Retrospective study comparing two materials commonly used in the LFS technique for CCLR.

Cranial cruciate ligament rupture (CCLR) is the most common cause of degenerative joint disease (DJD) in the stifle of adult dogs. Over the last several years, a new generation of nonabsorbable, multifilament, polyblend polyethylene orthopedic suture materials have been evaluated for use in the lateral fabellar suture (LFS) technique for surgical treatment of CCLR. This retrospective study compared the short-term outcome of 16 dogs that were treated using the LFS technique using either a proprietary polyblend polyethylene orthopedic suture material (FW) or monofilament nylon leader line (NLL). The FW was significantly more likely to fail compared with the NLL (P = 0.0379). Specifically, the FW was 14.667 times likelier to fail than the NLL. When one and two strands of NLL were compared with FW, the FW was 6 times more likely to fail than one strand of NLL and 32 times more likely to fail than two strands of NLL. To the authors' knowledge, this is the first study comparing the two materials used in the LFS procedure performed in clinical cases.

A randomized, prospective trial evaluating surgeon preference in selection of absorbable suture material.

This study is the first double-blinded, randomized comparison of two absorbable sutures. To better understand product characteristics and surgeon preference, we conducted a study of two similar-appearing FDA-approved sutures, glyconate and poliglecaprone 25. Four dermatologic surgeons were enlisted. A total of 48 patients with 53 surgical sites were examined. One half of each surgical wound was closed with one type of suture and the other half with the other type. Each half was evaluated for product characteristics. There was no statistically significant difference in surgeon preference for glyconate versus poliglecaprone 25 (P=0.64). Of the cohort preferring poliglecaprone 25, there was a correlation with speed of closure (P=0.06). Of the surgeons that preferred glyconate, we found significantly better visibility (P=0.03), reduced suture breakage during knot tying (P=0.05), and correlation with better handling properties (P=0.06) associated with that preference. The data from this study will enable products to be designed towards these needs and allow surgeons to select sutures that more precisely fit their particular requirements.

Osteolysis following resorbable poly-L-lactide-co-D, L-lactide PLIF cage use: a review of cases.

STUDY DESIGN: Report of case series. OBJECTIVE: To report a problem with bioabsorbable poly-L-lactide-co-D, L-lactide, PLDLLA, posterior lumbar instrumented fusion (PLIF) cage implants. SUMMARY OF BACKGROUND DATA: Synthetic bioabsorbable implants have recently been introduced to spinal surgery and their indications and applications are still being explored. There is evidence that the use of bioabsorbable cages may be of benefit in interbody spinal fusion. METHODS: We present a case series of nine patients who have undergone PLIF with bioabsorbable cages in the lumbar spine. RESULTS: At follow-up over at least 1 year, four of these patients were found to have osteolysis around the implant on CT scanning. One of these patients underwent an operation to remove the cage and histology sent during surgery suggested that the implant had caused the bone loss and there was no evidence of infection. Another patient had ongoing pain in relation to the lysis, while the other two patients with lysis remained asymptomatic. CONCLUSIONS: PLDLLA cage, which has high osteolytic nature, is considered not suitable as a fusion cage.

Comparative study of different techniques for the sterilization of poly-L-lactide electrospun microfibers: effectiveness vs. material degradation.

Electrospinning of biopolymeric scaffolds is a new and effective approach for creating replacement tissues to repair defects and/or damaged tissues with direct clinical application. However, many hurdles and technical concerns regarding biological issues, such as cell retention and the ability to grow, still need to be overcome to gain full access to the clinical arena. Interaction with the host human tissues, immunogenicity, pathogen transmission as well as production costs, technical expertise, and good manufacturing and laboratory practice requirements call for careful consideration when aiming at the production of a material that is available off-the-shelf, to be used immediately in operative settings. The issue of sterilization is one of the most important steps for the clinical application of these scaffolds. Nevertheless, relatively few studies have been performed to systematically investigate how sterilization treatments may affect the properties of electrospun polymers for tissue engineering. This paper presents the results of a comparative study of different sterilization techniques applied to an electrospun poly-L-lactide scaffold: soaking in absolute ethanol, dry oven and autoclave treatments, UV irradiation, and hydrogen peroxide gas plasma treatment. Morphological and chemical characterization was coupled with microbiological sterility assay to validate the examined sterilization techniques in terms of effectiveness and modifications to the scaffold. The results of this study reveal that UV irradiation and hydrogen peroxide gas plasma are the most effective sterilization techniques, as they ensure sterility of the electrospun scaffolds without affecting their chemical and morphological features.

