Patch Group Research Articles

Long-term outcomes of tetralogy of Fallot repair: A 30-year experience with 960 patients

ObjectiveThis study evaluates the long-term results of tetralogy of Fallot repair and assesses the risk factors for adverse outcomes. MethodsThis retrospective study included 960 patients who underwent transatrial transpulmonary tetralogy of Fallot repair between 1990 and 2020. ResultsA transannular patch was placed in 722 patients, and pulmonary valve preservation was achieved in 233 patients. The median age at tetralogy of Fallot repair was 9.4 (interquartile range, 6.2-14.2) months. The median follow-up duration was 10.6 (interquartile range, 5.4-16.3) years. There were 8 early deaths (0.8%) and 20 late deaths (2.1%). Genetic syndrome and pulmonary valve annulus Z score less than −3 were risk factors for mortality. The survival was 97.7% (95% confidence interval, 96.4-98.5) and 94.5% (95% confidence interval, 90.9-96.7) at 10 and 30 years, respectively. Freedom from any reoperation was 86.4% (95% confidence interval, 83.6-88.7) and 65.4% (95% confidence interval, 59.8-70.4) at 10 and 20 years, respectively. Postoperative right ventricular outflow tract peak gradient of 25 mm Hg or greater correlated with reoperation. Propensity score–matched analysis demonstrated that freedom from pulmonary valve replacement at 15 years was higher in the pulmonary valve preservation group compared with the transannular patch group (98.2% vs 78.4%, P = .004). Freedom from reoperation for right ventricular outflow tract obstruction at 15 years was lower in the pulmonary valve preservation group compared with the transannular patch group (P = .006). ConclusionsThe long-term outcomes of tetralogy of Fallot repair are excellent. A postoperative right ventricular outflow tract peak gradient less than 25 mm Hg appears to be optimal to prevent reoperation. If the pulmonary valve size is suitable, pulmonary valve preservation reduces the risk of pulmonary valve replacement, yet increases the reoperation rate for right ventricular outflow tract obstruction.

A Comparative Study to Investigate the Effects of Bisoprolol in Patients with Chronic Heart Failure and Hypertension When Switched from Tablets to Transdermal Patches.

Oral beta-blockers are effective for heart failure and hypertension. Here, we conducted a prospective study to investigate the efficacy of the beta-blocker bisoprolol in patients switching from the oral tablet to the transdermal patch. We studied 50 outpatients receiving oral bisoprolol for chronic heart failure and hypertension. After patients switched treatments, we measured heart rate (HR) over 24 h by Holter echocardiography as the primary endpoint. Secondary endpoints were (1) HR at 00:00, 06:00, 12:00, and 18:00, (2) the total number of premature atrial contractions (PACs) over 24 h and the incidence rate per time segment, and the total number of premature ventricular contractions (PVCs) over 24 h and the incidence rate per time segment, (3) blood pressure, (4) atrial natriuretic peptide and B-type natriuretic peptide, and (5) echocardiography. Minimum, maximum, mean, and total HR over 24 h was not significantly different between the two groups. Mean and maximum HR at 06:00, total PACs, total PVCs, and PVCs at 00:00 to 05:59 and 06:00 to 11:59 were significantly lower in the patch group. Compared with oral bisoprolol, the bisoprolol transdermal patch lowers HR at 06:00 and inhibits the onset of PVCs during sleep and in the morning.

Joint group dictionary-based structural sparse representation for image restoration

With the aid of image nonlocal self-similarity (NSS), recent studies have indicated that structural sparse representation (SSR) models with patch groups as processing units have a great potential in various image inverse problems. Most of existing works, however, only use the dictionary learned from internal or external patch groups for sparse representation. Consequently, such methods generally overfit degradation or do not adapt to the given image. In this paper, we propose a novel sparse representation model, termed joint group dictionary-based SSR (JGD-SSR) model, to alleviate the above problem. Compared with traditional SSR models, the proposed JGD-SSR provides an effective mechanism to exploit internal and external dictionaries jointly. Moreover, to make the proposed model more robust, the connection between JGD-SSR and maximum a posteriori (MAP) estimation is revealed to adaptively estimate regularization parameters. When we apply the proposed JGD-SSR to image restoration tasks, an alternating minimization scheme is developed to solve the resulting optimization problems. The experimental results, including image denoising, deblocking, and deblurring, demonstrate that the proposed JGD-SSR-based restoration algorithm outperforms many state-of-the-art competing methods in terms of both objective and visual qualities.

