Surgical Sealant Research Articles

Next-generation hydrogel films as tissue sealants and adhesion barriers.

The development of conveniently sprayed, tissue-adherent, inert hydrogel films has made possible the creation of novel products that can serve a dual function, as a surgical sealant to achieve immediate hemostasis, and as a barrier to prevent adhesion formation over time. A sprayable, in situ formed absorbable hydrogel film was evaluated as a tissue sealant in a heparinized canine carotid artery graft model. PTFE grafts with leaking end-to-side anastomoses were treated with the synthetic sealant, and hemostasis was evaluated upon restoration of blood flow. Also, the hydrogel films were evaluated as an adhesion barrier in a rabbit pericardial abrasion model. The sprayable, in situ forming hydrogel film was shown to immediately seal carotid-PTFE anastomoses in six of six applications. Hydrogel application in a rabbit pericardial abrasion model resulted in a statistically significant reduction in the number and tenacity of adhesions. This novel in situ formed sprayable hydrogel film has demonstrated a dual function as an effective tissue sealant and as an adhesion barrier in cardiovascular preclinical models. These next generation synthetic biomaterials are currently undergoing clinical investigations.

Towards a sutureless vasovasostomy: use of biomaterials and surgical sealants in a rodent vasovasostomy model

Objective: With 500,000 to 800,000 vasectomies performed annually and a reversal rate of 3–8% in the U.S.A., vasectomy reversal has become a very commonly performed procedure. The multi-layer microsurgical vasovasostomy is the gold standard. However, this is a technically demanding, time consuming and expensive procedure. In the present study we evaluate the efficacy of recently FDA approved biomaterials and a surgical sealant to decrease the number of sutures employed, to enhance water tightness of the anastomosis, and to decrease the operative time without sacrificing the patency rate.

Surgical sealant in the prevention of early vein graft injury in an ex vivo model

Background: The amelioration of the adaptation process (arterialisation) of the vein graft wall to the arterial circulation in coronary artery bypass surgery by using extravascular support is clearly established in animal models and in in vitro and ex vivo set-ups. This support consists of some form of external graft-supporting modality like a prosthetic graft of stent. The clinical application of perivenous support, however, is hampered due to the fact that no easy applicable external support is available. Considering that application in the form of a spray is the most convenient modality, we evaluated whether polyethylene glycol is capable of providing adequate perivenous support. Polyethylene glycol is a synthetic, biodegradable product, used in cardiac surgery as a sealant, and is commercially available in the form of a spray. Methods: Segments of human saphenous vein graft obtained during coronary artery bypass graft (CABG) procedures were placed in an ex vivo model, a side loop of the extracorporeal perfusion circuit, and perfused with autologous blood, making the circumstances identical to the implanted saphenous vein grafts concerning pressure, temperature, level of complement and leukocyte activation and blood pressure. Alternately around every other study vein graft segment polyethylene glycol was applied. Unsupported grafts served as control. After 1 min of solidification, perfusion was started with a pressure of about 60 mmHg (nonpulsatile flow). Perfusion was maintained for 60 min, after which the grafts were collected for light microscopy and electron microscopy. Results: Light microscopy and electron microscopy showed remarkable attenuation of endothelial cell loss and less injury of smooth muscle cells of the circular and longitudinal layer of the media in the supported group compared to the nonsupported vein graft segments. Conclusion: Polyethylene glycol is able to provide adequate external vein graft support, preventing overdistension, in an ex vivo model. This provides a basis for clinical application. Further investigation is warranted to evaluate long-term effects.