Electrospinning/electrospraying coatings for metal microneedles: A design of experiments (DOE) and quality by design (QbD) approach.

The research presented here shows QbD implementation for the optimisation of the key process parameters in electrohydrodynamic atomisation (EHDA). Here, the electrosprayed nanoparticles and electrospun fibers consisting of a polymeric matrix and dye. Eight formulations were assessed consisting of 5% w/v of polycaprolactone (PCL) in dichloromethane (DCM) and 5% w/v polyvinylpyrrolidone (PVP) in ethanol. A full factorial DOE was used to assess the various parameters (applied voltage, deposition distance, flow rate). Further particle and fiber analysis using Scanning Electron Microscopy (SEM), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Fourier Transform Infrared Spectroscopy (FTIR), particle/fiber size distribution. In addition to this in vitro release studied were carried out using fluorescein and Rhodamine B as model dyes and in vitro permeation studies were applied. The results show a significant difference in the morphology of resultant structures as well as a more rapid release profile for the PVP particles and fibers in comparison to the sustained release profiles found with PCL. In vitro drug release studies showed 100% drug release after 7 days for PCL particles and showed 100% drug release within 120 min for PVP particles. The release kinetics and the permeation study showed that the MN successfully pierced the membrane and the electrospun MN coating released a large amount of the loaded drug within 6 h. This study has demonstrated the capability of these robust MNs to encapsulate a diverse range drugs within a polymeric matrix giving rise to the potential of developed personalised medical devices.

Biodegradability evaluation of polymers by ISO 14855-2.

Biodegradabilities of polymers and their composites in a controlled compost were described. Polycaprolactone (PCL) and poly(lactic acid) (PLA) were employed as biodegradable polymers. Biodegradabilities of PCL and PLA samples in a controlled compost were measured using a Microbial Oxidative Degradation Analyzer (MODA) according to ISO 14855-2. Sample preparation method for biodegradation test according to ISO/DIS 10210 was also described. Effects of sizes and shapes of samples on biodegradability were studied. Reproducibility of biodegradation test of ISO 14855-2 by MODA was confirmed. Validity of sample preparation method for polymer pellets, polymer film, and polymer products of ISO/DIS 10210 for ISO 14855-2 was confirmed.

The long-term behaviors and differences in bone reconstruction of three polymer-based scaffolds with different degradability.

Scaffolds composed of polymers and nano-hydroxyapatite (n-HA) have received extensive attention in bone reconstructive repair; however there is a lack of in-depth and long-term comparative study on the effect of scaffold degradability on bone reconstruction. In this study, the osteogenic behaviors of three polymeric composite scaffolds based on fast degradable poly(lactic-co-glycolic acid) (PLGA), slowly degradable polycaprolactone (PCL) and non-degradable polyamide 66 (PA66) were investigated and compared via implanting the scaffolds into rabbit femoral defects for 1, 3, 6 and 12 months. The in vivo results demonstrated that although the n-HA/PLGA scaffold could obtain higher new bone volume at 3 months, its fast degradation caused the loss of scaffold structural integrity and led to reduction of bone volume after 3 months. The n-HA/PCL scaffold displayed slow degradation mainly after 6 months (∼20% degradation) and the n-HA/PA66 scaffold showed no degradation during the entire 12 months; these two scaffolds could maintain their structural integrity and exhibited a constant increase in bone volume with the implantation time, and even achieved higher bone volume than the n-HA/PLGA scaffold at 12 months. The year-long in vivo research revealed the following important aspects: (1) bone reconstruction is strongly related to scaffold degradability, and the scaffold structural integrity should be maintained at least for one year before complete degradation in vivo; (2) the in vivo experiment of a bone scaffold must take more time than the conventional 3 or 6 months, which is normally neglected. The study suggests a principle for future design and application of bone scaffolds that must have a relatively stable osteogenic space and scaffold interface, or have a scaffold degradation speed slower than the time of bone reconstruction completion.

