Effects of ON101 for Hard-to-Heal Diabetic Foot Ulcers in A Randomized Phase III Trial: A Post hoc Analysis.

OBJECTIVE: Hard-to-heal diabetic foot ulcers (DFUs) are associated with higher mortality rates and an increased medical burden for patients. ON101, a new topical cream, exhibited better healing efficacy than the control dressing in a Phase III trial. In this post-hoc analysis, we further identify whether ON101 can improve the healing of ulcers with hard-to-heal risk factors in this cohort of DFU patients. APPROACH: To compare the efficacy of ON101 with absorbent dressing among various hard-to-heal wounds in patients with DFU, a post hoc analysis of a randomized phase III trial included 276 DFU patients was performed by subgrouping those patients based on ulcer depth, location, size, duration, and patients' glycated hemoglobin (HbA1c) levels and body mass index (BMI). RESULTS: In the full analysis set, the proportion of patients achieving healing was 61.7% in the ON101 group and 37.0% in the comparator (P =0.0001). In sub-group analysis according to risk factors, ON101 demonstrated superior healing capacity on Wagner grade 2 ulcers (P < 0.0001); plantar ulcers (P = 0.0016), ulcers size ≥5 cm² (P = 0.0122), ulcers duration ≥3 months (P = 0.0043); for patients with HbA1c ≥9% (P = 0.0285); and patients with BMI ≥25 (P = 0.0005). INNOVATION: ON101, a novel therapeutic drug, can modulate the functions of macrophages and demonstrate superior healing rates to conventional absorbent dressing in patients with hard-to-heal DFUs. CONCLUSIONS: The results of this post hoc study suggest that ON101 is a better therapeutic option than conventional dressing used in treatment for DFU patients with higher HbA1c, BMI, or ulcers with complex conditions such as longer duration, deeper wounds, larger size, and plantar location.

Dilute Povidone-Iodine Solution Soaking Is Ineffective in Improving Outcomes of Necrotizing Fasciitis Caused by Diabetic Foot.

ABSTRACT: Wound soaking is a physical debridement method that helps reduce bacterial colonization and consequently promotes wound healing. Although soaking in povidone-iodine solution was ineffective in reducing bacterial colonization in acute trauma wounds, there is still a lack of evidence supporting the efficacy of this method in treating severe soft tissue infection. This study aimed to explore the effects of wound soaking in 1% dilute povidone-iodine solution on necrotizing fasciitis caused by diabetic foot ulcers. We retrospectively reviewed and finally included 153 patients who were admitted because of diabetic foot ulcers after undergoing fasciotomy for necrotizing infection from January 2018 to December 2021. Results showed no statistical difference in the outcomes between patients in the soaking and nonsoaking groups. End-stage renal disease (P = 0.029) and high serum C-reactive protein level (P = 0.007) were the only independent factors for below-knee amputation in the univariate and multivariate logistic regression analyses. Therefore, soaking diabetic wounds with severe infection in 1% dilute povidone-iodine solution may not reduce the hospital length of stay, risk of below-knee amputation, and readmission rate.

Clinical outcomes and patient-reported outcomes after oncoplastic breast surgery in breast cancer patients: A matched cohort study.

BACKGROUND: Surgery is the recommended treatment for breast cancer, the most common cancer in women in Taiwan and the leading cause of cancer-related deaths. Although breast-conserving surgery (BCS) has good prognosis, in some cases, BCS may cause more significant deformities and interfere with the patient's psychosocial well-being. Oncoplastic breast surgery (OBS) is the treatment option in these cases. This study aimed to determine the outcomes of OBS and BCS regardless of clinical and patient-reported esthetic outcomes. METHODS: Between 2015 and 2020, 50 patients who underwent OBS at our hospital after complete treatment were enrolled. With 1:2 matched ratios, 100 patients were enrolled in the BCS control group. Clinical outcomes were analyzed. The BREAST-Q questionnaire was then assessed 6 months after the completion of treatment for subjective patient-reported outcomes. RESULTS: Due to the matching process, no difference was noted between the two groups in terms of demographic data such as age, comorbidities, or tumor characteristics. There were no significant differences in the local recurrence rate, disease-free survival, overall survival, positive margin rate, rewide excision rate, conversion to mastectomy rate, or complication rate (major or minor) between both groups. However, the OBS group showed higher satisfaction with breasts in the BREAST-Q questionnaire ( p < 0.001). The mean follow-up time was 38.77 ± 14.70 months in the BCS group and 29.59 ± 14.06 months in the OBS group. CONCLUSION: OBS seems to be a safe and feasible surgery in breast cancer patients because clinical outcomes are compatible with BCS. Moreover, the OBS group had better patient-reported outcomes in terms of satisfaction.

