537 Autologous Skin Cell Suspension for the Treatment of Small (≤10% TBSA) Mixed-Depth Burns

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.

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.


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 7 (Supplement_1) ◽  
pp. S659-S659
Author(s):  
Angela Talley ◽  
Archie Thurston ◽  
Grayson Moore ◽  
Myriah M Satterfield ◽  
Erika L Manyak ◽  
...  

Abstract Background SPR720 (phosphate pro-drug of SPR719) is a novel aminobenzimidazole bacterial DNA gyrase (GyrB) inhibitor in development for non-tuberculous mycobacterial lung disease (NTM-LD) and pulmonary tuberculosis. SPR719 has broad-spectrum activity versus clinically relevant mycobacteria in vitro and in murine and hollow fiber (HF) infection models. In this first-in-human single ascending dose (SAD) /multiple ascending dose (MAD) study, the safety, tolerability and pharmacokinetics (PK) of SPR720/SPR719 were evaluated in healthy volunteers. Methods This was a Phase 1 randomized, double-blind, placebo-controlled trial with 7 SAD cohorts (including a food effect cohort) and 5 MAD cohorts. Healthy volunteers (n=8/cohort, 3:1 randomization) received SPR720 or placebo in single oral doses of ranging from 100 mg to 2000 mg or repeat total daily doses ranging from 500 mg to 1500 mg for 7 or 14 days. Safety monitoring and PK sampling occurred throughout the trial. Plasma and urine concentrations of SPR720/SPR719 were measured by validated LC-MS/MS methods. PK parameters were calculated using non-compartmental analysis. Results A total of 96 subjects (including 8 healthy elderly subjects, age ≥ 65 years) were randomized and received study drug. SPR720 was well-tolerated at daily doses up to 1000 mg for up to 14 days. Across SAD/MAD cohorts, the most common adverse events were gastrointestinal (nausea, vomiting and diarrhea) and headache, all of mild or moderate severity and dose dependent. No serious adverse events were reported. Across SAD cohorts, a dose proportional and greater-than-dose proportional increase in SPR719 plasma Cmax and AUC0-24, respectively were observed. SPR720 was rapidly absorbed with a mean SPR719 t1/2 of 2.9-4.5 h. Dosing with food decreased SPR719 plasma AUC by ~20%. No clinically meaningful effect of age on plasma AUC was observed. In the MAD cohorts, SPR719 plasma exposure declined approximately 40% between Day 1 and Day 7, suggesting induction of an elimination pathway. However, plasma AUC0-24 was similar at Days 7 and 14. Conclusion Together with HF pharmacodynamic data, human PK and safety data for SPR720 suggest that predicted therapeutic exposures can be attained with a well-tolerated once-daily dose. Further evaluation in a Phase 2 NTM-LD trial is planned. Disclosures Angela Talley, MD, Spero Therapeutics (Employee, Shareholder) Archie Thurston, Jr., PhD, Spero Therapeutics (Consultant) Grayson Moore, BA, RN, Spero Therapeutics, Inc. (Shareholder, Independent Contractor) Vipul Kumar, PhD, Spero Therapeutics (Employee, Shareholder) Suzanne Stokes, PhD, Spero Therapeutics (Employee, Shareholder) Aaron Dane, MSc, Spero theraputics (Consultant) David Melnick, MD, Spero Therapeutics (Employee)Spero Therapeutics (Employee)


Molecules ◽  
2021 ◽  
Vol 26 (9) ◽  
pp. 2554
Author(s):  
Marek Konop ◽  
Anna K. Laskowska ◽  
Mateusz Rybka ◽  
Ewa Kłodzińska ◽  
Dorota Sulejczak ◽  
...  

Impaired wound healing is a major medical challenge, especially in diabetics. Over the centuries, the main goal of tissue engineering and regenerative medicine has been to invent biomaterials that accelerate the wound healing process. In this context, keratin-derived biomaterial is a promising candidate due to its biocompatibility and biodegradability. In this study, we evaluated an insoluble fraction of keratin containing casomorphin as a wound dressing in a full-thickness surgical skin wound model in mice (n = 20) with iatrogenically induced diabetes. Casomorphin, an opioid peptide with analgesic properties, was incorporated into keratin and shown to be slowly released from the dressing. An in vitro study showed that keratin-casomorphin dressing is biocompatible, non-toxic, and supports cell growth. In vivo experiments demonstrated that keratin-casomorphin dressing significantly (p < 0.05) accelerates the whole process of skin wound healing to the its final stage. Wounds covered with keratin-casomorphin dressing underwent reepithelization faster, ending up with a thicker epidermis than control wounds, as confirmed by histopathological and immunohistochemical examinations. This investigated dressing stimulated macrophages infiltration, which favors tissue remodeling and regeneration, unlike in the control wounds in which neutrophils predominated. Additionally, in dressed wounds, the number of microhemorrhages was significantly decreased (p < 0.05) as compared with control wounds. The dressing was naturally incorporated into regenerating tissue during the wound healing process. Applied keratin dressing favored reconstruction of more regular skin structure and assured better cosmetic outcome in terms of scar formation and appearance. Our results have shown that insoluble keratin wound dressing containing casomorphin supports skin wound healing in diabetic mice.


