Lessons Learned From Two Survivors of Greater Than 90% TBSA Full-Thickness Burn Injuries Using NovoSorb Biodegradable Temporizing Matrix™ and Autologous Skin Cell Suspension, RECELL™: A Case Series

Author(s):  
Aldin Malkoc ◽  
David T Wong

Abstract Since autologous split-thickness skin grafts are scarce and lab skin growth requires a significant amount of time, there are limited available treatment approaches for patients with full-thickness burns greater than 90% TBSA. Additionally, to achieve the primary goal of skin coverage and resuscitation, there must exist a balance between fluid loss and metabolic derangement. Allografts and xenografts have traditionally been used early in the process to achieve these goals. Currently, novel approaches to treatment consider the additional use of synthetic dermal substitutes and autologous skin cell suspension to improve outcomes. This case series describes the treatment course of patients with greater than 90% TBSA full-thickness burn injuries using a staged, multifaceted approach of using NovoSorb Biodegradable Temporizing Matrix™ as the primary dermal substitute in conjunction with a RECELL™ Autologous Cell Suspensions Device applied with autograft and allograft to achieve improved resuscitation, limiting fluid loss, and finally skin coverage. Allograft and NovoSorb Biodegradable Temporizing Matrix™ were used early to cover excised burns, resulting in improved metabolic control by limiting the systemic inflammatory response syndrome and fluid loss. Both patients survived using this approach.


2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S123-S123
Author(s):  
Aldin Malkoc ◽  
David Wong

Abstract Introduction Advances in burn injury knowledge, critical care, and pharmacological developments have increased survival rates among extensive burn patients. Survival now dependents not just on skin coverage, but effective control of SIRS response, metabolic derangement, fluid loss and sepsis. Novel synthetic dermal substitutes create robustness, thickness, and pliability of the skin in addition to an improved aesthetic appearance while; point-of-care autologous skin cell harvesting enhances treatment by amplifying small split-thickness skin samples to produce an autologous skin cell suspension (ASCS) to cover a larger burn area. This study reports on two survivors with greater than 90% total body surface area full-thickness burns utilizing a combined treatment of a dermal substitute along with ASCS and traditional burn management strategies. Methods Chart review of two patients with >90% burns and inhalation injury after being trapped in a burning vehicle following a traffic collision occurred. Most of the burns in both patients were “leathery” and consistent with full thickness, sparing only the plantar and dorsal aspect of the feet and bilateral small areas of the hip in Patient 1. Patient 2 had fourth-degree burns in some areas of the chest and flank with only the bilateral groin regions and feet spared. The patients were treated with a multi-step process which included using allograft, dermal substitute, and ASCS with split-thickness skin grafts (STSG) in place of cultured epidermal autograft to achieve coverage of >90% burns with high meshed ratio. Results The dermal substitute was limited to deep burns that penetrated down to fat, muscle, and/or joints. Fluid loss was well controlled by the dermal substitute during initial resuscitation. Post reconstruction, areas covered with the dermal substitute and grafted with autogenous STSG with ASCS exhibited less hypertrophy and contracture bands. The elbow and knee joints showed minimal restriction with passive motion and good skin compliance, but contractures persisted in areas where 4th degree tendon and fascia thermal injury occurred. Areas that showed signs of infection were trimmed or unroofed and allowed to drain while maintaining the remainder of the dermal substitute. Conclusions The use of dermal substitutes and ASCS allowed the care team to achieve SIRS control, improved fluid management, enhanced skin coverage, and reduced hospitalization stay. The process experienced in these cases shows promise for future patients with extensive burns. Both patients were able to survive and show improvement during rehabilitation.



