Chun-Kai Chang’s research while affiliated with National Sun Yat-sen University and other places

Background: Hypersensitivity to the new dermal injectable porcine-based collagen with lidocaine featuring a novel cross-linking technology (test filler) for nasolabial fold correction was compared to the commercially available traditional cross-linked dermal injectable porcine-based collagen with lidocaine (control filler). Methods: Recruited participants (n = 279) received a single 0.1 mL intradermal injection of either test filler or control filler in the left forearm as a screening skin allergy test. Injection sites were assessed clinically at 24 h post-implant. Treatment was given to 252 successfully screened participants, and injection sites were monitored for 21 days. Immunological examinations were performed at screening and then at 4 and 24 weeks post-treatment. Observations for adverse events continued until the 52nd week. Results: Intradermal allergy testing results were negative for all the test recipients (0/124) and positive for two control recipients (2/132, 1.5%). Most of the participants exhibited no changes in serum immunoglobulin (IgG, IgM) and complement (C3, C4) levels. No serious adverse events related to the device were recorded. Most adverse events were common complications of dermal filler treatment and were related to the injection site. Most adverse effects were resolved or under control by 52 weeks. Conclusions: Hypersensitivity reactions with the test filler were lower than those with the control filler, validating the safe use of test filler for nasolabial fold correction without the need for pretreatment skin testing.

Purpose Porcine-based dermal injectable collagen is effective for nasolabial fold correction. In the present study, a new dermal injectable collagen, incorporating a novel cross-linking technology and premixed with lidocaine, was introduced. The study aimed to determine the efficacy of the new dermal injectable collagen in improving bilateral nasolabial fold wrinkles, and reducing pain during injection. Patients and Methods This prospective, double-blind, multicenter, parallel-group, randomized trial enrolled participants with moderate-to-severe bilateral nasolabial fold wrinkles from February 2019 to March 2021. Participants were randomly assigned to the test group (new dermal injectable collagen with lidocaine featuring a novel cross-linking technology) or control group (traditionally cross-linked dermal injectable collagen with lidocaine). Participants were monitored for adverse events (AEs), and for pain using the Thermometer Pain Scale (TPS) and a visual analog scale (VAS). Efficacy was measured using the Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS). Results On the poor or better sides, the 2 groups exhibited a significant decrease in WSRS scores at 4, 12, 24, and 36 weeks after treatment, compared to baseline WSRS scores (all, p < 0.05). Compared to the control group, the test group had a greater decrease in WSRS score (poor or better sides) at 12, 24, 36, and 52 weeks after treatment (all, p < 0.05). A similar observation was also found in the WSRS response rate and GAIS score of the 2 groups. VAS and TPS scores were not significantly different between the 2 groups (p > 0.05), indicating that pain reduction was similar in the 2 groups. All AEs were anticipated AEs associated with facial aesthetic injections, and most recovered within 0 to 30 days without sequelae. There were no differences in AEs between the 2 groups (all, p > 0.05). Conclusion The new dermal injectable collagen with lidocaine exhibited better efficacy for correcting nasolabial fold wrinkles compared to the control group. Both relieved pain and produced only transient and tolerable AEs.

