Evaluating Health Economic Outcomes of Autologous Skin Cell Suspension (ASCS) For Definitive Closure in US Burn Care Using Contemporary Real-World Burn Center Data

Abstract Introduction Donor site morbidity (DSM) is a major patient dissatisfier due to pain and scarring leading to aesthetic and functional limitations acutely and over time. Many of the recent advancements in burn care such as autologous skin cell suspension (ASCS), cultured tissues, and engineered tissues are driven to reduce DSM. One of the most important advancements in reducing DSM has been the approval of ASCS. Our study assesses donor site (DS) location using real-world data after ASCS procedures with an inconspicuous surgical approach for DS. Methods An IRB approved, retrospective chart review of all burn patients undergoing ASCS at an American Burn Center verified burn center between January 2019 and August 2020 was completed. Patients were excluded who received ASCS in combination with widely meshed skin graft or who died during their hospitalization. Demographics were reported including age, gender, % total body surface area (TBSA), length of stay (LOS), ASCS size in cm2 and % TBSA, and location of burn. All DS were harvested at 0.004–0.008 inch after clysis of the prep site with injectable saline and 0.25% Marcaine with a dermatome or Weck knife. Photographs of the DS and burn wounds were uploaded to the EMR by the surgeon of record and assessed by two experienced burn nurses that were blinded to DS location and intraoperative procedures. Results 83 patients underwent ASCS with 25 patients meeting inclusion criteria. The average age was 33 years (range 15 months to 88 years). 68% of patients were male with an average TBSA of 11% (range 2.5–40). The mean LOS was 5.8 days (range 1–16). Burn locations included face/neck (n=9), torso (n=16), extremity (n=20), hand (n=10), and two patients had single site involvement. The adult patient average size of ASCS applied was 1700cm2 (range 250–6200) while pediatric patients had an average size of 13% TBSA (range 6–32). 21 of the 25 patients had DS adjacent to the burn. No significant difference was noted in healing time, infection rate, or hypertrophic scarring. None of the patients complained of DS pain that was distinguishable from the burn wound. Blinded observers were unable to discern the DS in 56% of the patients from the initial burn wound. Conclusions DSM is an iatrogenic insult to non-burn skin and a significant cause of morbidity. ASCS DS may be taken adjacent to the burn wound without risk of delayed re-epithelization, infection, or hypertrophic scarring. Placing ASCS DS adjacent to the burn wound is a more patient-centered approach with indistinguishable pain from the burn wound, a more pleasing cosmetic outcome, and potential greater patient satisfaction.

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Autologous skin cell suspension in burn care saves costs

PharmacoEconomics & Outcomes News ◽

10.1007/s40274-019-5881-y ◽

2019 ◽

Vol 828 (1) ◽

pp. 7-7

Keyword(s):

Cell Suspension ◽

Burn Care ◽

Skin Cell

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541 72 Facial Burns Treated with Autologous Skin Cell Suspension- A Real World Data Analysis Across 5 U.S. Burn Centers

Journal of Burn Care & Research ◽

10.1093/jbcr/irab032.191 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

pp. S118-S119

Author(s):

Jeffrey E Carter ◽

Herbert Phelan ◽

Nicole M Kopari ◽

Steven Kahn ◽

Joseph Molnar ◽

...

Keyword(s):

Real World ◽

Burn Injuries ◽

Full Thickness ◽

Real World Data ◽

World Data ◽

Burn Centers ◽

Burn Care ◽

Skin Cell ◽

Facial Burn

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.

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656 Autologous Skin Cell Suspension is Associated with Decreased Hospital Length of Stay and Limited Surgical Interventions

Journal of Burn Care & Research ◽

10.1093/jbcr/irab032.322 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

pp. S194-S194

Author(s):

Nicole M Kopari ◽

Yazen Qumsiyeh

Keyword(s):

