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OBJECTIVE: Fibrin sealants are routinely used for intra-articular surgical fixation of cartilage fragments and implants. However, the mechanical properties of fibrin sealants in the context of cartilage repair are unknown. The purpose of this study was to characterize the adhesive and frictional properties of fibrin sealants using an ex vivo model. DESIGN: Native bovine cartilage-bone composites were assembled with a single application of Tisseel or Vistaseal. Composites were tested in tension and lap shear. In addition, the coefficient of friction (COF) was measured in a native cartilage annulus model alone and with minced cartilage. Finally, the effect of a double application of fibrin sealant was evaluated. RESULTS: There were no significant differences in tensile modulus, ultimate tensile strength (UTS), shear modulus, or ultimate shear strength (USS) between the 2 fibrin sealants. Both fibrin sealants demonstrated a UTS and USS of

Fibrin sealants are well‐established components of the surgical toolbox, especially in procedures that harbor a high risk of perioperative bleeding. Their widespread use as hemostats, sealants or tissue‐adhesives in various surgical settings has shown that the choice of the appropriate sealant system affects the clinical outcome. While many studies have compared the hemostatic efficiency of fibrin sealants to that of other natural or synthetic sealants, there is still limited data on how subtle differences in fibrin sealant formulations relate to their biological performance. Here, we performed an in‐depth physicochemical and biological characterization of the two most commonly used fibrin sealants in the US and Europe: TISSEEL™ ("FS") and VISTASEAL™/VERASEAL™ ("FS+Osm"). Our chemical analyses demonstrated differences between the two sealants, with lower fibrinogen concentrations and supraphysiological osmolality in the FS+Osm formulation. Rheological testing revealed FS clots have greater clot stiffness, which strongly correlated with network density. Ultrastructural analysis by scanning electron microscopy revealed differences between FS and FS+Osm fibrin networks, the latter characterized by a largely amorphous hydrogel structure in contrast to the physiological fibrillar network of FS. Cytocompatibility experiments with human fibroblasts seeded on FS and FS+Osm fibrin networks, or cultured in presence of sealant extracts, revealed that FS+Osm induced apoptosis, which was not observed with FS. Although differential sealant osmolality and amounts of fibrinogen, as well as the presence of Factor XIII or additives such as antifibrinolytics, may explain the mechanical and structural differences observed between the two fibrin sealants, none of these substances are known to cause apoptosis at the respective concentrations in the sealant formulation. We thus conclude that hyper osmolality in the FS+Osm formulation is the primary trigger of apoptosis—a mechanism that should be evaluated in more detail, as it may affect the cellular wound healing response in situ. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the use of Tisseel, a 2-component fibrin sealant agent for the control of minor bleeding and repair of the ovarian defect at the end of laparoscopic cystectomy (LC) of endometriomas. Materials and methods: From January 2011 to December 2015, an observational study of all patients who underwent LC of endometrioma using Tisseel (group A) was performed. The demographic and operative data, including age, body mass index, operative indications, operative time, estimated blood loss, complications, and postoperative hospital stay duration were recorded. A contemporary cohort of patients, who underwent LC of endometrioma without Tisseel (group B) was also retrospectively compared. Results: A total of 274 patients were recruited in this study (53 LCs with Tisseel and 221 LCs without Tisseel, respectively). Complete hemostasis was achieved in all patients. The mean size of main mass was significantly larger in the group A than in the group B (7.8 ± 2.4 cm vs. 7.0 ± 2.3 cm, p = 0.033) but the mean operating time, operative blood loss, febrile morbidity, and length of hospitalization were not significantly different between the two groups. Conclusion: This preliminary series demonstrated the use of Tisseel in LC of endometriomas without any bipolar coagulation and/or suturing of ovarian tissue is clinically safe and feasible.

