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1.
Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From An Efficacy and Safety Study of Vedolizumab Intravenous Compared to Adalimumab Subcutaneous in Participants With Ulcerative Colitis (VARSITY).
Peyrin-Biroulet, L, Loftus, EV, Colombel, JF, Danese, S, Rogers, R, Bornstein, JD, Chen, J, Schreiber, S, Sands, BE, Lirio, RA
Gastroenterology. 2021;(4):1156-1167.e3
Abstract
BACKGROUND AND AIMS VARSITY (An Efficacy and Safety Study of Vedolizumab Intravenous [IV] Compared to Adalimumab Subcutaneous [SC] in Participants With Ulcerative Colitis) showed superior clinical remission and endoscopic improvement in ulcerative colitis with vedolizumab vs adalimumab. This analysis compared histologic outcomes. METHODS Patients in VARSITY were randomized 1:1 to maintenance with vedolizumab IV 300 mg every 8 weeks or adalimumab SC 40 mg every 2 weeks (both following standard induction). Geboes Index and Robarts Histopathology Index (RHI) scores were used to assess prespecified histologic exploratory end points of histologic remission (Geboes <2 or RHI ≤2) and minimal histologic disease activity (Geboes ≤3.1 or RHI ≤4) at weeks 14 and 52. RESULTS In total, 769 patients received vedolizumab (n = 383) or adalimumab (n = 386). Mean baseline histologic disease activity was similar between vedolizumab and adalimumab groups. Vedolizumab induced greater histologic remission than adalimumab at week 14 (Geboes: 16.7% vs 7.3%, Δ9.4% [95% confidence interval {CI}, 4.9%-13.9%], P < .0001; RHI: 25.6% vs 16.1%, Δ9.5% [95% CI, 3.8%-15.2%], P = .0011) and week 52 (Geboes: 29.2% vs 8.3%, Δ20.9% [95% CI, 15.6%-26.2%], P < .0001; RHI: 37.6% vs 19.9%, Δ17.6% [95% CI, 11.3%-23.8%], P < .0001) overall and in both anti-tumor necrosis factor (TNF)-naïve and -failure subgroups. Results were similar for minimal histologic disease activity. Histologic outcomes were generally better in anti-TNF-naïve vs -failure patients. At week 52, rates of mucosal healing (composite end point of histologic plus endoscopic improvement) were also higher with vedolizumab than adalimumab (Geboes: 25.6% vs 6.7%; RHI: 30.5% vs 14.5%). CONCLUSIONS Higher rates of histologic remission, minimal histologic disease activity, and combined histologic plus endoscopic outcomes were observed with vedolizumab than with adalimumab in ulcerative colitis in both anti-TNF-naïve and -failure subgroups. REGISTRATION ClinicalTrials.gov NCT02497469; EudraCT 2015-000939-33.
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2.
Effectiveness of Topical Insulin Dressings in Management of Diabetic Foot Ulcers.
Bhettani, MK, Rehman, M, Altaf, HN, Altaf, OS
World journal of surgery. 2020;(6):2028-2033
Abstract
BACKGROUND Infected diabetic foot ulcers are always a problem for the surgeon, as well as, an economic burden upon the patient and state, in terms of increased hospital stay and cost of medications and dressings. Various methods have been devised for the treatment of infected wounds in history with varying results in different patients groups. The purpose of this study is to compare the effectiveness of topical insulin on the healing of diabetic foot ulcers with the conventional Pyodine® povidone iodine dressing. Our objective was to compare effectiveness of topical insulin with conventional Pyodine® povidone iodine dressings in frequency of healing of diabetic foot ulcers. MATERIALS AND METHODS It was a quasi-experimental study done at Pakistan Institute of Medical Sciences Islamabad over a period of 20 months from January 2015 to September 2016. One hundred ten patients were included in the study. Sampling technique used was non-probability consecutive. Patients were assigned into two groups, group A receiving treatment with solution of 30 International Units Insulin Regular in 30 ml of normal saline and group B receiving conventional dressing with normal saline. The wound were compared for both groups at the days 7, 14 and 21 for wound healing. Complete healing time of diabetic foot ulcers was determined from patients' followup visits in outpatient department. Data was by analyzed by SPSS 20. RESULTS A total of 110 patients were enrolled in the study. Patients were divided equally into both control and experimental groups. The mean age of the patients was 53.23 ± 6.21 years. The mean pre-treatment wound diameter was 4.81 ± 0.85 cm in the placebo group, while it was 4.84 ± 0.81 cm in the topical insulin group (CI 0.29-0.35, P = 0.875). The mean post-treatment wound diameter was 3.90 ± 0.76 cm in the placebo group, while it was 2.46 ± 0.57 cm in the topical insulin group (CI 0.44-0.58, P = 0.022). The mean wound difference was 0.91 ± 0.25 cm in the placebo group, while it was 2.4 ± 0.34 cm in the topical insulin group (CI 0.40-0.20, P = 0.041). The mean percent reduction in wound diameter was 19.2 ± 4.6% in the placebo group, while it was 49.7 ± 5.2% cm in the topical insulin group (CI 10.6-6.1, P = 0.001). CONCLUSION There was significant contraction seen in the size of the ulcer in both the study groups depicting the healing process.
