Polyvinylidene Fluoride Sutures Research Articles

The Effects of Cyanoacrylate on Clinical Healing and Self-Reported Outcomes Following Free Gingival Graft Surgery: A Randomized Clinical Study

Objective: This study aims to reveal the effects of cyanoacrylate application at the recipient bed and the donor site in free gingival graft surgery on graft dimensions, clinical healing parameters and patient-based outcomes. 
 Methods: Free gingival graft operations were conducted on individuals who were randomly assigned to control or test groups. In the test group, the graft was stabilized and the donor site was coated with cyanoacrylate. In the control group, 6/0 polyvinylidene fluoride sutures were used for stabilization, while the donor site was left untreated. Variables including re-epithelization, post-operative complications, pain, bleeding and quality of life at recipient site, and color match, graft dimensions at donor site were assessed for up to 6 months. 
 Results: Twenty-three individuals completed the study. No differences were observed in any variable between groups except horizontal dimension loss of the graft, which was more abundant in the cyanoacrylate group at six months (p>0.05, p

Comparison of the mechanical properties and anchoring performance of polyvinylidene fluoride and polypropylene barbed sutures for tendon repair.

Polyvinylidene fluoride (PVDF) has been considered as an alternative suture material to replace polypropylene (PP) due to its superior biocompatibility and mechanical properties, but it has never been examined for use in barbed sutures, particularly for tendon repair. This study fabricated size 2–0 PVDF and PP bidirectional barbed sutures and compared their mechanical properties and anchoring performance in patellar tendons. The mechanical properties were evaluated via tensile testing, and the anchoring performance of the barbed sutures was assessed by a tendon suture pullout test. Sixty porcine patellar tendons were harvested, transected to mimic a full‐thickness injury, and repaired using a cross‐locked cruciate suturing technique. The ultimate tensile force was 60% higher for the PVDF barbed sutures (22.4 ± 2.1 N) than for the PP barbed sutures (14.0 ± 1.7 N). The maximum pullout force was 35% higher for PVDF barbed sutures (70.8 ± 7.8 N) than for PP barbed sutures (52.4 ± 5.8 N). The force needed to form a 2‐mm gap, indicative of repair failure, was similar between the PVDF (29.2 ± 5.0 N) and PP (25.6 ± 3.1 N) barbed sutures, but both were greater than the 2‐mm‐gap forces for non‐barbed sutures of the same size. In this study, PVDF barbed sutures provided better mechanical properties and improved tissue anchoring performance compared to the barbed PP sutures for porcine patellar tendon repair, demonstrating that PVDF monofilament sutures can be barbed and used effectively for tendon repair.

Cross-section modified and highly elastic sutures reduce tissue incision and show comparable biocompatibility: in-vitro and in-vivo evaluation of novel thermoplastic urethane surgical threads.

Surgical sutures are indispensable for a vast majority of operative procedures. An ideal suture is characterized by high tissue compliance without cutting into the mended tissue and optimal biocompatibility. Therefore, we assessed these mechanical and biological properties for novel elastic thermoplastic polyurethane (TPU) and cross-sectional modified "snowflake" sutures. Circular and "snowflake"-shaped TPU threads were manufactured and compared to similar surface modified polyvinylidene fluoride (PVDF) sutures. Regular PVDF sutures were used as the control group. Single-axis tensile test with and without gelatinous tissue surrogates were performed to evaluate the suture incision into the specimens. Biocompatibility was evaluated by subcutaneous implantation (n = 18) in rats for 7 and 21 days. Histology and immunohistology was conducted for assessment of the foreign body reaction. Regular and modified TPU threads showed a significant reduction of incision into the tissue surrogates compared to the control. Both TPU sutures and the modified PVDF sutures achieved comparable biocompatibility versus regular PVDF threads. Detailed histology revealed novel tissue integration into the notches of the surface modified sutures, we termed this newly shaped granuloma "intrafilamentous" granuloma. Elastic TPU threads showed a significant reduction of tissue surrogate incision and suture tension loss. Biocompatibility did not significantly differ from standard PVDF. Histology demonstrated tissue ingrowth following the surface modification of the suture referred to as "intrafilamentous" granuloma. Further in vivo studies are required to illuminate the exact potential of the new sutures to optimize intestinal anastomosis.

