Clinical safety of enamel matrix derivative (EMDOGAIN®) in the treatment of periodontal defects

Abstract The aim of the present clinical trial was to test tolerability during 2 treatments with EMDOGAIN® in a large number of patients. An open, controlled study design in 10 Swedish specialist clinics was chosen, with a test group of 107 patients treated with EMDOGAIN® in connection with periodontal surgery at 2 surgical test sites per patient. The procedures were performed 2 to 6 weeks apart on one-rooted teeth with at least 4 mm deep intraosseous lesions. A control group of 33 patients underwent flap surgery without EMDOGAIN® at I comparable site. In total 214 test and 33 control surgeries were performed. Serum samples were obtained from test patients for analysis of total and specific antibody levels. 10 of the patients had samples taken before and after the first surgery. 56 other samples were taken after one treatment with EMDOGAIN®, and 63 after 2 treatments. None of the samples, not even from allergy-prone patients after 2 treatments, indicated deviations from established baseline ranges. This indicates that the immunogenic potential of EMDOGAIN® is extremely low when applied in conjunction with periodontal surgery. Comparison between the test and control groups demonstrated the same type and frequency of post-surgical experiences, i.e., reactions caused by the surgical procedure itself. Clinical probing and radiographic evaluation was performed at baseline and 8 months postsurgery. About half of the patients (44 test and 21 control) were also evaluated after 3 years. There was a significant difference between the test and control results at 8 months post surgery. and this difference had increased further at the 3 year follow-up. The 2.5–3 mm increase in attachment and bone level after treatment with EMDOGAIN® was of the same magnitude as seen in the studies with split-mouth design aiming for lest of effectiveness of EMDOGAIN®.     

Cerebral function of the guinea pig neonate after chronic intrauterine exposure to khat (Catha edulis Forsk.)

Cerebral function in normoxia and its reactions to standard periods of hypoxia of increasing severity were studied in 30 newborn guinea pigs less than 3 days old. Intrauterine growth retardation was induced either by uterine artery ligation at midgestation or by feeding the female in late gestation with khat leaves, an amphetamine-like stimulant chewed by men and women in several countries in eastern Africa and Arabia. After spontaneous delivery, the neonates were anesthetized and ventilated. Cardiovascular, metabolic, and neurophysiologic (somatosensory evoked potentials) parameters were monitored. Under normoxia, the khat-exposed group showed prolonged latency of the primary response of the somatosensory evoked potentials and a reduced amount of secondary components. Under hypoxia, this group also has a greater reduction of amplitude of the somatosensory evoked potentials. It is concluded that khat exposure during fetal life has an impact on the cerebral function during the neonatal period (at least up to 3 days of age) which is not solely explained by the concomitantly produced growth retardation.     

