Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial.

BACKGROUND: Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs). OBJECTIVES: To determine whether silicone foam dressings in addition to standard prevention reduce the incidence of PUs of category 2 or worse compared with standard prevention alone. METHODS: This was a multicentre, randomized controlled medical device trial conducted in eight Belgian hospitals. At-risk adult patients were centrally randomized (n = 1633) to study groups based on a 1 : 1 : 1 allocation: experimental groups 1 (n = 542) and 2 (n = 545) - pooled as the treatment group - and the control group (n = 546). The experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on the relevant body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU of category 2 or worse at the studied body sites. RESULTS: In the intention-to-treat population (n = 1605), PUs of category 2 or worse occurred in 4·0% of patients in the treatment group and 6·3% in the control group [relative risk (RR) 0·64, 95% confidence interval (CI) 0·41-0·99, P = 0·04]. Sacral PUs were observed in 2·8% and 4·8% of the patients in the treatment group and the control group, respectively (RR 0·59, 95% CI 0·35-0·98, P = 0·04). Heel PUs occurred in 1·4% and 1·9% of patients in the treatment and control groups, respectively (RR 0·76, 95% CI 0·34-1·68, P = 0·49). CONCLUSIONS: Silicone foam dressings reduce the incidence of PUs of category 2 or worse in hospitalized at-risk patients when used in addition to standard of care. The results show a decrease for the sacrum, but no statistical difference for the heel and trochanter areas.

Evaluation of current treatment techniques for distal radius fractures amongst Belgian orthopaedic surgeons.

This online questionnaire was initiated to investigate if a consensus on the treatment of distal radius fractures amongst orthopaedic surgeons in Belgium exist. Two cases were presented: an extra-articular fracture, with dorsal displacement (Frykman type I) and a displaced intra-articular fracture (Frykman type VII). Treatment of choice and rationale of choice were investigated. 158 responses were collected. In case of a Frykman type I, the majority of surgeons would have performed a closed reduction and intrafocal K-wiring (37.3%) or volar plating (34.8%). In case of a Frykman type VII, volar plating was the primary treatment of choice (66.5%), closed reduction and K-wiring was chosen in 24.7% and external fixation in 4.4%. We cannot conclude on a consensus in treatment choice amongst Belgian orthopaedic surgeons. Compared to previous research, an increase in the use of volar plating in intra- as well as in extra-articular distal radius fractures was noticed.

Massive Hemi-facial Edema After Permanent Filler Removal in an HIV-Positive Patient. Precautions and Patient Information.

UNLABELLED: HIV-related lipodystrophy and facial lipo-atrophy are well-described problems stigmatizing many HIV patients. As these patients often require large volumes of filler material, a more permanent solution is necessary. Before the popularization of lipofilling, synthetic permanent fillers have mostly been used. We describe a case report of a patient who had undergone removal of a permanent filler, polyacrylamide gel, because of dislocation of the filler, but who presented a massive hemi-facial edema immediately after the removal. Swelling subsided after 5 days. The use of permanent fillers has diminished due to frequent early and late complications, but a high awareness for permanent filler removal complications remains necessary. Possible pathways to explain these late complications are described. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The propeller flap concept used in vaginal wall reconstruction.

Most posterior vaginal wall defects are due to abdominoperineal resection for colorectal carcinoma involving the posterior vaginal wall or resection of local malignancies. The rectus abdominis myocutaneous flap, the modified Singapore flap and the gracilis myocutaneous flap remain workhorse solutions for this type of vaginal reconstruction. The introduction of the perforator concept has introduced new therapeutic options using the gluteal donor site region. Recently, perforator-based gluteal flaps have been described as a reliable solution for reconstruction of posterior vaginal wall defects, with low donor site morbidity. Here, we present a new technique to optimise results and minimise morbidity to the patient.

Cardioscopy and robotic assistance for the diagnosis of intraventricular endocarditis.

A 44-year-old male patient with an undefined mass in the left ventricular endocardium was scheduled for minimally invasive cardiac surgery. Ventricular investigation and tissue biopsies were completed with the help of a voice-controlled robotic arm. Pathologic examination revealed non-bacterial thrombotic endocarditis. In addition to videoscopy, robotic assistance allows an easier diagnostic and therapeutic approach of intraventricular pathologies.

A double-blind crossover comparison study of the safety and efficacy of mebeverine with mebeverine sustained release in the treatment of irritable bowel syndrome.