Analgesic potential of transdermal nicotine patch in surgery: a systematic review and meta-analysis of randomised placebo-controlled trials

We aimed (1) to systematically review the efficacy of transdermal nicotine patches (NP) for postoperative analgesia, (2) to establish the current quality of evidence and assist clinical decision-making on the subject, and (3) to identify methodological limitations and the need for more well-designed studies. We searched six electronic databases, protocol records, and other sources without date or language restriction until March 2022. To develop the search strategy, we formulated a clinical question by using the PICOD method. Eligibility criteria included randomised placebo-controlled trials on the analgesic potential of NP for surgical procedures. This systematic review followed the PRISMA 2020 statement, and we registered the protocol in PROSPERO (#CRD42020205956). We included 10 randomised placebo-controlled trials (535 patients). The NP administered before induction of anaesthesia and at beginning of surgery reduced the pain immediately after surgery (-0.38; 95% confidence interval [CI]: -0.73 to -0.02), and 6h (-0.34; 95% CI: -0.68 to -0.01), 12h (-0.43; 95% CI: -0.71 to -0.15) and 24h (-0.35; 95%CI: -0.59 to -0.10) after surgery, compared with the placebo patch (PP) group. Sensitivity testing suggests that opioid use could underestimate NP analgesia. Late demand for the first analgesic and consumption of rescue analgesics tended to be lower in the NP group. The current findings suggest, with low certainty of evidence, the analgesic potential of NP for surgical procedures. Perioperative use of NP significantly improved postoperative pain, even when opioids were administered or prescribed. Nevertheless, the clinical relevance should be interpreted with caution, owing to the effect sizes of the summary measures and methodological issues. The analgesic potential of NP as an adjuvant therapy to regulate pain and acute inflammation may offer certain clinical advantages, thus warranting further investigation.

Adult Bone Marrow-Derived Mesenchymal Stem Cells Seeded on Tissue-Engineered Cardiac Patch Contribute to Myocardial Scar Remodeling and Enhance Revascularization in a Rabbit Model of Chronic Myocardial Infarction.

Although the transplantation of tissue-engineered cardiac patches with adult bone marrow-derived mesenchymal stem cells (MSCs) can enhance cardiac function after acute or chronic myocardial infarction (MI), the recovery mechanism remains controversial. This experiment aimed to investigate the outcome measurements of MSCs within a tissue-engineered cardiac patch in a rabbit chronic MI model. This experiment was divided into four groups: left anterior descending artery (LAD) sham-operation group (N = 7), sham-transplantation (control, N = 7), non-seeded patch group (N = 7), and MSCs-seeded patch group (N = 6). PKH26 and 5-Bromo-2'-deoxyuridine (BrdU) labeled MSCs-seeded or non-seeded patches were transplanted onto chronically infarct rabbit hearts. Cardiac function was evaluated by cardiac hemodynamics. H&E staining was performed to count the number of vessels in the infarcted area. Masson staining was used to observe cardiac fiber formation and to measure scar thickness. Four weeks after transplantation, a remarkable improvement in cardiac functionality could be distinctly observed, which was most significant in the MSCs-seeded patch group. Moreover, labeled cells were detected in the myocardial scar, with most of them differentiated into myofibroblasts, some into smooth muscle cells, and only a few into cardiomyocytes in the MSCs-seeded patch group. We also observed significant revascularization in the infarct area implanted in either MSCs-seeded or non-seeded patches. In addition, there were significantly greater numbers of microvessels in the MSCs-seeded patch group than in the non-seeded patch group.

Predictive value of fetal echocardiographic parameters in surgical strategy for Tetralogy of Fallot.

