ENERGI-F703 gel, as a new topical treatment for diabetic foot and leg ulcers: A multicenter, randomized, double-blind, phase II trial.

Background: Diabetic foot and leg ulcers are a major cause of disability among patients with diabetes mellitus. A topical gel called ENERGI-F703, applied twice daily and with adenine as its active pharmaceutical ingredient, accelerated wound healing in diabetic mice. The current study evaluated the safety and efficacy of ENERGI-F703 for patients with diabetic foot and leg ulcers. Methods: This randomized, double-blind, multicenter, phase II trial recruited patients from eight medical centers in Taiwan. Patients with intractable diabetic foot and leg ulcers (Wagner Grade 1-3 without active osteomyelitis) were randomly assigned (2:1) to receive topical ENERGI-F703 gel or vehicle gel twice daily for 12 weeks or until complete ulcer closure. The investigator, enrolled patients and site personnel were masked to treatment allocation. Intention to treat (ITT) population and safety population were patient to primary analyses and safety analyses, respectively. Primary outcome was complete ulcer closure rate at the end of treatment. This trial is registered with ClinicalTrials.gov, number NCT02672436. Findings: Starting from March 15th, 2017 to December 26th, 2019, 141 patients were enrolled as safety population and randomized into ENERGI-F703 gel (n = 95) group or vehicle gel (n = 46) group. In ITT population, ENERGI-F703 (n = 90) and vehicle group showed ulcer closure rates of 36.7% (95% CI = 26.75% - 47.49%) and 26.2% (95% CI = 13.86% - 42.04%) with difference of 9.74 % (95 % CI = -6.74% - 26.23%) and 25% quartiles of the time to complete ulcer closure of 69 days and 84 days, respectively. There were 25 (26.3%) patients in ENERGI-F703 group and 11 (23.9%) patients in vehicle group experiencing serious adverse events and five deaths occurred during the study period, none of them related to the treatment. Interpretation: Our study suggests that ENERGI-F703 gel is a safe and well-tolerated treatment for chronic diabetic foot and leg ulcers. Further studies are needed to corroborate our findings in light of limitations. Funding: Energenesis Biomedical Co., Ltd.

Compromised Flap Salvage With Closed Incision Negative Pressure Therapy Under Real-Time Indocyanine Green Fluorescence Assessment.

BACKGROUND: Skin flap transfer is a commonly used technique by surgeons; however, compromised blood flow may result in flap ischemia and necrosis. We describe the use of closed incision negative pressure therapy (ciNPT) to help manage skin flap reconstructions with indocyanine green fluorescence angiography (ICG-FA) to assess perfusion of the flaps before and after ciNPT. METHODS: Three female and 5 male patients underwent various skin flap reconstructions, including local flaps, pedicled flaps, and propeller flaps, for wound defects related to trauma, infection, or cancer. After flap setting and suturing, ciNPT (-125 mm Hg) was applied to the closed incision for 7 days. Perfusion was assessed using ICG-FA before applying ciNPT and again at 24 hours later. The Shapiro-Wilk test and Wilcoxon signed rank test were used in statistical analysis. RESULTS: Initial postoperative survival was observed for all skin flaps; however, 1 flap failed after 2 weeks due to uncontrolled infection. The remaining 7 flaps healed well without any surgical revision. All patients were initially determined to have impaired flap perfusion; however, skin flap perfusion was significantly higher after ciNPT than before ciNPT in each case (P = 0.012). CONCLUSIONS: This study showed good healing outcomes for skin flap reconstructions without complications, despite the fact that each flap had compromised flap perfusion to some extent during the surgery. This case series is novel in that it used laser-assisted ICG-FA to provide a real-time assessment of skin flap perfusion before and after ciNPT.

Application of Auriculotherapy for Post-Burn Scar Syndrome in Young Adults with Major Burns.