The safety and efficacy of the sustained release (SR) mebeverine capsule was compared to the standard plain mebeverine capsule in the treatment of 60 patients suffering from irritable bowel syndrome. Patients, with a score of at least 44 on the Kruis scale, were randomized into a two-period crossover trial. Each treatment period lasted for 6 weeks during which the patients took mebeverine plain 135 mg, two capsules t.i.d., or mebeverine sustained release 200 mg (SR), two capsules b.i.d. After 6 weeks of each treatment, both treatments were regarded 'effective' or 'very effective' by the patient as well as the investigator in more than 80% of the cases. After 3 weeks of the first treatment, the disease score was rated light in 73% of the patients with both medications. After 6 weeks, nine patients (33%) were symptom-free with mebeverine plain, and five (18%) with mebeverine SR. During the second treatment period the number of symptom-free cases reached about 40% with both formulations. Considering the clinical general improvement, more than 70% of all patients had improved after 3 weeks of the first treatment. An additional improvement was reported in 13 patients with mebeverine plain and in 10 patients with mebeverine SR after the next 3 weeks. Abdominal pain was still present in more than 50% of patients but with lower intensity compared with baseline values. Mean scores of efficacy were very similar for both treatments after 3 and 6 weeks (2.0 for mebeverine plain vs. 1.9 for mebeverine SR). The statistical comparison of all scores between the two formulations did not show a significant difference at any time. Very few adverse events were noted and a causal relationship with the study medications was judged as improbable or definitely unrelated. Compliance was close to 100% for most of the patients. The results of the present study indicate that the mebeverine SR capsule provides equivalent efficacy and tolerance to mebeverine plain in the treatment of irritable bowel syndrome (IBS), while reducing the number of daily doses from three to two.

Epidemiological data of patients treated with fluvoxamine: results from a 12 week non-comparative multicentre study.

In an open multicentre study designed to closely reflect the clinical situation, 315 out-patients diagnosed by their psychiatrist as having depression and/or obsessive-compulsive disorder (OCD), and/or panic disorder, were treated for 12 weeks with fluvoxamine (100-300 mg/day). Twelve weeks of fluvoxamine therapy was completed by 229 (73%) patients. Longer illness duration prior to treatment was associated with a significantly reduced rate of treatment withdrawal, whereas a diagnosis of OCD was predictive of treatment withdrawal. The main reasons patients discontinued fluvoxamine therapy were adverse effects experienced before Week 8, and clinical improvement thereafter. Age, sex, and diagnosis had no predictive value for treatment outcome; however, psychiatric antecedents and duration and severity of illness at baseline were significant predictors of disease severity at endpoint. Fluvoxamine decreased both the frequency and severity of baseline symptoms, with improvement continuing for the duration of the study. Nausea was the only symptom to show an initial increase in frequency and severity, but this subsided after 4 weeks to levels below baseline frequency and severity.

Mutagenic activity of dichloroethylamino derivatives of nitronaphthofuran and some nitrobenzofurans in the Salmonella/microsome assay.

The mutagenic activity of five dichloroethylamino 2-nitrobenzofuran derivatives and one dichloroethylamino 2-nitronaphthofuran derivative was analysed in the Salmonella/microsome assay. We investigated the influence of the position of the dichloroethylamino and/or the methoxy groups on the mutagenic activity of these nitro arenofurans in S. typhimurium strain TA100 and its variant TA100NR, deficient in nitroreductase. Without metabolic activation 7-[bis(2-chloroethyl)amino]-2-nitronaphtho[2,1-b]furan (1), 4-[bis(2-chloroethyl)amino]-7-methoxy-2-nitrobenzofuran (2), 7-[bis(2-chloroethyl)amino]-4-methoxy-2-nitrobenzofuran (5) and 6-[bis(2-chloroethyl)amino]-2-nitrobenzofuran (6) are mutagenic in TA100, while 4-[bis(2-chloroethyl)amino]-5-methoxy-2-nitrobenzofuran (4) is weakly mutagenic and 5-[bis(2-chloroethyl)-amino]-2-nitrobenzofuran (3) toxic. In the NR deficient strain compounds 1, 3 and 6 are strong mutagens and 4 is weakly positive. The two isomers 2 and 5 are negative in that strain. The naphthofuran derivative 1 is highly mutagenic in the absence of S9 mix in both strains considered, but less than R7000 (7). A decrease in the electronic polarity of compound 1 versus compound 7 according to the hypothesis developed by Royer et al. is a possible explanation. After exogenous metabolic activation by S9 mix all the compounds tested are highly mutagenic in both Salmonella strains. The position of the dichloroethylamino group and/or the presence of a methoxyl on the alpha-nitroarenofuran derivatives seem to modify the activity of bacterial as well as exogenous nitroreductases or other activating enzymes.