This study aimed to evaluate whether fetal echocardiographic parameters were predictive of the postnatal surgical treatment required for fetuses with Tetralogy of Fallot (TOF). The fetal echocardiographic and postnatal clinical data of all cases of prenatal TOF at Xinhua Hospital from 2016 to 2020 were reviewed. Patients were categorized based on the operation type, and cardiac parameters were compared between groups. Of the 37 fetuses assessed, the development of the pulmonary valve annulus (PVA) was significantly poorer in the transannular patch group. Patients with a prenatal PVA z-score (Schneider's method) ≥ -2.645, a PVA z-score (Lee's method) ≥ -2.805, a PVA/aortic valve annulus diameter ratio ≥.697, and a pulmonary annulus index ≥ .823 were more likely to undergo pulmonary valve-sparing surgery. There was a strong correlation between prenatal and postnatal PVA z-scores. The PVA growth potential was greater in the pulmonary valve-sparing surgery group. PVA-related parameters evaluated by fetal echocardiography can predict the type of surgical intervention required and are valuable in improving prenatal counseling in fetal cases of TOF.

Glucose-Responsive Silk Fibroin Microneedles for Transdermal Delivery of Insulin.

Microneedles (MNs) have attracted great interest as a drug delivery alternative to subcutaneous injections for treating diabetes mellitus. We report MNs prepared from polylysine-modified cationized silk fibroin (SF) for responsive transdermal insulin delivery. Scanning electron microscopy analysis of MNs' appearance and morphology revealed that the MNs were well arranged and formed an array with 0.5 mm pitch, and the length of single MNs is approximately 430 μm. The average breaking force of an MN is above 1.25 N, which guarantees that it can pierce the skin quickly and reach the dermis. Cationized SF MNs are pH-responsive. MNs dissolution rate increases as pH decreases and the rate of insulin release are accelerated. The swelling rate reached 223% at pH = 4, while only 172% at pH = 9. After adding glucose oxidase, cationized SF MNs are glucose-responsive. As the glucose concentration increases, the pH inside the MNs decreases, the MNs' pore size increases, and the insulin release rate accelerates. In vivo experiments demonstrated that in normal Sprague Dawley (SD) rats, the amount of insulin released within the SF MNs was significantly smaller than that in diabetic rats. Before feeding, the blood glucose (BG) of diabetic rats in the injection group decreased rapidly to 6.9 mmol/L, and the diabetic rats in the patch group gradually reduced to 11.7 mmol/L. After feeding, the BG of diabetic rats in the injection group increased rapidly to 33.1 mmol/L and decreased slowly, while the diabetic rats in the patch group increased first to 21.7 mmol/L and then decreased to 15.3 mmol/L at 6 h. This demonstrated that the insulin inside the microneedle was released as the blood glucose concentration increased. Cationized SF MNs are expected to replace subcutaneous injections of insulin as a new modality for diabetes treatment.

Healing large Traumatic Tympanic Membrane Perforations Using Vaseline Gauze and Gelfoam Patching Alone.

The aim of this study was to evaluate the effect of vaseline gauze (VG) patching on the treatment of large traumatic perforation of tympanic membrane (TM). 90 patients with traumatic perforation larger than 25% of the TM were randomly allocated into the control group of observation only, VG group, and Gelfoam patch alone group. The closure rate and closure time among the 3 groups were compared at 3 months. In total, 82 large traumatic perforations were analyzed in this study. The closure rates in the control, VG, and gelfoam patch groups were 84.6%, 100.0%, and 89.3%, respectively (P = 0.637). Post-hoc multiple comparisons showed that the difference between the control and VG groups was significant (P = 0.047), but the difference wasn't significant between gelfoam alone and control groups (P = 0.699) or VG groups (P = 0.236). The mean closure times were 5.41 ± 1.47, 2.14 ± 0.93, and 3.00 ± 0.62 weeks for the control, VG, and gelfoam patch groups, respectively (P < 0.001). Post-hoc multiple comparisons showed that the difference was significant between the control and VG groups (P < 0.001) or gelfoam alone group (P < 0.001) or VG and gelfoam groups (P < 0.05). VG improved the closure rate and shortened the closure time compared with observation only, which could be an effective patch material for repairing traumatic lager perforations in the outpatient setting, which is readily available and convenient.

