BioGlue Group Research Articles

Guided Bone Regeneration Using BioGlue As a Barrier Material With and Without Biphasic Calcium Phosphate.

The aim of this study was to investigate the effects of Bioglue as a mechanical barrier with or without biphasic calcium phosphate (BCP) in a rat tibia model. Sixty Sprague Dawley male rats weighing 250 ± 20 g and 10 to 12 weeks of age were studied. Unicortical defects were created on the right tibia of all rats. Subjects were randomly divided into 3 groups. BioGlue group (24 rats); BioGlue alone, Graft group (24 rats); BioGlue + BCP and Control group; unfilled and uncovered (12 rats). Animals were euthanized at 7th, 21st, and 45th days postoperatively for histological and histomorphometric analyses. BioGlue material exhibited no adverse effects until the end of observation period. Bone-healing scores did not differ statistically between Control and BioGlue group, but found to be lower in Graft group on 21st and 45th days, (P < 0.001 and P < 0.01 on the 21st day and P < 0.01 and P < 0.05 on the 45th day, respectively). New bone formation in Graft group was found to be statistically different from Control group on the 7th and 21st days (P < 0.01 and P < 0.05 respectively), whereas no statistical difference was observed between BioGlue and Control group at all times. The present analysis indicates that BioGlue functioned well as a mechanical barrier allowing new bone formation. No additional benefit of combination treatment was detected in this study design and BCP did not offer any advantage for bone regeneration, thus it can serve as only a space maintainer.

Effects of albumin/glutaraldehyde glue on healing of colonic anastomosis in rats.

AIMTo evaluate the effect of local surgical adhesive glue (albumin/glutaraldehyde-Bioglue) on the healing of colonic anastomoses in rats.METHODSForty Albino-Wistar male rats were randomly divided into two groups, with two subgroups of ten animals each. In the control group, an end-to-end colonic anastomosis was performed after segmental resection. In the Bioglue group, the anastomosis was protected with extraluminar application of adhesive glue containing albumin and glutaraldehyde. Half of the rats were sacrificed on the fourth and the rest on the eighth postoperative day. Anastomoses were resected and macroscopically examined. Bursting pressures were calculated and histological features were graded. Other parameters of healing, such as hydroxyproline and collagenase concentrations, were evaluated. The experimental data were summarized and computed from the results of a one-way ANOVA. Fisher’s exact test was applied to compare percentages.RESULTSBursting pressures, adhesion formation, inflammatory cell infiltration, and collagen deposition were significantly higher on the fourth postoperative day in the albumin/glutaraldehyde group than in the control group. Furthermore, albumin/glutaraldehyde significantly increased adhesion formation, inflammatory cell infiltration, neoangiogenesis, and collagen deposition on the eighth postoperative day. There was no difference in fibroblast activity or hydroxyproline and collagenase concentrations.CONCLUSIONAlbumin/glutaraldehyde, when applied on colonic anastomoses, promotes their healing in rats. Therefore, the application of protective local agents in colonic anastomoses leads to better outcomes.

Use of BioGlue Surgical Adhesive in Hypospadias Repair

Purpose: To prospectively evaluate the efficacy of albumin glutaraldehyde tissue adhesive (BioGlue) in the surgical treatment of patients with hypospadias. Materials and Methods: Two groups of 20 patients each who underwent hypospadias repair were included in the study. In the first group we utilized BioGlue as an additional protective layer to the suture line of the neo-urethra, while patients in the second group were operated on utilizing a routine surgical technique. Results: There were no statistical differences between patients from the 2 groups in terms of surgical complications. Urethrocutaneous fistula was revealed in 4 (20%) patients after repair with BioGlue and in 3 (15%) patients from the control group (p = 0.686), suture line breakdown in 4 (20%) and in 1 (5%) patients (p = 0.478), meatal stenosis in 1 (5%) and in 1 (5%) patient (p = 1). Furthermore more patients in the BioGlue group (n = 12, 60%) demonstrated poor cosmetic results compared to the control group where most patients - 19 (95%) had acceptable cosmetic outcomes (p = 0.007). Conclusions: Our data showed no benefits of BioGlue use in hypospadias repair.