Surface interactions of oxidized cellulose with fibrin(ogen) and blood platelets

Hemostatic effects of oxidized cellulose are well known but the mechanism of its action is far from being well understood. Hemostatic (hemostyptic) biomaterials with their ability to initiate or accelerate thrombus formation belong to surgical sealants. Thrombus formation is a surface phenomenon. The exploitation of surface plasmon resonance sensing principle for the examination of interactions of oxidized cellulose with fibrinogen, fibrin and blood platelets is reported. Cellulose decreased and slowed down the interaction of immobilized fibrin monomer with fibrinogen as observed by surface plasmon resonance. Only weak interactions of cellulose with plasma proteins albumin and fibrinogen were observed. Delayed gelation and slower increase in turbidity occurred in fibrinogen–thrombin solutions in the presence of the cellulose. Platelets in plasma but not washed platelets in a buffer were activated in the presence of cellulose. We suppose that activation of the coagulation contact system of blood plasma initiated very likely by the negatively charged surface of the oxidized cellulose leads to the fibrin formation and activation and adhesion of blood platelets. The direct interactions of platelets and fibrinogen with the cellulose seem to play a secondary role.

Biliary Reconstruction is Enhanced with a Collagen-Polyethylene Glycol Sealant

Bile leaks occur in up to 27 per cent of liver transplant patients after biliary reconstruction. Synthetic sealants have not been investigated for these biliary procedures. We performed a randomized controlled study to evaluate a novel absorbable polyethylene glycol/collagen biopolymer sealant (CT3 Surgical Sealant) after incomplete end-to-end choledochocholedochostomy (CDCD) in pigs. Pigs (n = 18) underwent transection of the common bile duct and incomplete CDCD over a T-tube, leaving a one-sixth circumferential defect anteriorly. Animals were randomly assigned to treatment (CDCD with sealant, n = 9) or control (no sealant, n = 9). Drains were used to monitor leak volume and bilirubin (bili) concentration. Cholangiography was performed on postoperative day 3. Leaks were defined as drain bili/serum bill > 3, total drain output > 10 mL/kg, and/or extravasation on cholangiography. Animals sacrificed at 3 and 8 weeks (n = 4 and n = 5 from each group, respectively) underwent pathologic examination of the CDCD site. Statistical methods included Student's t test, chi2, linear regression, and analysis of variance procedures. The control group had a higher drain output rate over the first 4 postoperative days than the treatment group (P < 0.05, analysis of variance). Five of nine (56%) control and one of nine (11%) treatment animals had a bile leak (P < 0.05, chi2). There was no major inflammatory response to the sealant versus controls. We conclude that CT3 is effective in decreasing biliary leaks in an incomplete CDCD porcine model with no major adverse pathologic changes. This sealant should be considered for trials for biliary reconstruction in humans.

Surgical sealant for preventing air leaks after pulmonary resections in patients with lung cancer.

Postoperative air leak is a frequent complication after pulmonary resection for lung cancer. It may cause serious complications, such as empyema, or prolong the need for chest tube and hospitalisation. Surgical sealants of different types have been developed to prevent or to reduce postoperative air leaks. A systematic review was therefore undertaken to evaluate the evidence on their effectiveness. To evaluate the effectiveness of surgical sealants in preventing or in reducing postoperative air leaks after pulmonary resection for lung cancer. Electronic databases and, bibliographies were searched and, hand searching of conference proceedings was conducted to identify published and unpublished trials. Randomised controlled clinical trials were included in which standard closure techniques plus a sealant were compared with the same intervention with no use of any sealant in patients undergoing elective pulmonary resection provided that a large proportion of the patients studied had undergone pulmonary resection for lung cancer. Two reviewers independently selected the trials to be included in the review, assessed methodological quality of each trial and extracted data using a standardised form. Because of several limitations, narrative synthesis was used at this stage. Two hundred and thirty-two patients from 4 trials were included. In two trials no differences were found between treatment and control patients in terms of reduction of duration of air leaks, chest tube drainage, hospitalisation or complications attributable to prolonged intercostal drainage. In the other two trials, postoperative air leaks were significantly reduced in the treatment groups, but there were no differences in hospital stay, complications, fever, intraoperative and postoperative intubation times, chest tube drainage or cost. Systematic use of surgical sealants in clinical practice cannot be recommended at the moment. More randomised controlled clinical trials are needed.

