Sterilization Procedures Research Articles

Single-use versus reusable flexible ureteroscope: Technical and medico-economic aspects

Sate of the art on the indications, methods of implementation and medico-economic considerations of reusable flexible ureteroscopes (URSr) vs single use (URSuu)? Review of the literature (Pubmed) on reusable and single-use ureteroscopes, as well as on the expertise of our center. A PubMed search and narrative review of the data was performed in July 2021. Only articles in French or English were selected. The URSr and URSuu have similar technical characteristics and are suitable for the exploration of the upper urinary excretory tract: treatment of stones of the kidney <2cm or of the ureter. The URSr is the most common type of ureteroscope. URSuu are newer and associated with many advantages: no sterilization procedure, immediate availability of equipment in the operating room, reduced waste production at the institutional level. A hybrid use of URSr and URSuu currently seems to be the best compromise from a medico-economic point of view for high volume centers. In the case of a smaller activity or a secondary site, URSuu are more advantageous and the reduction in purchasing costs should accentuate this benefit. URSr and URSuu are technically similar and allow identical treatment of upper urinary tract pathologies. Their complementary use optimizes the care of urology patients. The barrier to the exclusive use of URSuu remains their cost.

Clinical relevance of masks in the operating room? A systematic review

• Face masks are recommended for sterile procedures, while data supporting this is lacking. • Combining several of the studies favored not wearing a mask in prevention of surgical site infection. • The results indicate no difference in surgical site infections between mask and maskless operations. Face masks are recommended for sterile procedures, while the data supporting this recommendation is lacking. Here we systematically review randomized control trials on mask efficacy in the operating room as a means to preventing surgical site clinical infection. PubMed, Google Scholar, Web of Science, and National Institute for Occupational Safety and Health Publications and Products were searched and articles were included if they fit the criteria of 1) randomized control trial, 2) clinical patient outcomes, 3) mask efficacy, 4) surgery setting, 5) in vivo, and 6) article was in English. The results indicate no difference in surgical site infections between the operations where masks were worn versus the operations where no mask was worn. With such limited evidence and the great cost that accrues from purchasing face masks for all surgical staff, we hope for larger, well designed randomized control trials to evaluate the true clinical efficacy of surgical masks in the operating room.

1387 Audit of Pregnancy Status Documentation in Emergency Admissions to A Tertiary Colorectal Surgery Unit

Abstract Aim Documenting pregnancy status (PS) is an important component of the medical assessment of all females of reproductive age (FRA), defined as age 16-55 years old when admitted to hospital. This audit aims to determine the rate of documentation of PS amongst FRA admitted to a tertiary colorectal surgical unit via the surgical admissions unit (SAU) or transfer from other departments between 01/10/20 – 13/11/20. Method A complete documentation of PS comprises of results of urine or serum (β-hCG) and relevant gynaecological history (i.e., last menstrual period and any contraceptive use) clearly reported in the admission clerk-in. Patients with presenting complaint excluding abdominal pain, current pregnancy, history of hysterectomy or sterilisation procedures were excluded. Results During the audit duration, 29 FRA were admitted of which 13 (44.8%) were included for analysis. Of patients included, 4/9 (44.4%) and 1/4 (25.0%) admitted via SAU or transferred from other departments respectively had a past colorectal history. 4 (30.8%) had complete documentation of PS of which, 3 (75.0%) were patients transferred from other departments. Conclusions Low rates of documentation of PS especially amongst emergency admissions via SAU, is possibly associated with a narrow differential diagnosis influenced by pre-existing colorectal history. This audit did not look at PS documentation prior to any subsequent surgical intervention. A re-audit following the implementation of a guidance poster in SAU is currently underway.

Impacts of NaOCl and Irritrol irrigation solutions with/without autoclave sterilisation on the cyclic fatigue resistance of different nickel-titanium files.

