Abstract Introduction Severe burn injuries often require temporizing strategies before definitive wound closure. Advanced Dermal Matrices (ADMs) are designed to integrate into the wound bed and support subsequent split-thickness skin grafting (SSG). This pivotal, randomized, controlled trial (RCT) evaluates the safety and effectiveness of a novel, synthetic, biodegradable dermal matrix* compared to standard of care (SOC) treatments in patients with deep dermal and full-thickness thermal burns to determine the safety and efficacy of the novel ADM. Methods This multicenter, IDE, RCT was sponsored by BARDA and enrolled adult patients (18–75 years) with 3–60% TBSA burns. Subjects were randomized 2:1 to receive the novel, synthetic, biodegradable dermal matrix or SOC (e.g., an ADM containing cross-linked bovine collagen and chondroitin-6-sulfate or cadaveric allograft) before SSG. The primary effectiveness endpoint is the total percent wound closure calculated for each randomized subject based on an Independent Panel assessment of study lesions at 4 weeks after split-thickness skin grafting and serves as the dependent variable. The primary safety endpoint is a composite of device (BTM group)-/treatment (SOC group)-related mortality, skin graft loss requiring re-operation and device (BTM group)-/treatment (SOC group)-related AEs requiring re-operation. In this trial the subject served as the sampling unit for this composite endpoint; individual elements of this endpoint, such as skin graft loss, infection, and matrix removal, and is tabulated based on each treated burn site. Twenty-two sites in the USA and 3 in India participated. Results 127 subjects were enrolled and 120 randomized and treated with the first enrollment on 9-20-2021, and the final enrollment on 08-19-2024. Demographic Data is in the attached table. Conclusions The CP-003 study is among the largest RCT performed to date comparing the outcomes of dermal matrices in deep second- and third-degree burns. The demographic data demonstrate excellent randomization between the novel, synthetic, biodegradable dermal matrix and SOC. Efficacy and safety results are being finalized for submission to the FDA as part of a PMA submission package and will be shared once the PMA review is complete. Applicability of Research to Practice Safety and clinical efficacy of a novel, synthetic, biodegradable advanced dermal matrix that may promote faster healing and have improved cosmetic outcomes in severe burn injuries. Funding for the study The Biomedical Advanced Research & Development Agency (BARDA).
Abstract Introduction Skin cell suspension autograft (SCSA) is increasingly used in acute burn and wound care to support healing while minimizing donor site requirements. Prepared from a small autologous skin sample, SCSA contains keratinocytes, fibroblasts, and melanocytes essential for epidermal regeneration. To promote consistency in preparation, an Automated Autologous Cell Harvesting Device (A-ACHD) was developed to standardize enzymatic and mechanical disaggregation. The biological attributes of A-ACHD–prepared SCSA have not been evaluated using burn patient skin samples. This study compared SCSA prepared using A-ACHD and the manual ACHD with paired skin samples from burn patients. Methods Discarded donor skin from patients undergoing split-thickness grafting was processed with ACHD and A-ACHD per manufacturer protocols. Cell yields were quantified by propidium iodide assay and flow cytometry, with standardized gating to exclude debris. Phenotyping used antibodies for keratinocytes (pan-cytokeratin), fibroblasts (Vimentin), and melanocytes (P-mel). Non-inferiority was evaluated using a 70% margin, and paired t-tests were performed. Results Paired donor samples from 17 patients were analyzed. Non-inferiority testing confirmed that A-ACHD–prepared suspensions were non-inferior to those generated using ACHD (total cell yield, live cell yield, percent keratinocytes, fibroblasts, and melanocytes). A statistically significant higher average total yield of cells and live yield of cells were found in suspensions prepared using the automated device (p=.013 and p=.002, respectively). Conclusions Both devices produced viable SCSA suspensions with yields observed comparable with previously reported literature. The automated system additionally provided higher yields while standardizing preparation, supporting its role as an effective evolution of this technology. Applicability of Research to Practice Automation of SCSA preparation constitutes a technological advancement, offering standardized processes and streamlined workflow integration that expand its accessibility for acute wound management. Funding for the study Foundation Funding; Devices and reagents were supplied by the manufacturer.