Right Hepatic Lobectomy Using the Staple Technique in 101 Patients

Background Application of linear stapling devices for extrahepatic vascular control in liver surgery has been well-established. However, the technique for use of stapling devices in hepatic parenchymal transection is not well defined. Purpose To describe the safety and efficacy of our technique for use of vascular stapling devices in hepatic parenchymal transection during open right hepatic lobectomy is the purpose of this study. Methodology We reviewed our experience with 101 consecutive open right hepatic lobectomies performed by a single surgeon between January 2003 and July 2006, in which vascular staplers were utilized for the parenchymal transection phase. Results Of the 101 patients who underwent resection, 53 (52%) were female. The mean age was 58 years. Malignant disease was the indication for resection in the majority of patients (88%). Of those with cancer, 78% (69 of 89) had metastatic colorectal cancer, 6% (5 of 89) had metastatic neuroendocrine tumor, 4% (4 of 89) had hepatocellular carcinoma, 4% (4 of 89) had cholangiocarcinoma, and the remaining 8% were other metastatic cancers. Twelve patients (12%) underwent resection for hepatic adenoma or symptomatic benign disease (FNH or hemangioma). Forty-eight patients (48%) underwent a major ancillary procedure at the time of hepatic resection. Thirty-nine patients (39%) had a nonanatomic wedge resection of a left lobe lesion, 27 patients (27%) had one or more lesions treated with radiofrequency ablation (RFA), and 6 patients (6%) were treated with a synchronous bowel resection. The median total operative time was 336 min (range 155–620 min). A Pringle maneuver for temporary vascular inflow occlusion was utilized in all cases, with a median time of 9 min (range 4–17 min). Ten patients (10%) required blood transfusion during surgery or in the postoperative period. The maximum transfusion was 2 U of packed red blood cells (PRBC) in seven patients and 1 U of PRBC in three patients. The mean nadir postoperative hematocrit was 28.2. All patients with malignant disease had tumor-free margins at the completion of the procedure. The average hospital length of stay was 6.0 days. One patient (1%) developed a clinically significant bile leak requiring a postoperative endoscopic retrograde cholangiography (ERCP). No patient required reoperation. The 30 and 60-day postoperative survival was 100%. Conclusion These findings indicate that application of vascular stapling devices for parenchymal transection in major hepatic resection is a safe technique, with low transfusion requirements and minimal postoperative bile leak. The technique allows for rapid transection of the entire right hepatic lobe in under 10 min. Short video clips of the technique will be demonstrated. Presented at the 2007 American Hepato–Pancreato–Biliary Association, Las Vegas, Nevada, April 19–22, 2007 (oral presentation/video presentation).     

Brain type creatine kinase in relation to oxygen desaturation in the blood of children with congenital heart disease

The concentration of brain type creatine kinase (CK-BB) was measured in blood from the internal jugular vein in 32 children (less than 1 year old) with congenital heart disease. In transposition of the great arteries the CK-BB levels were significantly higher than in children without cyanosis (10.1 +/- 4.1 vs. 3.0 +/- 0.5 ng/ml). A negative correlation was found for CK-BB concentration and arterial oxygen saturation (r = -0.41, p less than 0.02 for all children and r = -0.62, p less than 0.05 for those with tetralogy of Fallot). It is suggested that the increased CK-BB levels in the blood of cyanotic children reflect chronic cerebral hypoxia, which may explain other reports of reduced psycho-intellectual function in patients with cyanotic heart disease.     

Preventing the airborne spread of Staphylococcus aureus by persons with the common cold: effect of surgical scrubs, gowns, and masks.

OBJECTIVE: Transmission of Staphylococcus aureus via air may play an important role in healthcare settings. This study investigates the impact of barrier precautions on the spread of airborne S. aureus by volunteers with experimentally induced rhinovirus infection (ie, the common cold). DESIGN: Prospective nonrandomized study. SETTING: Wake Forest University School of Medicine (Winston-Salem, NC).Participants. A convenience sample of 10 individuals with nasal S. aureus carriage selected from 593 students screened for carriage. INTERVENTION: Airborne S. aureus dispersal was studied in the 10 participants under the following clothing conditions: street clothes, surgical scrubs, surgical scrubs and a gown, and the latter plus a face mask. After a 4-day baseline period, volunteers were exposed to a rhinovirus, and their clinical course was followed for 12 days. Daily swabs of nasal specimens, pharynx specimens, and skin specimens were obtained for quantitative culture, and cold symptoms were documented. Data were analyzed by random-effects negative binomial models. RESULTS: All participants developed a common cold. Incidence rate ratios (IRRs) indicated that, compared with airborne levels of S. aureus during sessions in which street clothes were worn, airborne levels decreased by 75% when surgical scrubs were worn (P<.001), by 80% when scrubs and a surgical gown were worn (P<.001), and by 82% when scrubs, a gown, and a face mask were worn (P<.001). The addition of a mask to the surgical scrubs and gown did not reduce the airborne dispersal significantly (IRR, 0.92; P>.05). Male volunteers shed twice as much S. aureus as females (incidence rate ratio, 2.04; P=.013). The cold did not alter the efficacy of the barrier precautions. CONCLUSIONS: Scrubs reduced the spread of airborne S. aureus, independent of the presence of a rhinovirus-induced cold. Airborne dispersal of S. aureus during sessions in which participants wore surgical scrubs was not significantly different from that during sessions in which gowns and gowns plus masks were also worn.     