Total Surface Area of a Through-and-Through Oromandibular Defect Is Associated With Thromboembolic Events for Reconstruction With a Single Fibula Free Flap.

BACKGROUND: Reconstruction of through-and-through composite oromandibular defects (COMDs) has been a challenge to plastic surgeons for decades. When using a free osteoseptocutaneous fibular flap, the skin paddle is restricted by the orientation of the peroneal vessels and the inset of bone segment(s). Although the combination of double flaps for extensive COMDs is viable and reliable, the decision of single- or double-flap reconstruction is still debated, and the risk factors leading to complications and flap failure of single-flap reconstruction are less discussed. AIM AND OBJECTIVES: The aim of this study was to determine objectively predictive factors for postoperative vascular complications in through-and-through COMDs reconstructed with a single fibula flap. METHODS: This was a retrospective cohort study in patients who underwent single free fibular flap reconstruction for through-and-through COMDs in a tertiary medical center from 2011 to 2020. The enrolled patients' characteristics, surgical methods, thromboembolic event, flap outcomes, intensive care unit care, and total hospital length of stay were analyzed. RESULTS: A total of 43 consecutive patients were included in this study. Patients were categorized into a group without thromboembolic events (n = 35) and a group with thromboembolic events (n = 8). The 8 subjects with thromboembolic events were failed to be salvaged. There was no significant difference in age, body mass index, smoking, hypertension, diabetes mellitus, and history of radiotherapy. The length of bony defect (6.70 ± 1.95 vs 9.04 ± 2.96, P = 0.004) and the total surface area (105.99 ± 60.33 vs 169.38 ± 41.21, P = 0.004) were the 2 factors that showed a significant difference between the groups. Total surface area was the only significant factor in univariate logistic regression for thromboembolic event (P = 0.020; odds ratio, 1.02; 95% confidence interval [CI], 1.003-1.033) and also in multivariate logistic regression analysis after adjusting confounding factors (P = 0.033; odds ratio, 1.026; 95% CI, 1.002-1.051).The cutoff level of total surface area in determining thromboembolic event development was 159 cm2 (P = 0.005; sensitivity of 75% and specificity of 82.9%; 95% CI, 0.684-0.952). CONCLUSIONS: Free fibula flap has its advantages and drawbacks on mandible restoration. Because there is a lack of indicators before, a large total surface area may be an objective reference for single-flap reconstruction of through-and-through COMDs due to an elevated risk of thromboembolic event.

Development of a deep learning-based tool to assist wound classification.

This paper presents a deep learning-based wound classification tool that can assist medical personnel in non-wound care specialization to classify five key wound conditions, namely deep wound, infected wound, arterial wound, venous wound, and pressure wound, given color images captured using readily available cameras. The accuracy of the classification is vital for appropriate wound management. The proposed wound classification method adopts a multi-task deep learning framework that leverages the relationships among the five key wound conditions for a unified wound classification architecture. With differences in Cohen's kappa coefficients as the metrics to compare our proposed model with humans, the performance of our model was better or non-inferior to those of all human medical personnel. Our convolutional neural network-based model is the first to classify five tasks of deep, infected, arterial, venous, and pressure wounds simultaneously with good accuracy. The proposed model is compact and matches or exceeds the performance of human doctors and nurses. Medical personnel who do not specialize in wound care can potentially benefit from an app equipped with the proposed deep learning model.

