Hemostatic Sealant Research Articles

Closing the tract of mini-percutaneous nephrolithotomy with gelatine matrix hemostatic sealant can replace nephrostomy tube placement

Objectives To investigate the outcomes using gelatine matrix hemostatic sealant to close the tract after mini-percutaneous nephrolithotomy (mini-PCNL), resulting in a tubeless setting. Methods After complete stone removal after mini-PCNL, a double- J ureteral stent was placed in an antegrade manner. After withdrawing the 17F Amplatz sheet from the collecting system under direct vision without irrigation, the urothelium collapsed. While retracting the sheet further, the gelatine matrix hemostatic sealant was injected. The skin incision was closed with glue. An ultrasound examination was performed on the first postoperative day to exclude the presence of urine extravasation. Results Mini-PCNL was performed in 11 patients, either as a primary, small stone, single-access procedure or as a second-look mini-PCNL because of small residual fragments after extracorporeal shock wave lithotripsy. The time to seal the mini-PCNL tract through the kidney parenchyma was 2 to 5 minutes. The mean operative time was 79 minutes. In the first 5 cases, intravenous urography was performed in addition to ultrasonography and demonstrated an intact collecting system. The subsequent procedures demonstrated similar findings, with the exception of 1 case of temporary paravasation. In all other patients, the catheter was removed on the first postoperative day. Ten of 11 patients had an uneventful follow-up until removal of the double- J catheter. No major complications were observed. Conclusions Closing the tract of the mini-PCNL with gelatine matrix hemostatic sealant is a safe and fast alternative and provides the option of discharging the patient in good condition without the commonly used nephrostomy tube.

Damage Control Management of Experimental Grade 5 Renal Injuries: Further Evaluation of FloSeal Gelatin Matrix

We developed a porcine grade 5 renal laceration damage control model to evaluate the hemostatic efficacy of FloSeal gelatin matrix (Baxter Healthcare, Corp., Deerfield, Ill). Ten commercial swine underwent celiotomy, contralateral nephrectomy, and cooling to 32 degrees C after a well-established hypothermia protocol to simulate a damage control scenario. Following prospective randomization, a complex grade 5 renal injury was uniformly produced on the remaining kidney. Control animals (group 1, n = 5) were treated with direct manual compression with a gelatin sponge. Experimental animals (group 2, n = 5) were treated by application of FloSeal gelatin matrix followed by direct compression with a gelatin sponge. Operative blood loss and efficacy of hemostasis were compared. Creatinine levels were obtained daily until postoperative day 7. Abdominal computed tomography was performed at 10 days. Use of FloSeal gelatin matrix hemostatic sealant resulted in significantly less mean blood loss than gelatin sponge bolster compression alone (202.4 mL vs. 540.4 mL, respectively, p = 0.016). Hemostasis was complete in 60% (three out of five) of experimental animals after 2 minutes, but was incomplete in all control animals. After an initial increase, serum creatinine approached baseline by postoperative day 7 in all animals. Axial imaging 10 days postoperatively revealed no evidence of significant delayed perirenal hemorrhage. FloSeal gelatin matrix performed well as a rapidly deployable, effective hemostatic agent in a hypothermic grade 5 renal injury damage control model. The absence of delayed bleeding and nephrotoxicity suggests a possible increased role for FloSeal in the treatment of devastating renal injuries in damage control surgery.

278. Therapeutic Activities of IL-12 Gene- Modified Macrophages Embedded in Gelatin Matrix Hemostatic Sealant (FloSeal®) in a Mouse Model of Residual Prostate Cancer

INTRODUCTION AND OBJECTIVE: Despite improved surgical techniques local tumor recurrence after radical prostatectomy is not uncommon. We previously reported that IL-12 gene modified macrophages (IL-12/M|[Phi]|) suppress tumor growth and metastasis in pre-clinical mouse models of prostate cancer (Satoh et al, Cancer Res., 63: 7853-7860, 2003).

