. Early signs of integration were evident on Day 4. The patient was discharged home on Day 7 and returned as an outpatient twice a week to monitor integration and perform outer dressing changes. On Day 63, the patient returned to the operating room where the sealing membrane was removed, and a split-thickness sheet skin graft was applied.
  • 16 months post-op, full range of motion of the patient’s toe extensors was observed. The surgeons concluded BTM being applied over a denuded tendon does not seem to restrict glide or induce tethering.
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Use of Biodegradable Temporizing Matrix (BTM) in large trauma induced soft tissue injury: a two stage repair

  • A 9-year-old male sustained extensive injuries after a traumatic incident in which he was dragged underneath a vehicle. The patient had traumatic abrasions to his groin, left and right thighs, and lower abdomen. He also had a degloving injury to his penis, a left iliac crest fracture, and avulsion injuries to the scrotum and bilateral testicles.
  • BTM was applied to the lower abdomen, left hip, right thigh, left suprapatellar region, and scrotum. BTM was secured using staples and outer dressings which included Negative Pressure Wound Therapy (NPWT) to manage fluid exudate over the larger wounds. Splints were used in mobile areas to prevent any shearing motion.
  • On day 36, BTM was delaminated and a meshed split-thickness skin graft was secured using staples and outer dressings. On day 12 post-grafting, all dressings and staples were removed. Intensive rehabilitation commenced.
  • Benefits of using BTM were demonstrated in this case where there was an absence of epidermal potential and poor dermal structure, including providing good support for skin grafts. There was no report of infection after application of BTM, despite the nature of the injury being a traumatic road abrasion.
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Minimally invasive successful reconstruction of a severely traumatized upper extremity using platelet-rich plasma and tissue scaffold: a case report

  • 64-year-old male patient who presented with multiple co-morbidities and injuries following a motor vehicle collision. The patient’s injuries included extensive degloving, skin necrosis, extensor and flexor forearm muscle crush injuries, and ruptured extensor tendons.
  • Initial treatment consisted of serial wound debridement combined with platelet-poor plasma injection into the muscles, platelet-rich plasma injections into the tendons and subcutis, and low NPWT to salvage the injured soft-tissues.
  • BTM was subsequently applied, delaminated at 2 months, and a skin graft applied.
  • Excellent pliability and cosmesis of the reconstructed wound were reported, with near-to-full range of motion given the initial extent of the injury to the musculature and positive outcomes reported by the patient.
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Tissue engineered successful reconstruction of a complex traumatized lower extremity

  • Attached article reports the case of a patient who presented after motor vehicle accident with major trauma to his right thigh and knee. After conservative surgical debridement, and creative use of Platelet-Rich Plasma (PRP) injections and cyclic NPWT to prepare the wound bed, BTM was applied to the 24 x 11 cm skin defect.
  • 5 weeks post-application, BTM was delaminated and a skin graft was applied, with complete skin graft take after 1 week. At 6 months follow up, the patient had a mature, pliable skin graft and regained his full range of knee motion.
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Biodegradeable Temporizing Matrix (BTM) used in a traumatic chest wound

  • 23-year-old female who suffered a traumatic injury as the result of a farm accident and presented with multiple injuries including a contaminated chest wound (8% TBSA) involving exposed bone and breast tissue.
  • Initial treatment involved wound debridement and use of VAC dressing, followed by further debridement and the application of BTM on day 16 post injury, with NPWT again used. Four weeks later, BTM was delaminated and a split-thickness skin graft applied. No infection was reported, despite the heavily contaminated injury site.
  • At 4 months, the wound had healed well, with good contouring of the breast tissue and no restriction of shoulder movement. The patient was able to return to work.
  • Of particular interest is the patient’s perspective of her treatment and (excellent) clinical outcome.
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Biodegradable Temporizing Matrix (BTM) for the reconstruction of defects following serial debridement for necrotizing fasciitis: a case series

  • Case series consists of 7 patients, ranging from 32–76 years old (4 males, 3 females) with a variety of co-morbidities and risk factors. The size of defects ranged from 1.5-24%% Total Body Surface Area (TBSA) in the anterior neck to extensive loss of soft tissues on both legs respectively.
  • Following surgical debridement, stabilization of the patient, and preparation of the wound bed, BTM was cut to size and secured. All exposed bone stripped of periosteum was drilled to provide a bleeding bed. Dressings were changed twice a week and Negative Pressure Wound Therapy (NPWT) was used in cases where excessive fluid was generated.
  • All 7 patients survived their life-threatening necrotizing soft-tissue infection and achieved good cosmetic and functional outcomes. The time to delamination after BTM application ranged from 26-42 days. The potential for NPWT to shorten the integration time in such wounds was also demonstrated.
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Limb salvage through intermediary wound coverage with acellular dermal matrix template after persistent Pseudomonas aeruginosa infection in a burn patient

  • 69-year-old diabetic patient who suffered from a deep partial thickness circumferential burn injury of both legs totalling 15% TBSA.
  • After initial therapy and early debridement with immediate skin-graft coverage, there was progressive loss of skin graft due to local wound contamination with Pseudomonas aeruginosa. After the course of several surgical debridements and topical anti-infective therapy, the surgeons were confronted with a deep lower leg defect with uncovered tendons and persisting Pseudomonas aeruginosa wound contamination.
  • In this case, coexisting diabetes meant that the patient was predisposed to a prolonged infection and poor wound healing. Despite repeated debridements, the patient had a persistent infection resulting in a total skin loss putting the patient at risk of a bilateral lower leg amputation.
  • After minimizing the Pseudomonas aeruginosa wound colonization, debridement with Versa-Jet was performed and the wounds covered with BTM secured using staple
  • After 21 days, delamination of the integrated BTM showed a well vascularized wound bed and autologous skin-grafting was performed with a successful outcome
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The evidence for antimicrobial and hard to infect regenerative matrices

