Surgical applications of intracorporal tissue adhesive agents: current evidence and future development.

Introduction: Traditional mechanical closure techniques pose many challenges including the risk of infection, tissue reaction, and injury to both patients and clinicians. There is an urgent need to develop tissue adhesive agents to reform closure technique. This review examined a variety of tissue adhesive agents available in the market in an attempt to gain a better understanding of intracorporal tissue adhesive agents as medical devices.Areas covered: Fundamental principles and clinical determinants of the tissue adhesives were summarized. The available tissue adhesives for intracorporal use and their relevant clinical evidence were then presented. Lastly, the perspective of future development for intracorporal tissue adhesive were discussed. Clinical evidence shows current agents are efficacious as adjunctive measures to mechanical closure and these agents have been trialed outside of clinical indications with varied results.Expert opinion: Despite some advancements in the development of tissue adhesives, there is still a demand to develop novel technologies in order to address unmet clinical needs, including low tensile strength in wet conditions, non-controllable polimerization and sub-optimal biocompatibility. Research trends focus on producing novel adhesive agents to remit these challenges. Examples include the development of biomimetic adhesives, externally activated adhesives, and multiple crosslinking strategies. Economic feasibility and biosafety are limiting factors for clinical implementation.

Intravascular catheter migration: A cross-sectional and health-economic comparison of adhesive and subcutaneous engineered stabilisation devices for intravascular device securement.

The Infusional Services Team at a large cancer centre in Belfast, Northern Ireland, performed a cross-sectional analysis of two catheter securement technologies to address an area of frequent, but underestimated concern - peripherally inserted central catheter migration and dislodgement. Healthcare practitioner and patient feedback, along with economic impact, were assessed. The costs associated with catheter replacement during the adhesive device group study period were calculated using an average cost per insertion, based on material costs required for the procedure. Other factors were the replacement cost of the adhesive engineered securement device with each dressing change. In the subcutaneous securement group, the material costs were adjusted for use of the subcutaneous device as it remained in situ for the duration of the catheters' dwell time. This review found that subcutaneous securement offers both patient and facilities a safe, effective and economical alternative for device securement with patients who are unable to tolerate or have successful securement with adhesive securement devices. The use of subcutaneous devices provided for reduced risks for peripherally inserted central catheters in terms of dislodgement, migration or malposition, alleviating the potential risks to develop catheter-related thrombosis and device-related infection.

Efficacy of fibrin sealant in thyroid surgery. Is drainage still necessary?

INTRODUCTION: The routinely use of drains in thyroid surgery is a traditional and well-defined method, even if there is no clear evidence of significant improvement in patients outcomes. Aim of our study is to define the feasibility, safety and cost- effectiveness of fibrin sealant in total thyroidectomy in order to overcome the use of drains. MATERIALS AND METHODS: We enrolled 262 patients (45 men and 217 women, mean age 54.7 yrs) undergone total thyroidectomy in University Hospital of Palermo (Italy), between July 2015 and October 2017. We randomized patients into group A (drain) and group B (no drain, fibrin sealant application). RESULTS: We registered statistical difference between the two groups in mean operative time, visual analogue scale of pain, post-operative stay, incidence of seromas and/or deep and superficial hematomas, re-operation and wound infection (reduced in the fibrin sealant group). No significant difference have been found in intraoperative blood loss, postoperative cough, post-operative use of analgesic and in incidence of hypoparathyroidism or recurrent palsy. CONCLUSIONS: Our study demonstrates that there is no evidence that the use of suction drains improves patients outcome and that routinely use of fibrin sealant can be advocated in thyroid surgery as an adjunct to a good surgical procedure. KEY WORDS: Complication, Drainage, Fibrin Sealant, Thyroidectomy.

Length of stay and hospitalization costs for patients undergoing lung surgery with Progel pleural air leak sealant.