Tensile strength study of the abdominal wall following laparotomy synthesis using three types of surgical wires in Wistar rats.

PURPOSE: To study the tensile strength of the abdominal wall following laparotomy synthesis utilizing three types of surgical wires. METHODS: Thirty Wistar rats were randomized into three groups of ten rats each. Each group underwent a 3cm-laparotomy which was closed with 3-0 polyglactin 910, polyglecrapone and catgut wires. After 63 days, euthanasia was performed and part of the abdominal wall was removed with which a strip was produced measuring 2.0 cm in length by 6.0 cm in width comprising the abdominal muscles with the implanted mesh. The sample was fixed in a mechanical test machine in which constant force was applied contrary to the tissue strips. Maximum force was considered, expressed in Newton, until full rupture of the tissue occurred. The non-parametrical Kruskal - Wallis test was used for the statistical analysis, admitting p

Absorbable sutures in general surgery - review, available materials, and optimum choices.

Sutures are the most versatile materials used in surgery. Despite recent technological advances and availability of novel materials such as tissue cements, it appears that surgical sutures will continue to be used for many years to come. The objective of this study was to provide an overview of the most common absorbable sutures used in general surgery. The appropriate suture choice for a particular procedure is of key importance for the success of that procedure.

The effect of different thermal treatment on the physical properties of PGA/PCL copolymer suture material.

Samples of polyglycolic acid PGA/polycaprolactone PCL copolymer absorbable suture materials, which is called Poliglecaprone PGC copolymer suture, were thermally treated by two different processes. The first method is the direct heat exposure, from 20 to 38 °C, in the surrounding medium. Which is an environmental study. The other method is the annealing process at temperatures ranged from 65, 80, 100, 120, and 140 °C, for two different duration periods 60 and 120 min. This is an extensive technical study. The refractive indices of thermally treated PGA/PCL copolymer sutures were measured using multiple-beam Fizeau fringes. The birefringence profiles across the suture cross-sections were studied for different annealing conditions. The effect of heat on the polarizabilty per unit volume, dielectric properties, and suture diameter were investigated. The activation energy for the heating processes was calculated using Arrhenius equation. Microinterferograms are given for illustration.

Usability and effectiveness of Suprathel® in partial thickness burns in children.

PURPOSE: Evaluation of usability and effectiveness of Suprathel® in the treatment of partial thickness burns in children. METHODS: A prospective, observational study to evaluate adherence of Suprathel® to the wound bed, reepithelialization time, grafting, wound colonization and infection, pain, dressing changes, length of hospital stay (LOS) and scar formation. RESULTS: Twenty-one children (median age 2.4 years, range 5 months-14 years) with a median total body surface area (TBSA) of 4 % (range 1-18) were included. Median LOS was 10 days (range 3-20). Median outer layer dressing changes was 3 (range 1-14). Suprathel® was only adherent in wounds debrided with Versajet®. Median reepithelialization time was 13 days (range 7-29). Three patients needed a split skin graft. There were 7 (33 %) patients with wound colonization before application of Suprathel®. This increased to 12 (57 %) patients during treatment. One patient developed a wound infection. Median visual analog scale (VAS) scores for background and procedural pain in patients >7 years were 3.2 (range 2-5) and 3.5 (range 2-5), respectively. In younger patients, median background and procedural COMFORT-B scores were 13.8 (range 10-23) and 14.8 (range 13-23, p = 0.03), respectively. Patient and Observer Scar Assessment Scale (POSAS) scores were favorable after 3 and 6 months post burn. CONCLUSIONS: Suprathel® provides potential advantages regarding pain and scar formation, but extensive wound debridement is needed to achieve adequate adherence.