Efficacy, safety and tolerance of oral sustained-release ritodrine given after intravenous administration in the treatment of premature labor.

45 patients in premature labor entered the study, four dropped out for administrative reasons. The remaining 41 patients started all with an intravenous treatment followed by oral treatment with sustained-release ritodrine at a daily dosage of 120 mg per day until the 36th week of gestation. The mean gestational age at entry was 31.26 weeks +/- 3.27 and at delivery 37.76 weeks +/- 2.11 or a mean gain in days of 44.61 days +/- 20.85. A cluster analysis splitting the patients into four groups regarding the gestational age at entry and the Baumgarten tocolytic index showed that even the high-risk patients benefit remarkably by the treatment. The side effect rate was low as well for palpitation as for tremor. The patient compliance was excellent. No neonatal deaths or stillborns occurred during this study.

In-vivo carcinogenicity of 2-nitro-oxaphenalenes.

2-Nitro-oxaphenalenes are synthetic chemicals which were synthesized in the authors' laboratory. They are the most efficient mutagenic compounds on mammalian cells in culture. They are chemically related to the nitro-naphthofuran family by the displacement of the heterocycle on the naphthalene ring. Since nitro-naphthofurans have a strong mutagenic activity in bacterial tests without metabolic activation and are active in-vivo carcinogens, the purpose of this study was to demonstrate the carcinogenic activity of two 2-nitro-oxaphenalenes. The two compounds were injected s.c. into Wistar rats initially 6-weeks-old. They were dissolved in dimethylsulfoxide (DMSO) at a concentration of 1 mg/ml. A s.c. injection of 0.5 ml containing 0.5 mg of carcinogen was given once a week in the neck of each animal tested. Five control animals were not injected and five animals received 0.5-ml injection of DMSO every week to serve as a control. The animals developed tumors only at the site of injection. The tumors were classified as high grade fibrosarcomas. This experiment demonstrates that: (i) 2-nitro-oxaphenalenes are very active in-vivo carcinogens in rats; (ii) there is a good correlation between the high mutagenic activity especially in mammalian tests and the strong carcinogenicity of the compounds; and (iii) the presence of a 6-methoxy group increases by two-fold the carcinogenic potential.

Comparison of two equine oestrogen-dydrogesterone regimens in the climacteric.

Menopausal women receiving 0.625 mg/day conjugated oestrogen continuously for 6 mth were also given either 10 mg/day dydrogesterone continuously or 20 mg/day for the first 12 days of each calendar month in order to evaluate both the efficacy and the tolerance of each regimen. The following parameters were assessed: subjective symptoms, bleeding patterns, lipid metabolism, glycaemia, weight and blood pressure. Of the 81 patients who entered the study, 60 opted for the continuous treatment and 21 for the cyclic treatment. Seven (7) patients dropped out, 6 for administrative reasons and 1 because of nausea. The two groups were comparable with regard to all parameters, with the exception of the duration of pretreatment amenorrhoea, which was longer in the continuous-treatment group (40.6 vs. 19.1 mth), and the initial lipid profile levels, which were higher in the same group. The subjective symptoms were influenced rapidly and positively by both treatments. The other parameters remained unchanged, except for a clinically insignificant rise in triglycerides in both groups. Both treatments were quite satisfactorily accepted by the patients, in spite of a 70% rate of withdrawal bleeding in the cyclic group and a 40% rate of spotting in the continuous-treatment group. Sixty-two (62) patients remained free of side effects, while mastodynia was reported in 9 cases.

Genotoxic effects of glycidyltrimethylammonium chloride.

Evaluation of the genotoxicity of epoxides is best carried out on a case by case basis. Although glycidyltrimethylammonium chloride (GTAC) is widely used in several industrial applications, its genotoxicity is poorly documented. Therefore, we have evaluated GTAC in a battery of 4 in vitro short-term tests for genotoxicity. We report here that GTAC mediates the induction of base-pair substitutions in S. typhimurium, gene conversion in S. cerevisiae (D7), chromosomal aberrations in CHO cells and viral DNA amplification in Chinese hamster CO6O cells. In view of these results, it is advisable to consider GTAC a potential carcinogen.

Prognostic factors in the myelodysplastic syndromes: importance of initial data on peripheral blood counts, bone marrow cytology, trephine biopsy and chromosomal analysis.

