Novel Peripheral Intravenous Catheter Securement for Children and Catheter Failure Reduction: A Randomized Clinical Trial.

Importance: Peripheral intravenous catheters (PIVCs) facilitate essential treatment. Failure of these essential devices is frequent and new securement strategies may reduce failure and improve patient outcomes. Objective: To evaluate clinical effectiveness of novel PIVC securement technologies for children to reduce catheter failure. Design, Setting, and Participants: A 3-arm, parallel group, superiority randomized clinical trial was conducted at 2 regional Australian hospitals from February 5, 2020, to January 14, 2022. Children aged 6 months to 8 years who were anticipated to require admission with a PIVC for at least 24 hours of in hospital treatment were eligible. Data were analyzed from May 25, 2022, to February 20, 2024. Interventions: Participants were randomly allocated in a 1:1:1 ratio to standard care, bordered polyurethane (Tegaderm [3M]), integrated securement dressing (SorbaView SHIELD [Medline]), and integrated securement dressing with tissue adhesive (Secureport IV). One catheter was studied per patient. Main Outcomes and Measures: Primary outcome was PIVC failure, defined as premature cessation of PIVC function for any reason prior to completion of planned treatment. Secondary outcomes were PIVC complications (any time dislodgement, occlusion, infiltration, partial dislodgement, extravasation, device leaking, phlebitis, pain), PIVC longevity, intervention acceptability (clinicians, participants, caregivers; 0-10 scale), and pain on removal (participants and caregivers; 0-10 scale relevant to age), adverse events, and health care costs. Results: A total of 383 patients (51% female; median age 36 [25th-75th percentiles, 22-72] months) were randomized 134 to standard care, 118 to integrated securement dressing, and 131 to integrated securement dressing with tissue adhesive. PIVC failure was lowest in integrated securement dressing with tissue adhesive (15 [12%]; adjusted hazard ratio [aHR], 0.47; 95% CI, 0.26-0.84) compared with integrated securement dressing (24 [21%]; aHR, 0.78; 95% CI, 0.47-1.28) and standard care (43 [34%]). Direct costs were significantly lower for integrated securement dressing with tissue adhesive (median, Australian dollars [A$], 312 [A$1 is equal to $0.65 US dollars]; IQR, A$302-A$380) and integrated securement dressing (median, A$303; IQR, A$294-A$465) compared with standard care (median, A$341; IQR, A$297-A$592; P ≤ .002) when considering the economic burden related to failure of devices. PIVC longevity and intervention acceptability were similar across all groups. Conclusions and Relevance: In this study, PIVCs secured with integrated securement dressings and tissue adhesive, in comparison with standard care, bordered polyurethane dressings, were associated with significantly reduced PIVC failure, for children admitted to hospital via the emergency department. Further research should focus on implementation in inpatient units where prolonged dwell and reliable intravenous access is most needed. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12619001026112.

Assessment of leakage pressure following enterotomy closure reinforced by tissue adhesive in a caprine cadaver model.

AIMS: To compare the combination of suture and tissue adhesive with suture alone for closure of enterotomy incisions in an ex vivo caprine jejunal model, by measuring the intraluminal pressure at which leakage occurred and the proportion of closures that leaked at intraluminal pressures <40 mmHg. METHODS: Jejunal tissue was harvested from a goat following euthanasia, and enterotomy incisions (4 mm in length) were made in each of 24 isolated jejunal segments. The enterotomies were randomly assigned to be closed using a single interrupted suture alone (n=12) or in combination with biopolymer tissue adhesive (n=12). The jejunal segments were infused with saline containing fluorescent dye and leakage pressure was defined as the peak pressure attained when visible leakage of saline solution occurred. The number of enterotomies that did or did not exhibit leakage at <40 mmHg intraluminal pressure was also recorded. RESULTS: Enterotomies closed using a combination of suture and tissue adhesive leaked at higher intraluminal pressure (58.2 (SD 4.7) mmHg) than those closed with suture alone (29.8 (SD 4.2) mmHg; p<0.001). The proportion of enterotomy closures in which the intraluminal pressure failed to reach 40 mmHg before leakage occurred was higher in enterotomies closed using suture alone (9/12, 75%) compared to those closed using both suture and tissue adhesive (3/12, 25%; p=0.002). CONCLUSIONS AND CLINICAL RELEVANCE: Use of tissue adhesive in addition to sutures increased the intraluminal pressure achieved before leakage occurred, compared to sutures alone, following enterotomy closure in a caprine cadaver model. In vivo studies are indicated to further assess the value of supplementing intestinal suture lines with tissue adhesive.