Evaluating Pull-Out Strength of Barbed Suture In Vitro by Using Porcine Tissue and Polydimethylsiloxane (PDMS).

Using barbed thread lifting for facial rejuvenation has become popular these days due to its minimally invasive procedures with reduced complications. However, only limited studies regarding its mechanical properties for face suspension were published. The aim of this study was to evaluate suture-holding ability regarding its facelift property, and different specimens were tested in order to establish an in vitro model. Fresh porcine tissue and the synthetic material polydimethylsiloxane (PDMS) were selected to simulate human skin for evaluating barbed suture pull-out strength by the universal material testing machine. The results showed that the pull-out strength of barbs between different porcine tissues varied without consistency. By contrast, PDMS (30:1) showed more consistent pull-out strength in each testing, and the average maximum load force was close to porcine tissue. Furthermore, after submerging barbed sutures in PBS for 0 days (T0), 7 days (T7) and 14 days (T14), a trend of decreased average maximum load force, displacement and force of 1.5 mm/2 mm/3 mm displacement could be detected by in vitro testing with PDMS (30:1). These results provide support for using PDMS (30:1) to evaluate suture pull-out strength and holding/lifting capacities in vitro to obtain consistent and objective information for evaluating substantial equivalence of devices. The established in vitro method could be used for the future development of barbed thread lifting technology.

Complications of free-flap procedures for phalloplasty in female-to-male transgender surgery: 25-year experience a single medical center.

BACKGROUND: To present the complications of free-flap phalloplasty in three-staged female-to-male transgender surgery. METHODS: This retrospective study included patients who underwent a three-staged free-flap phalloplasty for female-to-male transgender surgery between January 1988 and December 2013. Data regarding demographics, operative techniques, and complications were collected and analyzed. RESULTS: A total of 101 patients with a mean age of 30.2 years were included. Phalloplasty with traditional free forearm tube-in-tube fasciocutaneous flap was performed in 25 (24.8%) patients, free forearm fasciocutaneous flap with vaginal mucosa for a prefabricated urethra in 30 (29.7%) patients, free radial forearm osteocutaneous flap with vaginal mucosa for a prefabricated urethra in 22 (21.8%) patients, and free fibula osteocutaneous flap with vaginal mucosa for a prefabricated urethra in 24 (23.8%) patients. Complication rates of partial flap loss, urethrocutaneous fistula, urethral stricture, and hair or stone formation were 12.9%, 49.5%, 24.8%, and 5.0%, respectively. Patients receiving fibula osteocutaneous flap phalloplasty had the lowest overall complication rate (33.3%), followed by those with radial forearm osteocutaneous flap (40.9%), forearm fasciocutaneous flap (43.3%), and forearm tube-in-tube fasciocutaneous flap (80.0%). Forearm tube-in-tube fasciocutaneous flap procedure was associated with significantly higher rates of overall complications (p = 0.05), urethrocutaneous fistula (p = 0.005), and hair or stone formation (p = 0.002) compared with the other three types of procedures. Rates of all complications did not significantly differ among fibula osteocutaneous flap, radial forearm osteocutaneous flap, and forearm fasciocutaneous flap procedures. CONCLUSION: In free-flap phalloplasty for female-to-male transgender surgery, utilization of free fibula osteocutaneous flap with vaginal mucosa for a prefabricated urethra resulted in the lowest complication rate. Further comparisons among different procedures of phalloplasty are warranted.

Accuracy of the Application of 3-Dimensional Printing Models in Orbital Blowout Fractures-A Preliminary Study.