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3.
Plantar Ulcers and Neuropathic Arthropathies: Associated Diseases, Polyneuropathy Correlates, and Risk Covariates.
Andrews, KL, Dyck, PJ, Kavros, SJ, Vella, A, Kazamel, M, Clark, V, Litchy, WJ, Dyck, PJB, Lodermeier, KA, Davies, JL, et al
Advances in skin & wound care. 2019;(4):168-175
Abstract
OBJECTIVE To evaluate the associated diseases, polyneuropathy correlates, and risk covariates of neuropathic plantar ulcers (PUs) and neuropathic arthropathies (NAs). DESIGN The authors conducted a retrospective, observational study over 3.5 years of 69 patients with neuropathy, NA, or PU seen in a wound clinic who also had a comprehensive neurologic evaluation and neurophysiologic testing. Comparisons were made to a population representative cohort of patients with diabetes mellitus (DM; n = 259). RESULTS Of the 69 wound clinic patients, 32 had PUs, 14 had NAs, and 23 had both. Of the 61 adequately assessed patients, 37 (61%) had DM, 22 (36%) had no known associated disease, and 2 (3%) had hereditary sensory and autonomic neuropathy. Of the 37 patients with DM, 35 had distal polyneuropathy, and 2 did not. In 22 patients with chronic idiopathic axonal polyneuropathy, 20 had distal polyneuropathy. CONCLUSIONS Although DM was the disease most commonly associated with PUs and NAs, chronic hyperglycemia may not have been the major underlying risk factor. The major risk covariates are sensation loss from polyneuropathy, old age, obesity, repetitive foot injury, and inadequate foot care or treatment. Physicians and other healthcare providers can help by identifying patients at risk and instituting measures such as adequate foot care to decrease these risks.
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A prospective randomized trial of a potassium competitive acid blocker vs proton pump inhibitors on the effect of ulcer healing after endoscopic submucosal dissection of gastric neoplasia.
Komori, H, Ueyama, H, Nagahara, A, Akazawa, Y, Takeda, T, Matsumoto, K, Matsumoto, K, Asaoka, D, Hojo, M, Yao, T, et al
The Journal of international medical research. 2019;(4):1441-1452
Abstract
BACKGROUND/AIMS: Vonoprazan is a new a potassium-competitive acid blocker (P-CAB) that was recently developed in Japan. However, vonoprazan's efficacy in healing gastric ulcers after endoscopic submucosal dissection (ESD) remains controversial. This study aimed to compare the efficacy of P-CABs and proton pump inhibitors (PPIs) in healing post-ESD ulcers. MATERIALS AND METHODS This prospective randomized controlled trial (UMIN000017386) enrolled 40 patients with gastric neoplasia, who underwent ESD at our hospital from April 2015 to January 2016. Before ESD, patients were randomly divided into the following two groups: group V, vonoprazan 20 mg/day; or group R, rabeprazole 10 mg/day. Medications were taken 1 day before to 4 weeks after ESD. The ESD-induced artificial ulcer size was measured just after ESD and 4 weeks after ESD to calculate the reduction rate as follows: (ulcer area 4 weeks after ESD)/(ulcer area just after ESD) × 100. RESULTS Eighteen patients in group V and 15 patients in group R were analyzed. The mean reduction rate was significantly different in groups V and R (93.3% vs 96.6%, respectively). Post-ESD bleeding was observed in two patients in group R and drug-induced hepatic injury in one patient in group R. CONCLUSION Rabeprazole facilitated the healing process post-ESD.