Influence of gentamicin-coded PVDF suture material on the healing of intestinal anastomosis in a rat model.

Intestinal anastomosis is a fundamental procedure in general surgery and required to restore intestinal continuity following resection. The aim of this study was to evaluate whether a gentamicin-coated polyvinylidene fluoride (PVDF) suture material has beneficial effect on anastomotic healing. Ninety Sprague-Dawley rats were divided into three groups: a PVDF-suture group, a gentamicin-coated PVDF (GPVDF)-suture group and a control group using Maxon® (polyglycolid-co-trimethylene carbonate). For each animal, a colonic anastomosis was performed. Ten animals from each group were sacrificed on postoperative days 3, 5, and 14. Measurements of anastomotic bursting pressure were performed on days 3 and 5. At each time, collagen type I/III ratio, MMP 2 and MMP-9 expression and the proliferation index (Ki67) were analyzed. In total, 90 animals underwent surgery without postoperative complications. Bursting strength in the GPVDF group was significantly elevated on day 5. Immunohistochemistry showed significant increase of the collagen type I/III ratio for PVDF and GPVDF on days 3 and 5. MMP2 was significantly increased for PVDF on days 3 and 5 and for GPVDF on day 5. The analysis of MMP9 revealed significant increase compared to control on day 3 and 5 (GPVDF) as well as on day 5 (PVDF). Staining for Ki67 revealed a significant elevation on postoperative day 3 for the PVDF and the GPVDF group. The present data shows the feasibility of PVDF as suture material for colonic anastomosis and confirms the ability of gentamicin to increase the stability of colonic anastomosis when used as coating material.

Polyvinylidene Fluoride as a Suture Material: Evaluation of Comet Tail-Like Infiltrate and Foreign Body Granuloma

Background: Biocompatibility and tissue integration of a surgical suture are decisive factors for wound healing and therefore for the success of sutures. The optimal suture material is still under discussion. Polyvinylidene fluoride (PVDF) is described to have superior properties of biocompatibility and is therefore frequently used as a mesh component. Only little information is available about its use as a suture material. The aim of this study was to evaluate the biocompatibility of PVDF as a suture material in comparison to 5 different established sutures in a rat model. Methods: In 30 male rats, a monofilamental PVDF suture (Resopren®) and 5 established control suture materials [polyester (Miralene®), polytetrafluoroethylene (Gore®), poliglecaprone (Monocryl®), polydioxanone (Monoplus®), polyglactin 910 (Vicryl®), USP size 3-0] were placed in the subcutaneous layer of the abdominal wall without knot or tension. After 3, 7 or 21 days, the abdominal walls were explanted for histopathological and immunohistochemical investigation with special regard to the size and quality of foreign body granuloma and the length of the comet tail-like infiltrate (CTI). Results: The PVDF sutures showed the smallest size of foreign body granuloma (60 ± 14 µm) and the smallest CTI length (343 ± 60 µm) of all polymers after 21 days. Only PVDF (Resopren) and polydioxanone (Monoplus) showed a significant collagen I/III ratio increase between days 3 and 21 (p = 0.009 and p = 0.016). The quality of foreign body reaction regarding inflammation, proliferation and fibrotic remodeling was similar between all suture materials. Conclusions: Our data indicate that monofilamental PVDF sutures show a favorable foreign body reaction with small granuloma sizes and CTI length in comparison to established sutures. Its use as a suture material in general surgery could therefore be extended in the future. To reinforce these findings, further clinical studies need to be conducted.

Mesh contraction: in vivo documentation of changes in apparent surface area utilizing meshes visible on magnetic resonance imaging in the rabbit abdominal wall model