Background: Anal stenosis is a rare but frustrating condition that usually occurs as a complication of hemorrhoidectomy. The severity of anal stenosis can be classified into three categories: mild, moderate, and severe. There are two main surgical treatments for this condition: scar revision surgery and anoplasty; however, no studies have compared these two approaches, and it remains unclear which is preferrable for stenoses of different severities. Aim: To compare the outcomes of scar revision surgery and double diamond-shaped flap anoplasty. Methods: Patients with mild, moderate, or severe anal stenosis following hemorrhoidectomy procedures who were treated with either scar revision surgery or double diamond-shaped flap anoplasty at our institution between January 2010 and December 2015 were investigated and compared. The severity of stenosis was determined via anal examination performed digitally or using a Hill-Ferguson retractor. The explored patient characteristics included age, sex, preoperative severity of anal stenosis, preoperative symptoms, and preoperative adjuvant therapy; moreover, their postoperative quality of life was measured using a 10-point scale. Patients underwent proctologic follow-up examinations one, two, and four weeks after surgery. Results: We analyzed 60 consecutive patients, including 36 men (60%) and 24 women (40%). The mean operative time for scar revision surgery was significantly shorter than that for double diamond-shaped flap anoplasty (10.14 ± 2.31 [range: 7-15] min vs 21.62 ± 4.68 [range: 15-31] min; P < 0.001). The average of length of hospital stay was also significantly shorter after scar revision surgery than after anoplasty (2.1 ± 0.3 vs 2.9 ± 0.4 d; P < 0.001). Postoperative satisfaction was categorized into four groups: 45 patients (75%) reported excellent satisfaction (scores of 8-10), 13 (21.7%) reported good satisfaction (scores of 6-7), two (3.3%) had no change in satisfaction (scores of 3-5), and none (0%) had scores indicating poor satisfaction (1-2). As such, most patients were satisfied with their quality of life after surgery other than the two who noticed no difference due owing to the fact that they experienced recurrences. Conclusion: Scar revision surgery may be preferable for mild anal stenosis upon conservative treatment failure. Anoplasty is unavoidable for moderate or severe stenosis, where cicatrized tissue is extensive.

Introduction: Fluoroquinolone exposure is reportedly associated with a higher risk of tendon disorders, tendonitis, or tendon rupture. However, studies in East Asian populations have not confirmed these risks in patients with comorbidities or concomitant medication use. This cohort study was designed to investigate the associations among fluoroquinolone exposure, comorbidities, medication use, and tendon disorders in Taiwan. Materials and Methods: This population-based, nationwide, observational, cohort study used data from the National Health Insurance Research database in Taiwan, a nationwide claims database that covers more than 99% of the Taiwanese population. The study period was from January 2000 to December 2015, and the median follow-up time was 11.05 ± 10.91 years. Patients who were exposed to fluoroquinolones for more than three consecutive days were enrolled, and patients without fluoroquinolone exposure who were matched by age, sex, and index year were enrolled as controls. The associations of comorbidities and concomitant medication use with tendon disorder occurrence were analyzed using Cox regression models. Results: The incidence of tendon disorders were 6.61 and 3.34 per 10⁵ person-years in patients with and without fluoroquinolone exposure, respectively (adjusted hazard ratio, 1.423; 95% confidence interval [1.02,1.87]; p = 0.021). Sensitivity analyses yielded similar results. Patients under 18 and over 60 years with fluoroquinolone exposure; those with chronic kidney disease, diabetes, rheumatologic disease, cardiac disease, lipid disorder, or obesity; and those who concomitantly used statins, aromatase inhibitors, or glucocorticoids, had a significantly higher risk of tendon disorders. Conclusion: The long-term risk of tendon disorders was higher in patients with fluoroquinolone exposure than in those without fluoroquinolone exposure. Clinicians should assess the benefits and risks of fluoroquinolone use in patients at high risk of tendon disorders who require fluoroquinolone administration.

Diabetes-related lower extremity amputations are an enormous burden on global health care and social resources because of the rapid worldwide growth of the diabetic population. This research aimed to determine risk factors that predict major amputation and analyse the time interval from first hospitalisation to amputation by using standard management protocols and Kaplan–Meier survival curves. Data from 246 patients with diabetes mellitus and diabetic foot ulcers from the Division of Plastic and Reconstructive Surgery of the Department of Surgery at XXX Hospital between January 2016 and May 2020 were analysed. Univariate and multivariate analyses of 44 potential risk factors, including invasive ulcer depth and C-reactive protein levels, showed statistically significant differences for those at increased risk for major amputation. The median time from hospitalisation to lower extremity amputation was approximately 35 days. Most patients with abnormal C-reactive protein levels and approximately 70% of patients with ulcers invading the bone were at risk for lower extremity amputations within 35 days. Therefore, invasive ulcer depth and C-reactive protein levels are significant risk factors. Other potential risk factors for major amputation and the time intervals from first hospitalisation to amputation should be analysed to establish further prediction strategies.