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5.
FACEDOWN POSITIONING AFTER VITRECTOMY WILL NOT FACILITATE MACULAR HOLE CLOSURE BASED ON SWEPT-SOURCE OPTICAL COHERENCE TOMOGRAPHY IMAGING IN GAS-FILLED EYES: A Prospective, Randomized Comparative Interventional Study.
Zhang, Y, Chen, X, Hong, L, Yan, Y, Zeng, M, Huang, Z, Liu, R, Ding, Q
Retina (Philadelphia, Pa.). 2019;(12):2353-2359
Abstract
PURPOSE To compare clinical outcomes in eyes with macular hole (MH) managed by either facedown (FD) or no-FD (nFD) postoperative positioning protocols. METHODS This is a prospective randomized cohort study. Eighty eyes of 80 consecutive patients with MH who had undergone vitrectomy surgery with internal limiting membrane peeling and gas tamponade were included in this study. Forty eyes of 40 patients who were kept in FD position for 3 days after surgery were assigned to the FD group, 40 eyes of 40 patients with nFD positioning were assigned to the nFD group. Macular hole was examined with swept-source optical coherence tomography images at 1 day, 2 days, 3 days, 2 weeks, 1 month, and 3 months after surgery. The MH closure rate and change of best-corrected visual acuity were compared. RESULTS At postoperative Day 1, MH was closed in 24 of 32 eyes (with clear optical coherence tomography images) (75%) in the FD group and 23 of 30 eyes (with clear optical coherence tomography images) (77%) in the nFD group (P = 0.97). At postoperative Day 2, MH closure was confirmed in 32 of 36 eyes (88.9%) in the FD group and in 31 of 33 eyes (94%) in the nFD group (P = 0.84), and the results were unchanged at Day 3. At 2 weeks after surgery, clear optical coherence tomography images were acquired from all eyes in both groups, and MH closure was confirmed in 36 of 40 eyes (90%) in the FD group and in 37 of 40 (92.5%) eyes in the nFD group (P = 0.91). Macular hole closure was not achieved in eyes that were kept open by Day 3 after surgery, and none of the eyes with confirmed MH closure by Day 3 had a reopening of the MH by 3 months. The distribution of macular configuration at 3 months was not significantly different between the two groups (P = 0.96). There was no difference in terms of the improvement in best-corrected visual acuity (Early Treatment Diabetic Retinopathy Study letters gain) between the 2 groups at 1 month (P = 0.22) and 3 months (P = 0.45). CONCLUSION The nFD protocol neither delayed the MH closure nor decreased the final closure rate after vitrectomy surgery. Therefore, postoperative prone position seems to be unnecessary for all MH repair procedures.
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Postoperative effects on lower third molars of using mouthwashes with super-oxidized solution versus 0.2% chlorhexidine gel: A randomized double-blind trial.
Coello-Gómez, A, Navarro-Suárez, S, Diosdado-Cano, JM, Azcárate-Velazquez, F, Bargiela-Pérez, P, Serrera-Figallo, MA, Torres-Lagares, D, Gutiérrez-Pérez, JL
Medicina oral, patologia oral y cirugia bucal. 2018;(6):e716-e722
Abstract
BACKGROUND The main objective of the present study is to evaluate the effects and possible benefits with regard to the postoperative period of lower third molar extractions, comparing the intraalveolar application of a bioadhesive gel of 0.2% chlorhexidine (CHX) to the use of a mouthwash with a super-oxidized solution, (SOS) Dermacyn® Wound Care (Oculus Innovative Sciences lnc., California, USA). MATERIAL AND METHODS A randomized double-blind study was carried out in 20 patients with a split-mouth design, with a total of 40 extractions of symmetrically impacted bilateral lower third molars. Patients were divided into two groups, a control group (C = 20) and an experimental group (D = 20). Any infectious complications, wound healing, plaque accumulation in the stitches, and presence of trismus and inflammation were evaluated using the distance between different facial points, at three, eight, and fifteen days after extraction. Pain, swelling, and amount of analgesics taken were evaluated using the VAS scale throughout the 15 days following extraction. Tolerance to treatment was evaluated using a verbal scale. Results were statistically compared using the Student's t- and chi-squared tests. RESULTS No statistically significant differences were found between the two groups with regard to infectious complications, swelling, or wound healing. Use of analgesics and self-reported pain levels were slightly lower in the experimental group than in the control group during days 6 and 7 of the study (p < 0.05). The global treatment tolerance was satisfactory and similar in both groups. CONCLUSIONS Both CHX and SOS are effective at improving the postoperative period after extraction of lower third molars.
