Vonoprazan Versus Lansoprazole for Healing and Maintenance of Healing of Erosive Esophagitis: A Randomized Trial

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From Waste to Healing Biopolymers: Biomedical Applications of Bio-Collagenic Materials Extracted from Industrial Leather Residues in Wound Healing

The biomedical properties of a porous bio-collagenic polymer extracted from leather industrial waste residues have been investigated in wound healing and tissue regeneration in induced wounds in rats. Application of the pure undiluted bio-collagen to induced wounds in rats dramatically improved its healing after 7 days in terms of collagen production and wound filling as well as in the migration and differentiation of keratinocytes. The formulation tested was found to be three times more effective than the commercial reference product Catrix^® (Heal Progress (HP): 8 ± 1.55 vs. 2.33 ± 0.52, p < 0.001; Formation of Collagen (FC): 7.5 ± 1.05 vs. 2.17 ± 0.75, p < 0.001; Regeneration of Epidermis (RE): 13.33 ± 5.11 vs. 5 ± 5.48, p < 0.05).     

Subcutaneous Gentamycin Implant to Reduce Wound Infections After Loop-Ileostomy Closure: A Randomized, Double-Blind, Placebo-Controlled Trial

BACKGROUND After loop-ileostomy closure subcutaneous wound infection is the most frequent postoperative complication. Implantation of local antibiotics has been shown to reduce the incidence of wound infection after different surgical procedures, therefore, a subcutaneous application of a gentamycin implant may also decrease infection rate after ileostomy-closure. METHODS We conducted a randomized, double-blind, placebo-controlled trial to evaluate the effectiveness of a subcutaneous gentamycin–collagen implant to reduce wound infection after loop-ileostomy closure. Patients had the same perioperative treatment and standardized anastomotic and closure technique. A collagen sponge with gentamycin was used in the treatment group and an identical collagen implant without antibiotics was used in the placebo group. RESULTS Eighty patients (40 per group) were included. There was no difference between the groups with respect to demographics or in the postoperative course. The total wound infection rate was 10 percent with no difference between the gentamycin (n = 4) and the collagen group (n = 4) (P = 1.0). CONCLUSION Subcutaneous implantation of a gentamycin sponge yields no clinically relevant reduction of the wound infection rate after loop-ileostomy closure so that routine use is not recommended in this procedure.     

A Multicenter,Randomized, Double-Blind Clinical Trial Examining the Effect of Oral Human Recombinant Epidermal Growth Factor on the Healing of Duodenal Ulcers

Background: Functional studies have shown that nitric oxide (NO) inhibits gastric acid secretion in a variety of species, including man. We have performed a morphological study with the intention of localizing the endothelial NO synthase (eNOS) in the human gastric mucosa. Methods: Fifteen healthy subjects voluntarily participated in the study, and mucosal biopsies were obtained from the cardia, corpus and antrum. The presence and localization of eNOS were studied using immunohistochemical techniques. Results: eNOS-immunoreactivity (eNOS-IR) is found in surface mucous cells of cardia, corpus and antrum. Unique to the oxyntic mucosa is the presence of eNOS-IR in 'endocrine-like' cells, found in close contact with parietal cells. Conclusions: eNOS-IR cells in close apposition to parietal cells provide morphological support for paracrine inhibition of gastric acid secretion by NO.     

Tenofovir Alafenamide for Drug-Resistant Hepatitis B: A Randomized Trial for Switching From Tenofovir Disoproxil Fumarate

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Comparison of Outcomes in Z-Plasty and Delayed Healing by Secondary Intention of the Wound After Excision of the Sacral Pilonidal Sinus: Results of a Randomized, Clinical Trial

