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.

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.

A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial.

BACKGROUND: Surgical site infections (SSIs) are common, occurring in up to 25% of > 4 million operations performed in England each year. Previous trials of the effect of wound dressings on the risk of developing a SSI are of poor quality and underpowered. METHODS/DESIGN: This study is a feasibility and pilot trial to examine the feasibility of a full trial that will compare simple dressings, no dressing and tissue-glue as a dressing. It is examining the overall acceptability of trial participation, identifying opportunities for refinement, testing the feasibility of and validating new outcome tools to assess SSI, wound management issues and patients' wound symptom experiences. It is also exploring methods for avoiding performance bias and blinding outcome assessors by testing the feasibility of collecting wound photographs taken in theatre immediately after wound closure and, at 4-8 weeks after surgery, taken by participants themselves or their carers. Finally, it is identifying the main cost drivers for an economic evaluation of dressing types. Integrated qualitative research is exploring acceptability and reasons for non-adherence to allocation. Adults undergoing primary elective or unplanned abdominal general surgery or Caesarean section are eligible. The main exclusion criteria are abdominal or other major surgery less than three months before the index operation or contraindication to dressing allocation. The trial is scheduled to recruit for nine months. The findings will be used to inform the design of a main trial. DISCUSSION: This pilot trial is the first pragmatic study to randomise participants to no dressing or tissue-glue as a dressing versus a simple dressing. Early evidence from the ongoing pilot shows that recruitment is proceeding well and that the interventions are acceptable to participants. Combined with the qualitative findings, the findings will inform whether a main, large trial is feasible and, if so, how it should be designed. TRIAL REGISTRATION: ISRCTN49328913 . Registered on 20 October 2015.

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.

Medical adhesives and patient safety: state of the science: consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries.

Skin injury related to medical adhesive usage is a prevalent but underrecognized complication that occurs across all care settings and among all age groups. If proper technique for application and/or removal of adhesive products is not used, tissue trauma can occur, impacting patient safety and quality of life and increasing healthcare costs. Little guidance exists in the literature regarding appropriate selection and proper use of adhesive products to minimize medical adhesive-related skin injury, as well as best practices for skin care preventive strategies, application and removal techniques, and assessment and treatment of such injuries. In an effort to define best practices for prevention of such injury, a consensus panel of 23 recognized key opinion leaders convened to establish consensus statements on the assessment, prevention, and treatment of medical adhesive-related skin injury. The consensus summit was held in December 2012 and was made possible by an unrestricted educational grant from 3M. This document details the consensus definitions and statements and identifies research priorities for development of new adhesive technologies and protocols for skin protection.

Antiepileptic intranasal Amiloride loaded mucoadhesive nanoemulsion: development and safety assessment.

Current investigation aimed to develop a novel Amiloride loaded mucoadhesive nanoemulsion formulation for nose-to-brain delivery. Furthermore, nasal irritation study and histopathological examination of the nasal mucosa were also carried out to assess nonirritant nature of the nanoemulsion. The optimized formulation, surface epithelium lining and the granular cellular structure of the nasal mucosa were totally intact, whereas KCl caused major changes in the ultrastructure of mucosa. Amiloride loaded mucoadhesive nanoemulsion formulations are non toxic on nasal mucosa and can be administered by intranasal route for effective treatment of epilepsy.

A prospective randomized trial comparing completion technique of fissures for lobectomy: stapler versus precision dissection and sealant.

OBJECTIVE: Alveolar air leaks are common after pulmonary resection, often prolonging hospitalization and increasing surgical morbidity and costs. Air leakages result from lung tissue traumatized by the dissection of fissures. This randomized and controlled trial evaluates 2 different surgical techniques for the completion of interlobar fissures during pulmonary lobectomy to establish which is superior in preventing air leakage. METHODS: There were 20 patients in each of the 2 groups: Electrocautery was used for precision dissection and collagen patches were coated with human fibrinogen and thrombin (TachoSil, Nycomed, Vienna, Austria) for aerostasis in the electrocautery and sealant group (ES), and the approved routine surgical procedure with staplers was used in the stapler group (ST). RESULTS: Statistically significant reductions of air leakage were found in the ES group in the overall incidence of air leaks (50% vs 95%, P = .0001), duration of air leaks (1.7 days vs 4.5 days, P = .003), and procedure costs (425 euros vs 630.5 euros, P = .0001). There were no complications related to the use of the patches, and a significantly lower incidence of dead pleural space was observed in the ES group (5% vs 40%, P = .020). CONCLUSION: The use of electrocautery dissection and collagen patches coated with human fibrinogen and thrombin (TachoSil, Nycomed, Vienna, Austria) for aerostasis to complete interlobar fissures seems to be safe and effective in reducing alveolar air leaks and procedure costs. Although this pilot study showed advantages in terms of hospitalization and cost benefits, further multicentric studies are required to clarify that these differences are statistically significant.