Comparison of the Efficacy of Epidural Blood Patch and Transnasal Sphenopalatine Ganglion Block in the Treatment of Postspinal Puncture Headache

Aim: Postspinal puncture headache (PDPH) affects postoperative recovery and patients' quality of life after surgery. PDPH is the most common complication of spinal anaesthesia that affects patients' well-being the most. The epidural blood patch (EBP) is the gold standard for interventional treatment of PDPH. Sphenopalatine ganglion block (SPGB), a new noninvasive method for treating PDPH, has come to the forefront. SPGB is noninvasive and very easy to perform compared with EBP. This study aims to compare the efficacy of the two interventional methods in treating PDPH. Material and Method: Between January 1, 2018, and February 1, 2023, 30 cases diagnosed with PDPH underwent EBP and 28 SPGB. Case demographics, type of surgery performed, whether complications occurred after the procedure, and the amount of acetaminophen taken within 24 hours were recorded in mg. The VAS scores were recorded 8 times, in the first half hour before and after surgery, and, 1, 2, 4, 6, 12 and 24 hours after the surgery. Results: There was no statistically significant difference between the distributions of sex, type of surgery, and amount of acetaminophen taken after surgery by groups (p values respectively p= 0.245, p=0.994, p=0.131 ). There was a statistically significant difference between the distributions of 4th-hour values VAS by group (p=0.008). There is a statistically significant difference between the groups' distributions of the values of the 6th-hour VAS (p=0.016). VAS scores were lower in the epidural blood patch group. There was no difference between the VAS scores in the blood patch and block group in all other measurement periods. Nevertheless, comparing the time variables of the groups, the main effect of time has a statistically significant impact on the VAS (p &lt; 0.001). There was a significant difference in the sphenopalatine ganglion block and epidural blood patch groups when the pre-surgery VAS value was compared with all post-surgery periods (p &lt; 0.001, p &lt; 0.001). Conclusion: The epidural blood patch is the gold standard in treating postspinal headaches. However, it is a difficult procedure to perform since it is an invasive procedure. Sphenopalatine ganglion blockade is a treatment modality with very close efficacy to epidural blood patches in treating postspinal headaches. It can be used as an alternative treatment method in cases that do not accept treatment with the epidural blood patch. As postspinal headache mostly occurs in obstetrics patients, it can be safely used to protect a newborn mother and the baby from the side effects of drugs that pass into the breast milk.

Incidence of branch pulmonary artery stenosis requiring intervention based on surgical repair type for tetralogy of Fallot

BackgroundTetralogy of Fallot is a common form of cyanotic congenital heart disease. The right ventricular outflow tract obstruction and pulmonary stenosis are typically repaired using either a transannular patch or valve sparing repair. Following repair, one recognized complication is branch pulmonary artery stenosis. ObjectiveThis study sought to evaluate if there was a higher incidence of branch pulmonary artery stenosis requiring intervention in patients with tetralogy of Fallot who underwent transannular patch repair as compared to valve sparing repair. MethodsIn this retrospective study, 62 pediatric patients with tetralogy of Fallot underwent surgical repair at our institution between January 1, 2006 and August 2, 2016. Data, including echocardiographic measurements, surgical repair details, and post-operative follow up was recorded. Statistical analysis was performed, including chi-square test, Student t-test, multiple logistic regression, and Kaplan-Meier analysis. ResultsMedian length of follow up was 7.3 years (IQR 4.7–9.1). Of the 62 patients, 8 (13 %) developed branch pulmonary artery stenosis requiring intervention. A significantly higher incidence was seen in the transannular patch group (n = 7, 37 %) compared to the valve sparing repair patients (n = 1, 2 %) (p = 0.0002). Most patients required intervention within one year following repair. The effect of repair type persisted after controlling for multiple potential confounding variables, including Blalock-Taussig shunt placement and patch augmentation of the branch pulmonary arteries. ConclusionThere is a significantly higher incidence of branch pulmonary artery stenosis requiring intervention in patients with classic tetralogy of Fallot who underwent transannular patch repair as compared to valve sparing repair.

Comparison of reconstruction methods used during liver transplantation in case of a graft with replaced or accessory right hepatic artery: A retrospective study.