Abstract Introduction Dermal scaffolds (DRT) have been used to assist in (burn) wound closure for decades, yet long term evaluation of scar outcomes are scarce. A standardized histological scar scoring system in general is not available. Some clinical parameters have been studied and published, but a thorough, controlled, clinical and histological study has not been performed in humans to date. Methods We invited long term burn survivors who received both, plain STSG and dermal scaffold plus STSG to close their wounds. Clinical measurements and POSAS evaluation was performed and biopsies were obtained from scars with and without dermal scaffold underlay. The biopsies were processed, stained and analyzed. A subset of patients’ samples (n = 6 for STSG and n = 5 DRT + STSG, n = 4 were matched samples) were analyzed using an extracellular matrix pattern Fiji (ImageJ) plugin, TWOMBLI to include semi-quantitative analysis of collagen fiber alignment, length, branching, endpoints, fractal dimension (measure of fiber complexity and organization), curvature, and distribution of fiber thickness (Wershof et al. 2021 Life Sci Alliance). Additional analysis was performed in Fiji (ImageJ) including measuring average width of epidermis and average length of rete pegs. We developed a new scoring system for histologic scar evaluation, that is being validated. Results While semi-quantitative histological analysis illustrated no statistical differences between the STSG alone and DRT + STSG scars for the metrics listed above in this small subset, we were able to note consistent differences in structure scoring. Some scars had evidence of intact rete pegs (4/6 for STSG samples, and 2/4 for DRT + STSG samples) (Fig. 1), which are typically diminished or non-apparent in post-burn scars (Carney et al 2024 Burns). Rete peg length ranged from 50-200um. In Fig. 1, the epidermis appears thicker and dermis appears less aligned for the STSG, relative to the DRT + STSG group where the epidermis appears thinner with a more aligned dermis. Scar scales and non-invasive quantitative measures of scar characteristic were previously reported and will be matched with histological findings. Conclusions In this small subset of available analyzed histologies differences can be seen between STSG scars and DRT + STSG scars years after wound healing in the same survivor. The further development and validation of our scar scoring system will highlight these differences further. Matched with the clinical data that were collected from the same individuals, we will validate our findings. Applicability of Research to Practice Characterization and objective evaluation of long term outcomes of burn scars that healed with different technologies. Funding for the study Foundation funding.
Split thickness skin grafting (STSG) is the standard treatment for burn wounds without healing potential (deep 2nd and 3rd degree) and other large full-thickness skin wounds. Harvesting a split thickness skin graft creates a new wound, called the donor site. While attention has recently been spent on the healing and scarring process of burn wounds, little light has been shed on the long-term outcomes of donor site wounds. Most (small) studies focus on healing time as opposed to long term sequelae. This study is an IRB-approved, retrospective chart review of the long-term outcomes of donor sites to identify the factors correlated with donor site dyspigmentation and scarring. Patients in this study were admitted to our burn center between May 22, 2015 – April 14, 2024. The study population was extracted from the trauma burn registry, and then manually reviewed in EPIC by study team members. Patient information reviewed included demographics, patient skin type, total body surface area (TBSA) burned, operative details (including the donor site location, dressing, and thickness), healing time of the donor site, complications, discomfort, and donor site morbidity were extracted from their chart. Patients of all ages were included in the study. Skin type was determined using the Fitzpatrick Scale. Photographs and clinical notes from the patient’s follow-up visits were utilized to assess donor site morbidity and/or discomfort. 1014 patients treated with a STSG were entered into the study. 66.3% were male, 33.5% were female., 77.8% white, 6.3% Black and 11.1% Hispanic. The average age was 46 at the time of grafting. The average depth of graft taken was 0.01 inches, in 90.3% from the thigh. 32.9% had dyspigmentation of donor sites on their second follow up visit and 5.8% had hypertrophic scarring. 1.5% ultimately required treatment for their donor site scarring in our institution. The most highly correlated factors in dyspigmented donor sites were higher age and Fitzpatrick Skin Types 4-5. Donor sites with hypertrophic scarring were found to be most correlated with Fitzpatrick Skin Types 4-5. Donor sites can leave long-term scarring and/or dyspigmentation in a significant percentage of patients treated with a split thickness skin graft, especially in darker skin type patients and older patients. Reduction of donor sites and take from inconspicuous areas during the initial treatment of these patients should be attempted. immediate Institutional foundation funding
