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At least 631 records · Page 35Linked to original sources
PubMed1989

Results of a multicenter outpatient burn study on the safety and efficacy of Dimac-SSD, a new delivery system for silver sulfadiazine.

Dimac with silver sulfadiazine (Dimac-SSD), a new silver sulfadiazine delivery system, was evaluated prospectively in a multicenter study for the treatment of outpatient burn injuries. The goal of this study was to evaluate the effect of Dimac-SSD on the microbiology of the burn wounds and to quantitate its clinical safety and efficacy. A total of 197 patients were evaluated. Eight (4%) of these patients did not complete the study. Six patients withdrew because of local discomfort caused by the Dimac-SSD and two patients were terminated because of technical problems. The mean +/- SD duration of treatment with Dimac-SSD was 12 +/- 8.5 days, during which time the mean number of dressing changes was 2.9 per patient. During treatment with Dimac-SSD, the burn wound bacterial flora remained stable and overgrowth with Pseudomonas species or Gram-negative bacilli did not occur. Only four (2%) patients developed clinical infections; thus the Dimac-SSD appeared to have good antimicrobial effectiveness. This dressing was not associated with any organ system or metabolic side-effects and patient discomfort during application and removal was minimal. Thus this new delivery system for silver sulfadiazine was associated with excellent wound healing, a low incidence of wound infections, reduced frequency for dressing changes, and excellent patient compliance.

Acrylates↗
PubMed1989

Nonoperative management of blunt splenic trauma: a multicenter experience.

The experience of six referral trauma centers with 832 blunt splenic injuries was reviewed to determine the indications, methods, and outcome of nonoperative management. During this 5-year period, 112 splenic injuries were intentionally managed by observation. There were 40 (36%) patients less than 16 years old and 72 adults. The diagnosis was established by computed tomography in 89 (79%) patients, nuclear scan in 23 (21%), ultrasound in four (4%), and arteriography in two (2%). There were 28 Class I, 51 Class II, 31 Class III, two Class IV, and no Class V splenic injuries. Nonoperative management was unsuccessful in one (2%) child and 12 (17%) adults (p less than 0.05). Failure was due to ongoing hemorrhage in 12 patients and delayed recognition of pancreatic injury in one patient. Of the 12 patients ultimately requiring laparotomy for control of hemorrhage, seven (58%) were successfully treated with splenic salvage techniques. Overall mortality was 3%; none of the four deaths was due to splenic or associated abdominal injury. This contemporary multicenter experience suggests that patients with Class I, II, or III splenic injuries after blunt trauma are candidates for nonoperative management if there is: 1) no hemodynamic instability after initial fluid resuscitation; 2) no serious associated abdominal organ injury; and 3) no extra-abdominal condition which precludes assessment of the abdomen. Strict adherence to these principles yielded initial nonoperative success in 98% of children and 83% of adults. Application of standard splenic salvage techniques to treat the patients with persistent hemorrhage resulted in ultimate splenic preservation in 100% of children and 93% of adults.

Adolescent↗
PubMed2001

Penetrating colon injuries requiring resection: diversion or primary anastomosis? An AAST prospective multicenter study.