AIM: Progel Pleural Air Leak Sealant (Progel) is currently the only sealant approved by the FDA for the treatment of air leaks during lung surgery. This study was performed to determine whether Progel use improves hospital length of stay (LOS) and hospitalization costs compared with other synthetic/fibrin sealants in patients undergoing lung surgery. METHODS: The US Premier hospital database was used to identify lung surgery discharges from January 1, 2010 to June 30, 2015. Eligible discharges were categorized as "Progel Sealant" or "other sealants" using hospital billing data. Propensity score matching (PSM) was performed to control for hospital and patient differences between study groups. Primary outcomes were hospital LOS and all-cause hospitalization costs. Clinical outcomes, hospital re-admissions, and sealant product use were also described. RESULTS: After PSM, a total of 2,670 discharges were included in each study group; baseline characteristics were balanced between groups. The hospital LOS (mean days ± standard deviation, median) was significantly shorter for the Progel group (9.9 ± 9.6, 7.0) compared with the other sealants group (11.3 ± 12.8, 8.0; p < .001). Patients receiving Progel incurred significantly lower all-cause hospitalization costs ($31,954 ± $29,696, $23,904) compared with patients receiving other sealants ($36,147 ± $42,888, $24,702; p < .001). LIMITATIONS: It is not possible to say that sealant type alone was responsible for the findings of this study, and analysis was restricted to the data available in the Premier database. CONCLUSIONS: Among hospital discharges for lung surgery, Progel use was associated with significantly shorter hospital LOS and lower hospitalization costs compared with other synthetic/fibrin sealants, without compromising clinical outcomes.

The Use of Tissue Glue for Circumcision in Children: Systematic Review and Meta-analysis.

OBJECTIVE: To evaluate the efficacy of tissue glue in pediatric circumcision. MATERIALS AND METHODS: A systematic review and meta-analysis of the English literature (1997-2017) was conducted according to the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) statement on children who underwent circumcision with tissue glue. Meta-analysis was conducted using RevMan 5.3, Comprehensive Meta-Analysis 2, and MedCalc 18. P values <.05 were considered significant. RESULTS: The search returned 15 studies for a total of 4567 circumcisions, of which 3045 (66%) were performed with tissue glue. The systematic review indicated that overall complication rates were 4.3% (tissue glue) and 5.9% (sutures). The use of tissue glue was associated with reduced postoperative pain, better cosmetic results, and reduced cost. Meta-analysis showed that there was no difference between the incidence of total postoperative complications (relative risk [RR] 0.86 [95% confidence interval {CI}: 0.62-1.19], P = .36) and wound infection and dehiscence between the 2 groups (RR 0.95 [95% CI: 0.59-1.56], P = .85). Postoperative bleeding and hematoma formation were reduced with the use of tissue glue (RR 0.55 [95% CI: 0.32-0.95], P = .03). Tissue glue also significantly shorten the operative time (mean difference -0.22 [95% CI: -0.39 to -0.05], P = .01). CONCLUSION: The incidence of postoperative bleeding and hematoma formation in pediatric circumcision is reduced with the use of tissue glue. Tissue glue has reduced operative time; furthermore, it might be associated with reduced postoperative pain, less overall cost, and superior cosmetic results.

Surgical glue in laparoscopic sleeve gastrectomy: An initial experience and cost-effectiveness analysis.

RATIONALE, AIMS, AND OBJECTIVES: Laparoscopic sleeve gastrectomy (LSG) is one of the most common bariatric procedures. Gastric leaks and bleeding are the most frequent complications, associated with a high clinical and economic burden. The best method of staple line reinforcement in LSG is debated. Surgical glue is one of the options available. The aim of this study was to assess the safety, efficiency, and relative cost-effectiveness of surgical glue used to perform LSG in morbid obese adults as compared with standard stapling. METHODS: A prospective, observational, and comparative before-after study was conducted. All consecutive patients undergoing LSG at Montpellier University Hospital in 2011 and 2012 were included and treated according to 2 groups: standard stapling (n = 99, group 1) and surgical glue reinforcement (n = 94, group 2). Clinical and economic outcomes were measured after 6 months. RESULTS: The duration of intervention was significantly shorter in group 2 (68 vs 82 minutes, P = .001). There was no significant difference regarding complications, but leaks in group 1 were more severe. Group 2 was also associated with a reduced initial length of stay (4.8 vs 5.2 days, P = .01). Six-month readmissions and total length of stay were also shorter in group 2 (5.5 vs 6.1 days, P = .003). Surgical glue use was associated with a significant reduction in the initial inpatient cost (€5488 vs €6152, P = .005) and in the 6-month total inpatient cost, including readmissions (€6006 vs €6754, P = .005). The incremental cost of glue to avoid a severe complication was -€5446.33 (95 confidence interval, -8202.01 to -2690.66). CONCLUSIONS: Surgical glue might be a safe and cost-effective intervention in laparoscopic sleeve gastrectomy.