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Efficacy of MAS063DP lotion vs 0.02% triamcinolone acetonide lotion in improving post-ablative fractional CO2 laser resurfacing wound healing: a split-face, triple-blinded, randomized, controlled trial.
Lueangarun, S, Tempark, T
International journal of dermatology. 2018;(4):480-487
Abstract
Proven as effective acne scar treatment, ablative fractional carbon dioxide (AFCO2 ) laser requires post-laser wound healing care. MAS063DP is a multicomponent nonsteroidal anti-inflammatory moisturizer for effective post-laser treatment. This study compares the efficacy of MAS063DP and 0.02% triamcinolone acetonide (TA) lotion for post-laser wound healing and complications. A split-face, triple-blinded, clinical study was performed in 16 patients, aged 20-50 years, receiving AFCO2 on both sides of the face, with MAS063DP on one side and 0.02% TA on the other side for 7 days twice daily. Digital photography, hemoglobin, and melanin index at baseline were obtained immediately after laser treatment and then at days 3, 5, 7, and 30. Erythema, edema, crusting, adverse effects, and post-inflammatory hyperpigmentation (PIH) were followed every visit. Sixteen patients, mean age 38.6 (8.4) years, with moderate-severe atrophic scar and skin phototype III-IV completed the study. Clinical improvement of edema, erythema, crusting, and hyperpigmentation was observed from day 3 to day 30 (P < 0.001), with no statistically significant difference in both groups. There was also no statistical difference of hemoglobin, melanin index, and texture at days 3, 5, 7, and 30. Melanin index at day 30 was significantly less than baseline in both MAS063DP and 0.02% TA. With PIH in 50% of cases, both treatments demonstrated good safety profiles and no serious adverse reactions. MAS063DP could be an effective treatment for post-laser wound healing and complications, compatible to 0.02% TA.
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8.
Pirfenidone Accelerates Wound Healing in Chronic Diabetic Foot Ulcers: A Randomized, Double-Blind Controlled Trial.
Gasca-Lozano, LE, Lucano-Landeros, S, Ruiz-Mercado, H, Salazar-Montes, A, Sandoval-Rodríguez, A, Garcia-Bañuelos, J, Santos-Garcia, A, Davila-Rodriguez, JR, Navarro-Partida, J, Bojórquez-Sepúlveda, H, et al
Journal of diabetes research. 2017;:3159798
Abstract
BACKGROUND Diabetic foot ulcers are one disabling complication of diabetes mellitus. Pirfenidone (PFD) is a potent modulator of extracellular matrix. Modified diallyl disulfide oxide (M-DDO) is an antimicrobial and antiseptic agent. AIM: To evaluate efficacy of topical PFD + M-DDO in a randomized, double-blind trial versus ketanserin in the treatment of noninfected chronic DFU. METHODS Patients received PFD + M-DDO or ketanserin for 6 months. Relative ulcer volume (RUV) was measured every month; biopsies were taken at baseline and months 1 and 2 for histopathology and gene expression analysis for COL-1α, COL-4, KGF, VEGF, ACTA2 (α-SMA), elastin, fibronectin, TGF-β1, TGF-β3, HIF-1α, and HIF-1β. RESULTS Reduction of median RUV in the PFD + M-DDO group was 62%, 89.8%, and 99.7% at months 1-3 and 100% from months 4 to 6. Ketanserin reduced RUV in 38.4%, 56%, 60.8%, 94%, 94.8%, and 100% from the first to the sixth month, respectively. Healing score improved 4.5 points with PFD + M-DDO and 1.5 points with ketanserin compared to basal value. Histology analysis revealed few inflammatory cells and organized/ordered collagen fiber bundles in PFD + M-DDO. Expression of most genes was increased with PFD + M-DDO; 43.8% of ulcers were resolved using PFD + M-DDO and 23.5% with ketanserin. CONCLUSION PFD + M-DDO was more effective than ketanserin in RUV reduction.
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Wound Healing Complications in Kidney Transplant Recipients Receiving Everolimus.