Myocardial metabolism during aortic valve replacement. II. Bolus infusion of cold blood for cardioplegia

Myocardial energy metabolism during hypothermic potassium cardioplegia with blood as the cardioplegia vehicle, given in one or two bolus doses, was studied in eight patients undergoing aortic valve replacement. Myocardial biopsies were taken from the left ventricle 10 min after aortic cross-clamping (a.c.) and immediately before declamping (d.c.) and were analyzed for ATP, creatine phosphate (CP), creatine (C) and lactate. The interindividual range of myocardial temperature was 11-19 degrees C at 10 min a.c. and 11-25 degrees C immediately before d.c. The myocardial ATP concentration fell (17.2 +/- 5.7-12.8 +/- 2.8 mmol X kg-1 dry muscle), the lactate concentration rose (64.7 +/- 35.8-136 +/- 33.8 mmol X kg-1 d.m.) and the total creatine pool (CP + C) was unchanged. Hypothermic blood cardioplegia conferred fairly good initial protection of the myocardium, but the reduction in ATP and the great lactate accumulation towards the end of cardioplegia, especially in patients with myocardial temperature reaching 19-25 degrees C, indicates that such protection is adequate only if the myocardial temperature is maintained between 11 and 18 degrees C.     

Growth hormone stimulates granulation tissue formation and insulin-like growth factor-I gene expression in wound chambers in the rat.

It has been reported that GH stimulates fibroblast growth and wound healing. In the present study we measured the effect of locally applied GH on insulin-like growth factor (IGF-I) mRNA concentrations and granulation tissue formation in wound cylinders, implanted s.c. Four stainless-steel wiremesh cylinders were implanted s.c. in the back of male rats (280 g). Each cylinder was then injected every day with either 0.014 or 0.14 U human GH, or vehicle only. Ingrown granulation tissue and wound fluid was obtained on day 17 after implantation. The wet weight of granulation tissue was determined and concentrations of IGF-I mRNA in the tissue were measured by solution hybridization/RNAase protection assay. Similar assays were used to measure the levels of IGF-I receptor mRNA and GH receptor mRNA, while the IGF-I concentration in wound fluid and serum was determined by radioimmunoassay (RIA) after acid-ethanol extraction. The concentrations of IGF-I mRNA in ingrown granulation tissue as well as the wet weight of this tissue were significantly higher in the GH-treated cylinders. There was no significant effect of GH on IGF-I receptor mRNA and GH receptor mRNA levels. Consistent with the results of previous studies, wound fluid IGF-I levels were lower than serum IGF-I levels, but no significant difference was found between the GH-treated cylinders and the control cylinders. The results of the present study show that GH stimulates granulation tissue formation and increases the concentration of IGF-I mRNA in the ingrown granulation tissue.     

Ethical Reasoning Among Registered Nurses Experienced in Dementia Care

Abstract. Registered nurses regarded as “experienced and good” in dementia care were interviewed about the feeding of a severely demented patient who showed refusal-like feeding behaviour. Not one of the twenty nurses could see herself using force against her patients. Most interviewees justified their decisions to feed a severely demented patient and answered questions about whether they would change their minds if there were certain circumstances in terms of words that could be interpreted as referring to the ethical principle of beneficence. The nurses stressed the difficulty to understand the meaning of severely demented patients' feeding behaviour and decide when force-feeding occurs. When asked to rank ethical principles of importance for the decision, however, the most common answer was that they would give priority to the ethical principle of autonomy. The nurses did not see the ethical principles as separate entities, that could be applied one by one, but tried to integrate them into a whole. The findings of this study were interpreted as indicating that principled ethics is not an adequate model to describe experienced nurses' ethical reasoning.