Pediatric sutureless circumcision: an effective and cost efficient alternative.

INTRODUCTION: Circumcision is the most commonly performed surgical procedures in male children. Maine is one of 18 states in the United States which does not pay for neonatal circumcisions. The aim of this study was to perform outcomes and cost analysis of a sutureless circumcision technique versus circumcision using sutures. Specifically, we evaluated Dermaflex (2-octyl cyanoacrylate, 2-OCA) surgical glue circumcision as a cost effective, faster, and safe alternative to traditional suture circumcision. MATERIALS AND METHODS: Our study was a non-randomized series. We collected the operative details prospectively, abstracted clinical outcomes retrospectively, and performed data analysis retrospectively. One hundred and twenty-six circumcisions were performed by two pediatric urologists over a 1 year period. Suture circumcisions were performed exclusively during the first 6 months, and 2-OCA glue circumcisions were performed during the second 6 months. Billing charges were analyzed to extrapolate variable costs between the two surgical procedures. The technique used to perform the sutureless circumcision was a modification of the standard sleeve technique, with the use of monopolar diathermy instead of scalpel, and application of 2-OCA glue to approximate tissue edges. RESULTS: From Jan 2013 to Jan 2014, 72 patients underwent circumcision with suture, and 54 patients underwent circumcision with 2-OCA glue. Mean age in the glue group was 61 months (range 8-202 months), and 50 months in the suture group (range 5-215 months), p = 0.19. All cases were performed under general anesthesia, as outpatient surgery. Mean operative cut time was 18.4 min for the glue group, and 28.6 min for the suture group (p < 0.01). The 10.2 min operative time difference translated to a $378 cost savings per glue circumcision case. Complication rates were not statistically significant between the two groups. CONCLUSION: The use of 2-OCA tissue adhesive for sutureless circumcision is an alternative to the standard technique. It results in faster operative times, with a significant cost savings, while maintaining comparable complication rates to the standard suture technique. This is a viable, less expensive surgical option for patients whose circumcisions are not covered by Medicaid.

Surgical Treatment of Pressure Ulcers with a Fibrin Sealant in Patients with Spinal Cord Injury: A Cost-Consequence Analysis.

BACKGROUND: A comparative study was performed to evaluate the effectiveness and costs of a fibrin sealant (Tissucol Duo [known as Tisseel in the United States], Baxter International, Deerfield, Illinois) to improve postoperative outcomes in patients with spinal cord injury undergoing surgical treatment for pressure ulcers (PrUs). METHODS: Between January and June 2011, 27 patients underwent surgical treatment for PrUs with the direct application of Tissucol Duo sprayed before closure. The costs and outcomes obtained in this cohort were compared with those obtained in a previous retrospective study where 71 patients underwent conventional surgery. RESULTS: Lower rates of hematoma-seroma were observed in the study group (3.7% vs 33.8%; P < .05). Drain removal occurred earlier (10 vs 15 days; P < .05), and the average drain volume was also lower (155 vs 360 mL; P < .05) for this group. The mean length of hospital stay was significantly lower in the study group and was the main contributing factor to the overall costs. CONCLUSIONS: The application of Tissucol Duo during surgical treatment of PrUs in patients with spinal cord injury has been shown to be effective in reducing postoperative complications and in shortening the duration of the hospital stay with a consequent savings in costs.

Cost-benefit analysis of outcomes from the use of fibrin sealant for fixation of skin grafts in small-size burns compared to staples as historical controls: a retrospective review.