Variations in graft arterial anatomy can increase the risk of postoperative hepatic arterial thrombosis (HAT), especially in presence of a replaced or accessory right hepatic artery (RHA). We retrospectively analyzed 223 cases of liver transplantations with the presence of an RHA on the graft. Patient outcomes were compared according to the four different reconstruction methods used: (i) the re-implantation of the RHA into the splenic or gastroduodenal artery (n= 106); (ii) the interposition of the superior mesenteric artery (SMA) (n= 83); (iii) dual anastomosis (n= 24); (iv) use of an aortic patch including the origins of both the SMA and the coeliac trunk (n= 10). A competing risk analysis and Inverse Probability Weighting (IPW) were used. We found that the interposition of the SMA method was associated with a significantly lower incidence of HAT, at 4.8% compared to the re-implantation method at 17.9%, dual anastomosis at 12.5%, and aortic patch at 20%, p= .03. In the competing risk analysis with IPW, the only risk factor for RHA thrombosis was the type of reconstruction. Taking the SMA interposition group as the reference, the sub-hazard ratio (sHR) was 5.05 (CI 95 [1.72; 14.78], p< .01) for the re-implantation group, sHR=2.37 (CI 95 [0.51; 11.09], p= .27) for the dual anastomosis group and sHR=2.24 (CI 95 [0.35; 14.33], p= .40) for the aortic patch group. There were no differences for intraoperative transfusion, hospitalization duration (p= .37) or incidence of severe complications (p= .1). The long-term graft (p= .69) and patient (p= .52) survival was not different. In conclusion, the SMA interposition method was associated with a lower incidence of RHA thrombosis.

Three-Dimensional Bio-Printed Autologous Omentum Patch Ameliorates Unilateral Ureteral Obstruction-Induced Renal Fibrosis.

Recent advances in the field of tissue engineering and regenerative medicine have contributed to the repair of damaged tissues and organs. Renal dysfunctions such as chronic kidney disease (CKD) are considered intractable owing to its cellular heterogeneity. In addition, the absence of definitive treatment options other than dialysis or kidney transplantation in advanced CKD. In this study, we investigated therapeutic effects of a three-dimensional (3D) bio-printed omentum patch as treatment source. Because omentum contains a lot of biological sources for immune regulation and tissue regeneration, it has been used in clinic for >100 years. By using autologous tissue as a bio-ink, the patch could minimize the immune response. The mechanically micronized omentum without any additives became small enough to print, but the original components could be preserved. Then, the 3D printed omentum patch was transplanted under renal subcapsular layer in unilateral ureteral obstruction (UUO) rat model. After 14 days of patch transplantation, the kidneys were analyzed through bulk RNA sequencing and histopathological staining. From the results, decreased tubular injury was observed in the omentum patch group. In addition, the omentum patch significantly altered biological process of gene ontology such as fibrosis-related gene and growth factors. RNA sequencing confirmed the antifibrotic effect by inhibiting fibrosis-inducing mechanisms within PI3K-AKT and JAK-STAT pathways. In conclusion, the omentum patch showed the effect of antitubular injury and antifibrosis on UUO kidneys. In particular, the omentum patch is expected to protect the organ from further degeneration and loss of function by inhibiting the progression of fibrosis. The omentum patch can be a novel therapeutic option for renal dysfunction. Impact statement Many studies and clinical trials are being conducted to develop new treatments for kidney disease. However, there are no newly developed renal replacement therapies. In this study, we developed a new treatment that can ameliorate renal interstitial fibrosis using three-dimensional (3D) bio-printed autologous omentum patch. The 3D printer enables precise patch printing, and the bio-ink made of autologous tissue minimizes the immune response after transplantation. The whole kidneys were analyzed by RNA sequencing and histopathological staining 14 days after transplantation. From the results, the omentum patch had the effect of relieving tubular injury in the injured state. Also, the omentum patch significantly altered biological process of gene ontology. In particular, genes related to fibrosis were observed to be downregulated by the omentum patch. RNA sequencing confirmed that the antifibrotic effect was owing to inducing mechanisms of PI3K-AKT and JAK-STAT pathways. The findings reported in this study represent a significant advancement in the application of 3D bio-printer to damaged organ treatments, especially fibrosis-related diseases.