Trial of a novel synthetic sealant in preventing air leaks after lung resection

Background. Postoperative air leaks are a major cause of morbidity after lung resections. This study was designed to evaluate the efficacy and safety of a new synthetic, bioresorbable surgical sealant in preventing air leaks after pulmonary resection.Methods. In a multicenter trial, 172 patients undergoing thoracotomy were randomized intraoperatively in a 2:1 ratio to receive surgical sealant applied to sites at risk for air leak after standard methods of lung closure (treatment group) or to have standard lung closure only (control group). The primary outcome variable was the percentage of patients free of air leakage throughout hospitalization. Secondary outcome variables were the control of air leaks intraoperatively and the time to postoperative air leak cessation. Time to chest tube removal, time to hospital discharge, and safety outcomes were also evaluated.Results. Air leaks were identified before randomization in 89 of 117 patients in the treatment group and in 39 of 55 patients in the control group. Application of the sealant resulted in control of air leaks in 92% of treated patients (p ≤ 0.001). A significantly higher percentage of treated patients than control patients remained free of air leaks during hospitalization (39% versus 11%, p ≤ 0.001). The mean times to last observable air leak were 30.9 hours in the treatment group and 52.3 hours in the control group (p = 0.006). In the treatment group, trends were observed for reduced time to chest tube removal and earlier discharge. No significant difference was identified in postoperative morbidity and mortality between the two groups.Conclusions. Air leaks after lung resection occur in most patients. The application of this novel surgical sealant appears to be effective and safe in preventing postoperative air leaks.

Randomized controlled trial of a synthetic sealant for preventing alveolar air leaks after lobectomy

Background. The intraoperative application of synthetic surgical lung sealant (SLS) to surfaces leaking air or at risk of air leaks has been advocated to reduce alveolar air leaks (AAL) after lobectomy.Methods. This study was designed to investigate the effectiveness of SLS in reducing AAL in patients considered intraoperatively to have moderate to severe AAL, after all conventional measures to reduce such leaks had been used. Over 17 months, 124 patients undergoing standard lobectomy were randomized to standard closure of parenchymal surgical sites, with or without SLS.Results. In treated patients, the mean numbers of intraoperative AAL after application of SLS were significantly smaller than in untreated patients (38.5 mL versus 59.9 mL, p = 0.0401). Postoperatively, the mean time to last observable AAL was shorter in the treated group (33.7 hours versus 63.2 hours, p = 0.0134) and the mean percentage of patients free of AAL at days 3 and 4 was smaller (87% versus 58.5%, p = 0.002). However, the occurrence of incomplete lung expansion after drain removal, and the length of the postoperative hospital stay due to prolonged AAL, were not different. In the treatment group, 4 patients developed localized empyema and incomplete lung expansion without bronchopleural fistula 7, 12, 15, and 20 days, respectively, after operation. In these 4 patients, inserted chest tubes drained infected sealant.Conclusions. Surgical lung sealant may be a useful adjunct to conventional techniques for reducing moderate and severe AAL after lobectomy, but its use seems to increase the risk of postoperative empyema.

Treatment of suture line bleeding with a novel synthetic surgical sealant in a canine iliac PTFE graft model

CoSeal™ surgical sealant (CoSeal) was evaluated for inhibiting suture line bleeding using a canine iliac PTFE graft model. Both iliac arteries of 12 heparinized canines were grafted with PTFE. CoSeal was applied to the suture lines of one graft in each animal. The contra-lateral graft served as a control and bleeding was controlled with gauze and pressure (tamponade). The cross-clamps were removed 30 s following application of CoSeal. Times to hemostasis and volume of blood loss at each graft site were determined. Compared to tamponade control, CoSeal significantly reduced the time to hemostasis (average of 5 min vs. greater than 15 min, p < 0.05) and blood loss (19 g vs. 284 g, p < 0.05). Small amounts of CoSeal were visible grossly or histologically at day 7. Histology showed moderate to marked inflammation in CoSeal sites and moderate inflammation in control sites at day 7. At 30 and 60 days, no CoSeal was visible grossly or histologically. Histology showed moderate inflammation in both CoSeal treated sites and in control sites at day 30 and mild to moderate inflammation in both CoSeal and control sites at day 60. CoSeal significantly reduced the time to hemostasis and blood loss in comparison to tamponade. © 2001 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 58: 308–312, 2001

Treatment of suture line bleeding with a novel synthetic surgical sealant in a canine iliac PTFE graft model.

