Staged versus nonstaged elective hybrid iliofemoral revascularization - analysis of ten years of prospective data.

BACKGROUND: Reports of large series of hybrid iliofemoral revascularization for chronic lower limb ischemia are scarce. The aims of this study were to evaluate outcomes for staged and nonstaged procedures, and to evaluate risk factors for outcomes at 90 days. METHODS: Patients were consecutively included between 2013 and 2023. Surgical site infection (SSI) was defined by the ASEPSIS criteria and major adverse limb events (MALE) as onset of acute or continuing or worsening chronic limb ischemia or major amputation. Factors associated with outcomes were tested in a multivariable logistic regression analysis and expressed in odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: Patients undergoing nonstaged procedures (n = 124) had higher Trans-Atlantic Inter-Society Consensus (TASC) class representing anatomical occlusive complexity, more often through-and through femoral guidewire access, more endoprosthesis, more covered stents, longer procedure time with open groin wounds, and less contralateral femoral access, than those undergoing staged procedures (n = 31). The median time interval between the staged procedures was 1 day, and iliac stenting was done first in 77%. The median in-hospital stay was nonsignificantly longer in staged procedure (8 vs. 6 days, P = 0.053). The overall SSI and MALE rates were 25.8% and 20.0%, respectively, without differences between groups. Diabetes mellitus (OR 3.7, 95% CI 1.2-7.2]) and presence of a foot ulcer (OR 3.7, 95% CI [1.5-9.4]) were independently associated with MALE at 90 days. Postoperative hyperglycemia was nonsignificantly associated with SSI (OR 2.1 (95% CI 1.0-4.5), P = 0.066) in multivariable analysis. CONCLUSIONS: The risks of SSI and MALE after elective hybrid iliofemoral revascularization were high. There appears to be no benefit in performing staged as opposed to nonstaged procedures. The extent of iliofemoral occlusive disease according to the TASC classification had little influence on outcomes whereas diabetes mellitus and presence of a foot ulcer had greater impact on MALE.

Multicenter parallel randomized trial evaluating incisional negative pressure wound therapy for the prevention of surgical site infection after lower extremity bypass.

OBJECTIVE: Incisional negative pressure wound therapy (iNPWT) applied over all incisions after lower extremity bypass in the prevention of surgical site infections (SSIs) is unclear. The primary and secondary aims of this study were to investigate if prophylactic iNPWT after the elective lower extremity bypass prevents SSI and other surgical wound complications. METHODS: This was a multicenter, parallel, randomized controlled trial. Patients undergoing elective lower extremity bypass in 3 hospitals were randomized to either iNPWT or standard dressings. SSIs or other wound complications were assessed within the first 90 days by wound care professionals blinded to the randomized result. The validated Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay (ASEPSIS) score was used to objectively assess the wounds. ASEPSIS score ≥21 is defined as an SSI. Unilateral and bilateral groups were analyzed with the Fisher exact test and the McNemar test, respectively. RESULTS: In the unilateral group (n = 100), the incidence of SSI in the iNPWT group was 34.9% (15/43), compared with 40.3% (23/57) in the control group, according to the ASEPSIS score (P = .678). In the bilateral group (n = 7), the SSI rate was 14.3% (1/7) in the iNPWT group compared with 14.3% (1/7) in the control group (P = 1.00). In the unilateral group, there was a higher wound dehiscence rate in the control group (43.9%) compared with the iNPWT group (23.3%) (P = .0366). No serious iNPWT-related adverse events were recorded. CONCLUSIONS: There was no reduction of SSI rates in leg incisions with iNPWT compared with standard dressings in patients undergoing elective lower extremity bypass, whereas iNPWT reduced the incidence of wound dehiscence.

Prospective Comparison of Wound Complication Rates after Elective Open Peripheral Vascular Surgery - Endovascular Versus Open Vascular Surgeons.