Skin grafts are not suitable for closing tendon- or bone-exposing wounds, which require flap surgery. Dermal regeneration templates have value for closing such wounds, but the disadvantages of the technique include implantation failures because of infection, hematoma formation, or inappropriate immobilization. Negative-pressure wound therapy was reported to increase graft acceptance in difficult wounds. This retrospective case series of 65 patients evaluated negative-pressure therapy combined with artificial dermis for the treatment of acute or chronic tendon- or bone-exposing wounds. The artificial dermis was placed after adequate wound-bed preparation, with simultaneous application of a vacuum-assisted closure system. Split-thickness skin grafting was performed after the implanted artificial dermis had become established. The overall success rate was 88.1% (59/67): 88.6% (39/44) in the chronic wounds group and 87% (20/23) in the acute-trauma group separately. The overall mean survival time of artificial dermis in success cases was 13.24 ± 7.14 days. In separately, the survival time of artificial dermis had no statistically difference in chronic wound group (13.64 ± 7.53 vs 12.60 ± 5.86. P = .943), but had significant statistical difference in acute trauma group (12.45 ± 6.44 days vs 23.33 ± 4.04 days, P = .018). Also, comorbidity of PAOD was found a strong risk factor of failure in chronic wound group (100% vs 23.1%, P < 0.001). We concluded that artificial dermis combined with negative-pressure therapy followed by split-thickness skin grafting might be a reliable and effective option for surgical reconstruction of tendon- or bone-exposing wounds, and could decreasing waiting periods of autologous skin graft.

Introduction: Proper wound care along with the use of skin grafts over deep burn wounds has been the standard treatment. However, the goal in burn wound care has shifted from achieving a satisfactory survival rate to improving long-term form and function of the healed wound, which is sometimes hindered by scar contracture. This has prompted surgeons to find alternative ways to treat burn wounds without compromising function. Among burn cases, hand injuries are the most problematic when it comes to delicate function recovery. Methods: This study presents the results of conjunctive use of a bilayer artificial dermis, negative pressure wound therapy, and split-thickness skin grafts for grafting over acute burn wounds and scar-releasing defects after severe hand burns. Results: Three months after the operation, the scar was soft and pliable, the aesthetic outcome was good, and the patients gained much improvement in hand function and quality oflife. Conclusions: The combined technique achieved a good scar quality and aesthetic effect on burned hands as well as excellent functional outcome, which resulted in major improvements and an independent life for the patient.

Preserving both esthetic and functional outcome remains challenging in facial burn injuries. The major issue is the initial treatment of injury. In this study, we focused on patients with partial-thickness facial burns admitted to the burn unit of Tri-Service General Hospital, Taipei, from November 2016 to November 2018. In 21 included patients, customized mask-style, transparent hydrogel-based dressing was applied to the burns. The mean age of included patients was 37.4 years. The mean area of burn injury was 11.9% of total body surface area, and the mean area of second-degree facial burns was 162.3 cm2. Full reepithelialization took, on average, 10.86 days. Scarring was acceptable in terms of texture and color, and no hypertrophic or keloidal scarring was noted. The mean Vancouver Scar Scale score was 2.07. Use of the hydrogel-based dressing masks seems to be a promising means of reducing pain, providing uninterrupted wound healing, facilitating observation, and positively affecting scarring in patients with second-degree facial burns.

With aging, pressure ulcers become a common health problem causing significant morbidity and mortality for physically limited or bedridden elderly persons. Here, we present our strategy for such patients. Between August 2010 and March 2019, 117 patients were enrolled. Patient age, etiology, defect size and location, flap reconstruction, outcome, and follow-up period were reviewed. Of these patients, 64 were female and 53 were male, with an age range of 21 to 96 years (mean 75.6). The mean area of defect was 61.5 cm. The most common etiology was dementia (33.3%), and ulcers were most frequently caused by sacral pressure (70.3%). The commonest surgical treatment was a V-Y advancement flap (50%). The complication rate was 27.5%, including dehiscence and late recurrence. Negative pressure wound therapy could be used if the initial defect was large. V-Y advancement flap is the most frequent surgical treatment for sacral pressure ulcers because it is simple and available for most types of defect. Primary closure may be considered as the simplest method if the defective area is <16 cm. Intraoperative indocyanine green angiography can help avoid secondary flap revisions. Our protocol ensures a short surgery time, little bleeding, and a low complication rate.