CoSeal mark surgical sealant (CoSeal) was evaluated for inhibiting suture line bleeding using a canine iliac PTFE graft model. Both iliac arteries of 12 heparinized canines were grafted with PTFE. CoSeal was applied to the suture lines of one graft in each animal. The contra-lateral graft served as a control and bleeding was controlled with gauze and pressure (tamponade). The cross-clamps were removed 30 s following application of CoSeal. Times to hemostasis and volume of blood loss at each graft site were determined. Compared to tamponade control, CoSeal significantly reduced the time to hemostasis (average of 5 min vs. greater than 15 min, p < 0.05) and blood loss (19 g vs. 284 g, p < 0.05). Small amounts of CoSeal were visible grossly or histologically at day 7. Histology showed moderate to marked inflammation in CoSeal sites and moderate inflammation in control sites at day 7. At 30 and 60 days, no CoSeal was visible grossly or histologically. Histology showed moderate inflammation in both CoSeal treated sites and in control sites at day 30 and mild to moderate inflammation in both CoSeal and control sites at day 60. CoSeal significantly reduced the time to hemostasis and blood loss in comparison to tamponade.

Soft tissue adhesive composed of modified gelatin and polysaccharides

Although fibrin glue has been clinically used as a surgical adhesive, hemostatic agent, and sealant, it has the risk of virus infection because its components, fibrinogen and thrombin, are obtained from human blood. To circumvent this problem, we employed bioabsorbable gelatin and polysaccharides to prepare a safer hemostatic glue. Gelatin was modified with ethylenediamine using water-soluble carbodiimide to introduce additional amino groups into the original gelatin, while dextran and hydroxyethyl-starch were oxidized by sodium periodate to convert 1,2-hydroxyl groups into dialdehyde groups. Upon mixing of the two polymer components in aqueous solution, Schiff base was formed between the amino groups in the modified gelatin and the aldehyde groups in the modified polysaccharides, which thus resulted in intermolecular cross-linking and gel formation. The fastest gel formation took place within 2 s, and its bonding strength to porcine skin was about 225 gfcm-2 when 20 wt% of an amino-gelatin (55% amino) and 10 wt% of aldehyde-HES (>84% dialdehyde) aqueous solutions were mixed. In contrast, the gelation time and bonding strength of fibrin glue was 5 s and 120 gfcm-2, respectively.

Thirty-sixth Annual Meeting January 31–February 2, 2000 Greater Fort Lauderdale/Broward County Convention Center, Fort Lauderdale, Florida

Thirty-sixth Annual Meeting January 31–February 2, 2000 Greater Fort Lauderdale/Broward County Convention Center, Fort Lauderdale, Florida

Effective application of fibrin sealant using a spray device with a double-tube structure

We developed a new device for applying a fibrin sealant to increase the strength of surgical seals. In the present study, the sealing effectiveness of fibrin sealant, using this newly developed spraying technique, was compared with conventional sequential or simultaneous applications of sealant. Sealing effectiveness of the three methods was evaluated by applying sealant to pinholes in plastic caps and measuring the amount of pressure necessary to rupture the seals at various intervals following application. When the spray application method was used, the pressure needed to burst the seal was higher than with either the sequential or simultaneous method. It was also determined that only 30–70% of the sealant was utilized when it was applied to a slanted surface using the two conventional methods while almost all of the sealant was utilized with the new spray technique. The results of this study indicate that the new spray device will provide the most effective means to apply fibrin as a surgical sealant.

Surgical Adhesives and Sealants: Current Technology and Applications.

Surgical Adhesives and Sealants: Current Technology and Applications.