INTRODUCTION: Historically, split-thickness skin grafts have been fixed onto the recipient site by suture and/or staples. Fibrin sealants have become available for the fixation in the past 10 years. Fibrin sealants have been shown to be at least as effective as staples, and recent reports show them to cause less pain. However, the product is much more expensive than traditional suture and/or staple fixation. The cost-benefit ratio of sealant has not yet been proven. METHODS: A review of charts for 202 consecutive patients was undertaken for patients with burns that were less than 10% total body surface area (TBSA) that underwent excision and grafting using fibrin sealant at the regional burn center. A historical control comprising 48 consecutive patients with burns that were less than 10% TBSA that underwent excision and grafting using staples as the only means of fixation was used for comparison. Demographics (such as age, weight, and sex), personal history of tobacco use, previous diagnosis of diabetes, type and depth of burn, TBSA, area of grafting, graft and donor locations, mesh type, rate of hematomas, rate of graft loss, rate of complete closure at 1 month, and time to discharge after surgery were recorded for each patient in both cohorts. The data were compared and statistical analysis performed for graft loss complications and number of days until the patient could be discharged home with outpatient wound care. RESULTS: Use of fibrin sealants has resulted in statistically significant lower rates of loss of graft at our institution. Additionally, a decrease in the number of days until discharge to outpatient wound care of nearly 2 days produced a lower cost of care in patients with less than 10% TBSA undergoing excision and grafting. CONCLUSIONS: The use of fibrin sealants allows for fewer graft loss complications and earlier discharge in patients who have burns that are less than 10% TBSA. This decrease in hospital days results in savings, although this difference is not statistically significant.

The use of "2-octyl cyanoacrylate" as skin adhesive in pediatric and congenital cardiac surgery.

AIM: The aim of this paper was to evaluate the safety and cost-effectiveness of "2-octyl-cyanoacrylate" as skin adhesive in congenital heart surgery. METHODS: From April 2010 to December 2011, we collected data from 300 patients who underwent cardiac surgery for congenital heart disease. We divided our population into 3 groups: group-1 (N.=100):"2-octyl-cyanoacrylate" has been used to replace the intra-dermal suture line; group-2 (N.=100):"2-octyl-cyanoacrylate" has been utilized as a barrier ("add-on measure") in addition to the intra-dermal suture line, group-3 (N.=100) with a standard intra-dermal suture line. RESULTS: Median age of patients was 1.36 years. One-hundred and thirty-nine patients were younger than 12 months and 56 older than 16 years. There were 11 wound dehiscence (3.6%) (2 in group-1 and 9 in group-3, P=0.001) and 1 superficial wound infection (group-1). Six patients (2%) required surgical wound revision (2 in group-1 and 4 in group-3, P=NS). Wound complication was significantly associated to delayed sternal closure (3/12 patients, 25% versus 13/288 patients, 4.5%) (P=0.04). Median cost (intra-/postoperative) for wound treatment was lower in group-1 and 2 (19±5.5 and 23.9±7.4 € respectively) when compared to Group-3 (26.7±3.2) (P<0.0001). CONCLUSION: The use of "2-octyl-cyanoacrylate" proved to be safe and effective; the "add-on measure" strategy provided the best cost-effective solution.

A pilot trial of bordered polyurethane dressings, tissue adhesive and sutureless devices compared with standard polyurethane dressings for securing short-term arterial catheters.