Mechanical fatigue resistance of an implantable branched lead system for a distributed set of longitudinal intrafascicular electrodes.

OBJECTIVE: A neural interface system has been developed that consists of an implantable stimulator/recorder can with a 15-electrode lead that trifurcates into three bundles of five individual wire longitudinal intrafascicular electrodes. This work evaluated the mechanical fatigue resistance of the branched lead and distributed electrode system under conditions designed to mimic anticipated strain profiles that would be observed after implantation in the human upper arm. APPROACH: Custom test setups and procedures were developed to apply linear or angular strain at four critical stress riser points on the lead and electrode system. Each test was performed to evaluate fatigue under a high repetition/low amplitude paradigm designed to test the effects of arm movement on the leads during activities such as walking, or under a low repetition/high amplitude paradigm designed to test the effects of more strenuous upper arm activities. The tests were performed on representative samples of the implantable lead system for human use. The specimens were fabricated using procedures equivalent to those that will be used during production of human-use implants. Electrical and visual inspections of all test specimens were performed before and after the testing procedures to assess lead integrity. MAIN RESULTS: Measurements obtained before and after applying repetitive strain indicated that all test specimens retained electrical continuity and that electrical impedance remained well below pre-specified thresholds for detection of breakage. Visual inspection under a microscope at 10× magnification did not reveal any signs of damage to the wires or silicone sheathing at the stress riser points. SIGNIFICANCE: These results demonstrate that the branched lead of this implantable neural interface system has sufficient mechanical fatigue resistance to withstand strain profiles anticipated when the system is implanted in an arm. The novel test setups and paradigms may be useful in testing other lead systems.

Cyclic loading of Achilles tendon repairs: a comparison of polyester and polyblend suture.

BACKGROUND: Early functional rehabilitation is widely used after open suture repair of the Achilles tendon. To our knowledge, no previous studies have assessed gap formation from cyclic loading and subsequent failure loads of simulated Achilles tendon repairs. A synthetic (polyblend) suture has been introduced for tendon repairs with reportedly greater strength than polyester suture. This stronger, stiffer suture material may provide stronger repairs with less elongation of the tendon repair. METHODS: Simulated Achilles tendon ruptures in bovine Achilles tendon were repaired with a four-strand Krackow suture technique using No. 2 polyester suture. Specimens were loaded for 3,000 cycles at maximal loads of 50, 75, 100, or 125 N, and gap formation at the repair site was continuously measured. After cyclic loading, each specimen was loaded to failure. Identical repairs were performed with number 2 polyblend suture and cyclically loaded to 75 N for 3,000 cycles. All specimens were loaded to failure. RESULTS: Cyclically loading polyester suture repairs to 50, 75, 100, or 125 N for 3,000 cycles resulted in mean gapping at the repair site of 3.0 +/- 0.8, 4.9 +/- 1.0, 7.2 +/- 0.9, and 7.9 +/- 0.8 mm, respectively. Cyclically loading the polyblend suture repairs for 3,000 cycles at 75 N, resulted in 3.3 +/- 0.3 mm of gap formation at the repair site, significantly less than polyester suture repairs (p < 0.001). The mean load to failure for polyester suture repair was 222 +/- 19 N and for polyblend suture repair was 582 +/- 49 N, a statistically significant difference (p < 0.001). Gap formation at 100, 1,000, and 2,000 cycles, as a percentage of total gap formation at 3,000 cycles, was 64.3%, 87.5%, and 95.4% for polyester suture and 45.8%, 78.5%, and 90.1% for polyblend repairs. All specimens in all groups failed at the knots during load-to-failure testing. CONCLUSIONS: Cyclic loading of simulated Achilles tendon repairs using a Krackow, four-core polyester suture technique showed progressive gap formation with increasing load. All repairs failed at the knot, and suture pull-out from tendon was not observed. Polyblend suture repair, when compared to identical repairs with braided polyester suture, resulted in a 260% higher load to failure and 33% less gap formation at the repair site after 3,000 cycles. CLINICAL RELEVANCE: The use of polyblend suture in a four-stranded Krackow configuration provides stronger repairs with less gap formation, which may provide increased security during early functional rehabilitation.