BACKGROUND: Skill and experience of surgeons are likely to influence the incidence of surgical wound complications (SWC) after open lower limb revascularization. Differences in SWC between surgeons with predominantly endovascular or open vascular surgical profiles could be expected. The aim of this study was to compare SWC rates after elective open vascular surgery between primarily endovascular and primarily open vascular surgeons. METHODS: Prospective data from patients undergoing elective surgery for peripheral artery disease (PAD) was collected between 2013 and 2019. Senior surgeons were assigned to the open-surgeon or the endo-surgeon group based on the percentage of their open surgical case load during the 6 year study period. SWC was measured by their clinical impact scale (grade 1-outpatient treatment to grade 6-death). Surgical site infection was defined by Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay (ASEPSIS) criteria. Propensity score adjusted analysis (PSAA) was used to account for differences in baseline and perioperative characteristics and expressed as odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: The proportion of chronic limb-threatening ischemia (P = 0.001), ipsilateral foot wound (P = 0.012) and femoro-popliteal bypass procedures (P < 0.001) were higher in the open-surgeon group. A lower incidence of SWC according to ASEPSIS criteria (25.6% vs. 38.6%, respectively, P = 0.042) and SWC grade ≥1 (33.7% vs. 51.0%, respectively, P = 0.010) was found in the endo-surgeon group (n = 86) compared to the open-surgeon group (n = 153). These differences disappeared after PSAA (OR 0.63, 95% CI 0.27-1.44, and OR 0.60, 95% CI 0.27-1.33, respectively). CONCLUSIONS: Patients operated by endo-surgeons had less advanced PAD and lower incidence of SWC compared to those treated by open-surgeons. No difference in SWC remained after PSAA.

Three-dimensional printing of silica glass with sub-micrometer resolution.

Silica glass is a high-performance material used in many applications such as lenses, glassware, and fibers. However, modern additive manufacturing of micro-scale silica glass structures requires sintering of 3D-printed silica-nanoparticle-loaded composites at ~1200 °C, which causes substantial structural shrinkage and limits the choice of substrate materials. Here, 3D printing of solid silica glass with sub-micrometer resolution is demonstrated without the need of a sintering step. This is achieved by locally crosslinking hydrogen silsesquioxane to silica glass using nonlinear absorption of sub-picosecond laser pulses. The as-printed glass is optically transparent but shows a high ratio of 4-membered silicon-oxygen rings and photoluminescence. Optional annealing at 900 °C makes the glass indistinguishable from fused silica. The utility of the approach is demonstrated by 3D printing an optical microtoroid resonator, a luminescence source, and a suspended plate on an optical-fiber tip. This approach enables promising applications in fields such as photonics, medicine, and quantum-optics.

Patients' Experiences Using Closed Incision Negative Pressure Wound Therapy Dressing After Infra-Inguinal Vascular Surgery.

The PICO™ dressing utilizes incisional negative pressure wound therapy in reducing surgical site infection after vascular surgery; however, no patient-reported investigations are available. The objective was to explore patients experiences wearing the PICO™ dressing for 7 days. Nine men and 6 women were interviewed, and analysis was conducted using qualitative content analysis. The PICO™ dressing system was well accepted by most patients. Most prominent problems were fear of dropping the pump to the floor, lack of information, and initial feelings of uncertainty. Four patients who had the PICO™ and standard dressing in opposite groins simultaneously, preferred the PICO™ dressing.

Surgical treatment of stoma-related hernias: retrospective cohort study of damage claims to the Swedish National Patient Insurance Company 2010-2016.

BACKGROUND: Parastomal hernia and stoma-site hernia are common stoma complications. Parastomal hernia repair is associated with high complication and recurrence rates. Insurance data can provide novel information on the consequences of perioperative complications from the patient's point of view. The aim was to investigate what types of complications associated with stoma-related hernia surgery that cause patients to apply for economic compensation through the patient insurance system and to investigate demographic and clinical differences among cases based on gender and type of center at which the surgery was performed. METHODS: A national patient damage claim database was searched for ICD-10 codes related to parastomal and stoma-site hernia surgery over a seven-year period. Medical records were screened for claims associated with parastomal hernia repair, relocation or reversal due to parastomal hernia, or stoma-site hernia repair. Claims were classified according to one of four primary complaints: surgical, anesthetic, medical or other. Clinical and demographic differences between genders and hospital types were investigated. Reasons for non-compensation were analyzed. RESULTS: Thirty claims met the inclusion criteria. Eighteen were related to parastomal hernia repair, seven to stoma-site hernia repair, three to stoma reversal and two to relocation due to parastomal hernia. Twenty-five claims were primarily surgical, two related to anesthesia and three classified as other. Seven claims were granted compensation. No demographic or clinical differences were found apart from female gender being associated with previous parastomal hernia repair [6 women and 0 men (p = 0.02)]. CONCLUSION: Surgical complaints predominated. Few claims were compensated, reflecting the complexity and unsatisfactory outcomes of these procedures. Many claims were identified in relation to the incidence of stoma-related hernia surgery. TRIAL REGISTRATION: Due to its retrospective and descriptive nature, the study was not registered in any registry.