Post-dural puncture headache is an uncommon entity in young children and adolescents. Percutaneous epidural blood patching has been classically used to manage refractory post-dural puncture headaches. Injectable fibrin sealant has been shown in a few adult cases to relieve symptoms where blood patching has either failed or was not appropriate. We report a 10-year-old boy who experienced rapid relief of post-dural puncture headache symptoms following percutaneous lumbar epidural fibrin sealant injection under computed tomography guidance. Percutaneous epidural fibrin sealant injection may be an acceptable treatment for post-dural puncture headaches refractory to epidural blood patching, or when an epidural blood patch is otherwise contraindicated. The pediatric interventional radiologist should be aware of this off-label use of fibrin sealant. [ABSTRACT FROM AUTHOR]

Background: Chronic pain is a common complication arising after conventional open herniorrhaphy and to a lesser extent postlaparoscopic inguinal hernia repairs as groin incision is avoided. Although published studies support elimination of mesh fixation during endoscopic procedures, the vast majority of surgeons will still recommend it by fear of encountering increased recurrence rates, if omitted. Regrettably, penetrating staple or tack fixation devices are the preferred methods to secure the mesh and cannot be applied at the level of the triangles of 'doom' and 'pain' where hernia tends to reoccur the most. This ongoing prospective cohort study aimed to confirm the safety and advantages of fibrin glue, as a substitute to staple mesh fixation during totally extraperitoneal (TEP) inguinal hernia repair.Methods: Over a 10-year period, 703 patients underwent 1000 elective TEP inguinal hernia repairs. Mesh fixation was achieved using exclusively fibrin sealant. Patients were reviewed at 2, 6 weeks and thereafter on an ad hoc basis if judged necessary until complete resolution of their symptoms. Quality of life (QoL) was assessed in a subgroup of 320 patients using the Carolina Comfort Scale (CCS).Results: No conversion to open surgery was observed. There were three cases of major morbidities and no mortality. Three months after surgery, only seven patients (1 %) experienced chronic groin or testicular discomfort and none of them required prescription painkillers. When using the CCS, at 2 weeks 93.1 % of the patients were either satisfied or very satisfied with their outcome. This satisfaction index increased up to 99.2 % at 6 weeks post surgery. Finally, only eight hernia recurrences (1.1 %) were reported, of which five occurred during the first month of the study.Conclusion: Fibrin glue mesh fixation of inguinal hernia during TEP repair is extremely safe and reliable, with a very high satisfaction index for the patients and limited risk of developing chronic pain. [ABSTRACT FROM AUTHOR]

Purpose: The authors evaluated the ability of a fibrin sealant (TISSEEL™: Baxter Healthcare Corp, Deerfield, IL, USA) to reduce the incidence of post-operative seroma following abdominal wall hernia repair.Methods: We performed a 4-year retrospective review of patients undergoing abdominal wall hernia repair, with and without TISSEEL, by a single surgeon (FEE) at The Johns Hopkins Hospital. Demographics, surgical risk factors, operative data and 30-day outcomes, including wound complications and related interventions, were compared. The quantity and cost of Tisseel per case was reviewed.Results: A total of 250 patients were evaluated: 127 in the TISSEEL group and 123 in the non-TISSEEL control group. The average age for both groups was 56.6 years (P = 0.97). The majority of patients were female (TISSEEL 52.8%, non-TISSEEL 56.1%, P = 0.59) and ASA Class III (TISSEEL 56.7%, non-TISSEEL 58.5%, P = 0.40). There was no difference in the average defect size for both groups (TISSEEL 217 ± 187.6 cm(2), non-TISSEEL 161.3 ± 141.5 cm(2), P = 0.36). Surgical site occurrences occurred in 18.1% of the TISSEEL and 13% of the non-TISSEEL group (P = 0.27). There was a trend towards an increased incidence of seroma in the TISSEEL group (TISSEEL 11%, non-TISSEEL 4.9%, P = 0.07). A total of $124,472.50 was spent on TISSEEL, at an average cost of $995.78 per case.Conclusions: In the largest study to date, TISSEEL™ application offered no advantage for the reduction of post-operative seroma formation following complex abdominal hernia repair. Moreover, the use of this sealant was associated with significant costs. [ABSTRACT FROM AUTHOR]