BACKGROUND: Application of 3-dimensional (3D) printing technology has grown in the medical field over the past 2 decades. In managing orbital blowout fractures, 3D printed models can be used as intraoperative navigators and could shorten the operational time by facilitating prebending or shaping of the mesh preoperatively. However, a comparison of the accuracy of computed tomography (CT) images and printed 3D models is lacking. MATERIAL AND METHODS: This is a single-center retrospective study. Patients with unilateral orbital blowout fracture and signed up for customized 3D printing model were included. Reference points for the 2D distance were defined (intersupraorbital notch distance, transverse horizontal, sagittal vertical, and anteroposterior axes for orbital cavity) and measured directly on 3D printing models and on corresponding CT images. The difference and correlation analysis were conducted. RESULTS: In total, 9 patients were reviewed from June 2017 to December 2020. The mean difference in the intersupraorbital notch measurement between the 2 modules was -0.14 mm (P = 0.67). The mean difference in the distance measured from the modules in the horizontal, vertical, and anteroposterior axes of the traumatic orbits was 0.06 mm (P = 0.85), -0.23 mm (P = 0.47), and 0.51 mm (P = 0.32), whereas that of the unaffected orbits was 0.16 mm (P = 0.44), 0.34 mm (P = 0.24), and 0.1 mm (P = 0.88), respectively. Although 2D parameter differences (<1 mm) between 3D printing models and CT images were discovered, they were not statistically significant. CONCLUSIONS: Three-dimensional printing models showed high identity and correlation to CT image. Therefore, personalized models might be a reliable tool of virtual surgery or as a guide in realistic surgical scenarios for orbital blowout fractures.

Perioperative Myocardial Infarction in Free Flap for Head and Neck Reconstruction.

INTRODUCTION: Acute myocardial infarction (AMI) is a postoperative complication of major surgical procedures, including free flap surgery. It is the most common cause of postoperative morbidity and mortality. Moreover, patients receiving free flap reconstruction for the head and neck have significant risk factors such as coexisting coronary artery disease (CAD). Our primary aim was to ascertain predictors of perioperative AMI to enable early detection and consequently early treatment of perioperative AMI. Our secondary aim was to determine the group of patients who would be at a high risk for perioperative AMI after free flap surgery. MATERIALS AND METHODS: This retrospective study enrolled patients who underwent free flap reconstruction surgery at the Division of Plastic and Reconstructive Surgery of Taipei Veterans General Hospital between 2013-01 and 2017-12. RESULTS: This study included 444 patients and 481 free flap head and neck reconstruction surgeries. Fifteen (3.1%) patients were diagnosed with perioperative AMI. Statistical analysis of the variables revealed that patients with underlying CAD or cerebrovascular accident (CVA) were at a high risk of developing perioperative AMI (odds ratio: 6.89 and 11.11, respectively). The flap failure rate was also higher in patients with perioperative AMI compared with those without perioperative AMI (P = 0.015). CONCLUSIONS: Patients with underlying diseases, such as CAD or CVA, constituted high-risk groups for perioperative AMI.

Long-Term Complications and Patient-Reported Outcomes After Alloplastic Breast Reconstruction.

BACKGROUND: The most widely used method for breast reconstruction in Taiwan is alloplastic breast reconstruction, and traditionally, it can be categorized into immediate or delayed, single-stage or 2-stage procedures. We evaluated clinical outcomes and analyzed patients' self-reported satisfaction and quality of life after alloplastic breast reconstruction based on a previous preliminary study. PATIENT AND METHODS: The patients who underwent primary alloplastic breast reconstruction after mastectomy were recruited in 2006 to 2020 at a single institute in Taiwan. The assessment of clinical outcomes was conducted by retrospective chart review and risk analysis. The patients also completed the BREAST-Q, a condition-specific patient-reported outcome measure, at least 6 months after treatment. RESULTS: A total of 237 patients with 247 reconstructed breasts were enrolled in this study. The demographics showed that 205 (83%) were reconstructed using a 2-stage tissue expander-based procedure and 42 (17%) were 1-stage direct-to-implant reconstructions. The mean follow-up time was 79.5 months. The clinical assessment revealed that the overall complication rate was 34%, with infection being the most common (21 patients; 8%). According to risk analysis, smoking (odds ratio, 7.626; 95% confidence interval, 1.56-37.30; P = 0.012), and nipple-sparing mastectomy (odds ratio, 3.281; 95% confidence interval, 1.54-6.99; P = 0.002) were significant risk factors for overall complications. The questionnaire response rate was 38% (94 of 247), at least 6 months after treatment. The total mean score was 69.78. CONCLUSIONS: At a single institute in Taiwan from 2006 to 2020, alloplastic breast reconstruction, either single- or 2-stage, have acceptable complication rate and good postoperative satisfaction based on patient-reported outcomes. Both patient- and surgery-related factors presented as significant risk factors. Precise patient selection and comprehensive discussion between the patient and physician may play the important role to achieve optimal aesthetic outcomes.