A prospective, randomized trial comparing BioGlue and Vivostat for the control of alveolar air leak

BioGlue (CryoLife, Europa Ltd, Surrey, UK) is effective in reducing alveolar air leak after pulmonary resection. However, concerns exist regarding the use of bovine-derived products. Vivostat (Vivostat A/S, Alleroed, Denmark) is an autologous fibrin sealant that confers certain advantages. It shows superior elastic properties, a faster absorption time, and the absence of risk of transmission of blood-borne diseases. We conducted a randomized, single blind controlled study to compare BioGlue and Vivostat in the control of postoperative air leak. Primary endpoints were duration of air leak, time to intercostal drain removal, and length of hospital stay. Secondary endpoints related to postoperative complications. Between December 2005 and December 2007, 103 patients were randomized. The analysis included 102 patients; 67% were male. Median age was 56 +/- 19 years. Indications for surgery were primary lung cancer in 41 patients (40%), secondary malignancy in 48 patients (47%), carcinoid in 6 patients (6%), and 7 patients underwent surgery for benign disease (7%). Bilobectomy was performed in 2 patients (2%), lobectomy in 41 patients (40%), lobectomy with lesser resection in 3 patients (3%), segmentectomy in 16 patients (16%), precision excision in 34 patients (33%), and 6 patients underwent other resections (6%). Median duration of air leak was 3 (0-32) days versus 2 (0-33) days for patients who received BioGlue and Vivostat, respectively (P = .677). Time to intercostal drain removal was 5 (1-32) days in the BioGlue group compared with 5 (1-34) days for the Vivostat group (P = .473). Median hospital stay was 8 (3-22) days versus 7 (2-29) days for the BioGlue and Vivostat groups, respectively (P = .382). There was no significant difference in the incidence of complications between the 2 groups (20 patients receiving BioGlue versus 19 patients receiving Vivostat, P = .839). There were no significant differences in the 3 clinical outcome measures of duration of air leak, time to intercostal drain removal, and length of hospital stay in those patients receiving BioGlue or Vivostat. Given the inherent advantages of our institutional preference is to use Vivostat in the control of postoperative air leaks after pulmonary resection.

Influence on Bladder Development of Prenatal Treatment of Surgically Induced Myelomeningocele in a Sheep Model

Purpose To assess if a surgically induced model of myelomeningocele (MMC) in sheep produces bladder malformations like those observed in human disease and to determine if fetal surgical repair allows normal bladder development. Material and Methods A MMC was created in 20 fetal lambs between 60 and 80 days of gestation. Ten of them did not undergo fetal repair (group A), 5 were repaired with an open two-layer closure (group B) and 5 with fetoscopic coverage using bioglue (group C). Clinical assessment of motor and urinary behaviour was performed at term. Bladders were examined externally and in transversal sections. Histological changes were assessed using H-E and Masson stained sections. Three normal lambs served as control. Results Five lambs in group A (50%), 2 in group B (40%) and 3 in group C (60%) were delivered at term (day 140) and sacrificed within 24 hours. Lambs in group A were paraplegic and incontinent for urine. Macroscopically, bladders were severely dilated and thin. Microscopically they showed some fibrous tissue lying immediately subjacent to the epithelium that was obviously thinner than controls. Muscular layer was thin and partially disrupted. Lambs in group C showed normal histological structure with mild epithelium changes and moderate thinning of the muscular layer. Bladders in group B and in control animals showed none of these changes. Conclusions Some of the bladder abnormalities associated to MMC in human patients are also found in the uncorrected fetal lamb model. Open two-layer prenatal closure could prevent completely these malformations

Effect of BioGlue® on the Incidence of Pancreatic Fistula Following Pancreas Resection

BackgroundDespite numerous modifications of surgical technique, pancreatic fistula remains a serious problem and occurs in about 10% of patients following pancreas resection. BioGlue is a new sealant that creates a flexible mechanical seal within minutes independent of the body’s clotting mechanism. HypothesisApplication of BioGlue sealant will reduce the incidence of pancreatic fistula following pancreas resection. MethodsA retrospective cohort study was performed with 64 patients undergoing pancreas resection. BioGlue sealant was applied to the pancreatic anastomosis (Whipple) or resection margin (distal pancreatectomy) in 32 cases. Factors that could affect the rate of postoperative pancreatic fistula were recorded. Pancreatic fistula was defined as greater than 50 ml of drain output with an amylase content greater than three times normal serum value after postoperative day 10. To improve the sensitivity of our study, we also examined pancreatic fistula with a strict definition of any drain output on or after postoperative day 3 with a high amylase content and graded the fistulas in terms of clinical severity. Grade A leaks were defined as subclinical. Grade B leaks required some response such as making the patient nil per os, parenteral nutrition, octreotide, antibiotics, or a prolonged hospital stay. Grade C leaks were defined as serious and life threatening. They were associated with hemorrhage, sepsis, resulted in deterioration of other organ systems, and mandated intensive care. Comparisons between the two groups were made using the chi-square test or Fisher’s exact test for categorical variables and by the Wilcoxon rank-sum test for continuous variables. P values of 0.05 or less were deemed statistically significant. ResultsThere were no differences between the patients who received BioGlue and the control cohort in terms of comorbid conditions, tumor location, texture of the pancreas, size of the pancreatic duct, or surgical technique. By the common definition, pancreatic fistula occurred in 6% (control) vs. 22% (BioGlue). By the strict definition, a fistula occurred in 41% (control) vs. 60% (BioGlue). In the control group, ten were subclinical (grade A) and two were clinically apparent leaks (grade B). In the BioGlue group, seven were subclinical (grade A), five were clinically apparent (grade B), and three were severe (grade C). There were no statistically significant differences in the incidence or severity grades of postoperative pancreatic fistulas between the two groups. ConclusionApplication of BioGlue sealant probably does not reduce the incidence of pancreatic fistula following pancreas resection.

