A Comparison of the Haemostatic Effect of Vivostat&lt;sup&gt;®&lt;/sup&gt; Patient-Derived Fibrin Sealant with Oxidised Cellulose (Surgicel&lt;sup&gt;®&lt;/sup&gt;) in Multiple Surgical Procedures

Hanks, John B.; Kjærgård, Henrik K.; Hollingsbee, D.A.

doi:10.1159/000072229

Cited by 51 publications

(40 citation statements)

References 13 publications

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“…The incidence of pathogen transmission with these glues is very low. At present, autologous-prepared P-RFS eliminates these risks and is supposed to have hemostatic and antibacterial effects [6][7][8][9] . Its feasibility in laparoscopic hernia repair has been described previously [18] .…”

Section: Discussionmentioning

confidence: 99%

“…Albeit at a very low frequency, human and bovine components of currently available fibrin sealants could contain blood-borne pathogens. Autologous platelet-rich fi-brin sealant (P-RFS) eliminates this risk and has additional advantages such as hemostatic and antibacterial effects [6][7][8][9] . Therefore, we assessed the feasibility of autologous P-RFS in inguinal hernia repair and focused on postoperative pain and impaired daily activities.…”

Section: Introductionmentioning

confidence: 99%

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Mesh Fixation with Autologous Platelet-Rich Fibrin Sealant in Inguinal Hernia Repair

Hingh

Nienhuijs²,

Overdevest³

et al. 2009

Eur Surg Res

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Background: Chronic pain is the main complication following inguinal hernia repair. A possible explanatory factor is the suture fixation of the mesh. Glue fixation might overcome this problem. Albeit at a very low frequency, human and bovine components of fibrin sealants currently available could contain blood-borne pathogens. Autologous platelet-rich fibrin sealant (P-RFS) eliminates this risk and has additional advantages such as hemostatic and antibacterial effects. Therefore, its feasibility was assessed in inguinal hernia repair, with a focus on pain. Methods: In 22 patients with primary inguinal hernia, the mesh was fixated with P-RFS. Data included operative variables, complications, pain scores and neurological examinations. Long-term follow-up was 22.2 months (SD 2.2) postoperatively. Results: After 2 weeks, visual analogue scale and disability pain scores were lower than they were preoperatively. Complications at 3 months were 1 recurrence, 1 chronic pain and 6 sensory disturbances. At the last clinical evaluation, the recurrence was planned for repair due to discomfort. No chronic pain, sensory disorders or discomfort was reported at long-term follow-up. Conclusion: Mesh fixation with autologous P-RFS is feasible. If there is a preference for autologous material, P-RFS is indicated. If glue fixation becomes standard, further randomized studies are warranted for this alternative.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Mesh Fixation with Autologous Platelet-Rich Fibrin Sealant in Inguinal Hernia Repair

Hingh

Nienhuijs²,

Overdevest³

et al. 2009

Eur Surg Res

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“…14,62,65,67,88,94,[124][125][126][127]141,142,[193][194][195]206,207,225,227,232,238 One case was haemodynamically instable and post-procedural haemorrhage was observed in the drain 2 hours after surgery. This required the patient to be reoperated, and the source of bleeding was the resection area beneath the fibrin pad.…”

Section: Health-related Quality Of Lifementioning

confidence: 99%

The use of fibrin sealant during non-emergency surgery: a systematic review of evidence of benefits and harms

Edwards¹,

Crawford²,

Velthoven³

et al. 2016

Health Technol Assess

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BackgroundFibrin sealants are used in different types of surgery to prevent the accumulation of post-operative fluid (seroma) or blood (haematoma) or to arrest haemorrhage (bleeding). However, there is uncertainty around the benefits and harms of fibrin sealant use.ObjectivesTo systematically review the evidence on the benefits and harms of fibrin sealants in non-emergency surgery in adults.Data sourcesElectronic databases [MEDLINE, EMBASE and The Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and the Cochrane Central Register of Controlled Trials)] were searched from inception to May 2015. The websites of regulatory bodies (the Medicines and Healthcare products Regulatory Agency, the European Medicines Agency and the Food and Drug Administration) were also searched to identify evidence of harms.Review methodsThis review included randomised controlled trials (RCTs) and observational studies using any type of fibrin sealant compared with standard care in non-emergency surgery in adults. The primary outcome was risk of developing seroma and haematoma. Only RCTs were used to inform clinical effectiveness and both RCTs and observational studies were used for the assessment of harms related to the use of fibrin sealant. Two reviewers independently screened all titles and abstracts to identify potentially relevant studies. Data extraction was undertaken by one reviewer and validated by a second. The quality of included studies was assessed independently by two reviewers using the Cochrane Collaboration risk-of-bias tool for RCTs and the Centre for Reviews and Dissemination guidance for adverse events for observational studies. A fixed-effects model was used for meta-analysis.ResultsWe included 186 RCTs and eight observational studies across 14 surgical specialties and five reports from the regulatory bodies. Most RCTs were judged to be at an unclear risk of bias. Adverse events were inappropriately reported in observational studies. Meta-analysis across non-emergency surgical specialties did not show a statistically significant difference in the risk of seroma for fibrin sealants versus standard care in 32 RCTs analysed [n = 3472, odds ratio (OR) 0.84, 95% confidence interval (CI) 0.68 to 1.04;p = 0.13;I2 = 12.7%], but a statistically significant benefit was found on haematoma development in 24 RCTs (n = 2403, OR 0.62, 95% CI 0.44 to 0.86;p = 0.01;I2 = 0%). Adverse events related to fibrin sealant use were reported in 10 RCTs and eight observational studies across surgical specialties, and 22 RCTs explicitly stated that there were no adverse events. One RCT reported a single death but no other study reported mortality or any serious adverse events. Five regulatory body reports noted death from air emboli associated with fibrin sprays.LimitationsIt was not possible to provide a detailed evaluation of individual RCTs in their specific contexts because of the limited resources that were available for this research. In addition, the number of RCTs that were identified made it impractical to conduct independent data extraction by two reviewers in the time available.ConclusionsThe effectiveness of fibrin sealants does not appear to vary according to surgical procedures with regard to reducing the risk of seroma or haematoma. Surgeons should note the potential risk of gas embolism if spray application of fibrin sealants is used and not to exceed the recommended pressure and spraying distance. Future research should be carried out in surgery specialties for which only limited data were found, including neurological, gynaecological, oral and maxillofacial, urology, colorectal and orthopaedics surgery (for any outcome); breast surgery and upper gastrointestinal (development of haematoma); and cardiothoracic heart or lung surgery (reoperation rates). In addition, studies need to use adequate sample sizes, to blind participants and outcome assessors, and to follow reporting guidelines.Study registrationThis study is registered as PROSPERO CRD42015020710.FundingThe National Institute for Health Research Health Technology Assessment programme.