Autologous epithelial cell spray, prepared with a commercial kit, is now widely used in American Burn Centers in extensive second and third degree burns where donor skin may be scarce. However, the cell viability and yield of the autologous skin suspension has not been assessed in a real-world setting and there is limited data on patient age and other demographics that may influence the number of viable cells in the suspension. The purpose of this IRB approved study was to evaluate the cell viability of an autologous skin cell suspension in a variety of age groups and Fitzpatrick skin type individuals. Patients in our center with burn wounds scheduled to receive split thickness skin graft were consented to participate in the study. Discarded pieces of skin graft were processed immediately, using skin-cell suspension preparation kits according to manufacturer instructions, and processed cells were suspended in 1 mL of buffer solution per cm2 of skin. Cell yield and viability was then measured, partially by manual count in a hemocytometer and partially in an automated cell counter. Three aliquots of each suspension were counted. All data was collected in an online database and analyzed using SPSS statistical software. 64 skin samples from 55 different patients were processed. Patients ranged from 1-86 years old, 40 male, 24 female, 0.25-70.5% total body surface area (TBSA, 7.8% mean), 68.8% Caucasian, 9.4% Black, 21.8% multiracial with Fitzpatrick skin types I-VI. The cell suspensions contained an average of 1,899,367 cells/mL with an average of 785,254 live cells/mL (standard deviation 617,118 cells/mL). There was a wide range of both, cell count and viability across all samples. The average viability across all samples was 41.34% (standard deviation 14.5%). The viability of cell suspensions varied greatly independently of patient age, % TBSA or comorbidities. The yields of cell suspensions varied greatly and no correlation between patient age or TBSA or different users preparing the cell-suspensions with skin from the same patient was found. Our data is consistent with FDA submitted data from abdominoplasty specimens. Immediate Institutional foundation funding
Dermal skin substitutes are intended to compensate for the absence of dermal elements in traumatic wounds including severe burn injuries and are increasingly utilized in American Burn Centers. However, publications on the clinical performance of synthetic skin substitutes remain limited to small series or case reports. Furthermore, scarring outcomes after the two-step process of applying synthetic skin substitutes and split-thickness skin grafts (STSG) have hardly been studied at all. This IRB approved study was designed as a retrospective detailed assessment of the performance of synthetic skin substitutes, scarring outcomes, and their overall effectiveness in our center. This study included all patients who underwent the two-stage wound closure procedure between 9/1/2017 and 2/28/2024. Patient electronic records were reviewed retrospectively. The evaluated data points included complications, as determined by infection and failure rates, the time delay between the application of the synthetic skin substitute and STSG, LOS after skin substitute placement, Vancouver Scar Scale (VSS) assessments, Patient and Observer Scar Assessment Scale (POSAS) questionnaires, and scar shrinkage measurements during follow up visits. All data were entered into RedCap® for analysis. The study included 77 patients and a total of 124 dermal synthetic skin substitute applications (122 synthetic biodegradable, 2 collagen based). All applications were analyzed, and the infection rate overall was 8.8%. The failure rate was found to be 3.2%. The time delay between the application date of the skin substitute and STSG averaged 28 days, to wound closure 35 days. The LOS after skin substitute averaged 45 days, after wound closure 10 days. Data on postoperative dressings (Silver 54.8%, VAC 38.7%), STSG thickness (0.0085), exposed structures in the wound etc. were also collected. 3-12 months post hospital discharge, the mean Vancouver scar scale rating was 8.39 out of 15, the mean Patient and Observer Scar Assessment Scale rating was 36.86 out of 60, and the median scar shrinkage was 2.89% of the initial wound size. The usage of synthetic dermal skin substitute allows for a safe, reliable two-stage burn and wound closure. This burn/wound treatment exhibited minimal complications and long-term durability with acceptable scar formation and shrinkage. Immediate Institutional Burn research fund
In this article, an array of new developments in burn care, from diagnosis to post-burn reconstruction and re-integration, will be discussed. Multidisciplinary advances have allowed the implementation of technologies that provide more accurate assessments of burn depth, improved outcomes when treating full-thickness burns, and enhanced scar tissue management. Incorporating these new treatment modalities into current practice is essential to improving the standard of burn care and developing the next generation of burn wound management methodologies.