Purpose Pilonidal sinus is a common disease, mostly among young males. Although the conventional surgery, secondary repair of the wound after wide excision with or without curettage, is not technically difficult, it takes a long time, weeks or months, for a wound to heal. In this study, we compared outcomes and complications of Z-plasty repair with outcomes and complications of delayed healing by secondary intention (conventional surgery). Methods In a randomized, clinical trial, we recruited 72 patients in each arm. All of the patients were operated on by a general surgeon and were followed up for variable periods. Patients in the Z-plasty arm were followed for a mean period of 22.01 months. Patients conventional surgery arm were followed for a mean period of 22.23 months. The main studied outcomes were healing of the wound and disease recurrence during the follow-up period. The main complications that were taken into account were bleeding, hematoma, infection, and recurrence. Results The two arms were comparable in the age and gender distributions, duration of disease, and history of any types of operations. The duration of hospitalization after the operation was shorter in the conventional surgery group (1.76±0.75 days vs. 2.86±0.73 days, P<0.001). However, wounds healed much faster in the Z-plasty group (15.4 vs. 41 days, P<0.001). Moreover, it took longer for patients in the conventional surgery group to return to normal activity (17.5 vs. 11.9 days, P<0.001). There was no difference in postoperative complications regarding bleeding, hematoma, infection, or recurrence during the follow-up period in two arms. Conclusions Healing was considerably faster in patients who were treated with Z-plasty technique of wound closure. This procedure can be used as a desirable treatment for pilonidal sinus, which is a noncomplex method without increased rate of complications. Nonetheless, it might slightly increase the duration of hospitalization. Reprints are not available.     

Exploring ART Intake Scenes in a Human Rights-Based Intervention to Improve Adherence: A Randomized Controlled Trial

To assess the effectiveness of a psychosocial individual intervention to improve adherence to ART in a Brazilian reference-center, consenting PLHIV with viral load >50 copies/ml were selected. After 4 weeks of MEMS cap use, participants were randomized into an intervention group (IG) (n = 64) or control group (CG) (n = 57). CG received usual care only. The IG participated in a human rights-based intervention approach entailing four dialogical meetings focused on medication intake scenes. Comparison between IG and CG revealed no statistically significant difference in adherence measured at weeks 8, 12, 16, 20 and 24. Viral load (VL) decreased in both groups (p < 0.0001) with no significant difference between study groups. The lower number of eligible patients than expected underpowered the study. Ongoing qualitative analysis should provide deeper understanding of the trial results. NIH Clinical Trials: NCTOO716040.     

Improving Efficiency of Clinical Skills Training: A Randomized Trial

BACKGROUND

The rising number of medical students and the impact this has on students’ learning of clinical skills is a matter of concern. Cooperative learning in pairs, called dyad training, might help address this situation.

OBJECTIVE

The aim of this study was to evaluate the effect of dyad training on students’ patient encounter skills.

DESIGN

Experimental, randomized, observer-blinded trial.

PARTICIPANTS

Forty-nine pre-clerkship medical students without prior clinical experience.

INTERVENTION

All students underwent a 4-h course on how to manage patient encounters. Subsequently, the students were randomized into a dyad practice group (n?=?24) or a single practice group (n?=?25). Both groups practiced for 4 h on four different case scenarios, using simulated patients. Students in the dyad group practiced together and took turns as the active participant, whereas students in the single group practiced alone.

MAIN MEASURE

Performance tests of patient encounter skills were conducted 2 weeks after the training by two blinded raters. Students had no clinical training during those weeks. A questionnaire-based evaluation surveyed students’ confidence in their patient management skills.

KEY RESULTS

The dyad group scored significantly higher on the performance test, mean 40.7 % (SD 6.6), than the single group, mean 36.9 % (SD 5.8), P?=?0.04, effect size 0.61. Inter-rater reliability was 0.69. The dyad group expressed significantly higher confidence in managing future clinical patient encounters than the single group, mean 7.6 (SD 0.9) vs. mean 6.5 (SD 1.1), respectively, P?<?0.001, effect size 1.16.

CONCLUSION

Dyad training of pre-clerkship medical students’ patient encounter skills is effective, efficient, and prompts higher confidence in managing future patient encounters compared to training alone. This training format may help maintain high-quality medical training in the face of an increasing number of students in medical schools.     