[Shape-memory polymers for biomedical engineering applications].

The latest progress in shape-memory polymer for biomedical engineering applications was summarized in this paper. The mechanism responsible for shape memory effect was analyzed in reference to the polymer structure. Also introduced and reviewed were the characteristics of some shape-memory polymers (polyurethane polycaprolactone and polylactide) and their applications in medical engineering.

Breaking strength and diameter of absorbable sutures after in vivo exposure in the rat.

Although absorbable sutures are commonly used in clinical practice, the rate of decay of strength in various tissues has not been studied. The purpose of this study was to assess breaking strength (BS) and diameter of monofilament (chromic gut, polydiaxanone, Maxon, Monocryl) and multifilament (Vicryl, Dexon, Polysorb) absorbable sutures implanted in various sites and measured at specific time intervals. A 15 cm length of 4-0 suture from a single lot of each material was implanted in the pleural space, rectus abdominus muscle, subcutaneous tissue, intravascular space, peritoneal cavity, and stomach lumen in the rat. A precipitous decrease in BS was noted in all multifilament sutures after 7 days, and in chromic gut and Monocryl sutures after 1 day. Polydiaxanone and Maxon sutures maintained the highest BS over the 28-day period, 71 per cent and 59 per cent of their initial BS, respectively. Suture diameter remained essentially unchanged except for chromic gut and the multifilament sutures which exhibited increased diameter. This increase was attributed to inflammatory tissue infiltration.

Assessment of an epoxy-fixed pericardial patch with or without ionically bound heparin in a canine model.

In this study, an epoxy-fixed porcine pericardial patch with or without ionically bound heparin was evaluated in a canine model as an alternative to the glutaraldehyde-fixed biological patch for clinical applications. To evaluate the effectiveness of this epoxy-fixed patch, a composite membrane composed of: an epoxy-fixed porcine patch with ionically bound heparin; a glutaraldehyde-fixed porcine patch with ionically bound heparin; an ePTFE polymeric patch; a polyester polymeric patch; an epoxy-fixed porcine patch without ionically bound heparin; and a glutaraldehyde-fixed porcine patch without ionically bound heparin was made. This membrane was assessed orthopically in a canine model. The early results (1 approximately 4 weeks post implant) revealed that the biological patches with ionically bound heparin had the mildest tissue reactions (inflammatory reaction, fibrosis, and adhesion) among all the test samples. However, by 12 weeks postoperatively, all the test samples had mild to severe tissue reactions. The order of tissue reactions with increasing severity was: the biological patches with ionically bound heparin, the biological patches without ionically bound heparin, and the polymeric patches. The results suggest that heparin may be used to reduce adhesion. Additionally, the epoxy-fixed tissue caused a relatively lower degree of inflammatory reaction than the glutaraldehyde-fixed tissue.

Biomechanical analysis of suture anchors and suture materials used for toggle pin stabilization of hip joint luxation in dogs.