BACKGROUND: The management of colon injuries that require resection is an unresolved issue because the existing practices are derived mainly from class III evidence. Because of the inability of any single trauma center to accumulate enough cases for meaningful statistical analysis, a multicenter prospective study was performed to compare primary anastomosis with diversion and identify the risk factors for colon-related abdominal complications. METHODS: This was a prospective study from 19 trauma centers and included patients with colon resection because of penetrating trauma, who survived at least 72 hours. Multivariate logistic regression analysis was used to compare outcomes in patients with primary anastomosis or diversion and identify independent risk factors for the development of abdominal complications. RESULTS: Two hundred ninety-seven patients fulfilled the criteria for inclusion and analysis. Overall, 197 patients (66.3%) were managed by primary anastomosis and 100 (33.7%) by diversion. The overall colon-related mortality was 1.3% (four deaths in the diversion group, no deaths in the primary anastomosis group, p = 0.012). Colon-related abdominal complications occurred in 24% of all patients (primary repair, 22%; diversion, 27%; p = 0.373). Multivariate analysis including all potential risk factors with p values < 0.2 identified three independent risk factors for abdominal complications: severe fecal contamination, transfusion of > or = 4 units of blood within the first 24 hours, and single-agent antibiotic prophylaxis. The type of colon management was not found to be a risk factor. Comparison of primary anastomosis with diversion using multivariate analysis adjusting for the above three identified risk factors or the risk factors previously described in the literature (shock at admission, delay > 6 hours to operating room, penetrating abdominal trauma index > 25, severe fecal contamination, and transfusion of > 6 units blood) showed no statistically significant difference in outcome. Similarly, multivariate analysis and comparison of the two methods of colon management in high-risk patients showed no difference in outcome. CONCLUSION: The surgical method of colon management after resection for penetrating trauma does not affect the incidence of abdominal complications, irrespective of associated risk factors. Severe fecal contamination, transfusion of > or = 4 units of blood within the first 24 hours, and single-agent antibiotic prophylaxis are independent risk factors for abdominal complications. In view of these findings, the reduced quality of life, and the need for a subsequent operation in colostomy patients, primary anastomosis should be considered in all such patients.

Adult↗
PubMed1990

Early aneurysm surgery and preventive therapy with intravenously administered nimodipine: a multicenter, double-blind, dose-comparison study.

A European, multicenter, prospective, randomized, double-blind, dose-comparison study on preventive therapy with intravenously administered nimodipine was performed to evaluate the efficacy and tolerability of two different doses: 2 and 3 mg/h. Two hundred four patients fulfilled the criteria for enrollment in the study: surgery within 72 hours after the last subarachnoid hemorrhage, and age between 16 and 72 years. All patients who had Hunt and Hess grades of I to III were operated upon; patients who had poor Hunt and Hess grades (IV-V) were operated on according to the surgeon's choice. This treatment regimen was associated with a low incidence of delayed neurological dysfunction with no significant difference between the two dosage groups: three patients (1.5%) remained severely disabled and two (1%) moderately disabled due to vasospasm with or without additional complications. Among the patients with Hunt and Hess grades of IV or V, the long-term outcome was favorable (good-fair) for 40% and unfavorable for 60%. Among the patients with grades of I to III, the long-term outcome was favorable for 89% and unfavorable for 11%.

Dose-Response Relationship, Drug↗
PubMed1989

Timentin therapy for Staphylococcus aureus infections in children: results of a multicenter trial.

Multicenter trials of ticarcillin/potassium clavulanate (Timentin) for bone, joint, skin and soft tissue infections in children were performed from 1983 to 1986. Fifty children with culture-confirmed Staphylococcus aureus infections were identified. Sixteen children (ages 6.2 +/- 3.9 years) with bone and joint infections received Timentin for 8.7 +/- 2.4 days with 11 of 16 cures, 5 of 16 improved, 11 of 11 bacteriologic cures and 3.9 +/- 3.5 days of fever. Thirty-two children (ages 5.7 +/- 3.5 years) with skin and soft tissue infections received Timentin for 5.3 +/- 1.6 days with 22 of 32 cures, 10 of 32 improved, 32 of 32 bacteriologic cures and 1.4 +/- 1.3 days of fever. Three patients had S. aureus bacteremia; all were clinical and bacteriologic cures. All S. aureus isolates were susceptible to Timentin, 18 of 23 isolates tested produced beta-lactamase and 21 of 44 isolates tested were resistant to ticarcillin. The purpose of this report is to describe the clinical efficacy of Timentin in treating these types of S. aureus infections in children.

Child↗
PubMed1990

Long-term buspirone therapy for chronic anxiety: a multicenter international study to determine safety.

This report presents results from an international multicenter trial of the safety of buspirone in the treatment of anxiety disorders for periods up to one year, if needed; 424 patients were treated for six months, and 264 patients completed a full year of treatment. Chronic use of buspirone for up to 52 weeks was associated with emergence of no new or unexpected side effects that were not previously reported during shorter periods of treatment. Most patients were successfully managed on daily doses ranging from 15 to 30 mg/day. When buspirone therapy was abruptly discontinued after more than six months of therapy, assessments of patients yielded no evidence of a withdrawal syndrome or unusual events. Although long-term anxiolytic drug therapy is not generally recommended, this open study provides evidence of the potential usefulness of buspirone when used for up to one year. As a general guideline, when an anxiolytic agent is used for several months or longer to treat chronic anxiety, the need for drug therapy should be reevaluated periodically.