Our aim was to analyze the apparent contraction of meshes in vivo after abdominal wall reconstruction and evaluate histological and biomechanical properties after explantation. Nine New Zealand female rabbits underwent repair of two full-thickness 25 × 30-mm midline defects in the upper and lower parts of the abdomen. These were primarily overlaid by 35 × 40-mm implants of a polyvinylidene fluoride (PVDF) DynaMesh (n = 6) or polypropylene meshes Ultrapro (n = 6) and Marlex (n = 6). Edges of the meshes were secured with iron(II,III) oxide (Fe(3)O(4))-loaded PVDF sutures. Magnetic resonance images (MRIs) were taken at days 2, 30 and 90 after implantation. The perimeter of the mesh was traced using a 3D spline curve. The apparent surface area or the area within the PVDF sutures was compared with the initial size using the one-sample t test. A two-way repeat analysis of variance (ANOVA) was used to compare the apparent surface area over time and between groups. PVDF meshes and sutures with Fe(3)O(4) could be well visualized on MRI. DynaMesh and Marlex each had a 17 % decrease in apparent surface area by day 2 (p < 0.001 and p = 0.001), respectively, which persisted after day 90. Whereas there was a decrease in apparent surface area in Ultrapro, it did not reach significance until day 90 (p = 0.01). Overall, the apparent surface area decreased 21 % in all meshes by day 90. No differences in histological or biomechanical properties were observed at day 90. There was a reduction in the apparent surface area between implantation and day 2, indicating that most mesh deformation occurs prior to tissue in-growth.

A comparative in vivo study of tissue reactions to four suturing materials.

The purpose of this study was to compare the histopathologic reaction of four suturing materials: silk, polyvinylidene fluoride (PVDF), polyglycolic acid, and catgut in the oral mucosa of albino rabbits. The twenty-one male mature albino rabbits which were used in this study were randomly divided into three groups of seven each. Silk, PVDF, polyglycolic acid and catgut suture materials were tested in the oral mucosa of these animals. The animals were sacrificed 2, 4, and 7 days after suturing. Two pathologists evaluated the samples by determining the presence and level of inflammation, granulation tissue, and fibrosis formation. Data were statistically analyzed by Kruskal Wallis and Mann-Whitney U tests. Histological features of the samples showed that PVDF and plain catgut suture materials produced more fibrous tissue (favorable response) on the fourth day in comparison with silk suture (P=0.02). Also, in the 7-day samples PVDF sutures produced the mildest inflammation when compared with the silk sutures (P=0.015). According to the results of this study, it can be convey that PVDF suture materials created mild tissue reactions and can be a reasonable candidate for suturing oral tissues.

COMPARISON OF MECHANICAL PROPERTIES OF POLYVINYLIDENE FLUORIDE AND POLYPROPYLENE MONOFILAMENT SUTURES USED FOR FLEXOR TENDON REPAIR

We performed an experimental study to evaluate the mechanical properties of polyvinylidene fluoride sutures and to compare their use with that of standard polypropylene sutures for the circumferential, epitendinous suture of a flexor tendon repair. Polyvinylidene fluoride sutures had a smaller suture diameter, a greater knot pull strength and less delayed extension when under creep testing, than polypropylene sutures. Tendons repaired using polyvinylidene fluoride sutures had significantly greater gap and breaking strengths than those repaired using polypropylene sutures.

Polyvinylidene fluoride (PVDF) as a biomaterial: From polymeric raw material to monofilament vascular suture

This study identified the effects of various manufacturing processes on the crystalline microstructure, mechanical properties, and biocompatibility of a polyvinylidene fluoride (PVDF) suture. To achieve this, changes in the crystalline microstructure and the tensile behavior of PVDF monofilaments were monitored in vitro after different thermal processing, coloration, and sterilization treatments. In addition, the in vivo biocompatibility of the manufactured and sterilized PVDF suture was assessed by using it to anastomose a preclotted polyester vascular prosthesis as a thoracoabdominal bypass in a series of dogs. The tissue response was followed by histologic and scanning electron microscopy over implantation periods ranging from 4 h to 6 months. Differential scanning calorimetry and infrared spectroscopy (FTIR-ATR) showed that thermal processing and the addition of a coloring agent had a direct effect on modifying the crystalline microstructure and hence changing the mechanical properties. For example, thermal processing converted some of the alpha phase into the beta and gamma polymorphs, whereas coloration led only to a major increase in the beta-to-alpha ratio. The tensile properties were found to be optimized when the relative proportion of the beta and gamma phases combined compared to the alpha form gave rise to an FTIR A509/A532 absorption ratio between 4.0 and 4.5. Sterilization was found to cause some modifications to the crystalline microstructure near the surface of the monofilaments, but it did not change their mechanical properties. Pathologic examination of the anastomotic regions after different periods of implantation revealed a minimal cellular response, with no mineralization, intimal hyperplasia, or excessive fibrous tissue reaction. This good biocompatibility, together with other desirable characteristics such as ease of manipulation and satisfactory mechanical strength, makes PVDF an attractive alternative monofilament suture material for cardiovascular surgery.