This research aimed to examine the impact of NaOCl and Irritrol solutions with/without autoclave sterilisation on the cyclic fatigue resistance of ProTaper, WaveOne Gold and Reciproc NiTi files. Seventy files in every group were separated into seven subgroups (n = 10) according to irrigation solutions and sterilisation procedures. The mean and standard deviations of the time to fracture was calculated for each group, and the data statistical analysis was performed (P ≤ 0.05). Significantly higher cyclic fatigue resistance was found in Reciproc files than the other types of files. The differences between the control and other subgroups were found to be statistically insignificant (P > 0.05), except for subgroups 5 and 7 (P ≤ 0.05). Immersing NiTi files in NaOCl or Irritrol with sterilisation for three times considerably reduced the cyclic fatigue resistance of these files. Reciproc files exhibited the highest cyclic fatigue resistance in comparison with ProTaper and WaveOne Gold files.

Intervertebral disc decellularisation: progress and challenges.

Intervertebral disc (IVD) degeneration and the consequent low-back pain (LBP) affect over 80 % of people in western societies, constituting a tremendous socio-economic burden worldwide and largely impairing patients' life quality. Extracellular matrix (ECM)-based scaffolds, derived from decellularised tissues, are being increasingly explored in regenerative medicine for tissue repair. Decellularisation plays an essential role for host cells and antigen removal, while maintaining native microenvironmental signals, including ECM structure, composition and mechanical properties, which are essential for driving tissue regeneration. With the lack of clinical solutions for IVD repair/regeneration, implantation of decellularised IVD tissues has been explored to halt and/or revert the degenerative cascade and the associated LBP symptoms. Over the last few years, several researchers have focused on the optimisation of IVD decellularisation methods, combining physical, chemical and enzymatic treatments, in order to successfully develop a cell-free matrix. Recellularisation of IVD-based scaffolds with different cell types has been attempted and numerous methods have been explored to address proper IVD regeneration. Herein, the advances in IVD decellularisation methods, sterilisation procedures, repopulation and biocompatibility tests are reviewed. Additionally, the importance of the donor profile for therapeutic success is also addressed. Finally, the perspectives and major hurdles for clinical use of the decellularised ECM-based biomaterials for IVD are discussed. The studies reviewed support the notion that tissue-engineering-based strategies resorting to decellularised IVD may represent a major advancement in the treatment of disc degeneration and consequent LBP.

Necessity of Education and Training of the Healthcare Staffs Performing Sterilization and Disinfection of Surgical Instruments

The objective of this study is to evaluate the requirements of education among the healthcare staff that performs sterilization and disinfection of surgical instruments in the hospitals. The study was done from 3rd July to 5th August 2020 in a super-specialized hospital in Dhaka, Bangladesh. In the present study, the total sample was 73 which included the nurses and technicians and these people were involved in infection control procedures of the hospitals. Among them, 39 were nurses who completed their diploma or B.Sc in nursing, and 34 were technicians who do not have any degree in medical science. A close-ended questionnaire survey was administered. All 73 staff were invited individually to participate in this cross-sectional survey. Confidentiality of the responses was assured to the participants. The educated healthcare staff had a more positive attitude than the uneducated staff. All the educated staff had a positive attitude on having a centralized sterilization procedure, but the uneducated staff had only 58.52% positive attitude. 100% of the staff who were educated had the awareness of different sterilization and disinfection methods and their harmful effects, but this result was 73.52% in uneducated staff. Almost half of the population did not have an awareness of post sterilization management of surgical instruments. The percentage of positive responses in using different types of sterilization monitoring tools was not satisfactory as few people were not aware of it and the result was 87.17%. But a very poor result had been detected with the same question from the uneducated staffs which was 55.88%. A similar type of result had also been detected in the attitude level of using different types of disinfectants for cleaning surgical instruments. The positive response was 94.87% in educated staff whereas 64.70% in uneducated staff. The uneducated healthcare staffs need to be focused more as we saw there is a huge gap in the positive awareness and attitude level from the above result.

Trying: On Teaching Empathy.

Trying: On Teaching Empathy.

Reusing Face Covering Masks: Probing the Impact of Heat Treatment.