Absorbable Cyanoacrylate as a Vascular Hemostatic Sealant: A Preliminary Trial

No absorbable cyanoacrylate tissue adhesive for safe internal surgical use is available. This prospective multicenter preliminary study was designed to evaluate the safety and effectiveness of an investigational absorbable cyanoacrylate (IAC) as an adjunct to hemostasis in arteriovenous shunt (AVS) procedures for dialysis access. Consenting adults (10) underwent placement of expanded polytetrafluoroethylene (ePTFE) upper extremity vascular grafts for AVS access using continuous 5-0 or 6-0 polypropylene after heparinization (> or =3000 units i.v.). Arterial anastomoses were evaluated after sealing with IAC followed by 120 seconds of polymerization time. After vascular clamp removal, the mean time to hemostasis was 9.1 +/- 28.8 seconds. Additionally, 90 per cent (9/10) and 100 per cent (10/10) achieved hemostasis by 1 and 5 minutes, respectively. No patients required further adjunctive hemostatic measures. Adverse event safety data analysis through 12 weeks revealed occlusion of graft or vessel in four patients and graft thrombosis in one patient, all thought unrelated to sealant use. Other unrelated adverse events (bleeding, death, deep venous thrombosis, edema, erythema, hematoma, infection, and rash) occurred in single patients. Thus, IAC could be a useful sealant for vascular procedures with a potentially satisfactory safety profile. Larger, randomized, multicenter, prospective trials to further evaluate the use of this material are indicated and appropriate.

Prospective, Randomized, Controlled Clinical Trial of a Novel Matrix Hemostatic Sealant in Patients with Acute Anterior Epistaxis

Floseal, a novel hemostatic sealant composed of collagen-derived particles and topical bovine-derived thrombin, is applied as a high-viscosity gel for hemostasis. This study is a prospective, randomized, controlled clinical trial of Floseal compared with nasal packing in patients with acute anterior epistaxis. Institutional review board-approved, prospective, randomized, controlled, nonblinded, crossover clinical trial. Seventy consecutive patients presenting with acute anterior epistaxis were randomized to receive Floseal or nasal packing for control. Patients were crossed over to the other technique after two unsuccessful attempts of the first technique. Patients were seen in the clinic within 7 days for follow-up. Ten-point visual analogue scales were used to rank effectiveness (1 = ineffective, 10 = effective), physician technical ease (1 = difficult, 10 = easy), physician satisfaction (1 = unsatisfied, 10 = satisfied), patient discomfort during hemostasis (0 = none, 9 = unbearable), patient discomfort at follow-up office visit, and patient satisfaction. Additional data included need for subspecialist consultation to control bleeding, rebleeding rates within 7 days, and rebleeding at follow-up visit. Floseal (n = 35) was judged by physicians to be more effective than nasal packing (n = 35) at initial control of anterior epistaxis (9.9 vs. 7.7, P < .001). Physicians found Floseal to be easier to use (9.4 vs. 3.2, P < .001) and were more satisfied with Floseal (9.6 vs. 3.5, P < .001). Patients experienced less discomfort with Floseal than with nasal packing both at initial control (1.4 vs. 8.9, P < .001) and at follow-up visit (0.0 vs. 8.5, P < .001), and Floseal patients were more satisfied overall (9.1 vs. 2.9, P < .001). Fewer in-person otolaryngology consultations were requested for Floseal patients (8.6% vs. 31.0%, P < .05). Floseal patients experienced fewer rebleeding rates within 7 days (14% vs. 40%, P < .05). Rebleeding rates at follow-up visit were higher in the nasal packing than the Floseal group at time of packing removal (63% vs. 0%, P < .001). Eight (23%) patients were crossed over from the nasal packing group to the Floseal group when nasal packing was ineffective. One Floseal patient (3%, P < .05) was crossed over into the nasal packing group. There were no complications in either group. Floseal hemostatic sealant is a better tolerated, more effective, safe, and easy alternative to nasal packing in patients presenting with acute anterior epistaxis. Future studies may wish to evaluate Floseal's use in posterior epistaxis.

Persistent Retropubic Bleeding Complicating SPARC Midurethral Sling

In Brief Background: The midurethral sling procedure has become popularized because of its less invasive technique. Few major intraoperative and postoperative complications have been reported. We report a case of persistent retropubic bleeding at the time of placement of a midurethral sling and conservative management using FloSeal (Baxter International Inc., Deerfield, IL). Case: A 56-year-old nonobese woman with stress urinary incontinence underwent a SPARC midurethral polypropylene mesh sling procedure. Intraoperatively, hemorrhage from the right retropubic space was encountered. Despite bimanual compression and other attempts to control the hemorrhage, brisk bleeding continued. FloSeal, a combination of collagen-derived particles and topical thrombin, was used, which immediately controlled the bleeding. The patient recovered uneventfully and required no further intervention. Conclusion: FloSeal, a hemostatic sealant, can be used to conservatively manage persistent retropubic bleeding encountered while performing a midurethral sling procedure. Use of a hemostatic sealant is a safe and conservative way to control persistent retropubic bleeding.

