Suture Material Research Articles

The effect of medical grade honey on tensile strength, strain, and Young's modulus of synthetic absorbable suture material used in equine surgery.

Medical grade honey (MGH) has been introduced as a protective measure against surgical site infections in equine surgery, but the effect on suture material has not been investigated. To evaluate the effect of MGH on the tensile properties of three synthetic absorbable suture materials. In vitro experiments. Ten strands of Polydioxanone USP 2 (PD2), Polyglactin 910 USP 2 (PG2) and Polyglecaprone USP 2-0 (PC2-0) were incubated 1, 7, 14, 21 and 28 days in MGH, phosphate-buffered saline (PBS), equine plasma (EP) and MGH mixed with equine plasma (HP). Mechanical testing was performed recording maximum load at failure (N), strain at failure and Young's modulus (N/mm2 ). The results were reported from a Welch or regular ANOVA. PD2 in MGH had a significantly higher tensile strength compared to PD2 in EP (p < 0.05, mean difference (md) = 16.95 N, CI95% (9.19-24.70 N)) and PBS (p < 0.05, md = 14.48 N CI95% (6.73-22.23 N)) on day 7 and the remaining time points. PG2 incubated in MGH had a significantly higher tensile strength compared to EP (p < 0.05, md = 69.28 N CI95% (64.16-74.40 N)) and PBS (p < 0.05, md = 56.90 N CI95% (51.78-62.02 N)) until day 28. PC2-0 incubated in MGH had a significantly higher tensile strength compared to EP (p < 0.05 md = 12.40 N CI95% (4.59 N-20.20 N)) and PBS (p < 0.05 md = 11.23 CI95% (3.42-19.03 N)) on day 7 and the remaining time points. The sutures were unloaded during incubation and a single cycle to failure test was only performed, which does not reflect the in vivo environment where shear forces are present. MGH did not negatively affect the tensile strength of the suture material and can safely be applied in contact with suture materials commonly used in equine surgery.

Biomechanical Comparison of Nonlocked Minimally Invasive and Locked Open Achilles Tendon Simulated Rupture Repairs.

Open repair of Achilles tendon ruptures is associated with a risk of infection and other wound complications. Although percutaneous repairs reduce these complications, they may increase the risk of nerve injury. This study was designed to determine whether a percutaneous nonlocking repair can approach the gapping resistance offered by a standard open repair under conditions approximating typical postoperative physiotherapy. Ten pairs of cadavers Achilles tendons were transected in situ 5 cm above the insertion. One tendon from each pair was repaired using an open 4-strand Krackow locking loop, and the contralateral tendon was repaired with the Achillon system using the same suture material. Displacement transducers were attached to the medial, lateral, anterior, and posterior aspects of the tendon, spanning the repair. Each tendon underwent 1000 tensile loading cycles to 86.5 N, simulating passive ankle range-of-motion physiotherapy. Gapping was documented on the 1st, 50th, 100th, 500th, and 1000th cycles. The ultimate tensile strength of each repaired tendon was then measured by distracting until gross failure occurred. Gapping of the percutaneous repairs exceeded that of conventional open repairs on the first, 500th, and 1000th load cycles. All 10 conventionally repaired tendons withstood 1000 load cycles without gross failure, but 4 of 10 percutaneous minimally invasive repairs failed, one on the 9th load cycle and the others between the 100th and 500th cycles. On average, tendons repaired with the open technique withstood 66% greater tensile load in failure testing than those repaired with the percutaneous technique. Open Krackow Achilles tendon repairs may better withstand more aggressive postoperative physiotherapy than nonlocked percutaneous repairs. The study suggests that surgeons should consider locking suture approaches to avoid loss of repair integrity with early motion.

Sustainable Antibacterial Surgical Suture Based on Recycled Silk Resource by an Internal Combination of Inorganic Nanomaterials.