Background: Abdominal wall and inguinal hernia repair are the most frequently performed surgical procedures in the United States and Europe. However, traditional methods of mesh fixation are associated with a number of problems including substantial risks of recurrence and of postoperative and chronic pain. The aim of this systematic review is to summarize the clinical safety and efficacy of Tisseel/Tissucol fibrin sealant for hernia mesh fixation. Methods: A PubMed title/abstract search was conducted using the following terms: (fibrin glue OR fibrin sealant OR Tisseel OR Tissucol) AND hernia repair. The bibliographies of the publications identified in the search were reviewed for additional references. Results: There were 36 Tisseel/Tissucol studies included in this review involving 5,993 patients undergoing surgery for hernia. In open repair of inguinal hernias, Tisseel compared favorably with traditional methods of mesh fixation, being associated with shorter operative times and hospital stays and a lower incidence of chronic pain. Similarly, after laparoscopic/endoscopic inguinal hernia repair, Tisseel/Tissucol was associated with less use of postoperative analgesics and less acute and chronic postoperative pain than tissue-penetrating mesh-fixation methods. Other end points of concern to surgeons and patients are the risks of inguinal hernia recurrence and of complications such as hematoma formation and intraoperative bleeding. Comparative studies show that Tisseel/Tissucol does not increase the risk of these outcomes and may, in fact, decrease the risk compared with tissue-penetrating fixation methods. When used in the repair of incisional hernias, Tisseel/Tissucol significantly decreased both postoperative morbidity and duration of hospital stay. Conclusions: Clinical evidence published to date supports the use of Tisseel/Tissucol as an option for mesh fixation in open and laparoscopic/endoscopic repair of inguinal and incisional hernias. Guidelines of the International Endohernia Society recommend fibrin sealant mesh fixation, especially in inguinal hernia repair. Nonfixation is reserved for selected cases. [ABSTRACT FROM AUTHOR]

Background: This is the first case-control study on the use of a fibrin sealant (Tisseel) on uterine suture during laparoscopic myomectomy (LM), with the primary endpoint to evaluate the intraoperative bleeding and postoperative blood loss. In addition, we evaluated the time required to achieve hemostasis using Tisseel and how much it can influence operative time. Methods: From December 2009 to January 2011, consecutive patients older than 18 years with symptomatic isolate intramural myoma with maximal diameter ≤6 cm and ≥4 cm and with a sonographically diagnosed free myometrium margin ≥0.5 cm were included in the study. We selected from our institute's database a group of consecutive patients with homogeneous features of the study group, who underwent laparoscopic myomectomy without Tisseel application. Results: Fifteen women with symptomatic myoma were enrolled in the study (group A). Regarding the control group (group B), we selected a homogenous group of 15 patients with the same preoperative characteristics of the study group. Mean operative time was 47.7 min and 62.1 min, for groups A and B respectively ( p < 0.05). Mean time required to achieve complete haemostasis was 195.5 s in group A and 361.8 in control group B ( p < 0.0001). Mean estimated blood loss was 111.3 mL and 230 mL in groups A and B, respectively ( p < 0.05). Mean hemoglobin decrease was 1.36 g/dL and 2.04 g/dL in groups A and B, respectively ( p < 0.05). Conclusions: The use of Tisseel during LM may represent a valid alternative solution for obtaining hemostasis, reducing intra- and postoperative bleeding. Furthermore, it may help the surgeon to obtain a rapid healing of the injured surfaces, probably reducing the use of electrocoagulation and traumatisms. [ABSTRACT FROM AUTHOR]