GELATIN MATRIX TREATMENT OF COMPLEX RENAL INJURIES IN A PORCINE MODEL

We developed a complex porcine renal laceration model at our laboratory to test the efficacy of an abbreviated, sutureless treatment regimen using FloSeal gelatin matrix hemostatic sealant (Baxter Healthcare Corp., Fremont, California). We evaluated the influence of preliminary renal arterial occlusion on hemostatic efficacy and assessed the risk of delayed hematoma or urinoma formation after treatment. A total of 21 commercial swine underwent celiotomy with creation of a complex upper pole renal injury using a 4 x 4 cm cruciate press instrument. The injury was uniformly produced at the caudal extent of the upper third portion of the left kidney. Subjects were prospectively randomized into 3 treatment groups. Experimental animals were treated with the application of gelatin matrix with (7 in group 1) or without (7 in group 2) preliminary renal arterial occlusion. Control subjects (7 in group 3) were treated with conventional horizontal mattress sutured gelatin sponge bolsters over the capsular injury. Operative blood loss, time to hemostasis and volume of gelatin matrix required for hemostasis were compared among the groups. Abdominal computerized tomography with intravenous contrast medium was performed in each animal 7 days postoperatively. Gelatin matrix use resulted in significantly less mean blood loss (80.7 and 99.0 ml in groups 1 and 2, respectively) vs conventional suture treatment (191.8 ml in group 3, p = 0.036). Time to hemostasis was similarly decreased (1.1, 2 to 2.5 and 5.8 minutes in groups 1 to 3, respectively, p = 0.009). Followup abdominal computerized tomography with contrast medium revealed no clinically significant perinephric fluid collections (greater than 2 cm). FloSeal gelatin matrix hemostatic sealant provided effective hemostasis after complex renal injury with and without preliminary vascular control. No delayed bleeding or clinically significant urinoma formation was noted. These findings suggest a possible increased role for FloSeal gelatin matrix in renal salvage surgery.

A cautionary note regarding long-term sequelae of biologic glue

Postoperative hemorrhage remains a significant cause of mortality and morbidity after repair of acute aortic dissection. Accordingly, there has been great interest in the development and application of biologic hemostatic tissue sealants for use during this and other aortic surgical procedures. Among these agents, BioGlue (Cryolife, Inc, Kennesaw, Ga) appears remarkably effective and has rapidly gained wide acceptance. However, because it is composed of 45% (wt/vol) purified bovine albumin and 10% (wt/vol) glutaraldehyde in a 4:1 ratio, we have been concerned that it might not be completely innocuous. We have recently encountered a case of late anastomotic pseudoaneurysm potentially related to the use of BioGlue.