The current antibacterial treatment methods of silk sutures can only be finished by surface modification, leading to problems of short antibacterial effects, easy slow-release consumption, prominent toxicity, and susceptibility to drug resistance. Speculatively, surgical sutures combining antibacterial material internally will possess a more promising efficacy. Hence, we extracted recycled regenerated silk fibroin (RRSF) from waste silk resources to make RRSF solutions. Internally combining with inorganic titanium dioxide (TiO2) nanoparticles, we fabricated antibacterial RRSF-based surgical sutures. The morphologies, mechanical and antibacterial properties, biocompatibility tests, and in vivo experiments were carried out. The results showed that the surgical sutures with 1.25 wt % TiO2 acquired 2.40 N knot strength (143 μm diameter) and achieved a sustainable antibacterial effect of 93.58%. Surprisingly, the sutures significantly reduced inflammatory reactions and promoted wound healing. Surgical sutures in this paper realize high-value recovery of waste silk fibers and provide a novel approach to preparing multifunctional sutures.

Differential target multiplexed spinal cord stimulation using a paddle-type lead placed at the appropriate site for neuropathic pain after spinal cord injury in patients with past spinal surgical histories: study protocol for an exploratory clinical trial

BackgroundNeuropathic pain after spinal cord injury (SCI), both traumatic and non-traumatic, is refractory to various treatments. Spinal cord stimulation (SCS) is one of the neuromodulation therapies for neuropathic pain, although SCS has insufficient efficacy for neuropathic pain after SCI. The reasons are presumed to be inappropriate locations of SCS leads and conventional tonic stimulation itself does not have a sufficient analgesic effect for the pain. In patients with past spinal surgical histories, the cylinder-type leads are likely to be placed on the caudal side of the SCI because of surgical adhesions. Differential target multiplexed (DTM) stimulation is one of the latest new stimulation patterns that is superior to conventional stimulation.MethodsA single-center, open-label, randomized, two-way crossover trial is planned to investigate the efficacy of SCS using DTM stimulation placing a paddle lead at the appropriate site for neuropathic pain after SCI in patients with spinal surgical histories. The paddle-type lead delivers energy more efficiently than a cylinder-type lead. This study consists of two steps: SCS trial (first step) and SCS system implantation (second step). The primary outcome is rates of achieving pain improvement with more than 33% reduction 3 months after SCS system implantation. The secondary outcomes are to be evaluated as follows: (1) effectiveness of DTM and tonic stimulations during the SCS trial; (2) changes of assessment items from 1 to 24 months; (3) relationships between the result of the SCS trial and the effects 3 months after SCS system implantation; (4) preoperative factors associated with a long-term effect, defined as continuing for more than 12 months; and (5) whether gait function improves from 1 to 24 months.DiscussionA paddle-type lead placed on the rostral side of SCI and using DTM stimulation may provide significant pain relief for patients with intractable neuropathic pain after SCI in patients with past spinal surgical histories.Trial registrationJapan Registry of Clinical Trials (jRCT) jRCT 1042220093. Registered on 21 November 2022, and last modified on 6 January 2023. jRCT is approved as a member of the Primary Registry Network of WHO ICTRP.

The effect of suture materials with different absorption times on isthmocele: a retrospective study.

With the increasing rate of cesarean operations, the formation of niches and related early and late complications have been observed more frequently. In this study, we examined the effects of using a suture material that can be absorbed faster than conventional sutures on the formation of niches. This study was designed as a retrospective study and completed with a total of 101 patients. During the cesarean operation, the uterus was closed with Rapide Vicryl® in 49 patients and Vicryl® in 52 patients. The uterine niche was measured with a sonohysterogram 6 months after the operation. The primary outcome of the study was determined as uterine niche formation and the secondary outcome was the post-menstrual spotting (PMS) rate. Duration of surgery, intraoperative/postoperative blood loss, and hospitalization time were similar between the two groups. Niche formation was significantly lower in the Rapide Vicryl group (22.4%) when compared to the Vicryl group (42.3%) (p = 0.046). Also, PMS was observed significantly lower in the Rapide Vicryl group (16.2% and 52.8% in Rapide Vicryl and Vicryl groups, respectively; p = 0.002). The formation of niches and associated PMS rates were less with suture materials that were absorbed faster.