The Effect of Biological Scaffold (Biodesign) in Postmastectomy Direct-to-Implant Breast Reconstruction: A 5-Year Single-Institution Experience.

BACKGROUND: Direct-to-implant (DTI) breast reconstruction is one of the immediate implant-based breast reconstruction methods. If the amount of soft tissue (eg, muscle or fascia) is insufficient to completely cover the implant, biological scaffold or acellular dermal matrix can be safely used for implant coverage. In this study, we used an acellular porcine small intestinal submucosa (SIS) mesh (Biodesign; Cook Medical Inc, Bloomington, IN) for DTI reconstruction to explore the impact of its use on breast reconstruction results. METHODS: We retrospectively assessed cases involving DTI reconstruction at Taipei Veterans General Hospital from 2015 to 2019. Women, 18 years or older, who underwent immediate DTI reconstruction after mastectomy were included in the study. Mastectomy may have been performed because of therapeutic or prophylactic reasons. Patients who did and did not use SIS mesh for reconstruction were studied separately, and the 2 groups were compared in terms of clinical outcomes and complications. The validated, self-administered BREAST-Q Reconstruction Module version 2.0 survey was used to evaluate health-related quality of life and satisfaction among patients who underwent breast reconstruction. RESULTS: A total of 30 DTI breast reconstructions were enrolled. The mean age was 49.2 years, and the mean body mass index was 22.3 kg/m2. The mean postoperative follow-up duration was 17.1 months. Nipple-sparing mastectomy was performed for 26 cases (86.7%), and DTI breast reconstructions using SIS mesh for implant coverage were done in 14 cases (46.7%). The overall complication rate was 53.3% in 30 reconstructions, with nipple complications being the most common complication. The non-SIS and SIS-using groups had a similar overall complication rate postoperatively. As for the quality-of-life assessment, the SIS group obtained a higher score on BREAST-Q than those for whom SIS was not used. CONCLUSIONS: Porcine SIS mesh might be a safe and effective alternative to biological scaffolds in immediate 1-stage implant-based breast reconstruction to improve the quality of life after surgery.

Postoperative Sedation Duration as an Independent Risk Factor for Postoperative Pneumonia in Head and Neck Cancer Patients Undergoing Free Flap Reconstruction.

OBJECTIVE: Patients who had reconstruction for head and neck cancer usually have long duration of postoperative sedation and intensive care. This is due to the complex nature of large-area soft tissue defect surgeries and upper respiratory tract infections associated with them. Postoperative pulmonary complications are common in these patients. In this study, we analyzed the risk factors and the relationship between postoperative complications and the duration of sedation to improve the patients' recovery process after free flap reconstruction for head and neck surgery. MATERIALS AND METHODS: This was a retrospective study that included 188 patients who had head and neck surgery with free flap reconstruction in 2011 (traditional recovery group) and 2018 (early recovery group). Postoperative recovery events were compared between the 2 groups. Complications such as pneumonia, wound infection, vascular thrombosis, and bleeding were also analyzed. RESULTS: The results showed that the early recovery group had a shorter duration of sedation (P < 0.001), shorter duration of intensive care unit stay (P = 0.05), more rapid ventilator weaning (P < 0.001), and fewer pneumonia events (8.8% vs 39.1%) than the traditional recovery group. Wound- and vessel-related complications were not affected by the duration of sedation. CONCLUSIONS: Our study demonstrated that shortening the duration of postoperative sedation can effectively decrease the length of intensive care unit stay and reduce postoperative incidence of pneumonia without increasing wound- and vessel-related complications.

Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial.

Importance: Delayed healing of diabetic foot ulcers (DFUs) is known to be caused by dysregulated M1/M2-type macrophages, and restoring the balance between these macrophage types plays a critical role in healing. However, drugs used to regulate M1/M2 macrophages have not yet been studied in large randomized clinical trials. Objective: To compare the topical application of ON101 cream with use of an absorbent dressing (Hydrofiber; ConvaTec Ltd) when treating DFUs. Design, Setting, and Participants: This multicenter, evaluator-blinded, phase 3 randomized clinical trial was performed in 21 clinical and medical centers across the US, China, and Taiwan from November 23, 2012, to May 11, 2020. Eligible patients with debrided DFUs of 1 to 25 cm2 present for at least 4 weeks and with Wagner grade 1 or 2 were randomized 1:1 to receive ON101 or control absorbent dressings. Interventions: Twice-daily applications of ON101 or a absorbent dressing changed once daily or 2 to 3 times a week for 16 weeks, with a 12-week follow-up. Main Outcomes and Measures: The primary outcome was the incidence of complete healing, defined as complete re-epithelialization at 2 consecutive visits during the treatment period assessed on the full-analysis set (FAS) of all participants with postrandomization data collected. Safety outcomes included assessment of the incidences of adverse events, clinical laboratory values, and vital signs. Results: In the FAS, 236 eligible patients (175 men [74.2%]; mean [SD] age, 57.0 [10.9] years; mean [SD] glycated hemoglobin level, 8.1% [1.6%]) with DFUs classified as Wagner grade 1 or 2 (mean [SD] ulcer area, 4.8 [4.4] cm2) were randomized to receive either the ON101 cream (n = 122) or the absorbent dressing (n = 114) for as long as 16 weeks. The incidence of complete healing in the FAS included 74 patients (60.7%) in the ON101 group and 40 (35.1%) in the comparator group during the 16-week treatment period (difference, 25.6 percentage points; odds ratio, 2.84; 95% CI, 1.66-4.84; P < .001). A total of 7 (5.7%) treatment-emergent adverse events occurred in the ON101 group vs 5 (4.4%) in the comparator group. No treatment-related serious adverse events occurred in the ON101 group vs 1 (0.9%) in the comparator group. Conclusions and Relevance: In this multicenter randomized clinical trial, ON101 exhibited better healing efficacy than absorbent dressing alone in the treatment of DFUs and showed consistent efficacy among all patients, including those with DFU-related risk factors (glycated hemoglobin level, ≥9%; ulcer area, >5 cm2; and DFU duration, ≥6 months). Trial Registration: ClinicalTrials.gov Identifier: NCT01898923.

Using Various Skin Graft Techniques in Major Burn Reconstruction: A Lesson Learned From a Taiwanese Cornstarch Explosion.

PURPOSE: Four hundred and ninety-nine patients had burn injuries in an explosion in Taiwan on June 27, 2015, 24 were admitted to the intensive care units of Taipei Veterans General Hospital. This study details our experience with surgical management of these patients, focusing primarily on various skin graft techniques. MATERIALS AND METHODS: This single-center retrospective study included patients who underwent at least one of the previously mentioned skin graft techniques because of extensive skin defects. The demography, burn diagram, treatment modalities, postoperative outcome, and costs were all analyzed, and a comparison with traditional mesh skin grafts was performed. The literature was also reviewed. RESULTS: Fourteen patients underwent the Meek skin graft technique. Only 3 received ReCell and 1 cultured epithelial autograft (CEA) at separate time point. Overall, the autologous skin grafts, including Meek/ReCell/CEA were completed within 6 months. The average skin graft success rate was approximately 72.9%, 79.2%, and 38% in Meek, ReCell, and CEA, respectively. The infection rate was approximately 35.7%, 25%, and 100% in Meek, ReCell, and CEA, respectively. The average surgical cost and total medical cost were significantly higher in patients who underwent Meek/ReCell/CEA treatments. CONCLUSIONS: In our experience, Meek and ReCell treatments had acceptable success rates, but CEA treatment not. ReCell and CEA treatments are useful in the event of extremely limited donor sites, and they are fragile, easily infected, and technically challenging. These techniques also require longer hospitalization and tend to be more expensive, all factors that should be considered when assessing treatment options.