Inkjet Printing of Drug-Loaded Mesoporous Silica Nanoparticles-A Platform for Drug Development.

Mesoporous silica nanoparticles (MSNs) have shown great potential in improving drug delivery of poorly water soluble (BCS class II, IV) and poorly permeable (BCS class III, IV) drugs, as well as facilitating successful delivery of unstable compounds. The nanoparticle technology would allow improved treatment by reducing adverse reactions of currently approved drugs and possibly reintroducing previously discarded compounds from the drug development pipeline. This study aims to highlight important aspects in mesoporous silica nanoparticle (MSN) ink formulation development for digital inkjet printing technology and to advice on choosing a method (2D/3D) for nanoparticle print deposit characterization. The results show that both unfunctionalized and polyethyeleneimine (PEI) surface functionalized MSNs, as well as drug-free and drug-loaded MSN-PEI suspensions, can be successfully inkjet-printed. Furthermore, the model BCS class IV drug remained incorporated in the MSNs and the suspension remained physically stable during the processing time and steps. This proof-of-concept study suggests that inkjet printing technology would be a flexible deposition method of pharmaceutical MSN suspensions to generate patterns according to predefined designs. The concept could be utilized as a versatile drug screening platform in the future due to the possibility of accurately depositing controlled volumes of MSN suspensions on various materials.

Colorimetry as Quality Control Tool for Individual Inkjet-Printed Pediatric Formulations.

Printing technologies were recently introduced to the pharmaceutical field for manufacturing of drug delivery systems. Printing allows on demand manufacturing of flexible pharmaceutical doses in a personalized manner, which is critical for a successful and safe treatment of patient populations with specific needs, such as children and the elderly, and patients facing multimorbidity. Printing of pharmaceuticals as technique generates new demands on the quality control procedures. For example, rapid quality control is needed as the printing can be done on demand and at the point of care. This study evaluated the potential use of a handheld colorimetry device for quality control of printed doses of vitamin Bs on edible rice and sugar substrates. The structural features of the substrates with and without ink were also compared. A multicomponent ink formulation with vitamin B1, B2, B3, and B6 was developed. Doses (4 cm2) were prepared by applying 1-10 layers of yellow ink onto the white substrates using thermal inkjet technology. The colorimetric method was seen to be viable in detecting doses up to the 5th and 6th printed layers until color saturation of the yellow color parameter (b*) was observed on the substrates. Liquid chromatography mass spectrometry was used as a reference method for the colorimetry measurements plotted against the number of printed layers. It was concluded that colorimetry could be used as a quality control tool for detection of different doses. However, optimization of the color addition needs to be done to avoid color saturation within the planned dose interval.

Application of a colorimetric technique in quality control for printed pediatric orodispersible drug delivery systems containing propranolol hydrochloride.

The feasibility of a colorimetric technique was investigated in CIELAB color space as an analytical quality control method for content uniformity of printed orodispersible pediatric delivery systems. Inkjet printing was utilized to fabricate orodispersibe film formulations containing propranolol hydrochloride in a colored ink base using three different edible substrates. A thin sweetener coating layer of saccharin was successfully included in the final dosage forms for palatability purposes using a casting knife. Optical microscopy, scanning electron microscopy and scanning white light interferometry analyses were conducted to study the effect of printing on the surface morphology and topography of the substrates. Differential scanning calorimetry and attenuated total reflectance infrared spectroscopy were used to study the solid state properties and possible interactions between the drug and the excipients. The inkjet printing technique deposited precise and uniform escalating doses (0.08-3.16mg) of the active pharmaceutical ingredient onto the substrates (R(2)≥0.9934). A disintegration test with clear end-point detection confirmed that all the substrates meet the requirements of the Ph. Eur. to disintegrate within 180s. The colorimetric technique proved to be a reliable method to distinguish the small color differences between formulations containing an escalating dose of propranolol hydrochloride.