The strength of surgical knots involves a critical interplay between friction and elastoplasticity.

Knots are the weakest link in surgical sutures, serving as mechanical ligatures between filaments. Exceeding their safe operational limits can cause fatal complications. The empirical nature of present guidelines calls for a predictive understanding of the mechanisms underlying knot strength. We identify the primary ingredients dictating the mechanics of surgical sliding knots, highlighting the previously overlooked but critical effect of plasticity and its interplay with friction. The characterization of surgeon-tied knots reveals the relevant ranges of tightness and geometric features. Using model experiments coupled with finite element simulations, we uncover a robust master curve for the target knot strength versus the tying pre-tension, number of throws, and frictional properties. These findings could find applications in the training of surgeons and robotic-assisted surgical devices.

Novel Bioactive Glass/Graphene Oxide-Coated Surgical Sutures for Soft Tissue Regeneration.

The combination of a commercially available PGLA (poly[glycolide-co-l-lactide]), 90:10% suture material with bioactive bioglass nanopowders (BGNs) and graphene oxide (GO)-doped BGNs offers new opportunities for the clinical application of biomaterials in soft tissue engineering. In the present experimental work, we demonstrate that GO-doped melt-derived BGNs were synthesized via the sol-gel process. After that, novel GO-doped and undoped BGNs were used to coat resorbable PGLA surgical sutures, thereby imparting bioactivity, biocompatibility, and accelerated wound healing properties to the sutures. Stable and homogeneous coatings on the surface of the sutures were achieved using an optimized vacuum sol deposition method. The phase composition, morphology, elemental characteristics, and chemical structure of uncoated and BGNs- and BGNs/GO-coated suture samples were characterized using Fourier transform infrared spectroscopy, field emission scanning electron microscopy, associated with elemental analysis, and knot performance test. In addition, in vitro bioactivity tests, biochemical tests, and in vivo tests were performed to examine the role of BGNs and GO on the biological and histopathological properties of the coated suture samples. The results indicated that the formation of BGNs and GO was enhanced significantly on the suture surface, which allowed for enhanced fibroblast attachment, migration, and proliferation and promoted the secretion of the angiogenic growth factor to speed up wound healing. These results confirmed the biocompatibility of BGNs- and BGNs/GO-coated suture samples and the positive effect of BGNs on the behavior of L929 fibroblast cells and also showed for the first time the possibility that cells can adhere and proliferate on the BGNs/GO-coated suture samples, especially in an in vivo environment. Resorbable surgical sutures with bioactive coatings, such as those prepared herein, can be an attractive biomaterial not only for hard tissue engineering but also for clinical applications in soft tissue engineering.

Surgical Sealant with Integrated Shape-Morphing Dual Modality Ultrasound and Computed Tomography Sensors for Gastric Leak Detection.

Postoperative anastomotic leaks are the most feared complications after gastric surgery. For diagnostics clinicians mostly rely on clinical symptoms such as fever and tachycardia, often developing as a result of an already fully developed, i.e., symptomatic, surgical leak. A gastric fluid responsive, dual modality, electronic-free, leak sensor system integrable into surgical adhesive suture support materials is introduced. Leak sensors contain high atomic number carbonates embedded in a polyacrylamide matrix, that upon exposure to gastric fluid convert into gaseous carbon dioxide (CO2 ). CO2 bubbles remain entrapped in the hydrogel matrix, leading to a distinctly increased echogenic contrast detectable by a low-cost and portable ultrasound transducer, while the dissolution of the carbonate species and the resulting diffusion of the cation produces a markedly reduced contrast in computed tomography imaging. The sensing elements can be patterned into a variety of characteristic shapes and can be combined with nonreactive tantalum oxide reference elements, allowing the design of shape-morphing sensing elements visible to the naked eye as well as artificial intelligence-assisted automated detection. In summary, shape-morphing dual modality sensors for the early and robust detection of postoperative complications at deep tissue sites, opening new routes for postoperative patient surveillance using existing hospital infrastructure is reported.