Identifying major predictors of lower-extremity amputation in patients with diabetic foot ulcers.

BACKGROUND: The aim of the present study was to investigate the risk factors for amputation in patients with diabetic foot ulcer (DFU). METHODS: Between 2012 and 2017, 646 patients with DFU were admitted to our diabetic foot care center. A retrospective chart review was performed, and the end point was limb salvage and minor or major amputation. Chi-square test, dependent t test, and a multivariate logistic regression analysis were performed to identify risk factors in patients with DFUs. RESULTS: A total of 399 male and 247 female patients (mean age 64.6 years) were included in this study, of whom 159 (24.6%) underwent lower limb amputation (minor, 17.5; major, 7.1%). Independent risk factors of amputation were peripheral arterial disease (PAD) (odds ratio [OR], 3.196; p < 0.001), C-reactive protein (CRP) level (OR, 1.046; p = 0.001), and hospital stay (OR, 1.019; p = 0.001). Subgroup analysis based on all patients with PAD who underwent amputation showed that endovascular intervention (OR, 0.271; p = 0.049) was a protective factor for major amputation in addition to CRP level (OR, 1.116; p = 0.008). CONCLUSION: DFU remains a major medical and public health issue. PAD, CRP level, and hospital stay are independent risk factors for amputation. Endovascular intervention is an independent protective factor against major amputation among patients with PAD who underwent amputation.

Assessment and determinants of global outcomes among 445 mass-casualty burn survivors: A 2-year retrospective cohort study in Taiwan.

PURPOSE: To study outcomes among survivors of the mass-casualty powder explosion on 27 June 2015, at Formosa Fun Coast Waterpark, New Taipei City, Taiwan. METHODS: Using retrospective data on Taiwanese survivors, we analyzed prehospital management, burns assessment and prognosis, functional recovery, and medical costs, followed-up through 30 June 2017. We related outcomes to burn extent, categorized according to the percentages of total body surface area with second/third-degree burns (%TBSA) or autologous split-thickness skin grafts (%STSG), and an investigational scale: f{SASG} = (%TBSA + %STSG)/2, stratified by %STSG. Analyses included casualty dispersal, comparisons between %TBSA, %STSG and f{SASG}, and their relationships with length of hospitalization, times to rehabilitation and social/school re-entry, physical/mental disability, and medical costs. We also investigated how burn scars restricting joint mobility affected rehabilitation duration. RESULTS: 445 hospitalized casualties (excluding 16 foreigners, 23 with 0% TBSA and 15 fatalities) aged 12-38 years, had mean TBSA of 41.1%. Hospitalization and functional recovery durations correlated with %TBSA, %STSG and f{SASG} - mean length of stay per %TBSA was 1.5 days; more numerous burn scar contractures prolonged rehabilitation. Females had worse burns than males, longer hospitalization and rehabilitation, and later school/social re-entry; at follow-up, 62.3% versus 37.7% had disabilities and 57.7% versus 42.3% suffered mental trauma (all p ≤ 0.001). Disabilities affecting 225/227 people were skin-related; 34 were severely disabled but 193 had mild/moderate impairments. The prevalence of stress-related and mood disorders increased with burn extent. Treatment costs (mean USD-equivalents ∼$48,977/patient, ∼$1192/%TBSA) increased with burn severity; however, the highest %TBSA, %STSG and f{SASG} categories accounted for <10% of total costs, whereas TBSA 41-80% accounted for 73.2%. CONCLUSIONS: Besides %TBSA, skin-graft requirements and burn scar contractures are complementary determinants of medium/long-term outcomes. We recommend further elucidation of factors that influence burn survivors' recovery, long-term physical and mental well-being, and quality of life.