Smoking increases donor site complications in breast reconstruction with DIEP flap.

OBJECTIVE: Reconstruction with deep inferior epigastric perforator flap (DIEP) is considered to be the first choice for autologous breast reconstruction. The primary aims of this retrospective study were to find out if differences in smoking habits and BMI are useful predictors for postoperative complications in DIEP surgery. METHODS: Three hundred and one patients were included. Data regarding smoking habits, BMI, age at surgery, total and final flap weight, abdominal scars, parity, number of perforators, chemotherapy, post mastectomy radiation therapy, and preoperative mapping of perforators with either Computer Tomography Angiography or hand-held ultra sound Doppler were collected. Complications that occurred in the first 30 postoperative days were taken into account. RESULTS AND CONCLUSIONS: It was found that former smokers had a risk for donor site complication more than double that of never smokers (OR =2.12, CI =1.10-4.10, p = 0.025). Differences in BMI within the range from 18-33.7 did not have any significant impact on complication rates, neither at the donor site nor at the breast.

Improvement of dissolution rate of indomethacin by inkjet printing.

The aim of this study was to prepare printable inks of the poorly water soluble drug indomethacin (IMC), fabricate printed systems with flexible doses and investigate the effect of ink excipients on the printability, dissolution rate and the solid state properties of the drug. A piezoelectric inkjet printer was used to print 1×1cm(2) squares onto a paper substrate and an impermeable transparency film. l-arginine (ARG) and polyvinylpyrrolidone (PVP) were used as additional formulation excipients. Accurately dosed samples were generated as a result of the ink and droplet formation optimization. Increased dissolution rate was obtained for all formulations. The formulation with IMC and ARG printed on transparency film resulted in a co-amorphous system. The solid state characteristics of the printed drug on porous paper substrates were not possible to determine due to strong interference from the spectra of the carrier substrate. Yet, the samples retained their yellow color after 6months of storage at room temperature and after drying at elevated temperature in a vacuum oven. This suggests that the samples remained either in a dissolved or an amorphous form. Based on the results from this study a formulation guidance for inkjet printing of poorly soluble drugs is also proposed.

Inkjet printing of Chitlac-nanosilver--a method to create functional coatings for non-metallic bone implants.

Biostable fiber-reinforced composites, based on bisphenol-A-dimethacrylate and triethyleneglycoldimethacrylate thermoset polymer matrix reinforced with E-glass fibers have been successfully used in cranial reconstructions and the material has been approved for clinical use. As a further refinement of these implants, antimicrobial, non-cytotoxic coatings on the composites were created by an immersion procedure driven by strong electrostatic interactions. Silver nanoparticles (nAg) were immobilized in lactose-modified chitosan (Chitlac) to prepare the bacteriostatic coatings. Herein, we report the use of inkjet technology (a drop-on-demand inkjet printer) to deposit functional Chitlac-nAg coatings on the thermoset substrates. Characterization methods included scanning electron microscopy, scanning white light interferometry and electro-thermal atomic absorption spectroscopy. Inkjet printing enabled the fast and flexible functionalization of the thermoset surfaces with controlled coating patterns. The coatings were not impaired by the printing process: the kinetics of silver release from the coatings created by inkjet printing and conventional immersion technique was similar. Further research is foreseen to optimize printing parameters and to tailor the characteristics of the coatings for specific clinical applications.

Towards fabrication of 3D printed medical devices to prevent biofilm formation.

The use of three-dimensional (3D) printing technologies is transforming the way that materials are turned into functional devices. We demonstrate in the current study the incorporation of anti-microbial nitrofurantoin in a polymer carrier material and subsequent 3D printing of a model structure, which resulted in an inhibition of biofilm colonization. The approach taken is very promising and can open up new avenues to manufacture functional medical devices in the future.