Adolescent↗
PubMed1990

Results of a multicenter trial using an intensive active exercise program for the treatment of acute soft tissue and back injuries.

Dissatisfaction with current nonsurgical treatment of acute soft tissue and back injuries initiated a search for more effective treatment. A multicenter trial, involving 12 clinics, treated 1,072 patients. Treatment consisted of intensive, time-limited exercises emphasizing mobility, muscle strengthening, work conditioning, sequence training, and appropriate education sessions. Return to full-time work was proof that the patient had recovered fully. Time off work and compensation costs were parameters used to evaluate results. A detailed study of 703 patients treated at five clinics, operational for more than 12 months, showed superior results when compared with the comparison group of 2,172 matched control subjects. The treatment group returned to work earlier and realized substantial cost savings. This treatment program has proved to be superior to the miscellaneous variety of treatment modalities used for acute soft tissue and back injuries provided to the comparison group.

Back Injuries↗
PubMed2003

Protocol core needle biopsy and histologic Chronic Allograft Damage Index (CADI) as surrogate end point for long-term graft survival in multicenter studies.

This study is an investigation of whether a protocol biopsy may be used as surrogate to late graft survival in multicenter renal transplantation trials. During two mycophenolate mofetil trials, 621 representative protocol biopsies were obtained at baseline, 1 yr, and 3 yr. The samples were coded and evaluated blindly by two pathologists, and Chronic Allograft Damage Index (CADI) score was constructed. At 1 yr, only 20% of patients had elevated (>l.5 mg/100 ml) serum creatinine, whereas 60% of the biopsies demonstrated an elevated (>2.0) CADI score. The mean CADI score at baseline, 1.3 +/- 1.1, increased to 3.3 +/- 1.8 at 1 yr and to 4.1 +/- 2.2 at 3 yr. The patients at 1 yr were divided into three groups, those with CADI <2, between 2 and 3.9, and >4.0, the first two groups having normal (1.4 +/- 0.3 and 1.5 +/- 0.6 mg/dl) and the third group pathologic (1.9 +/- 0.8 mg/dl) serum creatinine. At 3 yr, there were no lost grafts in the low CADI group, six lost grafts (4.6%) in the in the elevated CADI group, and 17 lost grafts (16.7%) in the high CADI group (P < 0.001). One-year histologic CADI score predicts graft survival even when the graft function is still normal. This observation makes it possible to use CADI as a surrogate end point in prevention trials and to identify the patients at risk for intervention trials.

Biopsy, Needle↗
PubMed2006

Effect of blood transfusion on outcome after major burn injury: a multicenter study.

OBJECTIVE: To delineate blood transfusion practices and outcomes in patients with major burn injury. CONTEXT: Patients with major burn injury frequently require multiple blood transfusions; however, the effect of blood transfusion after major burn injury has had limited study. DESIGN: Multicenter retrospective cohort analysis. SETTING: Regional burn centers throughout the United States and Canada. PATIENT POPULATION: Patients admitted to a participating burn center from January 1 through December 31, 2002, with acute burn injuries of >or=20% total body surface area. OUTCOMES MEASURED: Outcome measurements included mortality, number of infections, length of stay, units of blood transfused in and out of the operating room, number of operations, and anticoagulant use. RESULTS: A total of 21 burn centers contributed data on 666 patients; 79% of patients survived and received a mean of 14 units of packed red blood cells during their hospitalization. Mortality was related to patient age, total body surface area burn, inhalation injury, number of units of blood transfused outside the operating room, and total number of transfusions. The number of infections per patient increased with each unit of blood transfused (odds ratio, 1.13; p<.001). Patients on anticoagulation during hospitalization received more blood than patients not on anticoagulation (16.3+/-1.5 vs. 12.3+/-1.5, p<.001). CONCLUSIONS: The number of transfusions received was associated with mortality and infectious episodes in patients with major burns even after factoring for indices of burn severity. The utilization of blood products in the treatment of major burn injury should be reserved for patients with a demonstrated physiologic need.