The Strengths and Weaknesses of Left Atrial Appendage Ligation or Exclusion (LARIAT, AtriaClip, Surgical Suture)

Left atrial appendage (LAA) epicardial exclusion has been associated with addressing 2 potential deleterious consequences attributed to the LAA, namely, thrombus formation and an arrhythmogenic contributor in advanced forms of atrial fibrillation. With more than 60 years of history, the surgical exclusion of the LAA has been firmly established. Numerous approaches have been used for surgical LAA exclusion including surgical resections, suture ligation, cutting and non-cutting staples, and surgical clips. Additionally, a percutaneous epicardial LAA ligation approach has been developed. A discussion of the various epicardial LAA exclusion approaches and their efficacy will be discussed, along with the salient beneficial affects on LAA thrombus formation, LAA electrical isolation and neuroendocrine homeostasis.

Arthroscopic Anterior Cruciate Ligament Primary Repair With Synthetic Augmentation and Fixation With the Knotless Suture Anchor

An anterior cruciate ligament (ACL) tear is one of the most common ligament injuries in athletes. The arthroscopic ACL reconstruction procedure is the gold standard for treatment. However, the improvement in injury classification and suture materials has subsequently made arthroscopic ACL primary repair an alternative surgical treatment option. This Technical Note describes an arthroscopic ACL primary repair with synthetic augmentation made of several high-strength sutures and fixation with the knotless suture anchor. The reinforced synthetic material acts as a structural tie to support the ACL while it heals.

3D printed elastic hydrogel conduits with 7,8-dihydroxyflavone release for peripheral nerve repair.

Nerve guide conduit is a promising treatment for long gap peripheral nerve injuries, yet its efficacy is limited. Drug-releasable scaffolds may provide reliable platforms to build a regenerative microenvironment for nerve recovery. In this study, an elastic hydrogel conduit encapsulating with prodrug nanoassemblies is fabricated by a continuous 3D printing technique for promoting nerve regeneration. The bioactive hydrogel is comprised of gelatin methacryloyl (GelMA) and silk fibroin glycidyl methacrylate (SF-MA), exhibiting positive effects on adhesion, proliferation, and migration of Schwann cells. Meanwhile, 7,8-dihydroxyflavone (7,8-DHF) prodrug nanoassemblies with high drug-loading capacities are developed through self-assembly of the lipophilic prodrug and loaded into the GelMA/SF-MA hydrogel. The drug loading conduit could sustainedly release 7,8-DHF to facilitate neurite elongation. A 12​mm nerve defect model is established for therapeutic efficiency evaluation by implanting the conduit through surgical suturing with rat sciatic nerve. The electrophysiological, morphological, and histological assessments indicate that this conduit can promote axon regeneration, remyelination, and function recovery by providing a favorable microenvironment. These findings implicate that the GelMA/SF-MA conduit with 7,8-DHF release has potentials in the treatment of long-gap peripheral nerve injury.

Waggle needling Yanglingquan (GB34) enhances cerebral blood flow and ameliorates condition of spastic paresis in rats with middle cerebral artery occlusion induced by surgical nylon suture.