2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S126-S127
Author(s):  
Rebecca Coffey ◽  
Rachel Penny

Abstract Introduction Strategies to remove necrotic tissue from burn wounds include excisional and non-excisional debridement. Alternative treatments could promote burn wound healing while minimizing patient discomfort and the need for surgery. We evaluated the usage of a concentrated surfactant gel (CSG) to promote burn wound healing in those with indeterminate depth and full thickness burn injuries. Methods An IRB approved retrospective study was conducted during a 10-patient new product trial period with enrollment between September and October 2019. Patients included in this study had indeterminate or full thickness burn wounds and were treated with a concentrated surfactant-based gel. Patients with non-burn diagnoses were excluded. Data collected included demographic information, injury descriptors, and additional burn wound characteristics. Results A total of 10 patients were included in this study as part of a new product trial. The subjects were 80% male with an average TBSA of 7.5%. 40% had indeterminate and 60% had full thickness burn wounds. Prior to initiation of the CSG, the burn wounds had been open for an average of 41 days. There were no infections or complications with usage of the CSG. 90% of patients reported less pain than the standard of care topical agents for burns. Average duration of treatment with the CSG until healing was 28 days. After usage of the CSG, no patients required surgery. Conclusions Our findings support the usage of a concentrated surfactant-based gel in patients with burn wounds. Patients reported decreased pain during dressing changes and ease of use compared to the standard topical agent in burn care. It also prevented surgical debridement in those with indeterminate and full thickness burn injuries.


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 &gt;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 &gt;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.


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 &gt;14 years of age with &gt;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.


2020 ◽  
Author(s):  
Shaobin Huang ◽  
Zhicheng Hu ◽  
Peng Wang ◽  
Yi zhang ◽  
Xiaoling Cao ◽  
...  

Abstract Background: Full-thickness wounds are a serious problem which badly affects patients’ life quality and also become the difficult problem for clinicians. Stem cells have great prospects in the treatment of wounds. Our previous experiments proved that autologous basal cell suspension can promote wound healing, and there are epidermal stem cells (ESCs) in basal cell suspension. We then conducted experiments to explore the effect of ESCs on full-thickness wound. Methods: In our study, the rat ESCs were isolated and expanded, and transfected with lentivirus to stably express EGFP. Experimental rats were randomly divided into 2 groups, in the ESCs group, the rat ESCs were sprayed on the Full-thickness wounds of the rats, while in control group, sprayed the PBS on the wound. Wound healing and neovascularization were then evaluated. Colonization, division and differentiation of ESCs on the wound were discovered by immunofluorescence.Results: The result suggested that rat ESCs can colonize, divide and proliferate in the wound. What’s more, the rat ESCs around blood vessels can differentiate into vascular endothelial cells and form a lumen-like structure. Compared with the control group, spraying the rat ESCs on the wound bed can promote angiogenesis and accelerate wound healing. Conclusions: Our study proved that rat ESCs were safe and effective for treating full-thickness wounds, and under certain conditions, ESCs can differentiate into vascular endothelial cells to promote angiogenesis and wound healing.


2019 ◽  
Vol 2019 ◽  
pp. 1-9 ◽  
Author(s):  
Alessandro Andreone ◽  
Daan den Hollander

The coverage of massive burns still represents a big challenge, even if several strategies are to date available to deal with this situation. In this study, we describe the use of a combination of platelet-rich fibrin and micrograft spray-on skin in order to increase the yield of grafted cells in patients. We treated a total of five patients, of which two were affected by massive burns and three with chronic burn wounds. Briefly, autologous micrografts were obtained by Rigenera technology using a class I medical device called Rigeneracons. The micrografts were then combined with PRF and sprayed on the wound bed by a Spraypen. Before applying PRF/micrograft spray-on skin, the wound bed was covered with an Integra® dermal template, and the wounds were dressed with a layer of antimicrobial dressing applied directly over the silicone layer. When the silicone layer of the dermal template started showing signs of separation, the wound was considered ready for grafting. In all cases, we observed a fast and complete skin graft on average after 7-10 days by PRF/micrograft spray-on skin treatment. In particular, two patients with massive burns reported rapid reepithelialization, and three patients with chronic burn wounds, two of whom had failed skin grafts before the procedure, had complete wound healing within a week. In conclusion, the results showed in this study suggest that the use of PRF/micrograft spray-on skin represents a promising approach in the management of burns or chronic burn wounds.


2011 ◽  
Vol 44 (01) ◽  
pp. 112-117 ◽  
Author(s):  
Salmi Mohamed Sukur ◽  
Ahmad Sukari Halim ◽  
Kirnpal Kaur Banga Singh

ABSTRACT Aim: The effect of Tualang honey on wound healing in bacterial contaminated full-thickness burn wounds was evaluated in 36 male Sprague Dawley rats. Materials and Methods: The rats were randomly divided into three groups (n = 12/group). Three full-thickness burn wounds were created on each rat. Each group of rats was inoculated with a different organism in the burn wounds: Group A was inoculated with Pseudomonas aeruginosa, Group B was inoculated with Klebsiella pneumoniae and Group C was inoculated with Acinetobacter baumannii. One wound on each rat was dressed with either Tualang honey, Chitosan gel or Hydrofibre silver. Each wound size was measured on day 3, 6, 9, 12, 15, 18 and 21 of the study. Results: The mean wound size of the Tualang honey-treated wounds was not statistically different than that of the Chitosan gel or Hydrofibre silver-treated wounds when the wounds were compared throughout the entire experiment (P > 0.05). However, comparing the mean wound size on day 21 alone revealed that the Tualang honey-treated wounds were smaller in comparison to that of the Chitosan gel and Hydrofibre silver-treated groups. Conclusions: This study shows that topical application of Tualang honey on burn wounds contaminated with P. aeruginosa and A. baumannii gave the fastest rate of healing compared with other treatments.


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