The COVID-19 pandemic resulted in imminent shortages of personal protective equipment such as face masks. To address the shortage, new sterilization or decontamination procedures for masks are quickly being developed and employed. Dry heat and steam sterilization processes are easily scalable and allow treatment of large sample sizes, thus potentially presenting fast and efficient decontamination routes, which could significantly ease the rapidly increasing need for protective masks globally during a pandemic like COVID-19. In this study, a suite of structural and chemical characterization techniques, including scanning electron microscopy (SEM), contact angle, X-ray diffraction (XRD), X-ray photoelectron spectroscopy (XPS), and Raman were utilized to probe the heat treatment impact on commercially available 3M 8210 N95 Particulate Respirator and VWR Advanced Protection surgical mask. Unique to this study is the use of the synchrotron-based In situ and Operando Soft X-ray Spectroscopy (IOS) beamline (23-ID-2) housed at the National Synchrotron Light Source II at Brookhaven National Laboratory for near-edge X-ray absorption spectroscopy (NEXAFS).

Prions and Oral Cavity: The Oblivious Single Handed Protein Machinery

BACKGROUND: The world today is facing an unprecedented situation with the spread of novel COVID-19. Covid era has brought the whole world to its knees. Oral health care professionals are at the risk of acquiring numerous diseases which amounts to occupational hazards. Now is the time to widen our horizons and look at different spectrum of diseases, prions being one of them. The short clinician course and long incubation period poses many challenges to this group of neurodegenerative diseases. AIM: The aim of this review is to highlight uncharted aspects of prions and oral health. REVIEW DETAILS: It sheds light on the spectrum of prion diseases. Since there is no known cure of this dreaded disease and it is ineffective with normal sterilization and disinfection procedures, prevention is the only way ahead. This review highlights the colliding world of prions and human body. This also keeps in mind the precautions and guidelines which will help health care professionals in combating this non curable fatal disease. CONCLUSION: Ensuing endeavors should be undertaken to help find plausible detection techniques, treatment options (if any), precaution and guidelines to be kept in mind to fight off this protein entity.&#x0D;

Role and Responsibility of Nurses in Central Line - Insertion and Maintenance

Introduction -A central venous catheter (CVC) is thin, a flexible tube (catheter) that is placed into a large vein above the Heart. It may be inserted through A vein in the Neck, (internal jugular) chest (subclavian vein. Axillary vein) groin (femoral vein), or through veins in the arms known as a PICC, or peripherally inserted central catheters. Site- Internal jugular vein, subclavian vein, axillary vein, femoral veins, the best approach or access point for Central line insertion. Indications - The indications for central venous access are broad and are often situational. Inability to obtain venous access in emergent situations, chemotherapy administration, medications administration (Vasopressors. inotropic administration Total Parental nutrition administration, Hemodynamic monitoring are common indications for CVC insertion. Contraindication- Local cellulitis, Low platelet count, Local infections, Thrombocytopenia, Congenital anomalies, Trauma are common contraindications of CVC insertion. Complications - Numerous potential complications can occur during the procedural placement of a central venous catheter, but also as a result of the indwelling equipment. Arrhythmias, Arterial puncture, Pulmonary puncture with or without resultant pneumothorax, Bleeding – hematoma formation, which can obstruct the airway, Tracheal injury, Air emboli during venous puncture or removal of the catheter, Pulmonary embolism, Local cellulitis, Catheter infection, Cardiac tamponade, Intravascular loss of guidewire, Hamo thorax, Phrenic nerve injury, Brachial plexus injury, Cerebral infarct from carotid artery cannulation, Bladder perforation, Bowel perforation, Sterile Thrombophlebitis. Post-procedural complications: Catheter-related bloodstream infections – bacterial or fungal, Central vein stenosis, Thrombosis, Delayed bleeding with multiple attempts in a coagulopathic patient Clinical Significance - Ensure that sterile products are not contaminated and that there is no evidence of damage to the packaging. Follow sterile procedures at all times. Central line infections can be a serious and life-threatening illness. Always ensure that the catheter is appropriately placed through one or several methods: radiographic evidence, measurement of CVP, or by analyzing a venous blood gas. Never use excessive force during any part of this procedure. It will lead to damage to local structures. Nursing Responsibility - After a CVC placement, nurses are responsible for maintaining, monitoring, and utilizing central venous catheters. The assigned nurse must check complications such as infections, hematoma, thrombosis of the catheter, and signs of pneumothorax and bleeding. Nurses are also responsible for ensuring that the site is maintained in a clean and sterile fashion. Daily inspection of the access site and device patency should be performed during nursing rounds. In particular, nursing officers must disinfect injection ports, catheter hubs, and needleless connectors with institutionally approved antiseptics. Intravenous administration sets should be changed regularly per hospital policy. The site should be checked for bleeding, hematoma formation, and signs of cellulitis, which include erythema, purulent drainage, and/or warmth. Dressings should be changed if visibly soiled. This must be performed with proper sterile technique. Keywords: CVC, Central Line, Central venous catheter.