What Happens to Hemostatic Agents in Contact with Urine? An in Vitro Study

As the indications for topical hemostatic agents increase in urology, the question arises: what happens to these agents when they enter the urinary collecting system? To answer this question, we performed a series of in-vitro experiments mixing three hemostatic agents with normal and sanguineous urine. Four commercially available topical hemostatic products: oxidized regenerated cellulose (Surgicel; Ethicon, Somerville, NJ), fibrin sealant (Tisseel VH Kit; Baxter Health Care Corporation, Irvine, CA), gelatin matrix hemostatic sealant (FloSeal; Baxter Health Care), and polyethylene glycol (CoSeal; Cohesion Technologies, Palo Alto, CA) were studied. Human urine (10 mL) was added to samples of each substance; this was done in triplicate. The 12 sample tubes were then capped and placed on a tube shaker at slow speed and 37 degrees C. Observations regarding consistency of the material were made at 6, 12, 24, 48, 72, 96, and 120 hours (5 days). Gelatin matrix hemostatic sealant was further tested in urine with various amounts of blood or blood clot; observations were again recorded out to 5 days. Surgicel maintained its solid form when it initially came in contact with urine, but over a period of 5 days, it transformed into a mucoid substance with visible free-floating fibers. It did not dissolve completely in urine within 5 days. Gelatin matrix was immediately transformed by urine into a fine colloidal suspension that did not change over the 5 days of the study. Fibrin glue, after mixing of the two components (fibrinogen and thrombin) directly in the urine, and polyethylene glycol immediately formed a solid clot at the bottom of the test tube on contact with the urine. When the mixture of fibrin sealant was allowed to form for 15 minutes and then added to urine, it again maintained a solid form. After 72 hours, the fibrin glue became a semisolid gelatinous plug. On analysis at 5 days, the fibrin sealant clot had transformed into a cohesive mucoid gel, and the polyethylene glycol clot had not changed. The gelatin matrix hemostatic sealant, when in contact with blood or blood clot, appeared to either become part of a clot or to remain in a colloidal suspension. At 5 days, all clots had dissolved to fine particulate suspensions, and the gelatin matrix appeared as a fine suspension. Fibrin glue and oxidized regenerated cellulose maintain a solid form when initially placed in direct contact with urine and then assume a semisolid gelatinous state, which is still present at 5 days. Polyethylene glycol forms a solid clot initially and does not change after 5 days. Only hemostatic gelatin matrix remained as a fine particulate suspension in both normal and sanguineous urine. The implications of these findings with regard to sealing the renal parenchyma or small violations of the collecting system after percutaneous or laparoscopic surgery await in-vivo testing.

Improved hemostasis during laparoscopic partial nephrectomy using gelatin matrix thrombin sealant

Objectives To evaluate whether using a biologic hemostatic sealant facilitates hemostasis during laparoscopic partial nephrectomy. Secure and durable parenchymal hemostasis is a critical requirement during laparoscopic partial nephrectomy. Methods Since September 1999, laparoscopic partial nephrectomy has been performed in more than 300 patients by a single surgeon, duplicating open surgical principles. Recently, from patient 225 onward, we modified our technique by incorporating topical application of a gelatin matrix thrombin sealant (FloSeal) to cover the partial nephrectomy bed before sutured renorrhaphy over a Surgicel bolster. The impact of FloSeal on reducing hemorrhagic complications was evaluated by comparing two sequential groups of patients: group 1 consisted of 68 patients in whom FloSeal was not used (patients 156 to 224) and group 2 consisted of 63 patients in whom it was used (patients 225 to 288). Results Groups 1 (no FloSeal) and 2 (FloSeal) were comparable in tumor size, number of central tumors, and performance of pelvicaliceal suture repair (84% versus 92%; P = 0.16). Intraoperative variables were also comparable in terms of mean warm ischemia time (36.1 versus 37.2 minutes; P = 0.55), blood loss (150 versus 106 mL; P = 0.36), operative time, and hospital stay. However, the FloSeal group had significantly fewer overall complications (37% versus 16%; P = 0.008) and tended toward a lower rate of hemorrhagic complications (12% versus 3%), although this did not achieve statistical significance ( P = 0.08). Conclusions The results of this study have shown that adjunctive use of gelatin matrix thrombin sealant substantially enhances parenchymal hemostasis and has decreased our procedural and hemorrhagic complications to levels comparable with contemporary open partial nephrectomy series. This gelatin matrix-thrombin tissue sealant is now a routine part of laparoscopic partial nephrectomy at our institution.

Hand-Assisted Laparoscopic Partial Nephrectomy in the Porcine Model Using Gelatin Matrix Hemostatic Sealant Without Hilar Occlusion

Gelatin matrix hemostatic sealant (GMHS) has been used for hemostasis during partial nephrectomy with hilar clamping. The objective of this study was to determine the ability of GMHS to achieve hemostasis without hilar clamping in the porcine model. In this feasibility study, eight farm pigs underwent a left-hand-assisted laparoscopic partial nephrectomy (HALPN). The lower fourth of the kidney was removed with cold scissors, and GMHS was applied laparoscopically. Samples were collected for measurement of serum hemoglobin (Hb) and creatinine (Cr) prior to surgery and at 4 and 30 days after HALPN. The kidneys were harvested at 30 days, and retrograde pyelograms and pathologic analysis were performed. Application of GMHS achieved complete hemostasis in all eight animals. The mean estimated blood loss was 40 mL, and the operating time was short (mean 92.5 minutes). In three kidneys, a significant collecting system opening was noted but not repaired. At harvest, there were no hematomas, infections, or urine leaks in any animals. In one animal, a 2-cm contained fluid collection was identified. There was no difference in the preoperative and harvest Hb (9.63 v 9.21 g/dL; P = 0.49), but there was a slight increase in Cr (1.21 v 1.46 mg/dL; P = 0.01) possibly because of the decreased renal mass after partial nephrectomy. Even without hilar occlusion, GMHS was 100% safe and effective in controlling bleeding after HALPN in the porcine model. Avoidance of hilar occlusion may reduce the risk associated with warm renal ischemia and the extra dissection required to isolate the hilum in preparation for clamping.

Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in children undergoing adenoidectomy

Floseal is a novel matrix hemostatic sealant composed of collagen-derived particles and topical bovine-derived thrombin. It is applied as a high-viscosity gel for hemostasis and has been clinically proven to control bleeding. This study is a prospective, randomized, controlled clinical trial of Floseal sealant compared to traditional suction cautery hemostasis in children undergoing adenoidectomy. Seventy patients (mean age 7.0 yrs, 45.7% male) with obstructive sleep apnea underwent traditional cold steel adenoidectomy with an adenoid curette and were then randomized to receive the hemostatic sealant (Floseal) or cautery to obtain hemostasis. Patients were crossed over to the other hemostatic technique if hemostasis was not achieved after more than 100 mL of blood loss or 15 minutes elapsed time. Objective data collected included time to hemostasis and blood loss during hemostasis. Visual analog scales (VAS) were used to record subjective data by the operating surgeon including bleeding following adenoid pack removal (0 = none, 3 = brisk) and ease of operation (1 = extremely easy, 6 = extremely difficult). Parents recorded diet on a journal and were contacted by phone at postoperative day 7 and questioned with regard to return to regular diet and use of narcotics. Compared to patients in the cautery group (n = 35), Floseal patients (n = 35) had significantly shorter times to hemostasis (0.6 +/- 1.3 minutes vs 9.5 +/- 5.4 minutes [mean +/- SD], P < 0.001), less blood loss (2.5 +/- 9.2 mL vs 29.4 +/- 27.1 mL, P < 0.001), less subjective bleeding (0.0 +/- 0.6 vs 2.0 +/- 0.7, [median 4-point VAS +/- SD], P < 0.001), and subjectively easier operations (2.6 +/- 1.0 vs 5.2 +/- 1.0 [mean 6-point VAS +/- SD], P < 0.001). Furthermore, Floseal patients returned to regular diet earlier (2.7 +/- 0.7 vs 4.1 +/- 0.5 days [mean +/- SD], P < 0.001) and had less use of narcotics at 7 days postoperatively (40% vs 69%, P < 0.05). Lastly, three patients in the cautery group were crossed over to the Floseal group, but no Floseal subjects were crossed over to the cautery group. The retail cost of Floseal is US 85 dollars. Operating room costs are estimated at US 12 dollars/minute. Reducing the operative length by 8.9 minutes on average produces a cost savings of US 106.80 dollars per operation. There were no complications in either experimental group including postoperative hemorrhage, hospitalization, blood transfusion, or aspiration. Floseal matrix hemostatic sealant is a safe, efficacious, easy, and cost-effective technique for obtaining hemostasis in children undergoing adenoidectomy. Limitations of the study include the fact that it is nonblinded, which does allow for some bias in the subjective data recorded. However, utilizing 4 different operating surgeons, 3 of whom were not affiliated with the study, minimized this. CLINICAL SIGNIFICANCE OF STUDY: This study demonstrates the safety and efficacy of a novel hemostatic sealant in children undergoing adenoidectomy. Floseal matrix hemostatic sealant can be used as a first-line hemostatic agent, and it is a good tool in the armamentarium of otolaryngologists who encounter significant bleeding following adenoidectomy.