Adult↗
PubMed2005

Variability of total serum immunoglobulin E levels from birth to the age of 10 years. A prospective evaluation in a large birth cohort (German Multicenter Allergy Study).

BACKGROUND: Many environmental factors influence the concentration of total serum IgE (tIgE); however, tIgE synthesis is believed to be under strong genetic influence. Multiple genetic studies on tIgE regulation have been performed. For these population-based studies tIgE was commonly determined at one time-point, assuming that tIgE phenotypes (adjusted for age and gender) are stable over time. OBJECTIVE: We assessed correlations of tIgE levels from birth to the age of 10 years in the birth cohort MAS (Multicenter Allergy Study; n=1314). MATERIALS AND METHODS: We determined cord-blood IgE levels, total and specific IgE at the age of 1, 2, 3, 5, 6, 7, and 10 years. Spearman correlation coefficients were calculated for tIgE at different time-points. All analyses were performed in the entire cohort, adjusted for gender, as well as in non-atopic children only. RESULTS: tIgE percentiles increased steadily from birth to the age of 10 years with higher values for boys than for girls at each time-point. tIgE values from birth to 3 years of age correlated poorly with tIgE levels at 10 years (r<0.5). However, good correlations (r>0.8) were observed for tIgE concentrations at 6, 7 and 10 years. The same results were observed when the analyses were limited to non-atopic children. CONCLUSION: In childhood, tIgE levels underlie remarkable variation over time even in the absence of atopy. For cross-sectional population-based genetic and epidemiologic studies, tIgE values of children <5 years should be interpreted with caution since these values correlate poorly with tIgE levels later in life.

Age Factors↗
PubMed1991

Multicenter evaluation of tetracycline fiber therapy: I. Experimental design, methods, and baseline data.

The study design and baseline characteristics of a multicenter trial to test the effectiveness and safety of locally delivered tetracycline for treatment of adult periodontitis are described. Local delivery was provided by 0.5 mm diameter ethylene vinyl acetate copolymer fibers loaded 25% with tetracycline hydrochloride which were placed into periodontal pockets and maintained by an adhesive for 10 (+/- 2) days. A total of 113 subjects (56 male and 57 female; mean age 49.3 yr) at five centers participated in the study. Subjects were selected who had 4 nonadjacent teeth with 6-10 mm pockets that bled on probing. The selected sites in each subject were randomly assigned to 4 test groups: tetracycline fiber, control fiber, scaling with root planing, or untreated. A balanced experimental design was thereby established in which each subject contributed equally by providing 4 clinically comparable sites for evaluation. To provide a more specific model for testing periodontitis therapy, gingivitis was treated prior to the initiation of the study by prophylaxis with supragingival calculus removal and home care instruction. Clinical response variables measured were pocket depth reduction, attachment level gain and bleeding on controlled-force probing measured at baseline, 30 d, and 60 d. Levels of 6 bacterial species selected as probable periodontal pathogens were measured by DNA probe analysis of plaque samples. The design of this study provided several unique analytical opportunities. Controls included a comparison with conventional treatment, analysis of vehicle effects, and effects at untreated sites. Comparison of the test group with controls permitted evaluation of the principal variables that could effect interpretation of results.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2005

Incidence of C4d stain in protocol biopsies from renal allografts: results from a multicenter trial.

C4d staining of renal allografts is regarded as an in situ marker of active humoral rejection. Few data are available about the incidence of C4d deposition in protocol biopsies compared to indication biopsies. To evaluate whether center-specific factors influence the incidence of C4d detection, we performed a multicenter study. From three European centers, 551 protocol and 377 indication biopsies were reclassified according to the updated Banff criteria and stained for C4d. C4d results were recorded as diffuse or focal positive and statistically correlated to clinical parameters, morphology and graft survival. In the protocol biopsies, a diffuse C4d stain was found in 2.0%, and a focal stain in 2.4%. In indication biopsies, 12.2% were diffusely and 8.5% focally C4d positive (protocol:indication p < 0.0001). The incidence of C4d deposition varied significantly between centers, attributable to variable numbers of presensitized patients with more C4d positive indication and protocol biopsies. Diffuse and focal C4d stain correlated with morphology of humoral rejection in protocol as well as in indication biopsies. Protocol biopsies show a significantly lower incidence of C4d deposition than indication biopsies. Subclinical C4d detection in protocol biopsies had no significant impact on allograft survival in our series.