Background: This study aimed to evaluate the acute and chronic fixation strength of fibrin sealant (FS) as an alternative method of fixation for laparoscopic ventral hernia repair (LVHR). Methods: Representative mesh types for LVHR included one nonabsorbable barrier mesh (Composix) and three absorbable barrier meshes (Sepramesh, Proceed, and Parietex composite). Macroporous polypropylene mesh (Prolite Ultra) served as the control mesh. Three methods of fixation were used, namely, 0-polypropylene suture + FS (ARTISS 4 IU), FS alone (ARTISS), and tacks alone, to secure 3 × 4-cm pieces of mesh (10 of each combination) to the peritoneal surface of New Zealand white rabbit abdominal wall. After 2 h of incubation at 37°C, specimens underwent acute testing. Subsequently, a chronic phase was completed using the aforementioned fixation methods (10 of each combination), in which two 4 × 4-cm pieces of mesh were secured intraperitoneally in each of 75 New Zealand white rabbits, which survived 8 weeks until they were sacrificed. A transparent grid overlay was used to measure the mesh and adhesion area. Adhesion tenacity was characterized using the Garrard adhesion scale. In both the acute and chronic samples, a 3 × 3-cm area of mesh-tissue interface underwent lap shear testing at a rate of 0.42 mm/s using a tensiometer (Instron 5542). The maximum load sustained by the mesh-tissue construct was recorded as the acute fixation strength in newtons (N). Data are given as means ± standard error of the mean. Statistical significance ( p < 0.05) was determined using a one-way analysis of variance (ANOVA) with Fisher's least significant difference (LSD) posttest or a nonparametric Kruskal-Wallis test (adhesion scores). Results: The acute fixation strength was significantly greater for all the meshes secured with either suture + FS or tacks alone than for FS alone ( p < 0.001 for all comparisons). All the meshes except Proceed demonstrated greater acute fixation strength with suture + FS than with tacks alone ( p ≤ 0.016). Composix achieved greater acute fixation with suture + FS than all the other meshes ( p ≤ 0.022). Acute fixation with suture + FS was greater for Parietex Composite and ProLite Ultra than for Proceed ( p ≤ 0.015). When the animals were sacrificed, 48 of 50 meshes fixed with FS alone were insufficiently affixed to the abdominal wall, which may have resulted in hernia recurrence in a hernia model. The chronic fixation strength was greater for all the mesh types with either suture + FS or tacks only than with FS alone ( p ≤ 0.0005). The chronic fixation strength was greater with suture + FS than with tacks for Proceed and ProLite Ultra ( p ≤ 0.013). Neither mesh area nor adhesion tenacity differed significantly with any mesh/fixation method combination. Conclusions: In a chronic rabbit model of LVHR, fixation strength with FS alone was inadequate for selected nonabsorbable and absorbable barrier-coated meshes. The acute and chronic fixation strengths of suture + FS were equivalent or superior to the fixation strength of tacks alone. Using a combination of suture and FS for mesh fixation in LVHR may provide adequate fixation while decreasing postoperative pain due to spiral titanium tacks. In this preclinical series, mesh secured to the peritoneal surface by FS alone may have led to early recurrence. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: To evaluate VH fibrin sealant''s influence on lower extremity lymphedema after inguinal lymphadenectomy in vulvar cancer patients. Methods: Patients undergoing an inguinal lymphadenectomy during the management of vulvar malignancy were randomized to receive sutured closure (SC) vs VH fibrin sealant sprayed into the groin followed by sutured closure (FS). Leg measurements were taken preoperatively and during postoperative encounters when surgical outcomes were assessed. Grade 2 or 3 lymphedema was defined as circumferential measurement increases of 3–5 cm and >5 cm, respectively. Results: 150 patients were enrolled. 137 patients were evaluable for lymphedema analysis with 67 and 70 patients in the SC arm and FS arm, respectively. The incidence of grade 2 and 3 lymphedema was 67%(45/67) in the SC arm, and 60% (42/70) FS arm (p =0.4779). The incidence of lymphedema was strongly associated with inguinal infection (p =0.0165). Lymphedema was not statistically increased in those who received adjuvant radiation. 139 patients remained evaluable for a descriptive analysis of their surgical complications. The overall incidence of complications was 61%(43/70) and 59% (41/69) for SC and FS arms, respectively. There was no statistically significant difference in duration of drains, drain output or incidence of inguinal infections, wound breakdowns or seromas. There was an increased incidence of vulvar infections in the FS arm (23/69) vs (10/70) (p =0.0098). The utilization of a Blake drain was associated with an increase in vulvar (p =0.0157) and inguinal wound breakdown (p =0.0456). Conclusion: VH fibrin sealant in inguinal lymphadenectomies does not reduce leg lymphedema and may increase the risk for complications in the vulvar wound. [Copyright &y& Elsevier]