2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S195-S195
Author(s):  
Nicole M Kopari ◽  
Yazen Qumsiyeh

Abstract Introduction Complex wounds (CW) resulting from necrotizing soft tissue infections (NSTIs) and soft tissue traumatic injuries create unique challenges. Radical debridement is often the first step in management but can result in disfigurement with impaired function and compromised cosmesis. The standard of care at our institution for full-thickness burn injuries of similar complexity is widely meshed autografting with application of autologous skin cell suspension (ASCS). Our study is a case series reviewing outcomes using ASCS for CW from non-burn etiology. Methods A retrospective chart review from March 2019 through July 2020 was performed to evaluate the effectiveness of ASCS and widely meshed autografting in CW. Patients presenting with CW underwent serial excisions of devitalized tissue by acute care and burn surgeons. Dermal substitute utilization for wound preparation was at the discretion of the surgeon. Definitive wound closure was achieved using ASCS in combination with a widely meshed autograft. The wounds were covered with a non-adherent, non-absorbent, small pore primary dressing along with bismuth-impregnated, petroleum-based gauze or negative pressure wound therapy dependent on wound bed contour. Further padding with gauze was applied along with compressive dressing. Results In total, 8 patients with CW were included in this review. The mean age was 58 years (range 27-85) with an equal number of males and females. Wound etiology included NSTI (n=5), degloving injury (n=2), and traumatic amputation (n=1). The average wound size measured 1,300cm2 (range 300-3,000). 50% of the patients were treated with a dermal substitute and negative pressure wound therapy prior to ASCS and autograft placement. 7 of 8 patients received split-thickness skin grafting in the ratio of 3:1 with one patient grafted at a 2:1 expansion. 7 of the 8 patients had >90% wound closure within 8-10 days of ASCS and autograft application. One patient had significant graft failure after removing surgical dressings and autograft in the early post-operative period secondary to dementia. One patient expired during the follow-up period secondary to medical comorbidities. The 6 remaining patients had durable wound closure and acceptable cosmetic outcome. All patients were discharged within 10 days of ASCS application with 4 patients discharging home and 4 patients discharging to an acute inpatient rehabilitation. Conclusions This study is the first case series to review ASCS in combination with widely meshed skin grafts in the management of CW from a non-burn etiology. Durable, timely wound closure and an acceptable cosmetic outcome was achieved in these often-challenging CW.



2019 ◽  
Vol 41 (1) ◽  
pp. 215-219 ◽  
Author(s):  
Kenneth W Larson ◽  
Cindy L Austin ◽  
Simon J Thompson

Abstract Dermal substitutes coupled with split thickness skin graft are the primary method of treating most severe full-thickness burns particularly when there is a lack of healthy donor skin. Although dermal replacements optimize functional and aesthetic outcomes in patients, the risk of infection and the amount of time required to process most dermal substitutes delay treatment potentially compromising graft take and the overall healing process. The purpose of this case series is to describe the treatment course of patients with severe burn injuries using a novel synthetic Biodegradable Temporizing Matrix (NovoSorb BTM) in conjunction with RECELL Autologous Cell Harvesting Device, a new methodology allowing for a timely point-of-care preparation of an autologous skin cell suspension in combination with a 3:1 split-thickness skin graft. To the best of our knowledge, this is the first reported case series to describe the treatment algorithm and clinical outcomes of deep full-thickness burns utilizing BTM in conjunction with RECELL ASCS.



2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S189-S190
Author(s):  
Alexandra Coward

Abstract Introduction Split-thickness skin grafting (STSG) is the standard of care for the treatment of full thickness skin injuries. Skin grafts are associated with long-term morbidity including graft loss, adjacent structural injury, anesthetic complications, scarring, and scar contractures. Large surface area burns are additionally challenging due to limited donor site availability. Autologous skin cell suspension (ASCS) is a new adjunct for STSG using device that provides a suspension of non-cultured, autologous skin cells applied overtop of STSG. Dermal matrix templates are placed on wounds after burn excision and induces dermal regeneration in preparation for STSG, allowing for a thinner graft to be harvested and applied. This technique has been shown to require both smaller areas of donor skin as well as thinner skin harvest which improves both healing time and aesthetic outcomes of donor sites, enhancing the time-tested and well accepted technique of STSG. Methods We present the case of a 5-year-old African American female who suffered 18% TBSA deep partial thickness burns and full thickness burns to her abdomen, trunk and left back after her shirt was accidentally lit on fire at home. She was transferred from a local hospital to our burn center for further evaluation. She was evaluated by both the burn surgery and pediatric teams and admitted for wound cares and surgical planning. Results On hospital day five she underwent burn excision and placement of acellular dermal regeneration template. She returned to the operating room on hospital day 22 after daily wound cares for autografting with autologous skin cell suspension application to anterior and posterior torso and left arm, as well as to back and thigh donor sites. Her takedown on hospital day 29 showed excellent graft take. She was ultimately discharged on hospital day 47. She continued to undergo wound care in the outpatient burn clinic and daily physical and occupational therapy. Conclusions This case illustrates the use of dermal matrix and ASCS on a large burn with excellent aesthetic outcomes and improved healing time. This case is unique in highlighting the versatility of this therapy in a darker skinned patient. There are significant challenges with long term morbidity from STSG and the use of both dermal regenerative matrix and ASCS may provide surgeons with new approaches to decreasing depth and size of donor sites, as well as improving the length of hospital stay and overall aesthetic outcomes of donor and graft sites, specifically in darker skinned patients.