Application of Thrombin Based Fibrin Glue and Non-Thrombin Based Batroxobin Glue on Intact Human Blood Vessels: Evidence for Transmural Thrombin Activity

An alternative method of uniting small diameter vessels to obtain tissue union while limiting the thrombogenic effect of suture placement at a vessel anastomosis involves the use of a thrombin based fibrin glue as a surgical sealant. This investigation addresses whether the in vitro application of a thrombin based glue (TG), or batroxobin glue (BG), a non-thrombin based glue made with the snake venom enzyme batroxobin, alters intravascular platelet deposition (PD) or cleaves blood fibrinogen, as measured by fibrinopeptide A (FPA) production, when the respective glue is applied to the external surface of an intact human placental artery or an artery with an anastomosis. When TG was applied to the adventitial surface of an intact vessel or an anastomosis (n = 7) of control and experimental vessels, there was a significant increase in intraluminal platelet deposition, an effect not realized with BG (n = 12, intact vessel TG p = 0.01, BG p = 0.66, anastomosis TG p <0.01, BG p <0.01). Both TG and BG significantly increased FPA levels when human whole blood was perfused through both intact vessels or vessels containing an anastomosis when compared to control vessels (intact vessel TG and BG p <0.01, anastomosis TG and BG p <0.01). Labelled thrombin studies document the rapid passage of thrombin through an intact vessel wall or vessels with an anastomosis when TG was applied to the adventitial surface of the vessel. The data suggest that TG and BG are drug delivery systems for their respective enzymes that either pass through or transfer a message across not only a surgically created anastomosis, but also an intact vessel wall.

SURGICAL ADHESIVES AND SEALANTS

SURGICAL ADHESIVES AND SEALANTS

Hemostasis with autologous fibrinogen

The production of fibrinogen from the patient's own blood for use as surgical sealant (hemostasis) is described. The advantages over the commercially available substance lie in the absence of possible contaminants (hepatitis virus A) and low cost.

Vasovasostomy: past, present and future.

No AccessJournal of Urology1 Jul 1974Vasovasostomy: Past, Present and Future Joseph E. Montie and Bruce H. Stewart Joseph E. MontieJoseph E. Montie More articles by this author and Bruce H. StewartBruce H. Stewart Current address: 9500 Euclid Ave., Cleveland, Ohio 44106. More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(17)59655-XAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail © 1974 by The American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited bySCHIFF J, LI P and GOLDSTEIN M (2018) TOWARD A SUTURELESS VASOVASOSTOMY: USE OF BIOMATERIALS AND SURGICAL SEALANTS IN A RODENT VASOVASOSTOMY MODELJournal of Urology, VOL. 172, NO. 3, (1192-1195), Online publication date: 1-Sep-2004.SCHIFF J, LI P and GOLDSTEIN M (2018) ROBOTIC MICROSURGICAL VASOVASOSTOMY AND VASOEPIDIDYMOSTOMY: A PROSPECTIVE RANDOMIZED STUDY IN A RAT MODELJournal of Urology, VOL. 171, NO. 4, (1720-1725), Online publication date: 1-Apr-2004.Xie-Yang Z and Yong-Xiong S (2018) Vasovasostomy With Use of Medical Needle as a SupportJournal of Urology, VOL. 139, NO. 1, (53-54), Online publication date: 1-Jan-1988.Middleton R and Henderson D (2018) Vas Deferens Reanastomosis without Splints and without MagnificationJournal of Urology, VOL. 119, NO. 6, (763-764), Online publication date: 1-Jun-1978.Hagan K and Coffey D (2018) The Adverse Effects of Sperm During VasovasostomyJournal of Urology, VOL. 118, NO. 2, (269-273), Online publication date: 1-Aug-1977. Volume 112Issue 1July 1974Page: 111-113 Advertisement Copyright & Permissions© 1974 by The American Urological Association Education and Research, Inc.MetricsAuthor Information Joseph E. Montie More articles by this author Bruce H. Stewart Current address: 9500 Euclid Ave., Cleveland, Ohio 44106. More articles by this author Expand All Advertisement PDF downloadLoading ...