The effect of mofettes and natural carbonated mineral water on accelerating bone healing in a femoral defect model in rats

(1) Background: The aim of the study was to investigate the effecs of mofettes and carbonated mineral water baths on bone healing using a rat femoral defect model; (2) Methods: A 2mm diameter unicortical defect in the left femoral diaphysis in 40 Wistar Rats was surgically creat-ed. Furthermore, the subjects were divided into 4 treatment-groups: control, mofette therapy, mofette therapy and carbonated mineral water bath, and carbonated mineral water bath. At the end of the 2-week treatment and at 4 and 6 weeks, the animals were evaluated through Mi-cro-CT analysis of the bone defect and histological analysis of bone tissue and skin; (3) Results: The processes of bone consolidation and repair are not completed at 6 weeks in all groups. However, comparing the proliferated bone tissue in the created orifice and the degree of thick-ening of the femoral wall, it can be affirmed that at 6 weeks, the best results are present in Group 4, treated with carbonated mineral water baths, followed by the combination of mofettes and carbonated water. (4) The use of these treatments could open a new possibility for shorten-ing the healing time in patients with bone defects, as it is non-invasive and accessible

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background: Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods: The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results: A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion: Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)

Reduction of the Number of Live Animals Used for Microsurgical Skill Acquisition: An Experimental Randomized Noninferiority Trial

Background Live animals have been used for decades as one of the many training models for developing surgical skills. Microsurgery in particular relies on training for skill acquisition and maintenance, using live animal models, especially rats (murine models). Efforts are underway to reduce the number of rats sacrificed to achieve this objective. Methods A group of students with minimal microsurgical experience, after having gone through a basic microsurgical course, were randomly split into three equal groups, all three groups following a 24-week standard training program based on low- and medium-fidelity training models with standardized murine training days. In addition to the standard training regimen, each participant performed supplementary training on live rats every 4, 6, or 8 weeks. According to the training program, the procedures have been performed on chicken legs, flower petals, and rats, each procedure being blindly assessed and evaluated using validated models and scales. The primary evaluated outcome was the Stanford Microsurgery and Resident Training (SMaRT) scale result of the final rat anastomosis performed by each group, for which the tested hypothesis was one of noninferiority. The secondary outcomes were represented by the final rat anastomosis time, final chicken leg anastomosis result and time, and the final petal score. Results After the 24th week, no differences were observed between the three groups regarding their microsurgical skills, as measured by the aforementioned surgical outcomes. All participants improved significantly during the study (mean [standard deviation] 19 ± 4 points on the SMaRT scale), with no significant differences between the groups, p < 0.001 for noninferiority. Conclusion A training regimen based on low- and moderate-fidelity models, with the addition of training on a live rat every 8 weeks was noninferior to a training regimen that used a live rat every 6 weeks and also noninferior to a training regimen that used a live rat every 4 weeks

Multilayered Porous Titanium-Based 3rd Generation Biomaterial Designed for Endosseous Implants

This work proposes a novel complex multi-layered material consisting of porous titanium as a substrate and a complex coating consisting of a chitosan film engulfing microsphere loaded with growth factors such as BMP2 (bone morphogenic protein 2) and IGF1 (insulin-like growth factor-1). The microspheres were obtained through deposition of dual layers of calcium cross linked pectin–chitosan/pectin polyelectrolyte onto a BSA (bovine serum albumin) gel core. The multilayer was conceived to behave like a 3rd generation biomaterial, by slow delivery of viable growth factors around implants, and to assist the healing of implantation wound and the development of new vital bone. The biologic effect of the delivery of growth factors was studied in vitro, on MSC-CD1 mesenchymal stem cells, and in vivo, on CD1 mice. Proliferation and differentiation of cells were accelerated by growth factors, especially IGF1 for proliferation and BMP2 for differentiation. In vivo tests analyzed histologically and by MicroCT show a more structured tissue around BMP2 samples. The present concept will give the best clinical results if both growth factors are delivered together by a coating film that contains a double population of microcarriers.</jats:p

Multilayered Porous Titanium-Based 3rd Generation Biomaterial Designed for Endosseous Implants