Medical and Economic Evaluation of FOREseal Bioabsorbable Reinforcement Sleeves Compared With Current Standard of Care for Reducing Air Leakage Duration After Lung Resection for Malignancy: A Randomized Trial.

OBJECTIVE: The objective of this study was to determine the efficacy of alginate staple-line reinforcement of fissure openings as compared with stapling alone, with or without tissue sealant or glue, in reducing the incidence and duration of air leakage after pulmonary lobectomy for malignancy. SUMMARY BACKGROUND DATA: No randomized trial evaluating alginate staple-line reinforcement has been performed to date. METHODS: The Staple-line Reinforcement for Prevention of Pulmonary Air Leakage study was a multicenter randomized trial, with blinded evaluation of endpoints. Patients over 18 years of age scheduled for elective open lobectomy or bilobectomy for malignancy were eligible for enrollment. At thoracotomy, patients were deemed ineligible if an unanticipated pneumonectomy was indicated, or if air leakage occurred after the liberation of pleural adhesions. Otherwise, if the fissure was incomplete or the lung had an emphysematous appearance, patients were randomized to either standard management or interventional procedure consisting of fissure opening with linear cutting staplers buttressed with paired alginate sleeves (FOREseal). The number of eligible patients necessary in each randomization arm was estimated to be 190, and an outcomes analysis was performed on an intention-to-treat basis. RESULTS: Of the 611 patients consented to study enrollment, 380 met the inclusion criteria and were randomized. Based on an intention-to-treat analysis, the primary endpoint of air leak duration was not different between the 2 groups: 1 day (range: 0-2 d) in the FOREseal group and 1 day (range: 0-3 d) in the control group (P = 0.8357). In addition, the 2 groups were similar in terms of the proportion of patients presenting with prolonged air leakage (7.8% in the FOREseal group vs 11.3% in the control group, P = 0.264) and the average duration of chest drainage (P = 0.107). Procedure costs were comparable for both groups. CONCLUSIONS: FOREseal did not demonstrate a significant advantage over standard treatment alone.

Fibrin Glue Injections: A Minimally Invasive and Cost-Effective Treatment for Post-Renal Transplant Lymphoceles and Lymph Fistulas.

Pelvic lymphoceles/lymph fistulas are commonly observed after kidney allotransplantation, especially when the kidney is placed in a retroperitoneal position. While the majority are <5 cm in diameter and resolve without intervention, some may continue to enlarge, and cause local or systemic symptoms or graft dysfunction. Among 1662 recipients of both living and deceased donor kidney transplants between January 2003 and July 2014, we found 46 (2.7%) patients with symptomatic lymphoceles requiring intervention. We studied the clinical outcomes and charges for three treatment modalities including open surgical drainage (22), laparoscopic surgical drainage (11), and percutaneous fibrin glue injections into the drained lymphocele cavity (13). The patient demographics and clinical characteristics were comparable for each treatment group, although maintenance immunosuppressive drugs differed by era. We found fibrin glue injections resulted in significantly lower (p = 0.04) rates of recurrence (1; 7.7%) than either laparoscopic (6; 54%) or open surgical drainage (6; 27.3%). In addition, fibrin glue injections generated significantly (p < 0.001) lower median ($4559) charges compared to either laparoscopic ($26,330) or open surgical drainage ($23,758). Fibrin glue treatment has the advantage of being an outpatient procedure, performed with the patient under local anesthesia, and does not incur the expense of an operative procedure or hospital admission associated with laparoscopic or open surgery.

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.

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.