Background: Scar contracture bands after burns are frequent problems that cause discomfort and physical limitation. This study investigates the efficacy of a minimally invasive contracture band release technique (MICBR) inspired by closed platysmotomy. Methods: Patients with burn scars treated with MICBR in our center were included retrospectively. Our routine scar and contracture treatments (non-invasive and invasive) were utilized prior to undergoing MICBR. Range of motion (ROM) and Vancouver Scar Scale was measured before and after the procedure when feasible. Results: Forty-five patients were included, with 97 total contracture sites treated all over the body. An average of 1.6 sites were treated per patient, with a maximum of six. Patients age was 6-68 years; total burn surface area ranged from 0.5% to 85%. 24% were performed under local anesthesia. 84% were in originally skin grafted areas. We found significant improvements in ROM and VSS. 84% of patients surveyed were "satisfied" or "very satisfied". 95% reported improved mobility. No significant adverse events occurred. Conclusion: This MICBR technique is a versatile, safe, and well-tolerated adjunct procedure that can help patients regain mobility after a burn injury. (c) 2024 Published by Elsevier Ltd.
Abstract Introduction Split-thickness skin graft (STSG) healing follows the imbibition, inoculation, and revascularization healing model. The stage of imbibition takes approximately 48-72 hours and requires direct contact with the wound for success. Prior to revascularization the graft is at increased risk for damage from shear stress. Many of the protocols in place are based on pathophysiology of wound healing and few published data exist on the timing and logistics of mobilization after lower extremity STSG for burns. There is discordance in the Burn community as to when it is safe to start ambulation with patients after lower extremity skin grafting. The timing of the first dressing change may accelerate or delay ambulation and increase time to hospital discharge. Methods Retrospective chart review of burn patients regardless of age, admitted to burn service with grafted burns to lower extremities, whether they had other concomitant burns with/without grafting to determine if earlier first postoperative dressing changes (≤ 3 days) to grafted lower extremity burns lead to earlier ambulation and shorter hospital stays. Secondary endpoints will be evaluation of the ideal time to change the dressing after initial STSG grafting of the lower extremity without increasing graft failure rates. Results The groups were even in time from surgery to 1st dressing change (1st DC) (167 had a 1st DC in ≤3 days post-op, and 163 had a 1st DC >3 days post-op). Demographics and medical history were nearly identical between the two groups, indicating there may be no association between the demographics or medical history collected and earlier dressing change. Median time from surgery to the 1st DC was 3 days (IQR: 3-5) in the entire sample, and from surgery to staple removal was 5 days (IQR: 4-6). The median length of hospital stay in the entire sample was 10 days, and this slightly differed between groups: those with a 1st DC of ≤3 days had a shorter hospital stay (9 days [IQR: 6-13]) than those with a 1st DC of >3 days (11 days [IQR: 7-16]), this is exemplified in Figure 2. 80.3% of patients were discharged home in the sample, with a greater proportion of patients discharged to a facility when they had a 1st DC >3 days post-op (24.5%) than if they had a 1st DC ≤3 days post-op (15%). A greater proportion of patients were discharged walking (47.6% vs 32.7%) when they had an earlier 1st DC than those who did not. Graft failure was seen in 6 patients with 5 of them needing re-STSG. Four due to graft loss and two due to cellulitis. Conclusions Patients who had 1st DC ≤ 3 days after surgery saw an earlier hospital discharge by 2 days without risk of graft loss due to hematoma or seroma regardless of comorbidities. Applicability of Research to Practice The data gathered will be used to establish a clinical based approach to lower extremity dressing changes. We hope to delineate a timeline based on tailored patient factors that can be used as guideline to safely expedite ambulation and minimize hospital stays without increasing graft failure rates.