OBJECTIVES: To improve arterial catheter (AC) securement and reduce AC failure; to assess feasibility of a large randomised controlled trial. DESIGN, SETTING AND PARTICIPANTS: A four-arm, parallel, randomised, controlled, non-blinded pilot trial with 195 intensive care patients taking part, in a tertiary referral hospital in Brisbane, Australia from May to November 2012. INTERVENTIONS: Standard polyurethane (SPU) dressing (controls); bordered polyurethane (BPU) + SPU dressing; tissue adhesive (TA) + SPU dressing; and sutureless securement device (SSD) + SPU dressing (no sutures used). MAIN OUTCOME MEASURES: AC failure, ie, complete dislodgement, occlusion (monitor failure, inability to infuse or fluid leaking), pain or infection (local or blood). RESULTS: Median AC dwell time was 26.2 hours and was comparable between groups. AC failure occurred in 26/195 patients (13%). AC failure was significantly worse with SPU dressings (10/47 [21%]) than with BPU + SPU dressings (2/ 43 [5%]; P = 0.03), but not significantly different to TA + SPU (6/56 [11%]; P = 0.18) or SSD + SPU (8/49 [16%]; P = 0.61). The dressing applied at AC insertion lasted until AC removal in 68% of controls; 56% of BPU + SPU dressings; 73% of TA + SPU dressings; and 80% of SSD + SPU dressings (all P > 0.05). There were no infections or serious adverse events. Patient and staff satisfaction with all products was high. Median costs (labour and materials) for securement per patient were significantly higher in all groups compared with the control group (SPU, $3.48 [IQR, $3.48-$9.79]; BPU + SPU, $5.07 [IQR, $5.07-$12.99]; SSD + SPU, $10.90 [IQR, $10.90-$10.90]; TA + SPU, $17.70 [IQR, $17.70-$38.36]; all P < 0.01). CONCLUSION: AC failure occurred significantly less often with BPU + SPU dressings than with SPU dressings. TA + SPU and SSD + SPU dressings should be further investigated and compared with BPU + SPU dressings as controls. The novel approach of TA + SPU dressings appeared safe and feasible.

Surgical site infection in spinal surgery: a comparative study between 2-octyl-cyanoacrylate and staples for wound closure.

BACKGROUND: Surgical site infection (SSI) after spinal surgery is a devastating complication. Various methods of skin closure are used in spinal surgery, but the optimal skin-closure method remains unclear. A recent report recommended against the use of metal staples for skin closure in orthopedic surgery. 2-Octyl-cyanoacrylate (Dermabond; Ethicon, NJ, USA) has been widely applied for wound closure in various surgeries. In this cohort study, we assessed the rate of SSI in spinal surgery using metal staples and 2-octyl-cyanoacrylate for wound closure. METHODS: This study enrolled 609 consecutive patients undergoing spinal surgery in our hospital. From April 2007 to March 2010 surgical wounds were closed with metal staples (group 1, n = 294). From April 2010 to February 2012 skin closure was performed using 2-octyl-cyanoacrylate (group 2, n = 315). We assessed the rate of SSI using these two different methods of wound closure. Prospective study of the time and cost evaluation of wound closure was performed between two groups. RESULTS: Patients in the 2-octyl-cyanoacrylate group had more risk factors for SSI than those in the metal-staple group. Nonetheless, eight patients in the metal-staple group compared with none in the 2-octyl-cyanoacrylate group acquired SSIs (p < 0.01). The closure of the wound in length of 10 cm with 2-octyl-cyanoacrylate could save 28 s and $13.5. CONCLUSIONS: This study reveals that in spinal surgery, wound closure using 2-octyl-cyanoacrylate was associated with a lower rate of SSI than wound closure with staples. Moreover, the use of 2-octyl-cyanoacrylate has a more time saving effect and cost-effectiveness than the use of staples in wound closure of 10 cm in length.

An inexpensive alternative to routine section adhesives for histology: the mucilaginous substance of the Assyrian plum.

We found that the mucilaginous substance of the Assyrian plum, Cordia myxa, can be used as an adhesive for attaching sections of animal tissues to slides. Unlike Mayer's albumen, this material left no stainable residue and had no noticeable effect on the histological structure of the tissue sections. The mucilaginous substance of C. myxa is a useful and inexpensive alternative to standard adhesives.

Hemostats, sealants, and adhesives III: a new update as well as cost and regulatory considerations for components of the surgical toolbox.