[Local haemostasis with an adhesive cyanoacrylate-coated membrane following tooth extraction in patients under anticoagulant or anti-platelet therapy]. / Hémostase locale par membrane enduite de cyanoacrylate, après avulsions dentaires sous anticoagulants ou anti-agrégants.

OBJECTIVE: Assessment of a local hemostasis with a compressive, extemporaneous gutter glued to the alveolar crest after tooth avulsion in patients under anticoagulant and/or platelet aggregation inhibitors, and economical impact of this technique. MATERIAL AND METHOD: Ninety-seven tooth extractions were performed in patients under AVK and/or anti-platelet drugs. The interventions were consecutive and concerned 251 teeth (138 different alveolar sites). The extraction alveolus was protected by an absorbable oxycellulose membrane coated with sterilized cyanoacrylate adhesive for medical use. This procedure was used with all patients, whatever the hemorrhagic risk (the only inclusion criterion was INR less than 4 for patients under AVK). All procedures were performed under local anesthesia. RESULTS: There was one hemorrhagic complication (0.72%) due to mechanical gutter destruction by an antagonist tooth. The adhesive did not run, there was no tissue necrosis, and no wound infection requiring gutter removal. DISCUSSION: This local hemostasis procedure is reliable. It may be an alternative to substitution of heparin, without or with hospitalization. This procedure, requiring modification of treatment, greatly decreases healthcare costs. Contra-indications include the presence of an antagonist tooth harmful for the gutter, and patients with impaired consciousness or tongue dyspraxia.

Intrasac fibrin glue injection after platinum coils placement: the efficacy of a simple intraoperative procedure in preventing type II endoleak after endovascular aneurysm repair.

OBJECTIVES: To verify in our experience if fibrin glue injection into the aneurysm sac, made at the end of endovascular aneurysm repair (EVAR), can reduce type II endoleak rates. METHODS: Between January 2005 and February 2008, 38 patients underwent EVAR for an unruptured abdominal aortic aneurysm. The first 20 consecutive patients (Group A) had standard EVAR while the last 18 patients (Group B) had EVAR with fibrin glue injection into the sac, regardless of type II endoleak's presence. RESULTS: There was no statistically significant difference between the two groups concerning the surgical time and the time of X-ray exposure (P=0.30 and 0.54, respectively). Type II endoleak rate was significantly higher in Group A compared to Group B (6 cases, 30% vs. 1 case, 5.5%, respectively, P=0.05). Primary short-term clinical success was 95% and 100%, respectively. At 12 months, selective lumbar embolization was performed in two patients in Group A and in one patient in Group B. Patients in Group A had less computed tomography (CT) studies than patients in Group B (2.0 vs. 1.2, respectively, P=0.024). CONCLUSIONS: Fibrin glue injection is a safe procedure and seems to reduce type II endoleak rates. Patients who received this procedure had fewer CT examinations, with reduced health-care costs.

Assessment of fibrin glue in pterygium surgery.

PURPOSE: To evaluate the efficacy and safety of fibrin glue in pterygium surgery with conjunctival autografting. METHODS: This was a prospective noncomparative case series. Patients were recruited from the general clinics for pterygium surgery. For pterygium surgery, autologous conjunctiva was harvested from the superior bulbar conjunctiva after pterygium excision. The graft was secured to bare sclera at the site of the pterygium by Tisseel fibrin adhesive. Patients were followed up with a standard form. Key parameters included visual acuity, graft integrity, and graft size. The rate of pterygium recurrence was monitored. RESULTS: A total of 24 patients were recruited, and 29 pterygia were excised with conjunctival grafting. All conjunctival grafts were secured adequately with no cases of dislodgement. Graft dimensions tended to decrease slightly in the early postoperative period, followed by stabilization. There were no cases of serious adverse events and no reduction in visual acuity. One pterygium recurrence occurred at 3 months. One spontaneous subgraft hemorrhage occurred with no effect on graft stability. CONCLUSIONS: Tisseel fibrin glue provided adequate adhesion of conjunctival grafts to the ocular surface. Healing was characterized by a comfortable eye, minimal inflammation, and good cosmetic result. There were no significant complications and the results appeared similar to those reported in the literature for sutured grafts.