Background: A burn scar is a type of hypertrophic scar that can cause significant clinical symptoms, discomfort, and post-burn scar (PBS) syndrome in up to 77% of patients with burn injuries. Medication and rehabilitation are rarely effective at managing patient discomfort, and both laser and surgical interventions are postponed until the scar stabilizes and discomfort is tolerable. Objectives: The present study was conducted to investigate the effectiveness of auricular acupuncture among burn victims from the Formosa Color Dust Explosion in Taiwan. Methods: We enrolled 31 victims of the 2016 Formosa Color Dust Explosion who met the study inclusion criteria. The intervention involved placement of magnetic beads over the auricular Shenmen and Subcortex acupoints on one ear. Patients performed selfmassage five times per day, and both magnet beads were removed between the fifth and seventh days during the sessions. Several evaluation tools were used to assess clinical symptoms: the visual analogue scale for pain assessment, Burn Man Itch Scale for perceived patient itchiness, 5-D Pruritus Scale for sleep quality, and heart rate variability (HRV) for effects on the autonomic nervous system. Results: The clinical symptoms were significantly decreased following the intervention, but the effect did not endure. The normal-to-normal heart rate interval, heart rate analysis abnormalities, and very low frequency heart rate were significantly decreased among patients with abnormal HRV (SD < 40) following treatment. Conclusion: Stimulation of the auricular Shenmen and Subcortex acupoints may effectively reduce pain, itchiness, and sleep disturbances among patients with PBS syndrome.

Modified Design of Anterolateral Thigh Flap for Total Pharyngolaryngectomy Reconstruction: A Single-Center Experience.

BACKGROUND: Defects after total pharyngolaryngectomy for hypopharyngeal cancer often require reconstruction via free tissue transfer. Recently, anterolateral thigh (ALT) flap has become the gold standard in many centers because of its advantages with respect to versatility, minimal donor-site morbidity, good speech quality, and relatively low fistula and anastomotic leakage rates. Moreover, ALT allows 2 surgical teams to work simultaneously. However, the height of the parallelogram in the ALT design for neoesophagus reconstruction is usually set at a minimum of 9.4 cm (circumference, 2πr) for smooth food passage. Because this height exceeds 8 cm, the donor site may not be closed primarily, which highly depends on the patient's body habitus and the skin tone or quality and requires other methods, such as local flap or skin graft for wound closure, which subsequently increase operating time and donor-site complication rate. OBJECTIVES: Thus, we aimed to construct a simple and modified ALT design that will not only include the advantages described earlier but also provide adequate donor-site primary closure without jeopardizing complication rates. METHODS: Ten patients with hypopharyngeal cancer underwent reconstructive surgery using our modified ALT design after total pharyngolaryngectomy between 2010 and 2017. Our modified ALT design converts this "classical" shape into a parallelogram so that the height of the modified design is always less than 8 cm, thus allowing for easy primary closure of the wound. RESULTS: The donor-site defects of all 10 patients were closed primarily. No donor-site complications and partial or total flap loss were observed. One patient experienced persistent wound infection with dehiscence, for which debridement was performed. The stricture and fistula rates were 10% (n = 1) and 20% (n = 2), respectively. The mean follow-up time is approximately 1 year. CONCLUSIONS: Minimizing donor-site morbidity is an important goal in reconstructive surgery. Our modified ALT flap design is simple, enabling easy primary closure of the donor-site defect, with improved results for the patient and operators. Furthermore, this design is also suitable for ALT flaps with widths larger than 8 cm.

Potential media influence on the high incidence of medical disputes from the perspective of plastic surgeons.

BACKGROUND/PURPOSE: The main purpose of this study is to investigate the prevalence of medical disputes among plastic surgeons in Taiwan and to elucidate their perspectives regarding the influence of medical litigation media coverage on the physician-patient relationship. METHODS: A self-administered questionnaire was distributed among plastic surgeons attending a series of continuing education training lectures organized by the Taiwan Society of Plastic Surgery in 2015. RESULTS: Of the 109 respondents, over a third (36.4%) had previously experienced a medical dispute. The vast majority of both physicians who had medical disputes (77.1%) and those who did not (72.1%) felt that the media tends to be supportive of patients in their reporting, and 37.1% of all plastic surgeons felt that the media always portrays the patient as a victim. Respondents who experienced medical disputes in this study felt that the top five leading causes of the high incidence of medical disputes were patient disappointment with procedure results (81.1%), insufficient patient psychological preparation or emotional instability (61.7%), inadequate risk communication on the part of the physician (64.9%), patient uneasiness with the procedure or perception of carelessness (60.6%), and insufficient physician training or incorrect medical evaluation (57.4%). CONCLUSION: Over a third of the respondents had previously experienced a medical dispute. This study highlights the perception among plastic surgeons that the media reporting of medical disputes and medical litigation is biased in favor of the patients, with 37.1% of the plastic surgeons surveyed opining that patients are always cast as victims.