Polyvinylidene Fluoride Monofilament Sutures: Can They Be Used Safely for Long‐Term Anastomoses in the Thoracic Aorta?

Polyvinylidene fluoride (PVDF) represents an attractive alternative to polypropylene as a monofilament vascular suture because of its satisfactory physicochemical properties, it ease of handling, and its good biocompatibility. However, the polymer's ability to remain mechanically and chemically stable when exposed to a mild hydrolytic environment over the long term has yet to be demonstrated. One in vitro study involved the comparison of the long-term relative resistance of PVDF and polypropylene sutures to hydrolysis for a period of 9 years. The PVDF suture showed major molecular rearrangements from the original ratio of three crystalline structures to the single beta crystalline phase. The observation of some surface oxidation and water inhibition did not significantly modify the tensile strength of the PVDF suture, which retained 92.5% of its original value. In contrast, the polypropylene sample did not undergo any recrystallization but was associated with more oxidation byproducts and more water molecules near the surface, which contributed to a 46.6% loss in initial tensile strength. An in vivo study confirmed that PVDF sutures are biocompatible and are able to maintain satisfactory biostability when used to anastomose thoracic aortic allografts for a period of 6 months in the dog. The cellular reaction of fresh allografts as well as the control autografts to PVDF sutures was minimal. In other allografts that had been preserved in a supplemented medium for 1 week prior to implantation, the PVDF sutures healed satisfactorily with the formation of neocollagen and few macrophages surrounding the monofilament. No evidence of instability at the allograft-host artery junction was observed, confirming that the PVDF sutures were able to ensure a secure anastomosis in the thoracic aorta. PVDF sutures have demonstrated superior long-term biostability in vitro and minimal tissue response in vivo. These are two essential requirements when evaluating the use of a suture for vascular surgery in general and thoracic aortic surgery in particular.

Why Make Monofilament Sutures Out of Polyvinylidene Fluoride?

In recent years some clinical reports have associated suture failures with polypropylene monofilaments. Therefore there is interest in developing an alternative suture material that is less thrombogenic than polyester and similar in handling characteristics but less prone to mechanical failure than polypropylene. To this end, Peters Laboratoire Pharmaceutique has developed a new monofilament suture material from polyvinylidene fluoride (PVDF), which has been subjected to a special treatment to modify its crystalline form and level of crystallinity. The purpose of this study was to evaluate its mechanical, chemical, and biologic properties and to compare its performance, in a peripheral vascular application, to that of a polypropylene control. A series of in vitro tests were performed to study the morphology, tensile properties, creep, surface chemistry, thermal characteristics, and resistance to iatrogenic trauma. In addition, an in vivo trial was undertaken in which vascular prostheses anastomosed with either PVDF or polypropylene sutures were implanted as a thoracoabdominal bypass for 6 months in the dog. Histologic and degradation analyses were performed on the explants. The results from the mechanical tests on 4-0, 5-0, and 6-0 PVDF and polypropylene sutures demonstrated that although both materials have similar breaking strengths, the PVDF has a higher extension at break, has less delayed extension when under tensile creep testing, and suffers less trauma than the polypropylene when compressed by a standard needle holder. While chemical analyses found evidence of surface oxidation on both types of sutures, thermal analysis confirmed that the level of crystallinity of the PVDF polymer is higher than that of the polypropylene control. During the pilot study in animals, PVDF sutures were found to have good handling and frictional characteristics that facilitated the tying of knots. Histologic analysis of the explants found no inflammatory cells in the tissue surrounding either the PVDF or polypropylene sutures, and scanning electron microscopic examination of the cleaned suture surfaces found no evidence of degradation during 6 months in vivo. Though preliminary in nature, these findings indicate that monofilament sutures made from PVDF provide an attractive alternative to those made from polypropylene for use in cardiovascular surgery. In addition to providing acceptable in vivo behavior and being easy to manipulate and more resistant to iatrogenic injury, PVDF materials can be sterilized by beta or gamma radiation and so can reduce dependence upon ethylene oxide and chlorofluorohydrocarbons.