Denoise ultra-low-field 3D magnetic resonance images using a joint signal-image domain filter

Ultra-low-field magnetic resonance imaging (MRI) could suffer from heavy uncorrelated noise, and its removal could be a critical post-processing task. As a primary source of interference, Gaussian noise could corrupt the sampled MR signal (k-space data), especially at lower B0 field strength. For this reason, we consider both signal and image domains by proposing a new joint filter characterized by a Kalman filter with linear prediction and a nonlocal mean filter with higher-order singular value decomposition (HOSVD) for denoising 3D MR data. The Kalman filter first attenuates the noise in k-space, and then its reconstruction images are used to guide HOSVD denoising process with exploring self-similarity among 3D structures. The clearer prefiltered images could also generate improved HOSVD learned bases used to transform the noise corrupted patch groups in the original MR data. The flexibility of proposed method is also demonstrated by integrating other k-space filters into the algorithm scheme. Experimental data includes simulated MR images with the varying noise level and real MR images obtained from our 50 mT MRI scanner. The results reveal that our method has a better noise-removal ability and introduces lesser unexpected artifacts than other related MRI denoising approaches.

On–Extracorporeal Membrane Oxygenation Congenital Diaphragmatic Hernia Repair: Decreased Bleeding Complications and Improved Survival with Muscle Flap Repair Technique

INTRODUCTION: Prosthetic patches (patch) and muscle flaps (flap) are different techniques used for repair of congenital diaphragmatic hernia (CDH) with a large defect unamenable to primary closure. We hypothesized that the flap technique for CDH repair while on extracorporeal membrane oxygenation (on-ECMO) would have decreased bleeding complications compared with patch due to the hemostatic advantage of native tissue, and therefore also be associated with improved survival. METHODS: A single-center retrospective study of patients who underwent on-ECMO CDH repair between 2008 and 2021 was performed. Statistical significance was determined by Mann Whitney U, Fisher’s exact, chi-square, and Student’s unpaired t tests as appropriate (p < 0.05 significant). RESULTS: Forty-eight patients met criteria: 17 patch (35.4%) and 31 flap (64.6%). Characteristics between these 2 groups are summarized in Table 1. Reoperation for surgical bleeding was significantly decreased with flap repair compared with patch (35.5% vs 64.7%, respectively; p = 0.05). 48-hour postoperative blood product transfusion was also significantly decreased with flap repair (176.3 mL/kg vs 328.7 mL/kg patch; p = 0.027). Additionally, survival to hospital discharge was significantly increased in the flap repair group compared with the patch group (64.3% vs 27.8%, respectively; p = 0.033). Table 1. - Characteristics of Prosthetic Patch and Muscle Flap Repair for Congenital Diaphragmatic Hernia on Extracorporeal Membrane Oxygenation Variable Prosthetic patch repair (n = 17) Muscle flap repair (n = 31) p Value Left-sided defect 9 (52.9%) 26 (83.9%) 0.039* Gestational age at delivery (wk) 38 (37 - 39) 38 (37 - 38) 0.21† Birth weight (g) 2,842 ± 473.9 2,812 ± 430.4 0.82‡ Percent predicted lung volume 13.94 ± 5.1 14.99 ± 4.4 0.64‡ Observed-to-expected lung-to-head ratio 37.4 (31.1–42.0) 30 (21–42.5) 0.40† Days on ECMO 15 (8.5–28.5) 18 (12–25) 0.57† Values expressed as count (percentage of group), means ± standard deviation, or median (interquartile range). Statistical analysis by*Fisher’s exact test,†Mann Whitney U test, or‡Student’s unpaired t-test CONCLUSION: We conclude that the muscle flap technique for on-ECMO CDH repair is associated with decreased bleeding complications compared with prosthetic patch repair, which may in part be responsible for the improved survival seen in the flap repair group. Despite comparable CDH severity, these results support the flap repair technique as the safer method for on-ECMO CDH repair.

A comparative study on a biodegradable hyaluronic acid microneedle patch with a needleless patch for dry skin in atopic dermatitis: a single-blinded, split-body, randomized controlled trial.