Length Of Stay ◽

Cell Suspension ◽

Average Length ◽

Total Body Surface Area ◽

Hospital Length ◽

Care Quality ◽

Hospital Length Of Stay ◽

Burn Patients ◽

Burn Care ◽

Skin Cell

Abstract Introduction Hospital length of stay is a measure of burn care quality and resource allocation. Traditionally, the average length of stay (LOS) for patients with burns is estimated at 1 day/% total body surface area (TBSA) although the 2016 American Burn Association National Burn Repository predicts closer to 3 days/%TBSA. Recent literature has shown that application of autologous skin cell suspension (ASCS) is associated with decreased hospital LOS and therefore is considered economically advantageous. Our study evaluated the LOS as it related to TBSA as well as the number of operations in patients treated with ASCS. Methods This is a single institution, retrospective review of burn patients at an American Burn Associated verified burn center admitted from August 2019 - August 2020 who underwent epidermal autografting. Patients were treated for partial thickness and full thickness burns either with epidermal grafting alone or in combination with widely meshed skin grafting. Demographics included age and sex of patient. The TBSA, LOS, number of operations, and re-admission rates were also collected. Results A total of 52 patients were included in the review. 73% were male with an average age of 42 years (range 15 months to 88 years. The patients were stratified into 4 different categories based on their burn TBSA: 0-10% (n=25), 11-20% (n=16), 21-30% (n=5), and >30% (n=6). The average number of operations increased with %TBSA (0-10%=1, 11-20%=1, 21-30%=2, >30%=4). The average LOS overall was 0.9 days/%TBSA (0-10%=1.0, 11-20%=0.7, 21-30%=0.9, >30%=0.8). Only one patient required re-admission after the first dressing takedown and underwent a second application of ASCS with subsequent healing. No patients required reconstructive surgery. Conclusions Burn patients treated with ASCS continue to demonstrate a decreased LOS/%TBSA and an overall decrease in the number of operations. The most significant impact may be noted as burn size increases.

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Evaluating real-world national and regional trends in definitive closure in US burn care: A survey of US Burn Centers

Journal of Burn Care & Research ◽

10.1093/jbcr/irab151 ◽

2021 ◽

Author(s):

Jeffrey E Carter ◽

H Amani ◽

Damien Carter ◽

Kevin N Foster ◽

John A Griswold ◽

...

Keyword(s):

Resource Utilization ◽

Resource Use ◽

Real World ◽

Practice Patterns ◽

Treatment Patterns ◽

Inpatient Setting ◽

Burn Treatment ◽

Burn Care ◽

Burn Center ◽

Number Of Patients

Abstract To better understand trends in burn treatment patterns related to definitive closure, this study sought benchmark real-world survey data with national data contained within the National Burn Repository version 8.0 (NBR v8.0) across key burn center practice patterns, resource utilization, and clinical outcomes. A survey, administered to a representative sample of US burn surgeons, collected information across several domains: burn center characteristics; patient characteristics including number of patients and burn size and depth; aggregate number of procedures; resource use such as autograft procedure time, and dressing changes; and costs. Survey findings were aggregated by key outcomes (number of procedures, costs) nationally and regionally. Aggregated burn center data were also compared to the NBR to identify trends relative to current treatment patterns. Benchmarking survey results against the NBR v8.0 demonstrated shifts in burn center patient mix, with more severe cases being seen in the inpatient setting and less severe burns moving to the outpatient setting. An overall reduction in the number of autograft procedures was observed compared to NBR v8.0, and time efficiencies improved as the intervention time per TBSA decreases as TBSA increases. Both nationally and regionally, an increase in costs were observed.The results suggest resource use estimates from NBR v8.0 may be higher than current practices, thus highlighting the importance of improved and timely NBR reporting and further research on burn center standard of care practices. This study demonstrates significant variations in burn center characteristics, practice patterns, and resource utilization thus increasing our understanding of burn center operations and behavior.

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56 Reduced Length of Stay with Autologous Skin Cell Suspension Reduces Burn Injuries

Journal of Burn Care & Research ◽

10.1093/jbcr/iraa024.060 ◽

2020 ◽

Vol 41 (Supplement_1) ◽

pp. S37-S38

Author(s):

Jeffrey E Carter ◽

Blake Platt ◽

Charles T Tuggle

Keyword(s):

Length Of Stay ◽

Cell Suspension ◽

Burn Injury ◽

Point Of Care ◽

Statistical Significance ◽

Burn Injuries ◽

Burn Care ◽

Skin Cell ◽

Donor Skin ◽

Injured Patients

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.

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658 Early Interventions with Autologous Skin Cell Suspension Leads to Positive Outcomes

Journal of Burn Care & Research ◽

10.1093/jbcr/irab032.323 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

pp. S194-S194

Author(s):

Nicole M Kopari

Keyword(s):