Radiation Sterilization of Antibiotics in Solid State

Background: Radiation sterilization is a promising method of obtaining sterile active pharmaceutical ingredients (API), excipients and formulations. One of the best methods of sterilization is to use ionizing radiation. The greatest advantage of ionizing radiation is the fact that it can be conducted at room temperature or lower. Therefore, this procedure of sterilization is reserved for drugs sensitive to the high temperature of autoclaving. Solutions of parenterally administered antibiotics must be absolutely aseptic. Most of the antibiotics are susceptible to degradation at increased temperature and humidity, so radiation is often used to obtain sterile bactericidal drugs. Methods: The available literature and published papers related to radiation sterilization as well as other sterilization methods were collected, analyzed, and reviewed to provide the comprehensive information about the radiation sterilization of antibiotics. The review was critically evaluated and concluded, emphasizing future perspectives for radiation sterilization of antibiotics. Results: The review presented the basic principles, merits, and demerits of radiation sterilization in pharmaceutical samples. Further, the review highlighted the updated summary of the recent advances in terms of the latest regulations and recommendations for radiation sterilization. Conclusion: Radiation sterilization has a promising future in pharmaceutical manufacturing processes. This approach is compatible with various types of material, is easy to control, does not increase the temperature of the process, and from the business point of view - can help to save money and time during manufacturing solid dosage forms of medicines. From the pharmaceutical sense, fully effective sterilization in the terminal step - finished packed product - is the most important advantage of radiation sterilization.

Potential of a mixed culture of microalgae for accumulation of beta-carotene under different stress conditions

Abstract Beta-carotene, a pigment found in plants, is mainly produced by microalgae. Nevertheless, this production has only been investigated in pure cultures. Beta-carotene production through mixed culture eliminates the costly procedure of sterilization and contamination prevention needed for pure cultures. In this study, for the first time, the growth, beta-carotene, and chlorophyll production of a mixed culture of microalgae from Caspian Sea was investiagted under different stress conditions. At the condition of tripled light intensity and nitrogen starvation, beta-carotene content increased from 18.03 to 43.8 and 46.5 mol beta-carotene g−1 protein, respectively. However, the salinity of 4 mol L−1 caused the beta-carotene content to fall to zero. The blank sample reached a constant value of 23 mol beta-carotene g−1protein. The comparable results with the specific monoculture species exhibit the high potential of a mixed culture of microalgae for beta-carotene production without need of the high sterilization cost. Nevertheless, more research is needed for where it can be a good substitute for pure culture.

Post-injection syringe bacterial contamination of hyaluronic acid fillers.

Hyaluronic acid (HA) gel fillers are the most commonly used filler materials for dermal purposes to augment soft tissue due to their superior properties and advantages over other alternative filling materials. One of the key drawbacks associated with the use of fillers is contamination and possible subsequent infection. A prospective cross-sectional study conducted in Renew Cosmetic Clinics and King Abdulaziz University, Faculty of Medicine, female section from November 2019 to March 2020. A total of 50 samples with different concentrations (from five different brands) of hyaluronic acid gel fillers were collected. Samples were taken at four different time points: before injection, immediately after injection, 1month after injection, and 3months after injection. The 50 samples were injected into nine different sites and collected from 27 females, aged between 18-55years. No bacteria were detected in the culture media from any samples from the aerobic and anaerobic culture plates. Our study did not find any evidence of contamination associated with the reuse of HA gel fillers regardless of the concentration and the injection site. Applying appropriate sterilization procedure for HA gel fillers extends its usability. There was no correlation between the length of storage time and the risk of contamination.