Ueno, P, Felipe, C, Ferreira, A, Cristelli, M, Viana, L, Mansur, J, Basso, G, Hannun, P, Aguiar, W, Tedesco Silva, H, et al
Transplantation. 2017;(4):844-850
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Abstract
BACKGROUND De novo use of mammalian target of rapamycin inhibitors after kidney transplantation is associated with a concentration-dependent incidence of wound healing adverse events (WHAE). The objective of this analysis was to compare the incidence of WHAE in patients receiving everolimus (EVR) or mycophenolate sodium (MPS). METHODS This was a predefined subanalysis of a single-center prospective randomized study in which 288 kidney transplant recipients receiving tacrolimus and prednisone were randomized for 3 different regimens: rabbit antithymocyte globulin (r-ATG)/EVR (N = 85); basiliximab (BAS)/EVR (N = 102); BAS/MPS (N = 101). Clinical WHAE were prospectively collected using a prespecified case report form in all study visits. Abdominal ultrasound was performed at 30 days posttransplant to capture subclinical abnormalities. Surgeons were blinded to randomized treatment and no specific surgical procedures were implemented. RESULTS A higher proportion of patients in BAS/EVR showed at least 1 clinical WHAE (22.3% vs 35.3% vs 22.0%, P = 0.03) and total clinical and subclinical WHAE (35% vs 42% vs 26%, P = 0.014) compared with BAS/MPS, respectively. A higher proportion of patients in r-ATG/EVR showed subclinical WHAE (13% vs 7% vs 4%, P = 0.025) compared with BAS/MPS, respectively. Patients receiving EVR showed a higher risk of developing clinical or subclinical WHAE (r-ATG/EVR vs BAS/MPS hazard ratio 1.30; BAS/EVR vs BAS/MPS hazard ratio 1.73, P = 0.028). CONCLUSIONS In this cohort of de novo kidney transplant recipients receiving tacrolimus and prednisone, the use of EVR was associated with higher incidence of combined clinical and subclinical WHAE compared with MPS.
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Histological and Histomorphometrical Evaluation of Postextractive Sites Grafted with Mg-Enriched Nano-Hydroxyapatite: A Randomized Controlled Trial Comparing 4 Versus 12 Months of Healing.
Canullo, L, Wiel Marin, G, Tallarico, M, Canciani, E, Musto, F, Dellavia, C
Clinical implant dentistry and related research. 2016;(5):973-983
Abstract
BACKGROUND Tooth extraction generally results in an alveolar bone loss and structural changes in the overlying soft tissue. The amount of this relocation might jeopardize prosthetically driven implant placement. Thus, there is a high interest in techniques, materials and timing to minimizing tissue resorption, using postextraction ridge preservation procedures. PURPOSE To assess by histological techniques, the outcomes of a socket preservation technique at 4 or 12 months after treatment with a magnesium-enriched hydroxyapatite (Mg-e HA). MATERIALS AND METHODS Postextraction site in 20 patients underwent ridge preservation procedure. Mg-e HA granules were mixed with blood and grafted into the socket. A bone specimen was collected from each site before implant placement after 4 or 12 months randomly. Each biopsy was processed for undecalcified histological analysis. All ground sections were observed under light and polarized microscope. A semi-quantitative analysis by mean of stereological method was performed to evaluate the average volume fractions of bone, biomaterial and medullary spaces, and the percentage of blood vessels for both timepoints. Nonparametric Mann-Whitney U test for unpaired data was used to detect eventual statistical differences between groups. RESULTS Histologically, the biomaterial appeared surrounded by newly formed bone in both groups without inflammatory infiltrate. At 4 months, the remodeling process of collagen matrix was starting from the apical portion toward coronal direction and was more active around grafted particles. At 12 months, the alveolar socket was completely regenerated and filled with mineralized and well-organized bone tissue around the residual biomaterial particles. In both groups, vessels were present to supply tissues around the graft (at 4 months: 4.95% ± 2.49; at 12 months: 7.45% ± 2.57). Tissue fractions at 4 versus 12 months were respectively: 31.85% ± 6.99 versus 41.32% ± 9.37 for bone (p = .021), 40.82% ± 6.71 versus 26.28% ± 11.49 for residual Mg-e HA (p = .009), and 27.33% ± 7.72 versus 32.40% ± 9.87 for medullary spaces. CONCLUSION Data from the present study show that Mg-e HA allows the complete healing of the tissue. Additionally, graft material demonstrated to undergo significant resorption during the experimental time frame.