Sutures can cause challenging surgical site infections, due to capillary effects resulting in bacteria permeating wounds. Anti-microbial sutures may avoid these complications by inhibiting bacterial pathogens. Recently, first triclosan-resistances were reported and therefore alternative substances are becoming clinically relevant. As triclosan alternative chlorhexidine, the “gold standard” in oral antiseptics was used. The aim of the study was to optimize novel slow release chlorhexidine coatings based on fatty acids in surgical sutures, to reach a high anti-microbial efficacy and simultaneously high biocompatibility. Sutures were coated with chlorhexidine laurate and chlorhexidine palmitate solutions leading to 11, 22 or 33 µg/cm drug concentration per length. Drug release profiles were determined in aqueous elutions. Antibacterial efficacy against Staphylococcus aureus was assessed in agar diffusion tests. Biocompatibility was evaluated via established cytotoxicity assay (WST-1). A commercially triclosan-containing suture (Vicryl Plus), was used as anti-microbial reference. All coated sutures fulfilled European Pharmacopoeia required tensile strength and proved continuous slow drug release over 96 hours without complete wash out of the coated drug. High anti-microbial efficacy for up to 5 days was observed. Regarding biocompatibility, sutures using 11 µg/cm drug content displayed acceptable cytotoxic levels according to ISO 10993-5. The highest potential for human application were shown by the 11 µg/cm chlorhexidine coated sutures with palmitic acid. These novel coated sutures might be alternatives to already established anti-microbial sutures such as Vicryl Plus in case of triclosan-resistance. Chlorhexidine is already an established oral antiseptic, safety and efficacy should be proven for clinical applications in anti-microbial sutures.
Objectives: Obstruction of the pancreatic duct is a common feature of chronic pancreatitis and often requires interventional therapy. The current prospective study investigated clinical success in 19 patients after initial endoscopic retrograde pancreaticography and relapse rates during a 2-year follow-up period. Methods: Seventeen of 19 patients with chronic pancreatitis (stage III according to the Cambridge classification) were treated by sphincterotomy and stent insertion. Endoscopic retrograde pancreaticography failed in 2 patients. Results: Strictures were cannulated, dilated, and stones were removed with a dormia basket in 13 of 17 patients. Extracorporeal shock wave lithotripsy was necessary in 5 patients. Polyethylene stents (7F-11.5F) were placed into the dilated pancreatic duct. Mean duration of internal pancreatic stenting was 5.6 months. Three of 17 patients had recurrence of pain during the first follow-up year after stent extraction; in the second follow-up year, another 2 patients had a relapse. Overall, patients' assessment of the stent therapy revealed complete satisfaction in 17 of 19 patients. Conclusions: Endoscopic stent therapy is a safe, minimally invasive, and effective procedure in patients experiencing pain attacks during chronic pancreatitis associated with dilated pancreatic duct. According to our results, a relapse rate of approximately 30% can be expected within 2 years after stent extraction. These patients may be treated by repeated stent therapy.
Acute cholangitis is a life-threatening bacterial infection of the biliary tract. Main focus of this study was to create a useful risk prediction model that helps physicians to assign patients with acute cholangitis into different management groups. 981 cholangitis episodes from 810 patients were analysed retrospectively at a German tertiary center. Out of eleven investigated statistical models fit to 22 predictors, the Random Forest model achieved the best (cross-)validated performance to predict mortality. The receiver operating characteristics (ROC) curve revealed a mean area under the curve (AUC) of 91.5 %. Dependent on the calculated mortality risk, we propose to stratify patients with acute cholangitis into a high and low risk group. The mean sensitivity, specificity, positive and negative predictive value of the corresponding optimal cutpoint were 82.9 %, 85.1 %, 19.0 % and 99.3 %, respectively. All of these results emerge from nested (cross-)validation and are supposed to reflect the model’s performance expected for external data. An implementation of our risk prediction model including the specific treatment recommendations adopted from the Tokyo guidelines is available on http://www2.imse.med.tum.de:3838/ . Our risk prediction model for mortality appears promising to stratify patients with acute cholangitis into different management groups. Additional validation of its performance should be provided by further prospective trails.
Sutures colonized by bacteria represent a challenge in surgery due to their potential to cause surgical site infections. In order to reduce these type of infections antimicrobially coated surgical sutures are currently under development. In this study, we investigated the antimicrobial drug octenidine as a coating agent for surgical sutures. To achieve high antimicrobial efficacy and required biocompatibility for medical devices, we focused on optimizing octenidine coatings based on fatty acids. For this purpose, antimicrobial sutures were prepared with either octenidine-laurate or octenidine-palmitate at 11, 22, and 33 μg/cm drug concentration normalized per length of sutures. Octenidine containing sutures were compared to the commercial triclosan-coated suture Vicryl® Plus. The release of octenidine into aqueous solution was analyzed and long-term antimicrobial efficacy was assessed via agar diffusion tests using Staphylococcus aureus. For determining biocompatibility, cytotoxicity assays (WST-1) were performed using L-929 mouse fibroblasts. In a 7 days elution experiment, octenidine-palmitate coated sutures demonstrated much slower drug release (11 μg/cm: 7 %; 22 μg/cm: 5 %; 33 μg/cm: 33 %) than octenidine-laurate sutures (11 μg/cm: 82 %; 22 μg/cm: 88 %; 33 μg/cm: 87 %). Furthermore sutures at 11 μg/cm drug content were associated with acceptable cytotoxicity according to ISO 10993–5 standard and showed, similar to Vicryl® Plus, relevant efficacy to inhibit surrounding bacterial growth for up to 9 days. Octenidine coated sutures with a concentration of 11 μg/cm revealed high antimicrobial efficacy and biocompatibility. Due to their delayed release, palmitate carriers should be preferred. Such coatings are candidates for clinical testing in regard to their safety and efficacy.