Abstract Introduction Scar contracture bands after burns are a persistent problem that cause discomfort and physical and aesthetic limitation. Standard treatment for contracture bands in burn scars involves physical therapy, stretching, splinting and laser treatment, as well as surgical releases with local/distant flaps and grafting. A minimally invasive transcutaneous approach for the release of scar bands was initiated in our institution 6 years ago. The method was derived from techniques pioneered by Jose Daher and Raul Gonzalez to interrupt platysma bands in neck rejuvenation. With IRB approval we evaluated this new approach regarding long term outcomes. Methods A retrospective review of 45 patient charts was conducted for those with burn scars who received subcutaneous contracture release from May 1, 2016, through March 31, 2022. The procedure involves introducing a braided suture to loop the contracture band and moving it in a sawing motion until it cuts through the band in multiple sites along the contracture. Demographic data, total burn surface area (TBSA), location, amount of contracture release increments, scar size, and duration of treatment was recorded. Concurrent scar treatments and whether performed under anesthesia was also noted. In follow up visits 3-12 months post release patients were surveyed on satisfaction with the treatment and whether they noticed increased mobility after the procedure. The Vancouver Scar Scale was administered pre- and post-treatment. Patient range of motion was measured pre-and post treatment to assess for change in mobility at treated sites. Results Male to female ratio was 51%:49%, average age was 38.8(6 to 68), 58% were white . TBSA ranged from 0.5% to 85%, with an average of 36.1 ± 22.3. The release was applied to 11 different sites spanning the entire body, 39% on the neck . The procedure involved an average of 19.0 ± 8.8 incremental releases, and the average scar size for treatment was 174.4 ± 140.0 cm2. 93% of the procedures involved laser treatment, 76% were done under anesthesia because of the laser, and 84% involved a site that was skin grafted. Only one of the 45 patients reported bleeding post-discharge, and none had an infection at a puncture site. Out of 20 responses, 13 patients reported being “satisfied” and 3 “very satisfied”; none reported being “dissatisfied”. 19 noted an increase in mobility at the contracture site and one did not. On average, patient range of motion increased by 13.6 degrees. Conclusions The minimally invasive contracture release described is a versatile, safe, and well-tolerated procedure that can help patients regain form and function after a burn injury. It was successfully applied to a large range of age groups, burn sizes, and scar contracture sites. Encouraging data regarding patient recovery and gain in mobility supports the use of this contracture release technique. Further studies should include prospective multicenter trials. Applicability of Research to Practice Immediate
Background: Healing of partial-thickness (2a and 2b) burns is notoriously unpredictable as far as healing time, scarring and (hypo)pigmentation is concerned. Epidermal blister grafting is an autologous grafting technique involving transfer of epidermal islands without dermal elements. CellutomeTM is an FDA-acknowledged epidermal harvesting device. This proof-of-concept study evaluates whether blister grafting of partial-thickness burns results in improved healing compared to standard acellular treatment.Methods: This is a randomized controlled trial with 8 patients in which each patient re-ceived both treatments randomized to different burn sites. Healing was assessed at regular intervals. Twelve months after treatment, outcomes were measured with the Vancouver Scar Scale (VSS), Patient and Observer Scar Assessment Scale (POSAS), photography, spectrometry, Semmes-Weinstein Filaments, cutometry and high-resolution ultrasound.Results: Areas treated with epidermal blister grafting healed slightly faster than acellular treatment. Epidermal treatment yielded healing with less erythema, closer to that of sur-rounding normal skin (p = 0.0404). Donor sites were not visible and not measurably dif-ferent than normal skin.Conclusions: Results favor cellular over acellular technique for the treatment of partial -thickness (2a and 2b) burns. Significant improvement in erythema implies a higher quality healing process. Further studies should look primarily at larger areas of treatment, and larger sample size.& COPY; 2022 Elsevier Ltd and ISBI. All rights reserved.
