scholarly journals Comparative effectiveness of Biobrane®, RECELL® Autologous skin Cell suspension and Silver dressings in partial thickness paediatric burns: BRACS randomised trial protocol

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. 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. S107-S108
Author(s):  
Linda E Sousse ◽  
Amanda Staudt ◽  
Christopher VanFosson

Abstract Introduction One of the hallmarks of critical illness and trauma is that it triggers resorptive bone loss, as well as an increase in bone fractures and a reduction in bone density. Sustained markers of bone resorption, bone formation, and regulators of bone signaling pathways are linked to prolonged inflammatory activities and the prolonged deterioration of bone microstructure. The objective of this study is to evaluate the bone fracture rate of the U.S Military, non-U.S. Military, North Atlantic Treaty Organization (NATO) Military, local civilian, and Coalition Forces population in Operation Enduring Freedom and Operation Freedom’s Sentinel with burns from 2005 to 2018 using the Department of Defense Trauma Registry (DoDTR; n=28,707). Our hypothesis is that there is a direct relationship between burn injury severity and bone fracture rates. Methods Pearson’s correlation coefficient and scatterplots were used in this retrospective, observational study to demonstrate the correlation between total body surface area (TBSA) burn and number of fractures by anatomical location. Results Approximately 15,195 patients (age: 26 ± 10 years) in Role 2 and Role 3 treatment centers reported fractures. Of those patients, 351 suffered from burns with 632 anatomical fracture locations. Facial fractures were most prominent (16%), followed by foot (12%), skull (12%), tibia/fibula (11%), hand (11%), and ulna/radius (10%). There was no initial correlation between n increasing severity of TBSA burn and count of fracture locations (ρ=-0.03, p=0.8572). Conclusions There was no acute correlation between burn severity and bone fracture rates; however, further analyses are required to assess chronic post-burn fracture rates.


2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S194-S195
Author(s):  
Lisa C Vitale ◽  
Jennifer Livingston ◽  
Erica Curtis ◽  
Katherine Oag ◽  
Christina M Shanti ◽  
...  

Abstract Introduction For children who have suffered a burn injury one of the greatest challenges is managing pain with an adequate yet practical burn wound dressing that will ultimately be managed at home. Medical product companies have created a variety of wound care products available on the market. These products are advertised to be more superior over one another in categories such as decrease in wound infections, minimization of pain, ease of dressing application, increased dressing wear time, and better wound healing. With all the options for burn wound care there are many factors to consider when choosing a burn dressing such as cost, ease of dressing for families at home, comfort, and efficacy. At our ten year verified pediatric burn center we have tried many different burn wound care products, however we have found Xeroform and bacitracin to be the most practical and easy to use for our patient population. Methods A retrospective chart review was performed from 2016–2018 of all cascading scald injuries to children 0–5 years of age treated at our verified pediatric burn center. 179 patients were included in this review. Of those patients a total of 52 patients were excluded, 28 patients had no follow up, 21 patients received alternate dressings, and 3 patients had full thickness injuries requiring a split thickness skin graft (STSG). Charts were reviewed for total body surface area (TBSA), length of stay (LOS), discharge dressing type, complications, and time to healing. All patients included routinely received consistent application of the Xeroform and bacitracin. Results 127 patients discharged with Xeroform dressings were included in this study with an average age of 1.4 years old (range 0–5 years) and average TBSA of 2.5% (range 0.25–13%). The average LOS was 1.6 days (range 1–10 days). In this sample 32 (25%) patients were healed within 7 days. 77 (61%) patients were healed within 7–14 days. 11 (9%) patients were healed within 14–21 days. 7 (5%) patients were healed in greater than 21 days. There were no wound complications identified within this study group. Conclusions Using Xeroform as our standard of practice has streamlined the care provided to our patients. We have demonstrated consistent effective re-epithelization, protection from infection, and ease of dressings for families and burn providers. In our experience Xeroform has provided a versatile way to care for partial thickness burn injuries. Applicability of Research to Practice We suggest Xeroform and bacitracin dressings be used for partial thickness burn injuries in patients under 5 years of age. This dressing may be superior to other products because it allows for bathing while providing good wound epithelization and is easy to use.


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. S194-S194
Author(s):  
Nicole M Kopari ◽  
Yazen Qumsiyeh

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.


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. S194-S194
Author(s):  
Nicole M Kopari

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.