Cell Suspension ◽

Early Treatment ◽

Wound Closure ◽

Delayed Presentation ◽

Average Hospital ◽

Burn Care ◽

Skin Cell ◽

Partial Thickness ◽

Small Pore ◽

Partial Thickness Burns

Abstract Introduction Following initial stabilization, the primary goal of burn care is rapid wound closure to restore the barrier function and mechanical integrity of the skin. Time to wound closure is an important consideration when establishing the treatment plan, with a goal of re-epithelialization by 21 days to reduce the risks of hypertrophic scars (HTS), however, new research suggests that HTS can occur when healing is achieved as early as day 8. Early treatment of deep partial-thickness burns with autologous skin cell suspension (ASCS) was implemented at our burn center to achieve early wound closure and decrease hospital length of stay (LOS). Methods An IRB-approved, retrospective chart review of patients admitted between January 2020 to July 2020 was completed to evaluate the effectiveness of ASCS when applied as an early treatment defined as within 3 days of injury. Burn patients were excluded with delayed presentation >7 days, patients who only received ASCS to donor sites, and patients who died from unrelated comorbidities. Patients were excised to viable tissue. Patients with intact dermis were treated with ASCS. Patients without intact dermis were treated with ASCS and widely meshed autograft. Non-absorbent, small pore dressings were applied to the wound then covered with bismuth-petrolatum dressing, dry gauze, and compression bandage. Patients appropriate for discharge were followed-up in clinic for the first dressing change. Results Twenty-three patients were treated with ASCS utilizing this early intervention approach with 16 patients meeting inclusion criteria. Patients ranged from 15 months to 73 years of age and included 6 females and 10 males. The median total body surface area (TBSA) was 7.3% (range 2-23). Patients were taken for ASCS application between post burn day 0-3 (average 1.5). Average hospital LOS was 2.4 days. Operative dressings were removed between day 7-12 and >90% re-epithelization was noted between day 7-18 (mean 11). The mean LOS/%TBSA was 0.3. No patients required re-operation for closure of their wounds or reconstructive interventions for scarring. Conclusions Early excision of deep partial-thickness burns with application of ASCS allowed for healing to be achieved in a timely fashion. Implementation of an early operative approach to burn care allowed for a decrease in LOS and a decreased overall number of dressing changes.

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Initial Experience With Autologous Skin Cell Suspension for Treatment of Deep Partial-Thickness Facial Burns

Journal of Burn Care & Research ◽

10.1093/jbcr/iraa037 ◽

2020 ◽

Vol 41 (5) ◽

pp. 1045-1051

Author(s):

Joseph A Molnar ◽

Nicholas Walker ◽

Thomas N Steele ◽

Christopher Craig ◽

Jeffrey Williams ◽

...

Keyword(s):

Cell Suspension ◽

Clinical Status ◽

Graft Loss ◽

Senior Author ◽

Initial Experience ◽

Burn Care ◽

Skin Cell ◽

Partial Thickness ◽

Facial Burns ◽

Cosmetic Outcomes

Abstract Facial burns present a challenge in burn care, as hypertrophic scarring and dyspigmentation can interfere with patients’ personal identities, ocular and oral functional outcomes, and have long-term deleterious effects. The purpose of this study is to evaluate our initial experience with non-cultured, autologous skin cell suspension (ASCS) for the treatment of deep partial-thickness (DPT) facial burns. Patients were enrolled at a single burn center during a multicenter, prospective, single-arm, observational study involving the compassionate use of ASCS for the treatment of large total BSA (TBSA) burns. Treatment decisions concerning facial burns were made by the senior author. Facial burns were initially excised and treated with allograft. The timing of ASCS application was influenced by an individual’s clinical status; however, all patients were treated within 30 days of injury. Outcomes included subjective cosmetic parameters and the number of reoperations within 3 months. Five patients (4 males, 1 female) were treated with ASCS for DPT facial burns. Age ranged from 2.1 to 40.7 years (mean 18.2 ± 17.3 years). Average follow-up was 231.2 ± 173.1 days (range 63–424 days). Two patients required reoperation for partial graft loss within 3 months in areas of full-thickness injury. There were no major complications and one superficial hematoma. Healing and cosmetic outcomes were equivalent to, and sometimes substantially better than, outcomes typical of split-thickness autografting. Non-cultured, ASCS was successfully used to treat DPT facial burns containing confluent dermis with remarkable cosmetic outcomes. Treatment of DPT burns with ASCS may be an alternative to current treatments, particularly in patients prone to dyspigmentation, scarring sequelae, and with limited donor sites.