The effect of sterilization and storage on the viscoelastic properties of human tendon allografts

Allografts have become increasingly preferred for anterior cruciate ligament replacement purposes. The risk of infections necessitates thorough sterilization procedures, and the allografts usually need to be stored prior to surgery. Classical mechanical tests have been performed with various types of tendons, however, tibialis anterior and peroneus longus tend to suffer the least biomechanical changes after irradiation. Only few results are available of the strain and creep behaviour of tendons, even though this information is necessary to provide suitable allografts. The aim of the present study is to analyze the effect of different tendon types (T-tibialis anterior, P-peroneus longus), sterilization methods (G-gamma irradiation of 21 kGy, E-electron beam irradiation of 21 kGy) and storage times (5 and 6 months) on the creep behavior, which is characterized by the strain at the end of the loading phase and creep deformation after static loading. Static creep tests were performed with 250 N load during 60 s. Deformation at the end of the loading phase of both tendons was significantly smaller after 5 months long storage than that after 6 months long storage. TE5 showed significantly less creep than group TE6, and TE6 significantly greater than PE6. The creep of TE5 was significantly lower than that of TG5. Based on the data, the peroneus longus sterilized by electron beam and stored deep frozen for 5 months is a better choice for anterior cruciate ligament reconstruction than tibialis anterior sterilized by gamma irradiation stored for 6 months.

Trends in opportunistic salpingectomy following vaginal delivery

<h3>Objectives:</h3> The fallopian tube has been implicated as the site of origin in up to 70% of ovarian carcinomas. In November 2013, the Society of Gynecologic Oncology (SGO) advised that women of average risk for ovarian cancer undergo opportunistic salpingectomy at the time of abdominal or pelvic surgery, such as hysterectomy or tubal sterilization, to reduce the risk of ovarian cancer. Opportunistic salpingectomy has previously been incorporated into various surgical procedures including cesarean section, however a paucity of data exists regarding salpingectomy following vaginal deliveries. Our objective was to assess the uptake of opportunistic salpingectomy as a form of postpartum sterilization after vaginal delivery following the 2013 release of the SGO clinical practice statement. <h3>Methods:</h3> We performed an IRB-approved, retrospective cohort study of all postpartum tubal sterilization procedures performed during delivery admissions between January 2009 and December 2019. All patients undergoing tubal sterilization within 48 hours of vaginal delivery were included. We collected patient demographics, medical history, peripartum and perioperative data. The primary outcome was proportion of sterilization procedures completed as salpingectomies before and after January 1st, 2014. Secondary outcomes included estimated blood loss (EBL), perioperative complications and readmission within 6 weeks postpartum. We used Pearson's c2 test, Fisher's exact and Student's t-test to compare the time periods. We analyzed trends using the Cochran-Mantel-Haenszel test. <h3>Results:</h3> A total of 317 postpartum sterilization procedures were performed during the study period. 113 salpingectomies were performed during or after 2014 (<i>p</i>-value < 0.001). Patient demographics before and after January 1st, 2014 did not significantly differ. In 2014, 5.9% of sterilization procedures were completed as salpingectomies. By 2019, salpingectomies comprised 80% of postpartum sterilization procedures (Figure 1, p-value for trend < 0.001). Prior to 2014, the majority of tubal sterilizations occurred with placement of occlusive Filshie Clips (53.7%). Their use decreased to 0% by 2016 (p-value for trend < 0.001). There were no differences in EBL, postoperative complications or readmission during the time periods studied. Patients undergoing tubal sterilization prior to 2014 were more likely to be prescribed opioids at discharge compared to after (OR 0.37, 95% CI [0.20-0.70]). <h3>Conclusions:</h3> Postpartum opportunistic salpingectomy rates following vaginal deliveries increased significantly from 2014 to 2019 after the release of the SGO recommendations to consider salpingectomy as an ovarian cancer prevention strategy. This trend in postpartum salpingectomy occurred without an observed increase in complications or readmissions. Opportunistic salpingectomy should be considered a safe and feasible means of potential ovarian cancer risk reduction for patients who undergo vaginal deliveries and desire immediate postpartum sterilization.