  • Surgeons compared previously reported experience with BTM in the presence of infection to their own experience.
  • Surgeons used BTM to treat 5 patients with highly colonized lower-extremity wounds.
  • At 21 days, 4 of 5 patients achieved excellent integration of vascularized tissue. 1 of 5 patients had a dense infection where BTM was unable to adhere.
  • Surgeons concluded, “BTM benefits from its inability to become infected… (referring to the BTM itself, not the wound where BTM is adhered) it was relatively resistant to bacterial infection, but not completely resistant, which is similar to the results reported in literature.”
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Single staged treatment of a complex full thickness debridement for Hidradenitis Suppurativa using NovoSorb® Biodegradable Temporizing Matrix (BTM)

  • Patient with recurrent and widespread axillary, inguinal, and gluteal hidradenitis suppurativa. The patient had a high-risk surgical profile and had failed previous attempts at medical management.
  • Patient was successfully treated using BTM as the primary dermal substitute without subsequent grafting to cover a 400 cm2 left gluteal excision due to patient non-compliance and a complicated medical path. The covered area subsequently spontaneously epithelized after six months of local home health care during the COVID- 19 pandemic.
  • Case demonstrated complete healing with a single stage surgery and minimal inpatient stay using only BTM without autologous skin graft in a high-risk surgical candidate during the Covid-19 pandemic.
  • Wound closure was achieved with no recurrence reported at 6 months and no dramatic lifestyle change.
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Reconstruction of chronic wounds secondary to injectable drug use with a Biodegradable Temporizing Matrix (BTM)

  • Case 1: A 36-year-old man presented with bilateral upper extremity soft-tissue defects sustained in a previous thermal burn complicated by Injectable Drug Use (IDU) at the site of injury. His wounds were full thickness with exposed ulnae. Bilateral ulnar shaft osteomyelitis and myositis were confirmed by an MRI.
  • Case 2: A 33-year-old woman with a 2-year history of bilateral forearm wounds secondary to IDU presented with worsening ulcerations. Necrotic bone was present in the wound base, and an MRI confirmed bilateral ulna osteomyelitis, myositis, and soft-tissue micro-abscesses.
  • Both cases: Serial surgical debridement of the initial wound bed was performed to a viable wound bed. Intravenous antibiotics were administered to manage the infections identified. Addiction was also managed by a multidisciplinary team. BTM was applied to the wound with the use of Negative Pressure Wound Therapy (NPWT). Autologous split thickness skin grafts (STSGs) were applied once BTM integrated and the sealing membrane was removed.
  • Both cases: Stable wound coverage was achieved. Some evidence of wound contracture was attributed to the use of NPWT, rather than BTM. The surgeons concluded the use of BTM provided a more straightforward surgical technique with fewer risks compared to alternative dermal matrices or surgical methods. There were no reports of infection, fluid collection, or matrix loss of the BTM.
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The evidence for antimicrobial and hard to infect regenerative matrices

  • Surgeons compared previously reported experience with BTM in the presence of infection to their own experience.
  • Surgeons used BTM to treat 5 patients with highly colonized lower-extremity wounds.
  • At 21 days, 4 of 5 patients achieved excellent integration of vascularized tissue. 1 of 5 patients had a dense infection where BTM was removed.
  • Surgeons concluded, “BTM benefits from its inability to become infected (referring to the BTM itself, not the wound where BTM is adhered) … it was relatively resistant to bacterial infection, but not completely resistant, which is similar to the results reported in literature.”
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Radiotherapy for wound treated with BTM: a case report and review of literature

  • 82-year-old man presented with basal cell carcinoma (BCC) over his left preauricular area. The area was previously treated with excisional surgery and split-thickness autograft. The patient had no significant medical history otherwise.
  • Excisional surgery was performed and BTM was applied to the wound, followed by an autograft that was harvested at 10/1000th-inch thickness. He was further treated with adjuvant radiation (45/Gyx20).
  • Patient did not incur any complications and showed a positive outcome of treating a wound with staged BTM, autograft, and subsequent radiotherapy.
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Neglected cutaneous skin malignancy: a patient with concurrent giant basal cell carcinoma and melanoma

  • Patient presented with a giant 15-cm basal cell carcinoma (BCC) on his back and an ulcerated melanoma on his elbow.
  • After surgical resection with surrounding margins, BTM was applied to the resulting wound bed. — BTM was delaminated after 4 weeks and a skin graft applied. At 4 months after reconstruction, the skin graft had matured and the patient was progressing well.
  • BTM partly considered for treatment (on the patients back) due to its durability to shearing forces and pressure.
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Free flap donor site reconstruction: a prospective case series using an optimized polyurethane Biodegradable Temporizing Matrix (BTM)

  • Case series includes 10 patients who required a harvest of a fibular osteocutaneous flap or radial forearm flap for head and neck cancer.
  • BTM was applied to the donor site from where the free flap was detached.
  • Subsequent graft take took completely in each case and none of the patients incurred infections.
  • 6 patients were evaluated at the 1-year mark. The study showed no safety issues or infections, easy and rapid delamination, and complete graft take with improved long-term outcomes.
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    References

    1. Wu et al., Performance of Biodegradable Temporizing Matrix vs Collagen-chondroitin Silicone Bilayer Dermal
      Regeneration Substitutes in Soft Tissue Wound Healing: A Retrospective Analysis, Wounds, 34(4): 106-115.