To overcome interruption of skin barrier in transdermal drug delivery, the microneedle (MN) patch penetrates the barrier by punching with its MNs. Setting a needleless patch (NL patch) as the control intervention, this study assessed the efficacy of a biodegradable hyaluronic acid MN patch (BHMN patch) for atopic dermatitis (AD) patients with dry skin. Similar two AD lesions were selected from the extremities of a participant. For one lesion, a BHMN patch was attached for 6-8h on where an aroma cream was applied (BHMN patch group). Simultaneously, an NL patch was attached on the other lesion as in the BHMN patch group (NL patch group). For 2weeks, the interventions were conducted 3 times a week. The local scoring AD (L-SCORAD) index, the visual analog scale for pruritus and skin dryness, skin hydration, the transepidermal water loss (TEWL), and safety were assessed. Fifteen participants finished this trial with no dropouts. Both groups improved the L-SCORAD index after 2weeks (p < 0.05), but the score of the BHMN patch group decreased more than that of the NL patch group (p < 0.05). The other outcomes, except for the TEWL, also showed statistical significance in intragroup comparisons. Nevertheless, none of the other outcomes showed statistical significance in intergroup comparisons. The TEWL showed no statistical significance even in intragroup comparison. Recoverable minor adverse events were reported in three cases. Considering the result of L-SCORAD index, the BHMN patch may be effective for ameliorating AD. However, a large-scale confirmatory trial is necessary to reassess other outcomes.Trial Registration: This study was registered with the Clinical Research Information Service, Republic of Korea (Submitted date: 04/01/2022, Registered date: 23/02/2022, The first participant enrollment: 01/12/2021, Registration No. KCT0007037).

Decellularized fish swim bladder patch loaded with mesenchymal stem cells inhibits neointimal hyperplasia.

We previously showed decellularized fish swim bladder can be used as vascular patch and tube graft in rats, mesenchymal stem cells (MSCs) have showed the capability to inhibit neointimal hyperplasia in different animal models. We hypothesized that decellularized fish swim bladder patch loaded with MSCs (bioinspired patch) can inhibit neointimal hyperplasia in a rat aortic patch angioplasty model. Rat MSCs were grown in vitro and flow cytometry was used to confirm their quality. 3.6 × 105 MSCs were mixed into 100 μl of sodium alginate (SA)/hyaluronic acid (HA) hydrogel, two layers of fish swim bladders (5 mm × 5 mm) were sutured together, bioinspired patch was created by injection of hydrogel with MSCs into the space between two layers of fish swim bladder patches. Decellularized rat thoracic aorta patch was used as control. Patches were harvested at days 1 and 14 after implantation. Samples were examined by histology, immunohistochemistry, and immunofluorescence. The decellularized rat thoracic aorta patch and the fish swim bladder patch had a similar healing process after implantation. The bioinspired patch had a similar structure like native aorta. Bioinspired patch showed a decreased neointimal thickness (p=.0053), fewer macrophages infiltration (p=.0090), and lower proliferation rate (p=.0291) compared to the double layers fish swim bladder patch group. Decellularized fish swim bladder patch loaded with MSCs can inhibit neointimal hyperplasia effectively. Although this is a preliminary animal study, it may have a potential application in large animals or clinical research.

With and without exogenous biological scaffolds for repairing traumatic perforations of tympanic membrane: Randomized clinical trials

ObjectiveThe objective of this study was to compare the efficacy of ofloxacin ear drops, vaseline gauze (VG) and dry gelfoam alone on the large traumatic perforations of tympanic membrane (TM). Material and methodsA randomized prospective analysis was performed for the treatment of traumatic perforation larger than 25 % of the entire TM. The closure rate, closure time, and hearing gain between ofloxacin ear drops, VG and gelfoam alone groups were compared at 3 months. ResultsFinal analysis was performed on 70 patients. The closure rates of perforation in the ofloxacin ear drops, VG, and dry gelfoam patch groups were 100.0 %, 92.0 %, and 87.5 %, respectively (P = 0.41).The mean closure times were 8.67 ± 3.1, 10.65 ± 4.2, and 14.33 ± 7.5 days for the ofloxacin ear drops, VG, and gelfoam patch alone groups, respectively. The closure times among the 3 groups were significantly different (P = 0.003). In addition, there was a significant difference between the ofloxacin ear drops and gelfoam patch alone groups with regard to closure time (P = 0.003), while there was no significant difference between the ofloxacin ear drops and VG groups (P = 0.080) or VG and gelfoam patch groups (P = 0.056).The mean hearing gain was 11.4 ± 2.3 dB for the ofloxacin ear drops group, 11.7 ± 4.1 dB for the VG group, and 12.2 ± 1.6 dB for the gelfoam patch group (P = 0.69). ConclusionsThe repairing of traumatic perforations didn't require an exogenous biological scaffold. Ofloxacin ear drops and VG were a deal material for repairing traumatic perforation in otology clinic, which not only was readily available and inexpensive but also showed faster closure compared with dry gelfoam alone.