Preoperative Oral Administration of Yunnan Baiyao and Its Effect on Coagulation Parameters in Tick-Borne Disease and/or Heartworm Seropositive Dogs: A Pilot Study

The overall goal of this clinically focused pilot study was to investigate the preoperative benefit of oral administration of Yunnan Baiyao (YB) to Ehrlichia. canis, Anaplasma platys and/or heartworm seropositive canines. A total of 12 clinically normal dogs undergoing sterilization procedures were randomly subdivided into Control/Placebo Group (n=6) or Treatment Group (n=6). Each patient received three oral doses of YB (0.5g/5kg) or placebo every twelve hours with the last dose given the evening before surgery. Citrated blood measurements for prothrombin time (PT), activated partial thromboplastin time (aPTT), and fibrinogen were obtained before the first YB dose and after the third dose. Intraoperative blood loss was estimated by blood-soaked gauze sponge counts. The study found the Control Group’s mean aPTT increased by 3.8% while the Treatment Group’s decreased by 0.42%. PT values were slightly decreased in both groups. Fibrinogen decreased in controls (9.7%) but had a modest increase in treated dogs (12.4%). Intraoperative blood loss was increased in controls (3%) compared to the Treatment Group (mean±SD: 6.6±6.8 vs. 6.4±3.6, respectively). Findings from the study which suggest preoperative benefits from YB administration to seropositive dogs include stabilizing aPTT and fibrinogen values along with reduced intraoperative blood loss in YB treated dogs. Although these modest findings were not statistically significant in this small study, the biological trends suggest potential benefits of preoperative administration of YB before routine elective surgeries in seropositive patients and support a clinical trial with larger sample size.

Preventing the primary debulking: An educational initiative to increase rates of salpingectomy at cesarean delivery

<h3>Objectives:</h3> Opportunistic salpingectomy is being performed at higher rates at benign hysterectomy and interval sterilization than at cesarean delivery (CD). The aim of the study was to assess physician practices in offering and performing bilateral salpingectomy (BS) at time of CD after an educational initiative. <h3>Methods:</h3> We conducted a prospective cohort study of OBGYN physicians who perform cesarean deliveries. We compared outcomes before and after an educational initiative, which comprised of a Grand Rounds presentation on the latest data on BS at CD reviewing feasibility, safety, cost effectiveness and surgical techniques. Chart abstraction assessed patient demographics and rates of BS at CD before and after the intervention. Anonymous physician surveys were also administered before and six months after the intervention. Chi-square or Fisher's exact test were used for categorical variables and T-test or ANOVA for continuous variables. The study was powered to detect a difference of 10% between rates of BS at CD (β=0.20). <h3>Results:</h3> There were 370 (14% of all CD) sterilization procedures completed at time of CD during the year prior to our intervention, and 168 (12% of all CD) in the subsequent 6 months. Rates of BS at CD increased from 5.1% to 17% (p<0.0001). Tubal ligation and BS had similar mean estimated blood loss (684 vs 718cc, p=0.45) and total operative time (51 vs 53min, p=0.59). Patients who underwent BS tended to be married (79% vs 59%, p=0.008), white (79% vs 60%, p=0.26), and non-Hispanic (78% vs 59%, p=0.02). When completing a BS, suture ligation and sealing bipolar electrocautery were utilized at similar rates (50% and 50% after the intervention, p=0.53). A total of 51 surveys were completed before the intervention and 43 completed 6 months afterwards (68% and 57% response rates of OBGYN providers who perform CD). Half of the providers who completed the post-intervention survey had attended the Grand Rounds. Provider characteristics were similar between the 2 groups. In the pre-intervention survey, 88% of providers reported offering their patients a salpingectomy at the time of hysterectomy, 86% at time of interval sterilization and only 37% at time of cesarean delivery. After the intervention, more physicians offered BS at CD to their patients considering permanent sterilization (37% vs 56%, p=0.09). Similarly, more providers reported having ever completed a BS at CD (71% vs. 88%, p=0.04). The most common reasons providers listed for not offering BS at CD included increased bleeding, increased operative time, and inexperience. Over 90% of providers reported that they would feel comfortable completing a BS with an electrocautery bipolar device and only 67% by using suture ligation. <h3>Conclusions:</h3> Educational initiatives can increase provider willingness to offer and to complete bilateral salpingectomy at cesarean delivery. Ongoing educational efforts to encourage bilateral salpingectomy may potentially prevent future cases of ovarian cancer.

Development and Validation of a Good Manufacturing Process for IL-4-Driven Expansion of Chimeric Cytokine Receptor-Expressing CAR T-Cells.