All Lactase Preparations Are Not the Same: Results of a Prospective, Randomized, Placebo-Controlled Trial

Objective: To compare the efficacy of three commercially available oral lactase preparations in adults with lactose intolerance. Methods: Design—Prospective, randomized, placebo-controlled trial. Setting—Outpatient study in a General Clinical Research Center. Subjects—Ten lactose-intolerant healthy volunteers were challenged with ice cream containing 18 g of lactose. Lactase or placebo was given immediately prior to challenge. Measurements—Symptoms and breath hydrogen excretion were recorded for 3 h following lactose challenge. Results: The three products differed in their abilities to influence symptoms and breath hydrogen excretion. Only Lactaid reduced the breath hydrogen excretion with lactose (mean peak, area under the curve and cumulative breath hydrogen excretion) ( P < 0.05). Lactrase and Dairy Ease influenced symptoms: Lactrase reduced pain, bloating and total symptomatic scores ( P < 0.05), whereas Dairy Ease only reduced pain ( P < 0.05). Lactaid administration did not reduce symptoms. Conclusion: In lactose-intolerant subjects, the available lactase preparations differ in their ability to improve both breath hydrogen excretion and symptoms. Lactrase may be the product of choice for achieving symptomatic improvement.     

Differentially Expressed miRNAs in Acute Wound Healing of the Skin: A Pilot Study

The aim of the present study was to compare expression of microRNAs (miRNAs) from scar and normal skin areas in patients who suffered acute injuries in the skin.A total of 9 patients with acute injuries in the skin who received surgical treatment from December 2012 to March 2013 were included in this pilot study. Specimens from the hypertrophic scar and normal skin areas were obtained from the same patient during surgery. To screen for differentially expressed miRNAs, we applied 3 statistical methods, namely the traditional t test, the false discovery rate (FDR), and a novel sure independence screening procedure based on the distance correlation (DC-SIS). We examined the functional trends and metabolic and regulatory pathways for the target genes of the identified miRNAs, and explored interaction of these miRNAs in the implication of scar healing using Ingenuity Pathway Analysis.DC-SIS identified 18 differentially expressed miRNAs, 4 of which (miR-149, miR-203a, miR-222, miR-122) were also identified by FDR. The target genes of the 4 miRNAs exhibit a variety of biological functions, and are involved in various pathways such as mitogen-activated protein kinase, Wnt signaling, and focal adhesion. We identified 1 network in which 14 out of the 18 differentially expressed miRNAs were involved. Many of the miRNAs in the network target genes were involved in cell proliferation and apoptosis.In this pilot study, we identified several miRNAs exhibiting differential expression in patients who suffered acute injuries in the skin. Further studies on these miRNAs are needed to validate our findings and explore their roles in the wound healing process of the skin.     

Brief Motivational Interviewing for DWI Recidivists Who Abuse Alcohol and Are Not Participating in DWI Intervention: A Randomized Controlled Trial