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“…Like other topical hemostats, Surgicel was approved by the FDA before clinical trial testing was required, but it has been used as a standard‐of‐care comparator in clinical trials of new hemostats. In a randomized trial in 69 patients undergoing cardiothoracic, general, obstetric and gynecologic, and vascular surgery, the mean time to hemostasis was 3.3 minutes for Surgicel compared with 1.6 minutes for Vivostat patient‐derived fibrin sealant (Vivostat A/S, Alleroed, Denmark) . Overall, 65% and 94% of patients required no additional hemostatic measures to control bleeding for Surgicel and Vivostat, respectively .…”

Section: Topical Hemostatsmentioning

confidence: 99%

“…In a randomized trial in 69 patients undergoing cardiothoracic, general, obstetric and gynecologic, and vascular surgery, the mean time to hemostasis was 3.3 minutes for Surgicel compared with 1.6 minutes for Vivostat patient‐derived fibrin sealant (Vivostat A/S, Alleroed, Denmark) . Overall, 65% and 94% of patients required no additional hemostatic measures to control bleeding for Surgicel and Vivostat, respectively . Surgicel has demonstrated broad‐spectrum bactericidal activity in vitro, but it should not be used in conjunction with topical thrombin because its low pH inhibits thrombin activity .…”

Section: Topical Hemostatsmentioning

confidence: 99%

An Essential Primer for Understanding the Role of Topical Hemostats, Surgical Sealants, and Adhesives for Maintaining Hemostasis

Gabay

Boucher

2013

Pharmacotherapy

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A wide variety of topical hemostats are approved as adjunctive therapies in the maintenance of hemostasis during surgical procedures in which conventional methods are insufficient or not practical. A multidisciplinary approach to the selection and application of these agents requires input from all members of the surgical team including surgeons, perioperative nurses, blood bank specialists, and pharmacists. However, pharmacist knowledge regarding topical hemostats may be limited based on lack of formal education within college of pharmacy curricula as well as their use being predominantly in the operating room setting. Furthermore, some of these agents might be procured through central supply rather than the hospital pharmacy. Topical hemostats include agents that act as a mechanical barrier to bleeding and provide a physical matrix for clotting, biologically active agents that catalyze coagulation, combination therapies, and synthetic sealants and adhesives. Although many of the topical hemostats were approved for use before the requirement for clinical trials, this review provides an overview of the available clinical evidence regarding the appropriate uses and safety considerations associated with these agents. Proper use of these agents is vital to achieving the best clinical outcomes. Specifically, knowledge of the contraindications and potential adverse events associated with topical hemostats can help prevent unwanted outcomes. Therefore, an understanding of the benefits and potential risks associated with these agents will allow hospital pharmacists to assist in the development and implementation of institutional policies regarding the safe and effective use of hemostatic agents commonly used in the surgical suite.

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A Comparison of the Haemostatic Effect of Vivostat<sup>®</sup> Patient-Derived Fibrin Sealant with Oxidised Cellulose (Surgicel<sup>®</sup>) in Multiple Surgical Procedures

Cited by 51 publications

References 13 publications

Mesh Fixation with Autologous Platelet-Rich Fibrin Sealant in Inguinal Hernia Repair

Mesh Fixation with Autologous Platelet-Rich Fibrin Sealant in Inguinal Hernia Repair

The use of fibrin sealant during non-emergency surgery: a systematic review of evidence of benefits and harms

An Essential Primer for Understanding the Role of Topical Hemostats, Surgical Sealants, and Adhesives for Maintaining Hemostasis

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