Review of preclinical and clinical studies of using cell-based therapy for secondary lymphedema.

Secondary lymphedema is associated with impaired lymph fluid drainage and remains incurable. Alternatively, cell-based therapy may pave the way for lymphedema treatment. We found 11 animal and seven human studies had been conducted from 2008 to 2018. Most studies showed great potential for this treatment modality. Emerging studies have focused on novel techniques, such as coupling cell therapy with lymph node transfer, or adding growth factors to cell therapy.

Prognostic Factors and Clinical Outcomes of Clinical Node-Negative Cutaneous Malignant Melanoma Patients: An Asian Single Institute Study.

INTRODUCTION: Cutaneous malignant melanoma is notorious for its aggressive behavior and relatively poor outcome compared with other common skin malignancies. Acral lentiginous melanoma (ALM) accounts for at least 50% of melanoma in the Asian population and has a significantly lower survival rate. However, previous studies of the prognostic factors of melanoma-specific survival were all conducted from Western institutions. Here, we performed a retrospective analysis to investigate this issue. METHODS: Fifty patients diagnosed as having clinical node-negative cutaneous malignant melanoma who underwent sentinel lymph node (SLN) biopsy at Taipei Veterans General Hospital between January 2007 and December 2018 were enrolled. Patient demographics, tumor characteristics, and lymph node characteristics were evaluated by chart review. RESULTS: Eighty-two percent of the melanoma in the sample population was ALM. Twelve patients (24.0%) presented at least 1 metastatic sentinel node, and the average number of retrieved SLNs was 3. Of the patients with positive SLNs who proceeded to completion lymph node dissection, only 2 (16.7%) had metastatic nonsentinel nodes (NSNs). The average follow-up time for all patients was 45 months. Recurrence and melanoma-specific death occurred in 21 patients (42.0%) and 15 patients (30.0%), respectively. Melanoma-specific survival was significantly lower in patients with ulcerative lesions (P = 0.005) and more metastatic SLNs (P = 0.036). The overall morbidity rate of completion lymph node dissection was 66.7%. CONCLUSIONS: The presence of ulcerations and number of metastatic SLNs were the most important prognostic factors in this ALM-dominant Asian cohort. Among patients with clinically negative nodes but positive SLNs, less than one-fourth of patients harbored metastatic NSNs. Completion lymph node dissection carries a relatively high risk of morbidity; therefore, further research regarding predictors of positive NSNs in the Asian population is necessary.

Albumin supplementation may have limited effects on prolonged hypoalbuminemia in major burn patients: An outcome and prognostic factor analysis.

BACKGROUND: Burns that affect ≥20% of the total body surface area (TBSA) trigger a major inflammatory response in addition to capillary leakage and loss of serum proteins including albumin. Persistent hypoalbuminemia is therefore common in major burn patients. The purpose of this study was to determine whether human albumin solutions can benefit major burn patients with persistent hypoalbuminemia. METHODS: We conducted a retrospective review of major burn patients with ≥20% of TBSA involved at Taipei Veterans General Hospital between January 2007 and December 2018. Thirty-eight patients were enrolled. Patient demographics, burn characteristics, fluid balance, laboratory results, and outcomes were recorded through chart review. RESULT: No significant differences were found in the baseline characteristics of patients who received <25 mg/kg/%TBSA/day of human albumin solutions and those who received more than this amount. Renal replacement therapy, duration of mechanical ventilation, length of stay in the burn unit, and in-hospital mortality rate were not statistically different between the two groups. The serum C-reactive protein/albumin ratio was associated with in-hospital mortality (p = 0.036). CONCLUSION: The administration of large amounts of albumin supplements for the correction of prolonged hypoalbuminemia in major burn patients had no significant benefits on mortality.