Since 1970 surgeons have managed deep burns by surgical debridement and autografting. We tested the hypothesis that enzymatic debridement with NexoBrid would remove the eschar reducing surgery and achieve comparable long-term outcomes as standard of care (SOC). In this Phase 3 trial, we randomly assigned adults with deep burns (covering 3-30% of total body surface area [TBSA]) to NexoBrid, surgical or nonsurgical SOC, or placebo Gel Vehicle (GV) in a 3:3:1 ratio. The primary endpoint was complete eschar removal (ER) at the end of the debridement phase. Secondary outcomes were need for surgery, time to complete ER, and blood loss. Safety endpoints included wound closure and 12 and 24-months cosmesis on the Modified Vancouver Scar Scale. Patients were randomized to NexoBrid (n = 75), SOC (n = 75), and GV (n = 25). Complete ER was higher in the NexoBrid versus the GV group (93% vs 4%; P < .001). Surgical excision was lower in the NexoBrid vs the SOC group (4% vs 72%; P < .001). Median time to ER was 1.2 and 3.9 days for the NexoBrid and SOC respectively (P < .001). ER blood loss was lower in the NexoBrid than the SOC group (14 +/- 512 mL vs 814 +/- 1020 mL, respectively; P < .0001). MVSS scores at 12 and 24 months were noninferior in the NexoBrid versus SOC groups (3.7 +/- 2.1 vs 5.0 +/- 3.1 for the 12 months and 3.04 +/- 2.2 vs 3.30 +/- 2.76 for the 24 months). NexoBrid resulted in early complete ER in >90% of burn patients, reduced surgery and blood loss. NexoBrid was safe and well tolerated without deleterious effects on wound closure and scarring.
Early burn excision and skin grafting have been essential to improving patient outcomes following a burn injury. However, there remain significant barriers to recovery for burn patients, especially in the post-discharge period, as follow-up care is essential to the timely identification of complications. While the infection is a common complication of a post-burn wound, Providencia rettgeri is an uncommon bacterial pathogen that rarely causes wound infections. Although P. rettgeri has been infrequently reported as a cause of wound infections, it is a pathogen with growing clinical significance due to innate and acquired mechanisms of antimicrobial resistance that may complicate patient treatment. While our report describes the clinical outcome of a patient with a wound infection with Providencia rettgeri, it also represents a case that underscores the importance of social determinants of health in the care of burn patients. This is a case report of an elderly male who sustained burns to his bilateral arms and back and was subsequently readmitted to our burn unit for graft loss associated with a Providencia rettgeri wound infection. His readmission required multiple operations to resect necrotic tissue and nonviable graft due to delayed wound healing and incomplete graft take. Inadequate access to transportation led to significantly delayed follow-up for this patient.
• Covid-19 has accelerated the use of medical photography, with many specialist services requesting it as part of the referral process • Poor quality images may lead to misinterpretation and a delay in diagnosis or treatment, but training in medical photography for clinicians and patients is limited • Ways to improve the quality of images captured with mobile devices include taking both overview and close-up images, increasing light, and holding devices at an appropriate distance from the subject.