2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S62-S63
Author(s):  
Kevin N Foster ◽  
James H Holmes ◽  
William L Hickerson ◽  
Jeffrey W Shupp ◽  
Robert Sheridan ◽  
...  

Abstract Introduction Treatment of large TBSA burn injuries is often limited by donor site availability and requires reharvesting to obtain definitive closure. Patients with severe injuries may have delayed closure compared to uncompromised patients that typically have their donor sites healed in 7–14 days. Autologous skin cell suspension (ASCS) can be prepared to treat burn wounds at the point-of-care. The safety and effectiveness have not yet been established for use in the treatment of donor sites. This study presents the use of ASCS for the treatment of donor sites in patients with life-threatening burn injuries that were enrolled in a prospective uncontrolled observational study (IDE 15945—NCT02992249). Methods ASCS was applied to the donor site after harvesting of STSGs. Clinical outcomes out to one year were evaluated including percentage of re-epithelialization, long-term cosmetic outcomes, and adverse events. Results Ninety-six subjects from 22 burn centers had their donor sites treated with ASCS as part of their treatment regimen. The average subject age was 30.1 and the average TBSA injury was 53.7 ±17.3%. The mean Baux score was 89.2 with 36% of subjects having a score greater than 100. Collectively, 528 donor sites were individually treated. In this compromised patient population 37.5% were ≥95% re-epithelialized by week 1 (n=435), and by week 2, 82.7% of the donor sites were ≥95% re-epithelialized (n=434), regardless of how many times they were harvested. Approximately 19% of the donor sites treated with ACSC were reharvested multiple times following initial healing (15% two times, 2.3% three times, and 7 donor sites were harvested 4 times) and retreated. Of donor sites harvested more than once, 39.3% (n=84), 81% (n=79), and 85.7% (n=77) of sites were ≥ 95% re-epithelialized by week 1, 2 and 4, respectively. One-year data was available for 427 donor sites and the majority had matched or mildly mismatched color, pigment, and texture. Adverse events included one site with a hematoma, one patient with donor sites that had fragile skin loss secondary to traumatic friction, one patient with active bleeding, two patients with anemia secondary to donor site bleeding, one patient with delayed closure due to mild infection of staph species. All AEs were unlikely or unrelated to the device. Conclusions ASCS has been successfully used to achieve closure of donor site wounds without significant safety risk in patients with extensive burn injuries. Applicability of Research to Practice Application of ASCS for donor site healing may be particularly relevant for patients with large burn injuries requiring subsequent reharvesting to achieve definitive closure.



2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S195-S195
Author(s):  
Joe Olivi ◽  
Megan Rodgers