Adoptive cancer immunotherapy using chimeric antigen receptor (CAR) engineered T-cells holds great promise, although several obstacles hinder the efficient generation of cell products under good manufacturing practice (GMP). Patients are often immune compromised, rendering it challenging to produce sufficient numbers of gene-modified cells. Manufacturing protocols are labour intensive and frequently involve one or more open processing steps, leading to increased risk of contamination. We set out to develop a simplified process to generate autologous gamma retrovirus-transduced T-cells for clinical evaluation in patients with head and neck cancer. T-cells were engineered to co-express a panErbB-specific CAR (T1E28z) and a chimeric cytokine receptor (4αβ) that permits their selective expansion in response to interleukin (IL)-4. Using peripheral blood as starting material, sterile culture procedures were conducted in gas-permeable bags under static conditions. Pre-aliquoted medium and cytokines, bespoke connector devices and sterile welding/sealing were used to maximise the use of closed manufacturing steps. Reproducible IL-4-dependent expansion and enrichment of CAR-engineered T-cells under GMP was achieved, both from patients and healthy donors. We also describe the development and approach taken to validate a panel of monitoring and critical release assays, which provide objective data on cell product quality.

Post-treatments of polydopamine coatings influence cellular response

Polydopamine (PDA) is the final oxidation product of dopamine or other catecholamines. Since the first reports of PDA coatings starting around 2007, these coatings have been widely studied as a versatile and inexpensive one-step coating option for biomaterial functionalization. The coating attach to a wide range of materials and can subsequently be modified with biomolecules or nanoparticles. However, as a strong candidate for biomaterial research and even clinical use, it is important to unravel the changes in physico-chemical properties and the cell-PDA interaction as a function of heat sterilization procedures and shelf storage periods. Four groups were examined in this study: titanium (Ti), PDA-coated Ti samples and PDA-coated Ti samples either stored for up to two weeks at room temperature or heated at 121 °C for 24 h, respectively. We used X-ray Photoelectron Spectroscopy (XPS), Time-of-Flight Secondary Ion Mass Spectrometry (ToF-SIMS) and Water contact angle (WCA) to characterize chemical composition and surface properties of the groups. Cell adhesion and proliferation was examined by three different cell types: human primary dermal fibroblasts (hDF), human epidermal keratinocytes (HaCaTs) and a murine preosteoblastic cell line (MC3T3-E1), respectively. Cells were cultured on PDA coated samples for 4 h, 3 days and 5 days. Both thermal treatment of PDA at 121℃ for 24 h and storage of the samples for 2 weeks increased the amount of quinone groups at the surface and decreased the amount of primary amine groups as detected by XPS and ToF-SIMS. Even though these surface reactions increased the WCA of the PDA coating, we found that the post-treatments increased cell proliferation for both hDFs, HaCaTs and MC3T3-E1 s as compared to pristine PDA. This emphasizes the importance of post-treatment and shelf-time for PDA coatings.

Urethral instillation of chlorhexidine gel is an effective method of sterilisation

ABSTRACT Objective: To examine the effectiveness of preoperative urethral sterilisation with chlorhexidine gel in rendering the urethra as sterile as the skin of the genital area, with the skin sterilised as per the International Society for Sexual Medicine guidelines for penile prosthesis implantation. Patients and methods: A total of 111 male patients undergoing sterile andrological surgical procedures were divided into a control group (N = 61) and a chlorhexidine gel group (N = 50). Patients in the chlorhexidine group received urethral instillation with 6 mL of chlorhexidine preoperatively and on table. Patients from both groups received on-table skin preparation using povidone iodine and chlorhexidine povidone iodine. At the end of surgery, swabs were obtained from urethra and the penile skin. Skin and urethral swabs were compared for bacterial colonisation by culture and sensitivity. Results: Of the 111 patients, 16 had urethral colonisation and 10 had skin contamination, and they were all in the control group. The most common organism detected in both the urethral and skin samples was coagulase-negative Staphylococcus aureus. Urethral colonisation was significantly greater in the control group compared to the chlorhexidine group, at 16/61 vs 0/50 (P = 0.001). Similarly, skin colonisation was significantly greater in the control group compared to the chlorhexidine group, at 10/61 vs 0/50, (P = 0.002). Conclusion: Chlorhexidine gel is a powerful sterilising agent that will render the urethra sterile.