Abstract Introduction A complex wound is a wound that will not heal spontaneously or with simple or standard closure techniques. Often functional structures (bone, tendon, fascia, joint capsule etc.) are exposed and a matrix can be used for bridging of these structures. The Temporizing Matrix is an entirely synthetic matrix made from polyurethane open-cell foam. This matrix was used in the burn center for three years for the indication “complex wound” with good success. The study objective was to evaluate success rate (leading to wound closure after STSG, duration of treatment) and complications (infection, failure, scarring) on this patient cohort. IRB approval was obtained. Methods All charts of patients receiving the Matrix between June 2017 through May 2020 were reviewed. Data collected were demographics, surgery dates, wound descriptions, healing, infection, failure, reapplication, time from application to STSG, time to healing, post discharge complications and scar quality. Results 33 patients with 37 complex wounds were identified to meet inclusion criteria, 61% male, 39% female, age ranging from 3 months to 72 years. The wounds were caused by Burns, necrotizing infections, trauma or amputation post burn. The Matrix was placed for widely exposed structures (70%), failed STSG(3%), thin subcutaneous tissue coverage over amputation stumps (15%) and other reasons (12%). Primary graft success was 97%. Infection rate was 15% with 8% reapplication. Most infections were treated locally. The average Vancouver scar scale rating after discharge was 9/15. Conclusions This temporizing Matrix in preparation to STSG led to successful wound closure in 97% of these complex wounds with low complication rates and an acceptable long-term scar.
Abstract Introduction Heterotopic ossification of large joints is a commonly seen and described entity in Burn survivors. We have observed a rather uncommon phenomenon in a series of 4 Burn survivors who presented to our Burn center for scar treatment and open wounds many years after their injuries. A chronic, small, splinter-like subcutaneous irritation led to open wounds and infections in their burn scars. A similar condition is known as dystrophic calcinosis cutis in the dermatologic literature, but caused by calcium metabolism changes in otherwise healthy skin. Methods The demographics and history of illness was documented in all 4 patients. A literature review was performed. The calcified bone-like irritant was removed surgically in all patients, sometimes in more than one location. Pathologic evaluation was performed on the removed specimen. Strategies leading to healing of the wounds were evaluated. Results Four publications were found addressing this phenomenon in Burn scars, all case reports. All of our patients had undergone curettage of the lesions by a dermatologist in the past without resolution. All lesions were excised surgically and proved to extend subcutaneously far more extensively than the visible skin lesion. X rays proved not helpful in preoperative assessment of the extent. All wounds healed after the irritant was removed. Conclusions All lesions appeared to have formed along tendon or fascia remnants underneath the burn scars, exerting pressure on the overlying epithelium which eventually led to breakdown and necrosis. This finding prompted the term “heterotopic cutaneous ossification”. Chronic tension and inflammation were assumed in the etiology, rather than calcium metabolism abnormalities or systemic connective tissue disease, which were not present in these patients. Research is needed to establish the prevalence, cause, and prevention of this condition in Burn survivors.
Contracture scars post-burn injury often develop in areas near joints and can restrict movement as well as cause cosmetic deformities.1,2 The goal of subcutaneous scar release is to maximize mobility and minimize the need for invasive procedures which can require more recovery time and cause less aesthetically pleasing outcomes, although this new minimally invasive technique may also be used in conjunction with invasive procedures or after more invasive reconstructions to yield the best functional and cosmetic outcome. Retrospective data from May 2016 to July 2019 were collected and analyzed for 28 patients ranging from ages 6 to 68 years old that were diagnosed with a subcutaneous contracture in one or more areas of their body. The data recorded included demographics, procedure specifics and outcomes, patients’ assessments, and areas of which the procedure was most frequently done on. Of the data available, range of motion per site improved by 19.1 degrees. Average pain scores reported directly after the procedure were relatively low at 1.5 on a 10-point scale. Vancouver Scar Scale scores decreased by 0.6 from pre-operatively (10.7) to post-operatively (10.1). The most frequently occurring areas that subcutaneous scar release was done on was the neck (15), axilla (7), and shoulder (7). Overall, 83% of patients reported being very satisfied or satisfied with the outcome of their procedure. Subcutaneous scar release improves burn patients’ range of mobility with less residual scarring and less recovery time than standard of care treatments for scar contractures.