The assessment of quality of life in a trial on lightweight mesh fixation with fibrin sealant in transabdominal preperitoneal hernia repair.

BACKGROUND: Chronic pain is a major concern in open and laparoscopic hernia repair. Study groups have adopted a variety of tools to assess postoperative (postOP) pain and quality of life (QoL). Unfortunately, modifications of existing tests and self-designed questionnaires are common, yielding unvalidated results and making comparison of data difficult. The aim of this study was to assess the QoL in transabdominal preperitoneal mesh repair (TAPP) with fibrin sealant (FS) for lightweight mesh fixation, applying the standardised Short Form 36 (SF36) questionnaire in its unmodified design. The SF36 has already been validated and implemented in a large number of studies. In this trial the physical-health-component summary measure (PHM), summarising the physical health-related scales, served as the primary outcome parameter. MATERIALS AND METHODS: After informed written consent was obtained, TAPP with fibrin mesh sealing was performed in 11 non-selected consecutive patients by a single surgeon. A direct control group (e.g. TAPP with staples) was not enrolled, because a favourable change in the QoL in patients subjected to the mesh sealing approach was the tested hypothesis and not the comparison of techniques. The macroporous mesh (TI-Mesh, GfE, Germany) was fixed with 1 ml of FS (FS, Tisseel, Tissucol, Baxter Biosciences, Austria), and the QoL and pain were assessed preoperatively and 1 year postOP using the SF36 survey and the visual analogue score (VAS). RESULTS: After 12 months, recurrences or complications were observed. The analysis of the unmodifed SF36 revealed a highly significant improvement in the PHM, based on significant changes of all physical-health-related scales. The scale 'social functioning' (SOCIAL), which belongs to the mental-health-related scale, had also significantly improved. The VAS was significantly reduced after 1 year. CONCLUSIONS: Despite a small number of patients (n = 11), a strikingly significant improvement in physical health and reduction of pain was detected with the unmodified SF36 and the VAS 1 year after TAPP repair with fibrin-sealed lightweight meshes. We suggest the use of the unmodified SF36 for QoL in hernia repair in order to assess all aspects of recovery (physical and mental) and to facilitate comparison of data.

Long-term assessment of the treatment of recurrent tracheoesophageal fistula with fibrin glue associated with diathermy.

PURPOSE: Recurrent tracheoesophageal fistula (RTF) is a serious common complication of the surgical treatment of esophageal atresia. We report the results of our technique of bronchoscopic treatment of RTF with fibrin glue (Tissucol), with a follow-up of over 1 decade. METHODS: A retrospective review between 1993 and 2004 was conducted, including all patients diagnosed with RTF and treated bronchoscopically with Tissucol, with over 1 year of follow-up. The procedure was implemented under general anesthesia using a rigid neonatal bronchoscope. A magnification chamber and previous diathermia using a urethral catheter were used in the latter 4 patients. The fibrin glue was injected through a clear catheter. The number of endoscopic sessions per patient was limited to 3. RESULTS: Seven patients were treated, with evidence of fistular closure in 6 (85%). One patient with satisfactory results, but a follow-up of 4 months, was not included. The age at bronchoscopy ranged from 14 to 20 days (mean, 16.7 days), and a total of 12 sessions were required (mean, 1.7). In the latter 4 patients, diathermia was associated with good results in all and a lower number of sessions (mean, 1.5). All patients were evaluated clinically and radiologically, and a control endoscopy was performed in 4 patients. The follow-up lasted from 2 to 11 years (mean, 7.4 years). CONCLUSIONS: Because we started to use Tissucol (1994), other authors have reported successful isolated cases, but a relatively large series and a long-term follow-up were lacking. We consider that the success of the procedure depends on several technical factors such as an early diagnosis, before epithelium is formed in the fistula, and the use of initial diathermia, associated in the latter 4 patients. The results obtained with 85% success with a follow-up over 1 year show that the fibrin adhesive is the reference substance for the treatment of RTF; we recommend its endoscopic application associated with diathermia as initial measure.