To evaluate the therapeutic efficacy and the influence on cerebral blood supply of waggle needling Yanglingquan (GB34) on spastic paresis (SP) rats after middle cerebral artery occlusion (MCAO) induced and investigate its mechanism of relieving neurobehavior deficiency. SP rat model was produced by permanent MCAO. Rats were divided into five groups: blank control group (Control), sham operation group (Sham), model group (Model), waggle needling group (WN) and perpendicular needling group (PN). SP rats were treated with acupuncture from day 3 after MCAO, once a day for 6 d. The modified neurological severity score (mNSS) and modified Ashworth scale (MAS) were conducted on days 0, 1, 3, 5, 7 and 9. Cerebral blood flow (CBF) in ischemic cortex was measured by laser speckle imaging 5 min pre ischemia, 5 min post ischemia, and after intervention on day 9. All rats were sacrificed at day 9 and the protein and mRNA expressions of γ2 subunit of the γ-aminobutyric acid receptor A (GABAAγ2) and K+-Cl?cotransporter 2 (KCC2) in the ischemic cortex and lumber enlargement was measured by Western blotting and real-time quantitative polymerase chain reaction. Both Control and Sham groups showed no changes in mNSS and MAS scores and in the regional CBF. Compared with Model group, both WN and PN treatments significantly ameliorated neurological deficit ( 0.01), decreased muscle tone ( 0.05), and enhanced CBF ( 0.001) in SP rats; moreover, WN showed superior effects than PN ( 0.001). In line with the improvement in neurobehavior, acupuncture interventions up-regulated the expressions of GABAAγ2 and KCC2 in the ischemic cortex as well as lumber enlargement ( 0.01) in SP rats, and those changes were more obvious in WN ( 0.05). Acupuncture at Yanglingquan (GB34) enhanced cerebral blood flow and ameliorated SP in permanent MCAO rats, while waggle needling was superior to regular perpendicular needling. Waggle needling Yanglingquan (GB34) would be a potential complementary therapy for SP.

Comparison of Three Different Suture Materials for Toggle Pin (TP) Technique in Induced Hip luxation in Dogs

Comparison of Three Different Suture Materials for Toggle Pin (TP) Technique in Induced Hip luxation in Dogs

Review on Fabrication and Application of Regenerated Bombyx mori Silk Fibroin Materials

Abstract Natural silk fiber derived from the Bombyx mori (B. mori) silkworm has long been used as a luxury raw material in textile industry because of its shimmering appearance and durability, and as surgical suture for its high strength and flexibility. Regenerated silk fibroin, as the main protein extracted from the cocoons of the B. mori silkworm, recently has gained considerable attention due to its outstanding properties, including facile processability, superior biocompatibility, controllable biodegradation, and versatile functionalization. Tremendous effort has been made to fabricate silk fibroin into various promising materials with controlled structural and functional characteristics for advanced utilities in a multitude of biomedical applications, flexible optics, electronics devices, and filtration systems. Herein, reverse engineered silk fibroin extraction methods are reviewed, recent advances in extraction techniques are discussed. Fabrication methods of silk fibroin materials in various formats are also addressed in detail; in particular, progress in new fabrication technologies is presented. Attractive applications of silk fibroin-based materials are then summarized and highlighted. The challenges faced by current approaches in production of silk fibroin-based materials and future directions acquired for pushing these favorable materials further toward above mentioned applications are further elaborated.

The influence of degradation in different pH buffer solutions on the optical and durability properties of Monocryl suture: (an in vitro study)

The objective of this work is to investigate the hydrolytic degradation of the Monocryl (PGA/PCL) surgical suture in different pH buffer solutions, and its correlation with the structural alterations the material undergoes. To this end, an in vitro degradation study was conducted under acidic (pH = 2), physiological (pH = 7.4), and alkaline (pH = 8.5) conditions at 37 °C, over 25 days. Changes in the swelling rate, structural and mechanical properties of the Monocryl sample with the degradation time were characterized, from which the related degradation mechanism of the material was concluded. Results showed that the structural values of the Monocryl sample were more sensitive in the alkaline medium than the acidic and neutral ones. It exhibited a reduction in birefringence values by 11.5% from the original one in the buffer solution of pH = 8.5, only 4% at pH = 2, and 2.6% at pH = 7.4, after 20 days of degradation durations. Over the same time period, mechanical loss in neutral, acidic, and alkaline media was decreased to 19, 14.9, and 8.3%, respectively. The obtained results revealed that the Monocryl suture exhibits enhanced degradation properties in neutral conditions rather than both acidic and alkaline ones, with a more homogeneous degradation behavior during the degradation process.Graphical abstract

External Z-plasty Technique for Correction of Alar Retraction in Asian Patients.