Reliable laparoscopic fixation of meshes prior to their fibrous incorporation is intended to minimize recurrences following transabdominal preperitoneal hernia repair (TAPP) and totally extraperitoneal repair (TEP) repair of inguinal hernias. However, suture-, tack- and staple-based fixation systems are associated with postoperative chronic inguinal pain. Initial fixation with fibrin sealant offers an atraumatic alternative, but there is little data demonstrating directly whether fibrin-based mesh adhesion provides adequate biomechanical stability for repair of inguinal hernia by TAPP and TEP. Using a newly developed, standardized simulation model for abdominal wall hernias, sublay repairs were performed with six different types of commercially available hernia mesh. The biomechanical stability achieved, and the protection afforded by the mesh–hernia overlap, were compared for three different techniques: nonfixation, point-by-point suture fixation, and fibrin sealant fixation. Mesh dislocation from the repaired hernia defect was consistently seen with nonfixation. This was reliably prevented with all six mesh types when fixed using either sutures or fibrin sealant. The highest stress resistance across the whole abdominal wall was found following superficial fixation with fibrin sealant across the mesh types. There was a highly statistically significant improvement in fixation stability with fibrin sealant versus fixation using eight single sutures ( p = 0.008), as assessed by the range of achievable peak pressure stress up to 200 mmHg. To ensure long-term freedom from recurrence, intraoperative mesh–hernia overlap must be retained. This can be achieved with fibrin sealant up to the incorporation of the mesh – without trauma and with biomechanical stability. [ABSTRACT FROM AUTHOR]

Matrix metalloproteinases (MMPs) and tissue inhibitors of matrix metalloproteinases (TIMPs) are important in regulating tissue remodeling of extracellular matrix. Dysregulation of MMPs is considered to be important to postoperative adhesion development. To examine whether Tisseel, a fibrin sealant, exerts an effect on expression of MMPs from human peritoneal mesothelial cells, normal peritoneal fibroblasts, and adhesion fibroblasts, a tissue culture study was conducted for 6, 12, 24, and 48 h under normoxic conditions. A multiplex reverse transcriptase–polymerase chain reaction technique using β-actin as a housekeeping gene was used to determine relative change in MMP-1, MMP-2, and TIMP-1 mRNA levels under six conditions (five fibrin sealant preparations and a control). Our results demonstrate that MMP-1, MMP-2, and TIMP-1 are all expressed by human peritoneal mesothelial cells and fibroblasts. All fibrin sealant compositions increased MMP-1 mRNA levels by all cell types, although the time course and pattern varied. The fibrin sealant compositions had variable effects on MMP-2 mRNA expression. Interestingly, in mesothelial cells, TIMP-1 mRNA levels were reduced by fibrin-sealant-containing aprotinin at both concentrations, while being further reduced by fibrin sealant without aprotinin, particularly at 6 and 12 h. In adhesion fibroblasts, there was generally no effect, while in normal fibroblasts, expression of TIMP-1 increased after 24 h. These results suggest that fibrin sealant, in addition to assisting in the achievement of hemostasis, exerts biological effects on human peritoneal mesothelial cells and fibroblasts and modulates MMP expression. Thus, fibrin sealant may influence tissue remodeling and may thereby be able to alter postoperative adhesion development. [ABSTRACT FROM AUTHOR]

Following the introduction of haemostatic agents, new opportunities are available when facing problematic bleeding. We report the first case of traumatic postpartum hemorrhage successfully controlled with a fibrin sealant. 26-year nulliparous patient had a rotational forceps delivery and developed multiple vaginal lacerations. Haemostasis could not be achieved after suturing, vaginal packing and IV tranaxemic acid. She lost approx. 3,500 ml blood and received 4 U transfusion. Tisseel was used as a thin layer on vaginal wall and bleeding settled. She had good recovery and perineum healed well. Tisseel consists of a two-component fibrin biomatrix to stop diffuse bleeding. When the tissues are very oedematous, it can be difficult to insert sutures. We tried this innovative option with very effective results. The absence of long-term complications is reassuring and we recommend its use in similarly extreme situations. [ABSTRACT FROM AUTHOR]