[The use of tissue glue and its effect on hospital cost in patients undergoing pulmonary surgery]. / Pulmoner rezeksiyon yapilan hastalarda doku yapistiricisi kullanimi ve hastane maliyetine etkisi.

Prolonged air leak following pulmonary resections is an important cause of morbidity and increased hospital costs. We compared 19 homologous/autologous tissue glue (fibrin glue) applied patients (FG group), 12 beriplast-P applied patients (beriplast group) and 27 control patients with respect to prolonged air leak, chest tube removal time and hospital costs. The mean ages for FG group (19 patients), beriplast group (12 patients) and control group (27 patients) were 48.5 +/- 14, 50.5 +/- 6.8 and 55 +/- 12.9 respectively. The groups were comparable with respect to age (p= 0.210), sex (p= 0.287) and the surgical procedure performed (p= 0.289). The incidence of prolonged air leak in FG group, beriplast group and the control group was 48%, 50% and 63%, respectively (p= 0.533). The mean chest tube removal time in FG group, beriplast group and the control group was 10.7 +/- 8.7, 9 +/- 4.1 and 8 +/- 3.1 days, respectively (p= 0.282). Mean hospital costs in FG group, beriplast group and the control group were 4633 +/- 3272 YTL, 4611 +/- 1583 YTL and 4015 +/- 911 YTL, respectively (p= 0.547). Fibrin glue had no effect on the incidence of prolonged air leak, chest tube removal time and hospital costs.

Does fibrin glue sealant decrease the rate of pancreatic fistula after pancreaticoduodenectomy? Results of a prospective randomized trial.

Despite substantial improvements in perioperative mortality, complications, and specifically the development of a pancreatic fistula, remain a common occurrence after pancreaticoduodenectomy. It was the objective of this study to evaluate the role of fibrin glue sealant as an adjunct to decrease the rate of pancreatic fistula after pancreaticoduodenectomy. One hundred twenty-five patients were randomized after pancreaticoduodenal resection only if, in the opinion of the surgeon, the pancreaticojejunal anastomosis was at high risk for development of a pancreatic anastomotic leak. After completion of the pancreaticojejunal anastomosis, the patients were randomized to topical application of fibrin glue sealant to the surface of the anastomosis or no such application. The primary postoperative end points in this study were pancreatic fistula, total complications, death, and length of hospital stay. A total of 59 patients were randomized to the fibrin glue arm, whereas 66 patients were randomized to the control arm and did not receive fibrin glue application. The pancreatic fistula rate in the fibrin glue arm of the study was 26% vs. 30% in the control group (p = not significant [NS]). The mean length of postoperative stay for all patients randomized was similar (fibrin glue = 12.2 days, control = 13.6 days) and the mean length of stay for patients in whom pancreatic fistula developed was also not different (fibrin glue = 18.9 days, control = 21.7 days). There were no differences with respect to total complications or specific complications such as postoperative bleeding, infection, or delayed gastric emptying. These data demonstrate that the topical application of fibrin glue sealant to the surface of the pancreatic anastomosis in this patient population undergoing high-risk pancreaticojejunal anastomosis did not reduce the incidence of pancreatic fistula or total complications after pancreaticodudodenectomy. There seems to be no benefit regarding the use of this substance in this setting.

Tissucol application in dermolipectomy and incisional hernia repair.

Biological adhesives have a lot of applications in surgical procedures. Here we present a prospective study with the aim of analyzing results of the application of Tissucol between the muscle layers and subcutaneous tissue after incisional hernia repair with polypropylene mesh and associated dermolipectomy. We assess clinical and technical parameters, local morbidity, and hospital stay. Fifty-six patients were divided into two groups. Patients with whom we used fibrin glue were older, with more obesity (P < 0.005) with associated diseases, and their incisional hernias were larger and more complicated to repair. Patients in the Tissucol group developed less local morbidity (hematomas or abscesses; P < 0.01), had a shorter mean hospital stay (P < 0.01), and required less wound care. The use of Tissucol improves the results of surgical repair of large abdominal incisional hernias repaired by mesh placement and dermolipectomy, and it decreases global morbidity and hospital stay are reduced.