111 10 Years of Clinical Experience Using Point of Care Non Cultured Autologous Skin Cell Suspension

2019 ◽  
Vol 40 (Supplement_1) ◽  
pp. S71-S72
Author(s):  
M Fear ◽  
F Wood

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. S37-S38
Author(s):  
Jeffrey E Carter ◽  
Blake Platt ◽  
Charles T Tuggle

Abstract Introduction Burn injuries remain a surgical challenge with few recent innovations. Grafting with split-thickness skin grafts (STSGs) has been the standard of care for decades. Although shown to have mortality benefits, STSGs are associated with significant morbidity in the form of pain and additional open wounds. For years, surgeons have looked for ways to decrease this associated morbidity. To that end, autologous skin cell suspension (ASCS) is a recently FDA-approved point of care regenerative medicine technology that reduces donor skin requirements without compromising clinical outcomes. Our study evaluated the cost and length of stay comparing STSG alone versus ASCS. Methods We obtained IRB-approval for single institution, retrospective chart review of patients age >14 years admitted with burn injuries from March 2018 – September 2018. Primary outcome was length of stay/%TBSA for patients undergoing STSG alone as compared to patients undergoing ASCS. The 2016 American Burn Association National Burn Repository (NBR) was used to benchmark LOS/%TBSA. Age, percentage burn injury (TBSA), LOS, mortality, and number of surgeries were reviewed. Student’s t-test was used to assess statistical significance of intragroup analysis. Results 36 patients were treated with ASCS in combination with meshed autografts for full-thickness acute burn injuries. 37 patients were treated with STSGs at our center. Mean age and %TBSA was 45.2 years and 6.6% for the STSG group and 46.0 years and 18.6% for the ASCS group. The LOS/%TBSA for the STSG was 1.72 versus 1.19 for the ASCS patients (p-value=0.02). The NBR predicts a LOS/%TBSA of 3.38 and 3.42 for the STSG and ASCS groups. Patients in the STSG group and ASCS group had statistically similar surgeries and mortalities. Conclusions Burn injured patients treated with ASCS had a decreased LOS/%TBSA when compared to both the STSGs and NBR predictions. ASCS is a novel technology allowing for point-of-care treatment that may decrease LOS for burn injured patients and should be considered as an adjunct to traditional techniques for burn patients. Applicability of Research to Practice Reduced length of stay compared to traditional burn care.



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.



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.





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.



2019 ◽  
Vol 7 ◽  
Author(s):  
Anjana Bairagi ◽  
Bronwyn Griffin ◽  
Zephanie Tyack ◽  
Dimitrios Vagenas ◽  
Steven M. McPhail ◽  
...  

Abstract Background Mixed partial thickness burns are the most common depth of burn injury managed at a large Australian paediatric hospital specialty burns unit. Prolonged time until re-epithelialisation is associated with increased burn depth and scar formation. Whilst current wound management approaches have benefits such as anti-microbial cover, these are not without inherent limitations including multiple dressing changes. The Biobrane® RECELL® Autologous skin Cell suspension and Silver dressings (BRACS) trial aims to identify the most effective wound management approach for mixed partial thickness injuries in children. Methods All children presenting with an acute burn injury to the study site will be screened for eligibility. This is a single-centre, three-arm, parallel group, randomised trial. Children younger than 16 years, with burns ≥ 5% total body surface area involving any anatomical location, up to 48 h after the burn injury, and of a superficial partial to mid-dermal depth, will be included. A sample size of 84 participants will be randomised to standard silver dressing or a Regenerative Epithelial Suspension (RES™) with Biobrane® or Biobrane® alone. The first dressing will be applied under general anaesthesia and subsequent dressings will be changed every 3 to 5 days until the wound is ≥ 95% re-epithelialised, with re-epithelialisation time the primary outcome. Secondary outcomes of acute pain, acute itch, scar severity, health-related quality of life, treatment satisfaction, dressing application ease and healthcare resource use will be assessed at each dressing change and 3, 6 and 12 months post-burn injury. Discussion The findings of this study can potentially change the wound management approach for superficial partial to mid-dermal burns in children locally and worldwide. Trial registration The Australian New Zealand Clinical Trials Registry (ACTRN12618000245291) approved prospective registration on 15 February 2018. Registration details can be viewed at https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374272&isReview=true.



2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S129-S130
Author(s):  
Joe A Olivi ◽  
Megan D Rodgers

Abstract Introduction There are accounts of various dressings being applied over epidermal spray cell suspension graft(s) (SCSG) with varying success and no one perfect dressing. We present 3 patients with ASCS grafts used in combination with mSTSG that were treated with vacuum assisted dressing with excellent outcomes. Methods All 3 of our patients received surgical debridement, down to healthy viable tissue with exposed tendon. BTM Dermal matrix was used in 2 of the 3 patients with exposed tendon. All three patients had mSTSG with ACSS autografts. All grafts were covered with telfa ™ clear, followed by tacky macroporous silver dressing, then a vacuum assisted closure device. These were left undisturbed until post operative day (POD) 5. Results All patients had their dressings taken down on POD #5 with excellent results. The interstices were closed quickly with no negative outcome noted from the vacuum dressings. All patients had excellent wound closure and good function postoperatively. Conclusions Vacuum assisted closure devices can be used to cover ASCS and wide meshed grafts with good outcomes. They provide patients with a stable dressing that does not need to be changed and leads to excellent graft take and wound closure.



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.



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