COMPRES: a prospective postmarketing evaluation of the compression anastomosis ring CAR 27(™) /ColonRing(™).

AIM: Preclinical studies have suggested that nitinol-based compression anastomosis might be a viable solution to anastomotic leak following low anterior resection. A prospective multicentre open label study was therefore designed to evaluate the performance of the ColonRing(™) in (low) colorectal anastomosis. METHOD: The primary outcome measure was anastomotic leakage. Patients were recruited at 13 different colorectal surgical units in Europe, the United States and Israel. Institutional review board approval was obtained. RESULTS: Between 21 March 2010 and 3 August 2011, 266 patients completed the study protocol. The overall anastomotic leakage rate was 5.3% for all anastomoses, including a rate of 3.1% for low anastomoses. Septic anastomotic complications occurred in 8.3% of all anastomoses and 8.2% of low anastomoses. CONCLUSION: Nitinol compression anastomosis is safe, effective and easy to use and may offer an advantage for low colorectal anastomosis. A prospective randomized trial comparing ColonRing(™) with conventional stapling is needed.

A national survey by the SDMA: use of evidence in nursing practice.

OBJECTIVE: Recently, two surveys were conducted by the Surgical Dressing Manufacturers Association (SDMA) to investigate the evidence required to support wound care products. These showed very clearly that industry provides significant amounts of evidence in a way that appears to meet the expectations of relevant health professionals and their practice for treating patients with wounds. The responses of health professionals refuted the opinion that evidence may be lacking for wound care products. Hopefully, the results of these surveys also add weight to the argument that the Cochrane Review approach is not always the most appropriate for wound care-where the comorbidities of patients are variable and often plural.

Clinical audit of a lymphoedema bandaging system: a foam roll and cohesive short stretch bandages.

OBJECTIVE: Late-stage lymphoedema is characterised by chronic swelling, shape distortion, inflammatory processes and tissue fibrosis. Our aim was to perform a clinical audit of a lymphoedema compression bandaging system (Rosidal Soft foam roll layer and figure-of-eight application of Actico cohesive inelastic bandages) specifically designed for patients with late stage lower limb lymphoedema. METHOD: The audit explored suitability of the bandaging system, benchmarking limb volume changes with research evidence, and reporting patient and practitioner evaluations. RESULTS: A mean reduction (33%) in excess limb volume was reported for the 11 patients with unilateral lymphoedema who completed a course of bandaging over 12 days. Mean percentage reduction of absolute limb volume after treatment was 8%. Patient and practitioner evaluations indicated the suitability of this bandage system for patients with late stage lymphoedema in terms of comfort and effectiveness. CONCLUSION: The bandaging system is suitable for patients with late stage chronic swelling. Two parameters for calculating change in limb volume are not interchangeable. Future evaluation of the bandaging system, using validated outcome measures within a comprehensive research study is required. DECLARATION OF INTEREST: Activa Healthcare provided financial support to the project and supplied the materials.

Update to RIFM fragrance ingredient safety assessment, 4-hexen-1-ol, 5-methyl-2-(1-methylethenyl)-, CAS registry number 58461-27-1.

4-Hexen-1-ol, 5-methyl-2-(1-methylethenyl)- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data show that 4-hexen-1-ol, 5-methyl-2-(1-methylethenyl)- is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to 4-hexen-1-ol, 5-methyl-2-(1-methylethenyl)- is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data from read-across analog 3-methylbut-3-en-1-ol (CAS # 763-32-6) show that there are no safety concerns for 4-hexen-1-ol, 5-methyl-2-(1-methylethenyl)- for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 4-hexen-1-ol, 5-methyl-2-(1-methylethenyl)- is not expected to be photoirritating/photoallergenic. The environmental endpoints were evaluated; 4-hexen-1-ol, 5-methyl-2-(1-methylethenyl)- was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients, based on its current volume of use (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.

SAP-containing dressings exhibit sustained antimicrobial effects over 7 days in vitro.

OBJECTIVE: To investigate the antimicrobial activity of SAP-containing wound dressings in vitro over a prolonged period of time (7 days) and to assess their ability to sustain the antimicrobial effect. METHOD: SAP dressings were tested according to the JIS L 1902:2002 against the pathogens Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli and Candida albicans.Additionally, effect on S. aureus and P. aeruginosa growth was investigated after a prolonged incubation period of 7 days. Furthermore, both SAP dressings were repeatedly inoculated with P. aeruginosa suspension and, after 7 days, microbial growth under the dressings was evaluated. RESULTS: Both SAP-containing wound dressings tested exhibited a significant to strong antimicrobial activity against Staphylococcus aureus, MRSA, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli, and Candida albicans in vitro. Moreover, it could be shown that they were able to sustain antibacterial efficacy over a prolonged period of time. Using a direct incubation method with repeated re-inoculation of the dressing samples, it could be shown that growth of P. aeruginosa was reduced after 4 days of treatment and completely inhibited after 7 days. No significant differences were observed between the two SAP-dressings tested. CONCLUSION: These in vitro experiments impressively demonstrated the antimicrobial mechanism of SAP-containing wound dressings: rapid up-take of fluid, binding of microorganisms to the SAP-core, and retention of the bacteria inside the dressing. Moreover, it could be shown that they are able to exhibit their antimicrobial activity over a prolonged period of time unless the amount of fluid present exceeds their fluid-handling capacity.

RIFM fragrance ingredient safety assessment, 2,4,6-cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)-, CAS Registry Number 499-44-5.

The existing information supports the use of this material as described in this safety assessment. This material has not been fully evaluated for photoallergenic potential. 2,4,6-Cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data show that 2,4,6-cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)- is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to 2,4,6-cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)- is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The skin sensitization endpoint was completed using the Dermal Sensitization Threshold (DST) for reactive materials (64 µg/cm2); exposure is below the DST. Based on data, 2,4,6-cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)- is a photoirritant but is not a concern under the current declared use levels. 2,4,6-Cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)- was not evaluated for photoallergenicity. The environmental endpoints were evaluated; for the hazard assessment based on the screening data, 2,4,6-cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)- was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients, based on its current volume of use (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.

Model-guided design of mammalian genetic programs.

Genetically engineering cells to perform customizable functions is an emerging frontier with numerous technological and translational applications. However, it remains challenging to systematically engineer mammalian cells to execute complex functions. To address this need, we developed a method enabling accurate genetic program design using high-performing genetic parts and predictive computational models. We built multifunctional proteins integrating both transcriptional and posttranslational control, validated models for describing these mechanisms, implemented digital and analog processing, and effectively linked genetic circuits with sensors for multi-input evaluations. The functional modularity and compositional versatility of these parts enable one to satisfy a given design objective via multiple synonymous programs. Our approach empowers bioengineers to predictively design mammalian cellular functions that perform as expected even at high levels of biological complexity.