Pain after laparascopic bilateral hernioplasty : Early results of a prospective randomized double-blind study comparing fibrin versus staples.

BACKGROUND: The use of fibrin for mesh fixation in laparascopic hernioplasty has theoretical advantages in that it could result in reducing postoperative pain. The objective of this study is to demonstrate this improvement in postoperative pain with the highest level of evidence possible. METHODS: Unicenter single surgeon prospective randomized double-blind study of transabdominal preperitoneal (TAPP) bilateral hernioplasties comparing autologous fibrin sealant (FG) used for mesh fixation on one side and staples (SG) on the other. Data were collected regarding anthropometric measures, costs, complications and pain evaluation at postoperative days 7, 30 and 180 using a visual analogue scale. The patients were also asked to answer the following simple question: "On which side do you have more pain?" RESULTS: Twenty-two eligible patients were included in the study. Both groups were comparable. The operating time was significantly longer (30 min more) in the FG. The incidence of seroma was similar in both groups, and that of hematoma was higher in the SG (0 vs. 9.1%). At 1 week, the visual analogue scale scores were significantly lower in the FG (median: 1.7 vs. 4.5; MWU:103.5, p < 0.05). At 1 month, this difference became clinical and statistically insignificant. 72.7% of the patients referred more pain on the side with staples at 1 week, 38% at 1 month, and 0% at 6 months (after patients with hernia recurrence were excluded). The recurrence rate was higher in the FG (9.9 vs. 13.6%). A hernia in the FG cost 200 Euros more than that in the SG, or even more if a complete economic study is considered. CONCLUSIONS: The use of fibrin produces less postoperative pain in the first week, but prolongs operating time and increases costs. Moreover, there appears to be a higher recurrence rate and a lower incidence of hematoma, while the incidence of seroma remains unchanged.

Prospective randomized trial of skin adhesive versus sutures for closure of 217 laparoscopic port-site incisions.

BACKGROUND: The purpose of this study is to determine whether closure of laparoscopic port-site incisions using octylcyanoacrylate (OCA) is feasible, whether it is faster than traditional subcuticular suturing, whether the number and length of incisions impact on closure time, and to determine wound morbidity and patient satisfaction outcomes. STUDY DESIGN: A prospective randomized trial was performed on adult patients scheduled for elective laparoscopic surgery in three surgical specialties at a tertiary referral center. Patients were randomized to have closure of laparoscopic port sites using either OCA or sutures. Patients were followed up 2 to 3 weeks postoperatively. At 2 months patients were mailed a questionnaire regarding their satisfaction with the method of closure and the appearance of their scars. RESULTS: A total of 175 incisions in 50 patients were closed with OCA, and 142 incisions in 42 patients were closed with subcuticular sutures. Time to close was significantly faster for OCA (median 2.5 minutes versus 6 minutes, p < 0.001). OCA was faster than traditional subcuticular suturing for cases involving three or more port sites (median 2.5 minutes versus 6 minutes, p < 0.001), and for cases with total length of incisions >4 cm (median 2.6 minutes versus 7 minutes, p < 0.001). OCA and subcuticular suturing groups did not differ significantly on patient acceptance or assessment of scars. CONCLUSIONS: Closure of laparoscopic port-site incisions is feasible with OCA. Closure with OCA requires significantly less operative time than subcuticular suturing, particularly in cases when three or more port sites are used or when total incision length is greater than 4 cm. OCA appears to have equivalent adverse wound outcomes and patient acceptance rates as subcuticular suturing.

Use of Tisseel fibrin sealant in neurosurgical procedures: incidence of cerebrospinal fluid leaks and cost-benefit analysis in a retrospective study.

OBJECTIVE: To determine the clinical efficacy and cost effectiveness of using the fibrin sealant (FS) Tisseel (Baxter Healthcare Corp., Deerfield, IL) for patients undergoing anterior cranial base, infratemporal, and retromastoid surgical procedures. METHODS: A retrospective review was performed, comparing two matched populations of patients who underwent surgical procedures using anterior cranial, infratemporal, or retromastoid approaches to intracranial pathological lesions. The incidences of cerebrospinal fluid (CSF) leaks in matched groups treated with the FS Tisseel or treated without FS were compared. The costs of Tisseel use were examined in comparison with the costs of postoperative management of CSF leaks and/or tension pneumocranium with spinal drainage and occasionally surgical reexploration, when lumbar drainage failed. RESULTS: Patients who received the FS Tisseel exhibited no detectable postoperative CSF leaks or tension pneumocranium. Patients who did not receive Tisseel demonstrated 4 to 16% incidences of postoperative leaks, depending on the surgical approach used. The costs of treating those leaks far exceeded the costs of using Tisseel, even if it were used indiscriminately for all patients. CONCLUSION: This retrospective review indicates that the FS Tisseel reduces the incidence of postoperative CSF leaks and tension pneumocranium while reducing overall management costs. Further prospective study is needed to determine which patients can benefit most from FS use.