This work proposes a novel complex multi-layered material consisting of porous titanium as a substrate and a complex coating consisting of a chitosan film engulfing microsphere loaded with growth factors such as BMP2 (bone morphogenic protein 2) and IGF1 (insulin-like growth factor-1). The microspheres were obtained through deposition of dual layers of calcium cross linked pectin–chitosan/pectin polyelectrolyte onto a BSA (bovine serum albumin) gel core. The multilayer was conceived to behave like a 3rd generation biomaterial, by slow delivery of viable growth factors around implants, and to assist the healing of implantation wound and the development of new vital bone. The biologic effect of the delivery of growth factors was studied in vitro, on MSC-CD1 mesenchymal stem cells, and in vivo, on CD1 mice. Proliferation and differentiation of cells were accelerated by growth factors, especially IGF1 for proliferation and BMP2 for differentiation. In vivo tests analyzed histologically and by MicroCT show a more structured tissue around BMP2 samples. The present concept will give the best clinical results if both growth factors are delivered together by a coating film that contains a double population of microcarriers

Reduction of the Number of Live Animals Used for Microsurgical Skill Acquisition: An Experimental Randomized Noninferiority Trial

Abstract Background Live animals have been used for decades as one of the many training models for developing surgical skills. Microsurgery in particular relies on training for skill acquisition and maintenance, using live animal models, especially rats (murine models). Efforts are underway to reduce the number of rats sacrificed to achieve this objective. Methods A group of students with minimal microsurgical experience, after having gone through a basic microsurgical course, were randomly split into three equal groups, all three groups following a 24-week standard training program based on low- and medium-fidelity training models with standardized murine training days. In addition to the standard training regimen, each participant performed supplementary training on live rats every 4, 6, or 8 weeks. According to the training program, the procedures have been performed on chicken legs, flower petals, and rats, each procedure being blindly assessed and evaluated using validated models and scales. The primary evaluated outcome was the Stanford Microsurgery and Resident Training (SMaRT) scale result of the final rat anastomosis performed by each group, for which the tested hypothesis was one of noninferiority. The secondary outcomes were represented by the final rat anastomosis time, final chicken leg anastomosis result and time, and the final petal score. Results After the 24th week, no differences were observed between the three groups regarding their microsurgical skills, as measured by the aforementioned surgical outcomes. All participants improved significantly during the study (mean [standard deviation] 19 ± 4 points on the SMaRT scale), with no significant differences between the groups, p &lt; 0.001 for noninferiority. Conclusion A training regimen based on low- and moderate-fidelity models, with the addition of training on a live rat every 8 weeks was noninferior to a training regimen that used a live rat every 6 weeks and also noninferior to a training regimen that used a live rat every 4 weeks.</jats:p

The Double Stitch Everting Technique in the End-to-Side Microvascular Anastomosis: Validation of the Technique Using a Randomized N-of-1 Trial

Abstract Background The double stitch everting (DSE) technique, in which time is won by leaving the needle inside the vessel wall in-between stitching, is a modification of the end-to-side (ETS) anastomosis in the interest of reducing anastomosis time. This ensures proper wall eversion, intima-to-intima contact, and improved suture symmetry. Materials and Methods We designed an N-of-1 randomized trial with each microsurgeon as their own control. We included 10 microsurgeons of different levels of experience who were then asked to perform classic and DSE ETS anastomoses on the chicken leg and rat femoral models. Every anastomosis was cut and evaluated using blinded assessment. Two-way analysis of variance (ANOVA) and multivariable logistic regression were used to analyze the results and for confounder adjustment. Results A total of 210 anastomoses were performed, of which 177 on the chicken leg and 43 on the rat femoral artery and vein. From the 210 anastomoses, 111 were performed using the classic technique and 99 using the DSE technique. The mean anastomosis time was 28.8 ± 11.3 minutes in the classic group and 24.6 ± 12 minutes in the DSE group (p &lt; 0.001, t-test). There was a significant reduction (p &lt; 0.001, two-way ANOVA) in the number of mistakes when using the DSE technique (mean 5.5 ± 2.6) compared with those using the classic technique (mean 7.7 ± 3.4). Conclusion The DSE technique for ETS anastomoses improves anastomoses times in experienced and moderately experienced microsurgeons while also improving or maintaining suture symmetry and lowering the number of mistakes.</jats:p