Background: Driving while impaired (DWI) recidivists with unresolved alcohol use problems pose an ongoing risk for traffic safety. Following conviction, many do not participate in mandated alcohol evaluation and intervention programs, or continue to drink problematically after being relicensed. This study investigated if, in DWI recidivists with alcohol problems and not currently involved in DWI intervention, Brief Motivational Interviewing (BMI) produced greater reductions in risky drinking at 6‐ and 12‐month follow‐up compared to an information‐advice control condition. Additional analyses explored whether BMI was associated with greater readiness to change, subsequent substance abuse treatment service utilization, and satisfaction compared to the control condition. Methods: Male and female recidivists with drinking problems and not currently engaged in DWI intervention were recruited, evaluated, and then randomly assigned to receive 1 of 2 manualized interventions: 30‐minute BMI session or information‐advice. Participants, interviewers, researchers, and statisticians were blind to assignment. Outcomes were changed in: percent of risky drinking days (i.e., ≥3 standard drinks/d for males; ≥2 for females) in the previous 6 months derived from the Timeline Followback, biomarkers of alcohol abuse (GGT, AST, ALT, MCV) by blood assay, and alcohol abuse‐related behaviors using the MMPI‐Mac scale. Data from the Readiness to Change Questionnaire, a substance abuse service utilization questionnaire, and the Client Satisfaction Scale were also collected. Results: Analyses revealed significant declines in risky drinking with both interventions. BMI (n = 92) resulted in a 25% reduction in risky drinking days at 12‐month follow‐up, which compared to the control intervention (n = 92) represented a significant decline from 6‐month levels. Exposure to BMI also produced significantly greater improvement at 6‐month follow‐up in a biomarker of alcohol abuse and a behavioral measure related to recidivism risk. Exploration of readiness to change, substance abuse service utilization, and satisfaction with intervention indicated a perception of BMI being more useful in coping with problems. Conclusions: Brief MI approaches warrant further implementation and effectiveness research as an opportunistic DWI intervention strategy to reduce risks associated with alcohol use outside of clinical and DWI relicensing settings.     

Effect of Perineal Self-Acupressure on Constipation: A Randomized Controlled Trial

BACKGROUNDThe efficacy of perineal self-acupressure in treating constipation is uncertain.OBJECTIVEWe aimed to evaluate whether perineal self-acupressure would improve patient reports of quality of life and bowel function at 4 weeks after training.DESIGNA randomized, parallel group trial was conducted.SETTINGThe study took place at the UCLA Department of Medicine.PATIENTSOne hundred adult patients who met Rome III criteria for functional constipation participated.INTERVENTIONThe control group received information about standard constipation treatment options, while the treatment group received training in perineal self-acupressure plus standard treatment options.MEASUREMENTSPrimary outcome was the Patient Assessment of Constipation Quality of Life (PAC-QOL). Secondary outcomes included patient assessments of bowel function (as measured by a modified Bowel Function Index (BFI)), and health and well-being (as measured by the SF-12v2).RESULTSThe mean PAC-QOL was improved by 0.76 in the treatment group and by 0.17 in the control group (treatment-effect difference, 0.59 [95 % CI, 0.37 to 0.81]; p < 0.01). The mean modified BFI was improved by 18.1 in the treatment group and by 4.2 in the control group (treatment-effect difference, 13.8 [95 % CI, 5.1 to 22.5]; p < 0.01). The mean SF-12v2 Physical Component Score was improved by 2.69 in the treatment group and reduced by 0.36 in the control group (treatment-effect difference, 3.05, [95 % CI, 0.85 to 5.25]; p < 0.01); and the mean SF-12v2 Mental Component Score was improved by 3.12 in the treatment group and improved by 0.30 in the control group (treatment-effect difference, 2.82, [95 % CI, −0.10 to 5.74]; p < 0.07).LIMITATIONThe trial was not blinded.CONCLUSIONAmong patients with constipation, perineal self-acupressure improves self-reported assessments of quality of life, bowel function, and health and well-being relative to providing standard constipation treatment options alone.

Electronic supplementary material

The online version of this article (doi:10.1007/s11606-014-3084-6) contains supplementary material, which is available to authorized users.KEY WORDS: perineum, constipation, acupressure     

A Randomized, Controlled Trial of Human Lymphoblastoid Interferon in Patients with Compensated Type C Cirrhosis