Efficacy and safety of 5% lidocaine patches for postoperative pain management in patients undergoing unilateral inguinal hernia repair: study protocol for a prospective, double-blind, randomized, controlled clinical trial

BackgroundAcute postoperative pain is a common complication of inguinal hernia repair. Pain management using local application of anesthetic agents over the skin surrounding the surgical incision may reduce the requirement for other pain medications. Targeted topical analgesics such as 5% lidocaine patches have been known to improve acute and chronic pain. However, the clinical effect of lidocaine patches on postoperative pain after inguinal hernia repair has not been studied, especially in patients undergoing surgery at day surgery units.Methods/designThis is a single-center, prospective, double-blind, randomized, controlled clinical trial. Participants with unilateral inguinal hernia will be randomized to the lidocaine patch group or the placebo patch group. Based on the randomized allocation sequence, either lidocaine patches or placebo patches will be attached near each participant’s surgical wound after open hernia repair under general anesthesia. Participants will be asked to follow up at our outpatient clinic on the first postoperative day and at 1 week after surgery. The primary outcome is pain intensity, which will be measured using the visual analog scale (VAS) at the time of discharge from the day surgery unit. The secondary outcomes are VAS score at 24 h and 1 week after surgery. We will collect and analyze the participants’ clinical data (amount of intraoperative opioid use, time to recovery, and pain intensity at 30 min after surgery) and demographic characteristics (age, sex, body weight, and height).DiscussionThis trial may not only provide evidence on the efficacy of a 5% lidocaine patch for acute postoperative pain management after unilateral inguinal hernia repair, but also demonstrate the efficacy and safety of the patch for post-discharge pain management.Trial registrationClinicalTrials.gov NCT04754451. Registered on February 10, 2021.

Randomised controlled trial of intramuscular tramadol versus transdermal buprenorphine patch for early postoperative surgical pain.

This study assesses the efficiency of the buprenorphine patch system compared to the routine use of tramadol intramuscular injections in the context of the South African public healthcare sector. Patients were randomised into two groups, who received routine tramadol injections 100 mg every 8 hours intramuscular and buprenorphine patches 5 mcg every hour. The study assessed the first 48 hours postoperatively. A visual discrete pain scale was used to assess the level of postoperative pain as well as all complications associated with insufficient analgesic administration. The sample size included 75 patients in the tramadol group and 75 patients in the buprenorphine patch group. Nine patients (12%, p-value < 0.0001) who received the buprenorphine patch subsequently required additional analgesia. The pain score was found to be significantly less in the buprenorphine patch group on both day 1 and day 2, as were complications such as vomiting, nausea, nightmares, sweating and insomnia. The pain score in the buprenorphine group as significantly lower compared to the tramadol group. The use of the buprenorphine patch showed a slight increase in costs compared to the tramadol group (R7 800.75 vs R7 537.50; p-value 0.483) in the whole study. The study showed that the use of the buprenorphine patch is a reliable and effective method of postoperative analgesia, although it is slightly more expensive compared to the routine use of tramadol. The buprenorphine patch showed significantly better results in all assessed parameters; thus, it may be recommended for use at the Dr George Mukhari Academic Hospital (DGMAH).

Comparison of Amblyopia Treatment Effect with Dichoptic Method Using Polarizing Film and Occlusion Therapy Using an Eye Patch.

We developed a novel, low-cost, easily administered method that uses a polarizing film to enable dichoptic treatment for amblyopia. In this study, we compared its effects with occlusion therapy using an eye patch. Fifty-eight patients (aged 4.7 ± 1.0 years) diagnosed with anisometric amblyopia were included and instructed to wear complete refractive correction glasses with either occlusion therapy using an eye patch (eye patch group) or dichoptic treatment using polarizing film (polarizing film group) for 2 h per day. We examined the improvement in the visual acuity and compliance rate of the patients 2 months after treatment initiation. After treatment, the polarizing film group showed significant improvement in visual acuity compared with the eye patch group. Moreover, the compliance rate was significantly better in the polarizing film group than in the eye patch group. In both groups, there was a significant correlation between the improvement in visual acuity and compliance rate. This new dichoptic treatment using a polarizing film was shown to be effective for anisometropic amblyopia.