OBJECTIVE: To compare in vitro mechanical properties of toggle pins and toggle rods used as suture anchors and of 3 suture materials (50-lb monofilament polybutester, No. 5 braided polyester, and 5-mm woven polyester) commonly used as prosthetic ligaments in the repair of hip joint luxation in dogs. SAMPLE POPULATION: Femoropelvic specimens from the cadavers of 18 dogs. PROCEDURE: Suture anchors were compared by use of pullout tests. Suture materials were compared by use of monotonic and cyclic tensile tests; cyclic tensile tests were performed with the suture placed over the edge of an aluminum bar to simulate the edge of the femoral bone tunnel. In vitro mechanical properties of the ligament of the femoral head were determined by use of monotonic tensile tests, using bone-ligament-bone cadaveric specimens. The in vitro mechanical properties of the acetabulum-ligament-femur complex and of this complex following rupture of the ligament and stabilization with a toggle rod and 5-mm woven polyester were determined by use of compression tests that simulated weight-bearing. RESULTS: Mechanical properties of the toggle rod were not significantly different from those of the toggle pin. Woven polyester had the longest fatigue life in cyclic testing. Hip joints stabilized with a toggle rod and woven polyester had less than half the strength in vitro of intact joints. CONCLUSIONS AND CLINICAL RELEVANCE: Results suggested that a toggle rod or toggle pin can be used for stabilization of hip joint luxations in dogs. Of the materials tested, braided polyester had the best in vitro mechanical properties.

Strength and knot security of braided polyester and caprolactone/glycolide suture.

BACKGROUND: Appropriate suture selection is necessary in providing mechanical stability to soft tissue reconstructions. Caprolactone/glycolide (Panacryltrade mark) became a popular suture, possessing excellent handling properties; however, clinical observations questioned the knot security of caprolactone/glycolide. Caprolactone/glycolide is still available on many commercial suture anchor systems. This study compared the security of the knots and ultimate tensile strength of braided caprolactone/glycolide suture to that of a commonly used suture material, braided polyester (Ethibondtrade mark). MATERIALS: Suture knots of No. 2 braided polyester suture and No. 2 braided caprolactone/glycolide suture were submersed in a physiologic saline solution and stressed using a continuous (non-cyclic) load, simulating a single maximal loading event in a clinical setting. Continuous loading was done to achieve clinical suture knot failure (3-mm knot slippage), then continued until catastrophic suture failure (suture breakage) occurred. Ten trials of each suture were tested. RESULTS: Force required to cause knot slippage of 3 mm was greater for braided polyester than for braided caprolactone/glycolide (p <. 0001, unpaired Students' t-test). Forces resulting in catastrophic failure were greater for braided polyester than braided caprolactone/glycolide (p = .0284, unpaired Students' t-test). CONCLUSIONS: These data have important implications in the selection of suture materials for repair of soft tissue injuries. In the clinical setting, a single maximal loading event may result in suture failure. These data indicate that braided polyester possesses superior in-vitro mechanical properties and suggest that braided polyester may provide greater security in-vivo than braided caprolactone/glycolide suture.

A study on elongation and knot slacking of various sutures.

The tension holding capacity of suture materials was measured by in vitro and in vivo experiments. Silk and expanded polytetrafluoroethylene sutures showed large elongation and significant knot slacking after tight tying. Although ultrahigh molecular-weight polyethylene suture had excellent creep resistance, it showed a relatively low tension holding capacity because of substantial knot slacking. On the other hand, polyester and high-strength poly(vinyl alcohol) sutures showed an excellent in vivo tension holding capacity, along with low elongation and insignificant knot slacking. Clinical performance of these sutures was briefly discussed from the mechanical point of view.

The resistance of absorbable sutures in fetal tissue and fluids.

The resistance of three different types of absorbable suture materials was studied in three groups which simulated intrauterine conditions. In group I the sutures were incubated in the amnioallantoic cavity of chicken embryo (CE) and in group II in the fetal tissue of CE. For incubation of sutures in group III, human amniotic fluid collected during cesarean section operations in the thirty-eighth week of pregnancy was used. We discovered that chromic catgut had a lower resistance in fetal tissue than in fetal fluid (p less than 0.01), which could be an important point in the selection of fetal dermal sutures. In vitro incubation in human amniotic fluid did not effect the known rate of loss of chromic catgut, proglactin 910 and polydioxanone.