Current strategies for correcting alar retraction mainly include cartilage grafting and composite grafting, which are relatively complicated and may produce injury to the donor site. Herein, we introduce a simple and effective external Z-plasty technique for correcting alar retraction in Asian patients with poor skin malleability. Twenty-three patients were presented with alar retraction and poor skin malleability, and they were very concerned about the shape of the nose. These patients undergoing external Z-plasty surgery were analyzed retrospectively. In this surgery, no grafts were needed, and the location of the Z-plasty was according to the highest point of the retracted alar rim. We reviewed the clinical medical notes and photographs. During the postoperative follow-up period, patients' reported satisfaction with aesthetic outcome were also evaluated. The alar retraction of all the patients was successfully corrected. The postoperative mean follow-up period was 8 months (range: 5-28mo). No incidents of flap loss, recurrence of alar retraction, or nasal obstruction were observed during postoperative follow-up. Within postoperative 3-8 weeks, minor red scarring was visible at the operative incisions in most patients. However, these scars turned unobvious after postoperative 6 months. There were 15 cases (15/23) being very satisfied with the aesthetic outcome of this procedure. Seven patients (7/23) were satisfied with the effect and the invisible scar of this operation. Only one patient was dissatisfied with the scar, but she was satisfied with the correction effect of the retraction. This external Z-plasty technique can be an alternative method for correction of alar retraction with no need of cartilage grafting, and the scar can be unobvious with fine surgical suture. However, the indications should be limited in patients with severe alar retraction and poor skin malleability, who should not particularly care about the scars.

Changes in the indicators of connective tissue metabolism in the blood serum of experimental rats under the conditions of modeling the development of degenerative processes in paravertebral muscles

Low back pain is a common health problem. To deepen the understanding of the pathogenesis of the disease, experimental studies on animals with modeling of the pathological process are necessary. Objective. Based on the analysis of biochemical markers of connective tissue metabolism in the blood serum of laboratory rats, the applicability of the studied models of degenerative muscle tissue damage to study the relationship between this condition and the development of disorders in spinal motor segments was assessed. Methods. Two models of reproduction of degenerative processes in the paravertebral muscles of white rats were tested: I (n = 5) — alimentary (diet-induced) obesity, by keeping it for 3 months on a high-calorie diet; II (n = 5) — ischemia, by tying the large rectus muscles of the back with suture material (45 days). Control group (n = 5) — intact animals of similar age and sex. The content of glycoproteins, total chondroitin sulfates (CS), hexosamines, protein-bound hexoses, seroglycoides, fractional distribution and total content of hydroxyproline and glycosaminoglycan sulfates (GAGs) were investigated in the blood serum of rats. The results. In the blood serum of rats of groups I and II, a significant increase compared to the control level of glycoproteins was determined, with a greater effect in the ischemia model, but no significant changes of protein-bound hexoses, hexosamines and CS were recorded. The level of inflammatory markers (sialic acids and seroglycoides) in the blood serum of animals of both groups did not differ significantly from the control, and changes in the parameters of hydroxyproline (except for the slightly changed protein-bound fraction) and GAGs were significant only for the ischemia model. Conclusions. Based on the analysis of biochemical markers of connective tissue metabolism in rats of groups I and II, changes characteristic of degenerative processes were determined, with a greater manifestation in the ischemia model. No significant increase in biochemical markers of inflammation was recorded. Both models can be used to reproduce dystrophic processes in osteochondrosis.

Fully Endoscopic Mitral Valve Repair with Percutaneous Cannulation of Groin Vessels.