The hemostat, sealant, and adhesive components of the surgical toolbox continue to evolve and enter clinical practice at a rapid rate. The goal of this comprehensive, sequential review is to update these components to include those now available (February 2012) as well as to explore cost and regulatory factors that impact the development and use of these materials. A unique system of definitions for organizing these components based on group, category, and class is used as a means of improving the understanding and appropriate use of these materials. The system will be used here to present the most recent additions to the toolbox, which are evaluated based on safety, efficacy, usability, and cost. These new additions include pooled human plasma fibrinogen and thrombin embedded in an equine collagen patch for cardiac surgical hemostasis, polyethylene glycol (PEG) and human serum albumin for lung surgical pneumostasis, modified PEG and trilysine amine for spinal sealing, octyl and butyl lactoyl cyanoacrylate for vascular sealing, and a variety of octyl and butyl cyanoacrylates with or without dyes and/or polyester mesh for skin closure with the creation of a bacterial barrier. The system of definitions will also be used to clarify key strategies in the current health care environment for reducing costs and for increasing understanding of Food and Drug Administration regulatory decisions for these materials.

[Blepharoplasty: to suture or to use cyanoacrylate?]. / Blefaroplastia: ¿suturar o usar cianocrilato?

OBJECTIVE: To study the safety and surgical time required when using the tissue adhesive 2-ethyl-cyanoacrylate compared with conventional suture in upper lid blepharoplasty. METHOD: A retrospective study was performed on 40 eyes of 20 patients who underwent bilateral upper lid blepharoplasty. In 7 patients, continuous non-absorbable suture (6-0 nylon monofilament Ethilon(®), Ethicon Inc., Somerville, NJ) was used for closure of the incision and in 13 patients 2-ethyl-cyanoacrylate (Epiglue(®), Meyer -Haake, Germany) was used. The variables studied were intraoperative time required to close the incision, the cost of the material used and the incidence of infections and suture dehiscence. RESULTS: The average time taken to close the incision was 6.069 minutes with cyanoacrylate and 11.914 minutes with conventional suture (P<.05). The price of surgical material used was practically similar. No cases of infection or wound dehiscence were found. CONCLUSION: The closure of the incision in upper lid blepharoplasty using 2-ethyl-cyanoacrylate is a safe, effective, and faster, but not less expensive method than conventional suture.

Wound healing outcomes after laceration repair with adhesive.

It is important to be able to demonstrate that clinical practice and choice of products are based on evidence. This article discusses findings from an audit of wound-healing outcomes, ease of use, and patient and practitioner satisfaction associated with the use of a tissue adhesive in an emergency department. It briefly discusses wound and adhesive types, and shows that using such products for specific lacerations can provide safe and effective closure and acceptable healing outcomes for patients and clinicians, and reports the results of the study.

Closure of minor wounds with tissue adhesive.

This article provides basic information on safe and effective wound closure using tissue adhesive. Although it is intended for staff who are new to emergency care, it can be used by more experienced staff as a refresher or teaching aid.

Use of tissue glues in endoscopic pituitary surgery: a cost comparison.

BACKGROUND: Post-operative cerebrospinal fluid (CSF) leaks are a common complication of endoscopic pituitary surgery and account for a significant proportion of hospital costs associated with this procedure. Tisseel® is a tissue glue commonly used as an adjunct in dural repair but is not optimal for this purpose. DuraSeal® has several properties advantageous for dural repair but is not widely accepted in Canada partly due to its increased cost. OBJECTIVE: A cost analysis of DuraSeal® versus Tisseel® in endoscopic pituitary surgery. METHODS: A cost analysis was performed based on typical endoscopic pituitary surgery cases performed at our tertiary care institution. Operating room, hospital admission, and surgical sealant costs were obtained directly while estimates of patient recovery time and post-operative CSF leak rates were based on consensus values reported in the literature. Outcomes were reported for various possible clinical scenarios of sealant use. RESULTS: In a model where surgical sealant is employed only in high-risk cases, use of DuraSeal® allows for a yearly cost savings of at least $4486.72. If surgical sealant is used in all cases, regular use of DuraSeal® versus Tisseel® either marginally reduces yearly costs or increases them by a maximum of $7619.25, depending on the case volume and estimated post-operative CSF leak rate. CONCLUSION: In most clinical scenarios, use of DuraSeal® in endoscopic pituitary surgery may reduce overall yearly hospital costs compared to Tisseel®.