Biopsy↗
PubMed1990

Multicenter prospective study of treatment of Brucella melitensis brucellosis with doxycycline for 6 weeks plus streptomycin for 2 weeks.

The effectiveness of treating human brucellosis caused by Brucella melitensis with a 6-week course of doxcycline plus streptomycin for 2 of those weeks was analyzed by a multicenter prospective study of 139 patients. Subjects with central nervous system involvement, endocarditis, or spondylitis were excluded from the study. All but 5 of the 139 patients completed the full treatment schedule and became afebrile in the first week of therapy. Four patients suffered relapses during the follow-up period. Of the five patients who did not complete the treatment, two left because of adverse secondary effects (1.4%), another two left for noncomplicance with the treatment (1.4%), and the remaining patient was considered a therapeutic failure because his symptoms persisted after the first week of therapy (0.7%). We concluded that the combination of doxycycline and streptomycin is an effective treatment for the types of brucellosis included in our study.

Adolescent↗
PubMed1995

Interlaboratory variability of CD8 subset measurements by flow cytometry and its applications to multicenter clinical trials. NAID/NICHD Women and Infants Transmission Study Group.

Recent studies have demonstrated the utility of measuring subsets of CD8+ T cells as prognostic markers in epidemiology cohort studies of human immunodeficiency virus (HIV)-infected patients. Most of these studies evaluating the value of CD8+ T-cell subsets have been performed at single centers, and few data are available on variability in the measurement of the CD8+ cell populations in multicenter trials. In the current study, we addressed this question by evaluating interlaboratory variability from the five laboratories enrolled in the Women and Infants Transmission Study sponsored by the National Institutes of Health. This study evaluated 35 HIV-positive and 28 HIV-negative proficiency testing samples sent to the laboratories for evaluation. The study focused on the robust coefficient of variation (RCV) for CD38 (11%), HLA-DR (21%), and CD57 (15%) expression on the CD8+ population. Data from the current study indicated that the variability in these measurements is greater than that for CD3+ CD4+ (RCV, 5%) and CD3+ CD8+ (RCV, 5%) cells. Knowledge of the variability of the CD8+ subset measurements should guide investigators in the design and analysis of clinical trials and epidemiology studies. Ability to obtain improved interlaboratory agreement on CD8+ subset measurements will facilitate further evaluation of these markers in HIV studies.

CD3 Complex↗
PubMed2001

Nationwide German multicenter study on the prevalence of antibiotic resistance in streptococcal blood isolates from neutropenic patients and comparative in vitro activities of quinupristin-dalfopristin and eight other antimicrobials.

In a prospective multicenter study (1996 to 1999), 156 episodes of bacteremic streptococcal infections of neutropenic patients were evaluated. Streptococcus oralis (26.3%), S. pneumoniae (26.3%), S. agalactiae (11.5%), S. mitis (9%), and S. pyogenes (5.8%) were the predominant species. Four strains (2.6%) were found to be intermediately resistant to penicillin. One strain (0.6%) was found to be highly resistant to penicillin (MIC, 8 mg/liter). Reduced susceptibility to penicillin was detected among S. oralis (14.6%), S. mitis (7.1%), and S. pneumoniae (4.9%) isolates but was not recorded among S. agalactiae and S. pyogenes. Resistance rates and intermediate resistance rates for other antimicrobials were as follows (all species): amoxicillin, 1.3 and 3.2%; erythromycin, 16 and 2.6%; clindamycin, 5.8 and 0%; ciprofloxacin, 1.9 and 7.7%. Quinupristin-dalfopristin showed good in vitro activity against most streptococcal isolates (MIC at which 50% of the isolates were inhibited [MIC(50)], 0.5 mg/liter; MIC(90), 1 mg/liter, MIC range, 0.25 to 4 mg/liter).