Abstract Introduction Deep Full thickness burns require tangential excision of the burned tissues down to viable tissue. This often leaves exposed muscle, tendon and bone. Coverage of these areas is vital to limb salvage. Multiple modalities are necessary with these type of patients, such as, dermal matrix graft, split thickness skin graft, sprayed autologous cell suspension (ACS) and wound vacuum therapy(VAC). A dermal matrix provides a scaffold for tissue and vascular en growth that is suitable for accepting a skin graft and also provides a layer between the muscle, tendon, bone and the skin graft which improves movement and produces a more pliable graft. Biodegradable temporizing matrix(BTM), produced by PolyNovo Ltd, was used to cover the muscle, bone and tendon. This product has a silicone backing which can be delaminated once it has matured with tissue and vascular en growth for auto grafting. A combination of a wide meshed skin graft at 3:1 ratio and a sprayed ACS allows for faster healing and less donor site usage which decreases the overall wound burden. Methods A 73 y/o male with total body surface area burn of 24 % suffered deep full thickness burns to the bilateral lower legs. He underwent multiple debridements with management of the right leg with irrigating wound vacuum therapy. The deeper right leg had a wound base with that consisted of muscle from the thigh down onto the foot with exposed tendons and anterior tibial bone. The open wounds to the right leg were grafted with BTM for dermal substitute coverage. Once the BTM was mature it was delaminated, and the wound surface was covered with a 3:1 ratio split thickness skin graft (STSG) and sprayed on autologous cell suspension. This resulted in using less donor skin than a 1.5 or 2:1 meshed graft STSG which decreased his wound burden. Donor sites were also sprayed with ACS. Results We had nearly 100% take of the STSG and sprayed autologous suspension epidermal graft. There was a small area over the patella tendon where the BTM did not incorporate. This is though to be because of lack of immobilization of his knee and a pseudomonal infection. Donor sites healed faster and there were minimal open areas to the graft POD 11 excluding the patella area. Conclusions BTM can be used to provide a suitable dermal substitute in complex wounds when muscle, tendon and/or bone are exposed. Immobilization of the joints is necessary to allow the tissue en growth into the dermal matrix. Wide meshed graft with sprayed ACS can be used with good results with wound vacuum therapy. Decreased wound burden and time to heal open wounds of the graft and donor sites. Applicability of Research to Practice Use of a dermal matrix, wide mesh split thickness graft and sprayed epidermal ACS with wound vacuum therapy is a good option for limb salvage when vital structures are exposed.



2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S201-S201
Author(s):  
Jeffrey E Carter ◽  
Kathryn Mai ◽  
Shana Lennard ◽  
Jeremy Landry ◽  
David G’sell ◽  
...  

Abstract Introduction Postoperative dressing and wound care are essential to optimize graft survival through imbibition, inosculation, and neovascularization. Autologous skin cell suspension (ASCS) using extended-wear dressings (EWD) as a primary or secondary has not been previously described in the literature. The goal of our study was to assess the feasibility of new dressing protocol for ASCS at reducing dressing changes without increasing reoperation rates for failure to close or mortality. Methods The study was an IRB approved, single-center, retrospective review of admissions between April 2018 to August 2019. Patients included in the study were >14 years of age with >3%TBSA partial-thickness and full-thickness burns undergoing excision and ASCS. EWD included a controlled-release silver antimicrobial dressing with active fluid management. Standard of Care (SoC) primary dressing with fine-pore, non-adherent polyethylene film followed by petroleum gauze, layered gauze, and compressive dressings. Data included age, gender, %TBSA, mortality, primary and secondary dressing, dressings changes prior to primary dressing change (DC), and failure to close (FTC) requiring reoperation. Fisher’s exact test was used to compare the two populations. Results A total of 53 ASCS cases were performed with 33 receiving standard of care (SOC) and 20 EWD post-operatively. The median age was 48 (range 14–85) with 26% of the patients being female. The median TBSA was 17% (range 3–72%). Median age for SoC was 57 and for EWD was 33 (p-value= 0.0289). Median %TBSA for SoC was 20% and for EWD was 15% (p-value= 0.0182). 1 SoC patient required reoperation from both groups (p-value= 0.5210). No EWD patients required reoperation. 1 patient expired (SoC) in the study secondary to decompensated cirrhosis. EWD required median 1 DC versus 3 in the SoC group (p-value= 0.0164). Conclusions EWD with ASCS reduced the total number of dressing changes and did not result in increased mortality or reoperation for FTC in our feasibility trial with partial-thickness and full-thickness burn injuries. Optimizing postoperative care with EWD in ASCS may serve to reduce dressing change costs and patient discomfort as well as to shorten hospital length of stay. Applicability of Research to Practice Reduced wound care following autologous skin cell suspension.