Endoscopic mitral valve surgery (EMS) has become a standard of care at specialized heart centers, further reducing surgical trauma compared to a traditional minimally invasive, thoracotomy-based approach. Exposure of the groin vessels for the establishment of cardiopulmonary bypass (CPB) via surgical cutdown in minimally invasive surgery (MIS) may result in wound healing disorders or seroma formation. The avoidance of surgical exposure of the groin vessels by using fully percutaneous techniques for the insertion of a CPB cannula with the implementation of vascular pre-closure devices has the potential to reduce these complications and improve clinical results. Herein, we present the utilization of a novel plug based vacsular closure device with a resobable collagen plug and the absence of suture material for closure of the arterial access for CPB in MIS. While this device was initially predominantly used in transcatheter aortic valve implantation (TAVI) procedures, with its safety and feasibility shown, we herein show that it can be used in CPB cannulation, since it is capable of closing arterial access sites up to 25 French (Fr.) in size. This device may be suitable to significantly reduce groin complications in MIS and simplify the establishment of CPB. Here, we describe the fundamental steps of EMS, including percutaneous groin cannulation and decannulation using a vascular closure device.

Evaluation of insertable cardiac monitor placement and safety in the LUX-Dx PERFORM study

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Boston Scientific Corporation Background The LUX-Dx PERFORM Study is designed to evaluate safety and performance of the LUX-Dx insertable cardiac monitor (ICM) in a general patient population. Enrollment and device insertions are complete, and all patients have completed 30 days of follow-up. This abstract describes the study population, characterizes device insertion, and reports on preliminary data for ICM system-related complications. Methods The LUX-Dx PERFORM study is a prospective, multi-center, single arm, post-market, observational study. The ICM system-related complication-free rate (CFR) at 30 days post-insertion was calculated using Kaplan-Meier methodology and the 97.5% one-side lower confidence limit (LCL) was compared to the prespecified performance target of 94%. All ICM system-related adverse events were adjudicated by independent physician reviewers. Results 727 patients were enrolled at 24 centers in the United States from March 2021 to May 2022. The study population was 49% male, 91% white and 66+/-14 years old. 717 patients had device insertions and were successfully registered in the LATITUDE Clarity data management system. There were 9 withdrawals prior to insertion and 1 aborted procedure due to deployment difficulty. ICM insertion was performed in-hospital 76% of the time (N=547) and in-clinic 24% of the time (N=171). 96% were de novo device insertions. A variety of closure techniques were used including surgical glue (62%), adhesive strips (45%), sutures (42%), and staples (9%). Median procedure time was 4 minutes (range 1 - 37). There were 4 ICM system-related complications in the first 30 days (CFR 99%, LCL 99%) which meets the acute safety performance goal. The system-related complications include 1 case of ICM deployment difficulty, 1 case of device expulsion three days post insertion, and 2 infections that were treated with oral antibiotics and resolved without further mitigation. Conclusion The LUX-Dx ICM can be inserted quickly, in both hospital and clinic settings, with a very low complication rate.

Secondary wound closure with anew transparent negative-pressure dressing.

Secondary healing surgical wounds can be treated with negative-pressure therapy. Dressing changes can be painful due to the strong adherence of the polyurethane foam placed in the wound. After debridement and conditioning of the wound bed, secondary surgical wound closure with asurgical suture can be performed. Cutaneous negative-pressure therapy is used preventively after primary surgical suturing. Descriptions for secondary wound closure without asurgical suture are not known to date. The preparation and handling of an innovative transparent dressing for the cutaneous application of negative-pressure therapy is demonstrated here. The dressing assembly consists of atransparent drainage film and atransparent occlusion film. Negative pressure is applied via atubing connector using anegative pressure pump. Anew method of secondary wound closure using the transparent negative-pressure dressing is presented based on acase example. The treatment cycle with instructions for making the dressing is shown in avideo.