Adolescent↗
PubMed1989

Lumbar myelography with iohexol in outpatients: prospective multicenter evaluation of safety.

A multicenter open, noncomparative evaluation of the safety of iohexol was prospectively conducted in 81 adult outpatients undergoing screen-film lumbar myelography. Iohexol (180 milligrams of iodine per milliliter) was administered via a lumbar route at a dose of 8-17 mL. Computed tomography (CT) was performed after myelography. The safety of iohexol was assessed by monitoring adverse reactions and neurologic status and by measuring vital signs and serum laboratory values. The most frequent adverse reaction was headache (16 of 81 patients [19.7%]). Twelve patients complained of a headache on the day of the myelographic procedure, and four patients reported a headache 24 hours after the procedure. Nausea or vomiting occurred in four of 81 patients (4.9%) only on the day myelography was performed. No other neurologic abnormalities were found. Iohexol produced myelographic and CT studies of good to excellent quality in all patients. This study indicates that iohexol can be employed safely in lumbar myelography of adult outpatients.

Adult↗
PubMed2005

Clinical features of chronic pancreatitis in Korea: a multicenter nationwide study.

BACKGROUND/AIMS: No reliable nationwide clinical data about chronic pancreatitis (CP) was available in Korea. The etiology and clinical features of CP were investigated using a multicenter nationwide study. METHODS: 814 cases of CP were enrolled retrospectively over the past 4 years at 13 hospitals. The following data were obtained from all patients: etiology, symptoms, complications, and surgery. RESULT: Alcohol (64.3%) was the major cause of CP and idiopathic CP (20.8%) was the second most common form. Mean patient age was 50.6 years and the male:female ratio was 6:1 (24:1 for alcoholic CP vs. 2:1 in idiopathic CP, p < 0.001). Diabetes (31.6%), pseudocysts (28.4%), biliary stricture (13.9%), and pancreatic ascites (6.6%) were the main complications. Of these, diabetes (35 vs. 26%) and pseudocyst (33.7 vs. 21.9%) were more frequent in alcoholic than in idiopathic CP. Pancreatic cancer developed in 25 patients (3.1%) during follow-up and their mean age was 59.1 years. CONCLUSIONS: In Korea, alcohol is the most common etiology of CP. Moreover, diabetes and pseudocysts are frequent complications, especially in alcoholic CP, and pancreatic cancer development is not infrequent.

Age Distribution↗
PubMed1989

Efficacy of tianeptine in anxious-depressed patients: results of a controlled multicenter trial versus amitriptyline.

265 adult outpatients with dysthymic disorder (DSM-III) associated with clinically manifest anxiety (according to FDA criteria) were included in a multicenter, randomized double-blind study. The trial consisted of three phases: placebo pretreatment phase and inclusion in the trial, treatment phase, placebo posttreatment phase. Patients were treated in monotherapy for 42 days with a mean dosage of 3 tablets per day corresponding to 37.5 mg/day of tianeptine or 75 mg/day of amitriptyline respectively. The following assessment instruments were used: the Montgomery and Asberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HARS), and the Check-List for the Evaluation of Somatic Symptoms of J.D. Guelfi and C.B. Pull (CHESS 82). Analysis of MADRS total scores showed an important and rapid improvement in tianeptine and amitriptyline groups, reaching statistical significance as soon as D7. At the end of the 6-week treatment period the tianeptine group reached a decrease of 64% in the initial MADRS total score versus 69% in the amitriptyline group. 78% of patients treated with tianeptine and 83% of patients treated with amitriptyline were considered as treatment responders. There was no difference in drop-out rates between the two groups. HARS scores showed a decrease in psychic as well as somatic anxiety in both groups. The action of tianeptine on anxious-depressive symptomatology was confirmed by the concomitant improvement of global clinical rating and patients' self-rating (HSCL). Statistical comparison of all clinical rating-scale scores in patients having completed the trial failed to show any significant group differences.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