Objective: To determine the efficacy of human lymphoblastoid interferon (L-IFN) in the treatment of compensated type C cirrhosis, 30 patients were assigned randomly to three groups, consisting of 10 patients each, who were treated as follows. Methods: The 1- and 3-megaunit (MU) groups received 1 or 3 MU of L-IFN, respectively, daily for 2 wk, and three times weekly for 24 wk thereafter. The control group received no treatment. All of the patients had positive C100–3 hepatitis C virus antibody (anti-HCV) titers. Results: The serum alanine aminotransferase (ALT) levels decreased 26 wk after L-IFN treatment was began, in both treatment groups. In the 3-MU group, the ALT levels became normal [complete response (CR)] in 40%, improved to less than twice the upper limit of the normal value [partial response (PR)] in 10%, and remained unchanged [no change (NC)j in 50%. In the 1-MU group, a PR occurred in 30%. There was NC in 70%, and NC occurred in the control group. Twenty-four weeks after stopping L-IFN, the CR and NC rates in the 3-MU group were 10% and 90%, respectively, and NC was observed in all of the 1-MU and control patients. 2',5'-Oligoadenylate synthetase activities increased in both treatment groups ( p < 0.05), but not in the control group. The anti-HCV titers decreased in the 3-MU group ( p < 0.05), but not in the 1-MU and control groups. Higher doses of L-IFN were more effective. No serious side effects occurred. Conclusions: These findings suggest that IFN administration can be effective and safe in patients with compensated type C cirrhosis, and that it would be worthwhile to evaluate IFN therapy for cirrhotic patients further.     

Foot Technology, Part 1 of 2: Wound Inflammatory Index: A ��Proof of Concept�� Study to Assess Wound Healing Trajectory

Diabetes around the globe results in one major limb amputation every 30 seconds, over 2500 limbs lost per day. The underlying pathophysiology sometimes leads to a chronic inflammatory stage, which may prevent appropriate healing, and therefore, the need for a clear strategy for assessing and classifying wounds and wound healing cannot be overstated. Temperature is a surrogate marker for inflammation. Quantitative thermography using a numerical index provides a useful way to assess wound healing. Advances in technology have afforded the availability of low-cost, high-resolution thermal imaging systems, which can be used to quantify sensitive changes on the skin surface and may be particularly useful to develop monitoring strategies for wounds. This article provides a standardized technique for calculating a thermal index (TI) supported with a case report from assessment of a diabetic foot ulcer. In this single case study, the TI/wound inflammatory index indicates a shift from negative to positive (p < .05) before it reaches zero.     

A Randomized Trial of Recombinant Human C1-Esterase-Inhibitor in the Prevention of Contrast-Induced Kidney Injury

ObjectivesThis study sought to determine the efficacy profile and safety of recombinant human C1 esterase inhibitor (rhC1INH) in the prevention of contrast-associated acute kidney injury after elective coronary angiography.BackgroundContrast-associated acute kidney injury is caused by tubular cytotoxicity and ischemia/reperfusion injury. rhC1INH is effective in reducing renal ischemia/reperfusion injury in experimental models.MethodsIn this placebo-controlled, double-blind, single-center trial 77 patients with chronic kidney disease were randomized to receive 50 IU/kg rhC1INH before and 4 h after elective coronary angiography or placebo. The primary outcome was the peak change of urinary neutrophil gelatinase-associated lipocalin within 48 h, a surrogate marker of kidney injury.ResultsMedian peak change of urinary neutrophil gelatinase-associated lipocalin was lower in the rhC1INH group (4.7 ng/ml vs. 22.5 ng/ml; p = 0.038) in the per-protocol population but not in the modified intention-to-treat analysis, and in patients with percutaneous coronary interventions (median, 1.8 ng/ml vs. 26.2 ng/ml; p = 0.039 corresponding to a median proportion peak change of 11% vs. 205%; p = 0.002). The incidence of a cystatin C increase ≥10% within 24 h was lower in the rhC1INH group (16% vs. 33%; p = 0.045), whereas the frequency of contrast-associated acute kidney injury was comparable. Adverse events during a 3-month follow-up were similarly distributed.ConclusionsAdministration of rhC1INH before coronary angiography may attenuate renal injury as reflected by urinary neutrophil gelatinase-associated lipocalin and cystatin C. The safety profile of rhC1INH was favorable in a patient population with multiple comorbidities. (Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy in High-risk Subjects [PROTECT]; NCT02869347)