2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S116-S117
Author(s):  
Jeffrey E Carter ◽  
James H Holmes ◽  
Kevin N Foster ◽  
David J Smith ◽  
Jeffrey W Shupp

Abstract Introduction Split-thickness skin grafts (STSGs) have been the standard of care for many decades. Despite their widespread use, STSGs frequently fail. Autologous skin cell suspension (ASCS) is an FDA approved point of care regenerative medicine technology that reduces donor skin requirements without compromising clinical outcomes. ASCS allows for early treatment and less donor skin harvested that may be useful for hard-to-treat anatomical locations, in compromised patients that have risks for impaired wound healing, or elderly patients with thinner skin. We examined ASCS treatment as an adjunct to meshed autografts in adults with small mixed-depth/full-thickness burns. Methods We obtained IRB-approval for a prospective, multi-center, uncontrolled observational study that allowed continued access to ASCS before FDA approval (ClinicalTrials.gov Identifiers: NCT03333941). Subjects with mixed-depth/full-thickness injuries that required skin grafting with a minimum treatment area of 320 cm2 and burns ranging from 5–50% TBSA were eligible for study enrollment. Our analyses included only patients >18 years of age and ≤10% TBSA mixed-depth/full-thickness injuries that had completed the trial. All subjects had ≥1 burn wounds treated with meshed autografts (2:1–4:1) in combination with ASCS. Healing outcomes were accessed following ASCS treatment by direct visualization of each individual wound and included healing, scar outcomes, and safety data. Results Analyses included 20 subjects older than 18 years of age with ≤10% TBSA mixed-depth/full-thickness injuries. Of these, compromised wound healing was seen in 50.0% of subjects. Burn wounds with ≥90% re-epithelialization increased over time, with 62%, 80%, and 100% of wounds achieving closure at Weeks 1, 2, and 8, respectively. Similar results were seen in subjects with comorbidities known to affect wound healing and in elderly subjects despite their risks for impaired healing. Total POSAS patient (37.8 and 35.4) and observer scores were comparable (23.3 and 18.4) at Weeks 12 and 24. Safety events were typical for this patient population, and no serious adverse events occurred for any of the wounds. Conclusions This analysis provides additional information supporting the use of ASCS for the treatment of small, mixed-depth/full-thickness acute thermal burn injuries in adults, notably those with risk factors for impaired wound healing.



2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S118-S119
Author(s):  
Jeffrey E Carter ◽  
Herbert Phelan ◽  
Nicole M Kopari ◽  
Steven Kahn ◽  
Joseph Molnar ◽  
...  

Abstract Introduction Optimal management of facial burn injuries remains a significant challenge in burn care. Acute surgical intervention is often coupled with delayed reconstructive procedures as an essential option for burn care. Experience with new surgical technologies could challenge historic reconstructive ladders. Our goal was to pragmatically assess the rate of successful intervention with autologous skin cell suspension (ASCS) for the treatment of facial burn injuries from real-world data. Methods A retrospective review from five burn centers over a three-year period was performed from deidentified registry data for facial burn injuries initially treated with ASCS. Cases of non-acute thermal burn and burns not involving the face were excluded. Data collection included: date of surgery, last follow-up date, need for grafting (split or full thickness skin graft, STSG or FTSG, respectively) or reapplication of ASCS within the same hospitalization, and reconstruction not including laser procedures due to scarring during the follow-up period. Descriptive statistics were calculated and data are reported as median with interquartile ranges where appropriate. Results A total of 72 burn injuries were treated with ASCS for facial burn injuries. Two burn centers treated 4 patients each, one treated 18, and the remaining two treated 22 and 24 patients. The median follow-up was 199 days (range 9 -1,150 days). Acute failure requiring a second treatment with ASCS or application of a full-thickness or split-thickness autograft occurred in 12 (16%) of the patients with 5 undergoing re-application of ASCS and 7 undergoing FTSG or STSG. reconstruction secondary to scarring during the follow-up period occurred in 10 (14%) of patients. Reconstruction was required in 1 of 5 patients that underwent a second treatment with ASCS as opposed to 4 of 5 patients treated with FTSG or STSG. Conclusions This study represents the largest experience with the use of ASCS for the management of facial burn injury in the reported literature. Use of ASCS from real-world data indicated that ASCS successfully resulted in definitive wound closure in 90% of the patients treated with facial burn injuries, with 10% requiring secondary intervention. This failure rate is below the previously published rate of 33%, indicating the disruptive potential of this technology for the management of facial burn injuries.



2019 ◽  
Vol 40 (Supplement_1) ◽  
pp. S70-S71
Author(s):  
J A Molnar ◽  
J Holmes ◽  
J Carter ◽  
J Lee ◽  
K Foster ◽  
...  


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