An analysis of clinical, haematological, histological and cytogenetic data was performed in 85 consecutive patients with myelodysplastic syndromes (MDS). The criteria for diagnosis of refractory anaemia (RA), acquired idiopathic sideroblastic anaemia (AISA) and chronic myelomonocytic leukaemia (CMML) were clearly defined, since the inclusion criteria provided by the FAB co-operative group are imprecise. None of these patients has received chemotherapy during the follow-up period. The median survival of the whole group was only 15 months, with less than 10% of the patients surviving after 5 years. Fifteen patients (17.6%) were still alive at time of analysis, 31 (36.5%) have developed acute myeloid leukaemia (AML) and only one of them is still alive; 30 (35.3%) died of infectious and/or haemorrhagic complications. Patients who developed AML had a shorter survival (median survival time 9.5 versus 15 months) but this difference was not significant (P = 0.10). Factors with prognostic value are in order of significance: abnormal localized immature myeloid precursors (= ALIP) in the trephine biopsy, circulating myeloblasts, excess of blasts in the bone marrow smears, age, FAB classification and granulocyte count. In comparison to refractory anaemia with excess of blasts (RAEB), CMML and RAEB in transformation (RAEBt), patients with RA and AISA had a lower incidence of evolution to AML (11% versus 56%), but a higher mortality rate from infections and/or bleeding (59.2% versus 29%). ALIP negative cases were only found among patients with RA and AISA, whereas ALIP positivity was observed in all cases of RAEB and RAEBt, in 10/11 patients with CMML and in almost half the cases of RA and AISA. In RA and AISA patients survival was significantly different between ALIP positive and ALIP negative cases (P = 0.009). Among MDS patients, ALIP negative cases developed significantly less AML than ALIP positive cases (5% versus 44%), but a similar percentage of mortality from infectious and/or haemorrhagic complications was seen in both groups (33% versus 36.5%). Chromosomal analysis proved to be of no significant prognostic value, although a trend for shorter survival was observed in patients with complex karyotype anomalies or without mitoses. Because of their prolonged survival, antileukaemic chemotherapy is contra-indicated in ALIP negative patients (median survival 50 months). Nevertheless they only constitute a minor subgroup of MDS cases. Prognosis in ALIP positive patients is poor (median survival 12.5 months); in these patients therapeutic trials with cytostatic drugs or with inducers of differentiation of myeloid precursor cells seem to be justified.

In vitro activity and human pharmacokinetics of teicoplanin.

The in vitro activity of teicoplanin, a new antibiotic related to vancomycin, was determined against 456 gram-positive cocci. The activity of teicoplanin in comparison with that of vancomycin was similar against staphylococci but 4 to 40 times higher against enterococci and beta-hemolytic and viridans streptococci. The single-dose pharmacokinetics of teicoplanin were studied in six healthy volunteers after administration of 3 and 6 mg/kg intravenously and of 3 mg/kg intramuscularly. The kinetic parameters after both intravenous doses were very similar. The curves for concentration in plasma for the 3- and 6-mg/kg intravenous doses showed a triexponential decline with elimination half-lives of 47.3 and 44.1 h, respectively. The percentages of the doses recovered in urine (0 to 102 h) were 43.2 and 44.1%, respectively. The areas under the plasma curves were dose related: 256.5 and 520.9 micrograms/h per ml, respectively. The bioavailability of teicoplanin after injection of 3 mg/kg intramuscularly was 90%, and the peak level was 7.1 micrograms/ml. The mean levels in plasma 24 h after the 3-mg/kg doses were 2.1 and 2.3 micrograms/ml, respectively, and the mean level in plasma 24 h after the 6-mg/kg intravenous dose was 4.2 micrograms/ml.

Bone marrow histology in myelodysplastic syndromes. I. Histological findings in myelodysplastic syndromes and comparison with bone marrow smears.

Forty bone-marrow trephine biopsies of patients with myelodysplastic syndromes (MDS) were studied and compared with bone marrow smears. It proved possible to make the diagnosis of MDS on the basis of bone-marrow biopsies. Features of abnormal erythropoiesis and myelopoiesis, although different from those observed in smears, were easily detectable. Moreover, obvious advantages of bone-marrow biopsy over bone-marrow smears were found. Firstly, the biopsy in MDS gives an exact assessment of the cellularity; secondly, the presence of reticulin fibres, increased in the majority of the cases, can be evaluated; thirdly, dysmegakaryopoiesis is more easily detected in trephine biopsies than in smears; finally, abnormal behaviour of myeloblasts, clustering centrally in the bone marrow, is frequently observed before the smears show an excess of myeloblasts. The bone-marrow biopsy also has a role in difficult cases, where the diagnosis of MDS can not be established on just bone-marrow smears. The five types of MDS, as described by the FAB group, do not represent recognizable histological entities.