Albumin-glutaraldehyde bioadhesive ("Bioglue") for prevention of postoperative complications after stapled hemorrhoidopexy: a randomized controlled trial

Hemorrhoidopexy using the circumferential stapler is an established method for surgical treatment of patients with prolapsing hemorrhoids. Despite its advantages, complications such as anal canal stenosis, hemorrhage and anastomosis leak with eventual intrapelvic sepsis can cause serious postoperative problems. The aim of this study was to evaluate the utility of a surgical adhesive, the biological albumin-glutaraldehyde glue "Bioglue", in reduction of these postoperative complications. Between January 2002 and November 2004, 200 patients undergoing stapled hemorrhoidopexy were enrolled in a prospective, randomized clinical trial. One hundred patients were randomly assigned to the control group; the study group consisted of 100 patients who received Bioglue in the mucosa anastomosis area. All patients received standardized postoperative analgesic, laxative and antibiotic treatment. We then evaluated the two groups for postoperative complications (after surgery and 6 months postoperatively). From the control group (no Bioglue application), two patients presented with anal stenosis, two with hemorrhage, three had anastomosis leak and one had thrombosis, whereas none of the patients from the Bioglue group had any of these complications. Both groups had patients with severe postoperative pain (3 each) and fecal incontinence (1 patient each). The overall difference in the number of complications in the two groups was statistically significant (p < 0.05). In this first study using Bioglue in patients undergoing circumferential stapled hemorrhoidopexy we have shown that application of the glue is effective in reducing postoperative complications.

Sutureless nephron-sparing surgery: Use of albumin glutaraldehyde tissue adhesive (BioGlue)

Objectives To determine the feasibility of using serum albumin glutaraldehyde tissue adhesive (BioGlue) to achieve hemostasis and prevent urine leakage during nephron-sparing surgery (NSS). Methods From February 1993 to April 2005, 174 NSS operations were performed for renal cell carcinoma at our institute. A total of 143 patients underwent NSS with the traditional suturing technique (suture group) and 31 patients underwent a sutureless BioGlue sealing-only procedure (BioGlue group). We compared the two groups for clinical and tumor characteristics and surgical outcome. Results The patient and tumor characteristics were similar in both groups. The average maximal tumor diameter was 4.21 cm (range 2.2 to 7) for the suture group and 3.67 cm (range 2 to 6.8) for the BioGlue group. The use of BioGlue reduced the mean warm ischemic time by 8.8 minutes (17.2 versus 26 minutes, P = 0.002). The mean estimated blood loss was 45.1 mL in the BioGlue group and 111.7 mL in the suture group ( P = 0.001). Blood transfusion was required in 1 patient (3.2%) of the BioGlue group and 24 (17%) in the suture group ( P = 0.014). None of the patients treated with BioGlue developed urinary fistula compared with three (2%) in the suture group. Conclusions Albumin glutaraldehyde tissue adhesive (BioGlue) alone provided adequate hemostasis during NSS, significantly decreasing the blood loss and transfusion rate, as well as the renal ischemic and operative times. BioGlue was easy to use and safe for sealing the kidney during partial nephrectomy. Future prospective clinical trials are necessary to validate its role during renal surgery.

Editorial comment

The authors describe their experience from 1993 to 2005 with 174 NSSs. A total of 141 patients had traditional suturing techniques and 31 underwent a sutureless BioGlue technique. It is important to recognize that the authors did suture the collecting system even when they used BioGlue. The patients appeared to have less warm ischemia time and less blood loss in the BioGlue group. The 17% transfusion rate in the suture group seems high. The average tumor size was larger for the suture group at 4.2 cm compared with 3.6 cm for the BioGlue group. This “nonstatistical” difference in diameter might have translated into a possible difference in “tumor volume.” The authors concluded that BioGlue significantly decreases blood loss, the transfusion rate, and the operative time. Sutureless nephron-sparing surgery: Use of albumin glutaraldehyde tissue adhesive (BioGlue)UrologyVol. 67Issue 4PreviewTo determine the feasibility of using serum albumin glutaraldehyde tissue adhesive (BioGlue) to achieve hemostasis and prevent urine leakage during nephron-sparing surgery (NSS). Full-Text PDF