Abstract Introduction Bromelain Based Debridement (BBD) of deep thermal burns has been approved for use in Europe, Argentina, Russia, South Korea, Peru, and Israel, and is an investigational product in the United States. Topline results of acute stage endpoints of the DETECT Phase 3 multicenter RCT have been reported previously. The aim of this abstract is to present the 12-month follow-up of predefined endpoints of scar quality, function and quality of life (QoL). Methods One-hundred and seventy-five adult patients with deep burns were randomized in a Phase 3 clinical trial to one of 3 treatment arms – BBD, Standard of Care (SOC), or Gel vehicle (placebo control) in a 3:3:1 ratio (75 BBD, 75 SOC, and 25 Gel). Scar quality (cosmesis) and function data were analyzed for longer-term data collected at 3, 6, 12 (and 24 - data not yet final) months. Cosmesis and function were measured using Modified Vancouver Scar Scale (MVSS) and Patient and Observer Scar Assessment Scale (POSAS) to demonstrate that BBD treatment was non-inferior to SOC treatment, as measured at 12 months from wound closure date, evaluated by assessors blinded to the treatment arm. QoL was measured by the EQ-5D (EuroQol 5 Dimensions), VAS (Visual Analog Scale) and BSHS-B (Burn Specific Health Scale – Brief) scales. Missing values were imputed in the analysis using multiple imputation, with best case-worst case imputations as sensitivity analyses. Results The 12-month follow-up mean MVSS scores were lower (better) for the BBD group (3.70±2.10) than for the SOC (5.08±3.11) and Gel groups (5.63±2.99). A regression analysis showed that BBD has a 1.36 MVSS point advantage over SOC after adjustment for all other variables in the model (p-value = 0.0027). The 95% CI for this treatment effect was -2.24 to -0.48, excluding the pre-defined non-inferiority margin of +1.9 points, thus establishing non-inferiority of BBD treatment compared with SOC. Note that the interval also excludes 0, indicating superiority of BBD over SOC. The 3- and 6-month follow-up MVSS scores are also lower for the BBD group (5.51±3.09, 4.43±2.59) than for the SOC (6.63±3.44, 5.43±3.75) and Gel (7.56±2.67, 8.89±3.37) groups. POSAS total scores followed similar trends to MVSS scores but did not reach statistical significance at 12 months. QOL was generally similar among the treatment arms. Conclusions In addition to the significant acute stage results presented previously, the long-term results of this RCT further demonstrate the safety of BBD treatment, including significantly better 12-month follow-up MVSS scores.
Background and Objectives: Porcine xenografts have been used successfully in partial thickness burn treatment for many years. Their disappearance from the market led to the search for effective and efficient alternatives. In this article, we examine the synthetic epidermal skin substitute Suprathel® as a substitute in the treatment of partial thickness burns. Materials and Methods: A systematic review following the PRISMA guidelines has been performed. Sixteen Suprathel® and 12 porcine xenograft studies could be included. Advantages and disadvantages between the treatments and the studies’ primary endpoints have been investigated qualitatively and quantitatively. Results: Although Suprathel had a nearly six times larger TBSA in their studies (p < 0.001), it showed a significantly lower necessity for skin grafts (p < 0.001), and we found a significantly lower infection rate (p < 0.001) than in Porcine Xenografts. Nonetheless, no significant differences in the healing time (p = 0.67) and the number of dressing changes until complete wound healing (p = 0.139) could be found. Both products reduced pain to various degrees with the impression of a better performance of Suprathel® on a qualitative level. Porcine xenograft was not recommended for donor sites or coverage of sheet-transplanted keratinocytes, while Suprathel® was used successfully in both indications. Conclusion: The investigated parameters indicate that Suprathel® to be an effective replacement for porcine xenografts with even lower subsequent treatment rates. Suprathel® appears to be usable in an extended range of indications compared to porcine xenograft. Data heterogeneity limited conclusions from the results.