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634 Utilizing Simulation Based Training to Teach Wound Management Strategies When Caring for Burns Treated with Autologous Skin Cell Suspension

Journal of Burn Care & Research ◽

10.1093/jbcr/irab032.284 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

pp. S173-S173

Author(s):

Cameron C Bell ◽

James E Johnson

Keyword(s):

Cell Suspension ◽

Real World ◽

New Technologies ◽

Real Life ◽

Split Thickness Skin Graft ◽

Skin Cell ◽

Partial Thickness Burn ◽

Clinical Scenarios ◽

Simulation Based ◽

Hands On

Abstract Introduction Simulation based training (SBT) is an experience meant to replace real-life events with guided simulated clinical scenarios. The goal is fully interactive training that closely replicates the real world. SBT is well known in military and aviation and has been well integrated into the education of new nurses and physicians however, it has not been fully integrated into the ongoing development of skills for clinicians practicing in hospitals that are learning new technologies. Following FDA approval of a regenerative medicine platform that prepares autologous skin cell suspension (ASCS), an opportunity was identified to augment conventional training with a SBT educational program giving clinicians the opportunity to practice wound care in a simulated learning environment. Methods A prototype was developed alongside experts from a university-based experiential learning center. It included an anatomical silicone mold of a thigh (model) with silicone cartridges of ASCS treatment areas (excised deep partial-thickness burn with dermis and excised full-thickness burn with wide meshed split thickness skin graft). The cartridges fit in a depressed area of the thigh and can be exchanged between case scenarios. The cartridge allows for moulage to be applied, enhancing the life-like appearance of the model. The initial prototype was tested during a pilot with burn center staff. A total of 4 case scenarios related to ASCS aftercare were evaluated. Following the pilot, the program was demonstrated to our internal clinical team to gain additional insight. The feedback was incorporated into a final design. Results There were 17 participants in the pilot training (6 hands-on/11 observers). All hands-on participants either agreed or strongly agreed that SBT was useful to their clinical practice. Comments included: “Very realistic”, “really liked the hands-on”, “confidence booster”, “these are the most common scenarios we see”. One participant commented that even though she had never participated in an ASCS dressing change, she has the confidence to do so now. Soliciting feedback from our internal team on the design and portability of the model was an important step to ensure barriers to use were removed. To date, 11 training systems including models, cartridges, case scenarios, debrief tools and dressing kits have been distributed with a total of 30 systems expected by the end of 2020. Conclusions During development of the SBT program, input from clinicians and educators helped gain insight to the program and ensured the scenarios were relative to real-world experiences. Early findings suggest SBT is a value add for clinicians caring for patients post ASCS application.

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728 The Faces of Autologous Skin Cell Suspension as Epidermal Grafts

Journal of Burn Care & Research ◽

10.1093/jbcr/iraa024.312 ◽

2020 ◽

Vol 41 (Supplement_1) ◽

pp. S195-S196

Author(s):

Justin Van Hoorebeke ◽

Alan Pang ◽

Nicole M Kopari

Keyword(s):

Cell Suspension ◽

Case Series ◽

Burn Center ◽

Skin Cell ◽

Partial Thickness ◽

Partial Thickness Burn ◽

Facial Burns ◽

The Face ◽

Cosmetic Outcomes ◽

Epidermal Graft

Abstract Introduction Facial burns are frequently severe and are difficult to skin graft, which may lead to increased morbidity including chronic pain, scarring, and psychosocial stigma. The aim of this study was to describe outcomes of patients with facial burns who received autologous skin cell suspension as an epidermal graft. Methods A retrospective chart review of patients with facial burns admitted to an ABA verified Burn Center from January 2019 to August 2019 was performed. Each patient underwent tangential excision of superficial and deep partial-thickness burn wounds followed by autologous skin cell suspension applied as an epidermal autograft. The wounds were covered with a non-adherent dressing along with bismuth-impregnated, petroleum-based gauze. The dressings were secured in place with sutures to prevent disruption. On post-operative day 6 the dressings were removed with transition to an antimicrobial ointment applied to any remaining open wounds or a moisturizing lotion. Results Five patients, aged 41–89 years, were included. Total body surface ranged from 7–50%. Etiology of the burns included: flame from metal fabricating, assault followed by dousing the patient in gasoline and lighting on fire, flash flame from a water heater explosion, hot oil contact, and involvement in a house fire. 3 of the 5 patients had complete healing noted by post-operative day 6 with excellent results. Two patients required a second excision and application of autologous skin to small portions of the lateral face after healing the majority of the face. One patient developed mild microstomia requiring oral splinting. One of the two patients that required a second application developed ectropian to one of her eyes which was treated with temporary tarsorrhaphy. The second patient that required a second application, died during her hospitalization secondary to complications from her burns and underlying medical co-morbidities. Surviving patients reported satisfaction with the cosmetic outcomes. Conclusions Autologous skin cell suspension as an epidermal graft is a viable option for cosmetically important areas such as the face. This case series provides evidence for its validity when treating partial-thickness burns utilizing the above described protocol in conjunction with a multidisciplinary care team within a burn center. Applicability of Research to Practice By sharing our institutions experience with this relatively new technique we hope to share our positive outcomes as an alternative to stand excision and grafting to areas of significant cosmetic outcomes.

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