2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S227-S228
Author(s):  
Kaitlyn Libraro ◽  
Jamie Heffernan ◽  
Jeremiah Lorico ◽  
Rachelle J Lodescar ◽  
Angela Rabbitts

Abstract Introduction Pediatric patients, between the age of newborn and 18 years, require legal guardian consent for any surgical procedure. In some cases, despite medical advisement, guardians refuse excision and skin graft for a minor in their care. In these cases, extended healing times, re-admission, scaring, contracture and physical disability may ensue. Our study aims to review contributing factors of guardian refusal and explore the outcomes of such refusals. Methods Retrospective chart review of all pediatric patients admitted to a large verified burn center between January 2018 through May 2019 were reviewed for total body surface area (TBSA) burned, age, depth of wound, mechanism, MD recommendation for surgical procedure, operative procedures conducted and length of hospital stay (LOS). Results Of the 265 pediatric patients admitted to the Burn Service, 32 (12%) were recommended surgical intervention during their hospitalization. Of these, 25 (78%) guardians consented for surgical skin grafting procedures following recommendation; 3 (9%) guardians delayed treatment consent by an average of 5 days; and 4 (13%) refused surgical consent for skin grafting procedures entirely. The average TBSA for patients recommended for surgical intervention was 8.7, those who accepted surgical intervention had an average TBSA of 8.35, compared to the 11.25 TBSA who refused surgical intervention. Average inpatient length of stay for patients whose guardians consented to surgical intervention promptly was 15.8 days. Despite an average 5 day delay in consent, guardians who deferred consent for surgical intervention doubled their length of stay (31.1 inpatient days). The four guardians who refused recommended surgical intervention had an average inpatient stay of 8.25 days. This finding is consistent with multi-day dressing use and outpatient clinic management. Of note, the four patients that did not receive surgical intervention for burn wound management were linked by common cultural background. Conclusions Pediatric burn injury is both acute and chronic, and the shock of initial injury is often overwhelming for both the patient and the guardian. Furthermore, guardians are then asked to make surgical decisions for a minor in their care. The burn team needs to have a heightened awareness of the cultural norms in the communities they serve to ensure quality care deliverance and patient safety. Applicability of Research to Practice Directly Applicable.


2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S100-S101
Author(s):  
Arhana Chattopadhyay ◽  
Courtney Swan ◽  
Clifford C Sheckter ◽  
Deepak Gupta ◽  
Yvonne L Karanas

Abstract Introduction An autologous skin cell suspension (ASCS) spray containing keratinocytes, fibroblasts, and melanocytes can be processed from a small split thickness skin sample for use at the point-of-care in the operating room. ASCS have been shown to facilitate epidermal regeneration in large TBSA partial thickness burns with minimal donor site morbidity. We hypothesized that ASCS in conjunction with a 3:1 split thickness skin graft applied to burn wounds and ASCS alone applied to the donor site would facilitate healing in a 95 year-old burn patient with 12% TBSA deep partial and full thickness scald burns to the abdomen and bilateral thighs. To our knowledge, she is the oldest patient to undergo epidermal autografting with ASCS. Methods All burn wounds were tangentially excised in the standard fashion to healthy tissue. Split thickness (12/1000 inch) skin graft was harvested from the right lateral thigh, meshed 3:1, and applied to all wound beds. ASCS were prepared and sprayed on grafted sites and the donor site. All areas were dressed with Telfa clear and Xeroform with bacitracin. Dressings were initially changed every 2 days, and wounds were photographed on day 2, 4, 6, 8, 10, and 20. Results All burn wounds were deep partial thickness or full thickness. The right thigh donor site was completely healed by POD 10. 90% of the burn wounds had healed by POD 10. The area of deepest burn, an approximately 20 cm2area on the left medial thigh, was healed by POD 20. Conclusions We believe that ASCS enhanced the rate of re-epithelialization of burn wounds in a 95 year-old patient compared to our experience with skin grafting alone in this population. ASCS also promoted complete healing of the donor site by POD 10. This technology may have a role in decreasing healing time in the geriatric burn population. These findings are important for this population as longer lengths of stay are associated with delirium, hospital acquired infections, and deconditioning. This patient’s improved donor site healing also has broader implications as split thickness skin grafts are used widely for wound coverage in plastic surgery. Applicability of Research to Practice Demonstrates efficacy of ASCS in very elderly patients with moderate-sized deep burns and with skin graft donor sites.


2020 ◽  
Vol 41 (5) ◽  
pp. 1045-1051
Author(s):  
Joseph A Molnar ◽  
Nicholas Walker ◽  
Thomas N Steele ◽  
Christopher Craig ◽  
Jeffrey Williams ◽  
...  

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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