Experience of Surgical Treatment for Occipital Migraine in Taiwan.

PURPOSE: Refractory migraine surgery developed since 2003 has excellent results over the past 10 years. According to the pioneer of migraine surgery, Dr. Bahman Guyuron, 5 major surgical classifications of migraines are described in the field of plastic surgery, namely, frontal migraine, temporal migraine, rhinogenic migraine, occipital migraine, and auriculotemporal migraine. In this study, we present the preliminary surgical results of the occipital migraine surgery. MATERIALS AND METHODS: A total of 22 patients with simple occipital migraines came to our outpatient clinic for help from June 2014 to February 2015. Thirteen cases were excluded owing to ineligibility for operation or other reasons. The patients who concurrently experienced other types of migraines were precluded even if they received combined migraine surgery. Therefore, 9 simple occipital migraine cases were enrolled in this study. Migraine severity was evaluated by uniform questionnaires to identify the source of migraine. Neurolysis was performed under general anesthesia, with the patient in a prone position. Postoperative conditions were evaluated at the second, fourth, sixth, and eighth weeks by posttreatment questionnaires. RESULTS: Of all the 9 patients, 5 experienced single-sided migraines of greater occipital nerve origin (2 left-sided and 3 right-sided cases). Two patients had bilateral migraines of greater occipital nerve origin, and unilateral right lesser occipital nerve origin was noted in one patient. The last patient had right-sided migraines of greater and lesser occipital nerve origin. As a result in the follow-up, a response rate greater than 90% was documented, and complete resolution was observed in 2 patients. Drug doses were reduced more than 50% in the remaining patients. The overall efficacy of occipital migraine surgery in this study was 88.8% (8/9 cases). CONCLUSION: Some patients with migraine are good candidates for surgical resolution with appropriate and meticulous selection. Similar to what is observed in Western countries, the migraine surgery is promising and could provide a better quality of life to selected refractory migraine patients in Taiwan.

Chimeric partial scapula and latissimus dorsi muscle flap for midfoot reconstruction: a case report.

Free muscular, osteomuscular, and fasciocutaneous flaps are widely used for midfoot reconstruction. The latissimus dorsi (LD) flap is rich in muscle mass, but the weight-bearing ability of the reconstruction with its combination with a scapula or rib has not been evaluated. Here, we report a case of reconstruction of the right midfoot with the trauma-related osteomyelitis using a free chimeric scapula and LD muscle flap in a 59-year-old woman with diabetes mellitus. After radical debridement and sequestrectomy, a 7 × 3 cm(2) wound with a 5 × 3 cm(2) bony defect was reconstructed with the chimeric scapula and LD muscle flap. The postoperative course was uneventful. The bony union was achieved 6 months after surgery. In 14 months follow-up, no clinical complications including a new ulcer or stress fracture were noted. At the end of follow-up, the gait analysis showed an unbalanced stress distribution on the right foot and a valgus gait. We suggest that this chimeric scapula and LD muscle flap may be an alternative option for midfoot reconstruction.

Rhabdoid tumor of the kidney with spontaneous rupture: case report and review of literature.

Spontaneous rupture of the kidney is uncommon; here we report a case of spontaneous rupture of the kidney due to a rhabdoid tumor. An 11-year-old boy presented with left flank pain and hematuria, was admitted to a hospital where he was found to have an abnormality of the left kidney on computed tomography (CT) scan. He was referred to our department for further evaluation and treatment on the next day. Spontaneous rupture of left renal tumor was suspected by a drop in hemoglobin level, hemoglobin decreased from 9.2 to 7.6 mg/dl within 72 h. The hemoglobin level continued to drop despite blood transfusion. Urgent trans-abdominal exploration of the left kidney was performed. During the operation, rupture of left renal tumor with massive bleeding was noted. Para-aortic lymph node metastasis is evident. The surgical specimen contained a large peri-renal hemorrhage and tumor rupture into peri-pelvic soft tissue. Histopathological diagnosis was rhabdoid tumor consisting of round nuclei, prominent nucleoli and eosinophic cytoplasm. Two courses of adjuvant chemotherapy with actinomycin D, vincristine and epirubicin and radiotherapy (1,200 cGY) were performed post-operatively. The patient died 5 months after operation due to metastasis of the tumor to the lung and intra-abdominal organs.