Floseal gelatin matrix treatment of complex renal injuries in a porcine model

Abstract Introduction: We developed a complex porcine renal laceration model and tested the efficacy of a treatment regimen based on FLOSEAL gelatin matrix hemostatic sealant (Baxter Healthcare Corp, Fremont, CA). We evaluated the influence of preliminary renal vascular occlusion on hemostatic efficacy and the risk of urinoma formation after treatment. Methods: A total of 19 commercial swine a complex upper pole renal laceration via a 2 × 2 cm cruciate press instrument. The injury was uniformly produced on the left kidney. Subjects were randomized into 3 treatment groups. Experimental animals were treated with FLOSEAL gelatin matrix with (Group 1, n = 7) or without (Group 2, n = 6) preliminary renal vascular occlusion. Control subjects (Group 3, n = 6) were treated by a conventional sutured repair. Operative blood loss and time to hemostasis was compared between the groups. Abdominal CT scan was performed on each animal at 7 days. Results: Use of FLOSEAL gelatin matrix resulted in significantly less mean blood loss (Group 1—80.7 cc, Group 2—99.0 cc) versus conventional suture treatment (Group 3—191.8 cc, p = 0.036). Time to hemostasis was similarly reduced (Group 1—1.1 min, Group 2—2.5 min, Group 3—5.8 min, p = 0.009). Follow up CT scan revealed no evidence of significant perirenal fluid collections. Conclusions: FLOSEAL gelatin matrix hemostatic sealant provided effective hemostatic treatment after complex renal injury, both with and without preliminary vascular control. No delayed bleeding or urinoma formation was noted.

New application method of fibrin glue for more effective hemostasis in cardiovascular surgery: rub-and-spray method.

This study was performed to determine the most effective application method of fibrin glue as a hemostatic sealant in cardiovascular surgery. The effectiveness of fibrin glue as a hemostatic sealant was compared between 4 methods of application; dripping, spray, spray-and-rub, and rub-and-spray methods. I. In vitro 'burst pressure' was measured in fibrin glue-sealed needle holes of polytetrafluoroethylene (PTFE) graft in each method. II. Fibrin glue-sealed needle holes of PTFE grafts implanted between an abdominal aorta and iliac arteries of a pig was microscopically examined to determine the effectiveness of fibrin glue sealing in each method. I. Burst pressures were 24.1 +/- 7.9 mmHg in dripping, 98.1 +/- 35.4 mmHg in spray, 140.8 +/- 34.8 mmHg in spray-and-rub and 206.7 +/- 26.1 mmHg in rub-and-spray method (statistically significant, p<0.01, between each method). II. Microscopically, no fibrin glue remained on the external surface of the PTFE graft in the dripping method. Fibrin glue plugged 1/3 or 2/3 of the depth of the needle hole in the spray method and spray-and-rub methods respectively. In the rub-and-spray method, fibrin glue covered the needle hole over the external surface of the graft, completely plugged the needle hole to its whole depth, leaving no spaces where blood came into the needle hole. The rub-and-spray method of fibrin glue application revealed the strongest sealing and hemostatic effects, and can be safely and effectively used for hemostasis in cardiovascular surgery that requires systemic heparinization or prolonged extracorporeal circulation.

Prospective, randomized trial of a novel hemostatic sealant in adenoidectomy

Problem: Floseal is a novel matrix hemostatic sealant composed of collagen-derived particles and topical bovine-derived thrombin. It is applied as a high viscosity gel for hemostasis. This study is a prospective, randomized, controlled clinical trial of Floseal sealant compared to traditional suction cautery hemostasis in children undergoing adenoidectomy. Methods: Seventy patients (mean age, 7.0 years; 45.7% male) with obstructive sleep apnea underwent traditional cold steel adenoidectomy and were then randomized to receive Floseal or cautery to obtain hemostasis. Patients were crossed over to the other technique after more than 100 mL blood loss or 15 minutes had elapsed. Objective data collected included time to hemostasis and blood loss during hemostasis. Visual analog scales (VAS) were used to record subjective data by the operating surgeon including bleeding following pack removal (0 = none, 4 = brisk) and ease of operation (1 = difficult, 6 = easy). Parents were contacted by phone at day 7 and questioned with regard to return to diet and narcotic usage. Results: Floseal patients (n = 35) had significantly shorter times to hemostasis (0.6 minutes vs 9.3; P < 0.001), less blood loss (2.5 vs 29.5 mL; P < 0.001), less subjective bleeding (0.0 vs 2.0; P < 0.001), and subjectively easier operations (2.6 vs 5.2 [mean 6-point VAS], P < 0.001). Furthermore, Floseal patients returned to regular diet earlier (2.7 vs 4.1 days, P < 0.001) and had less use of narcotics at 7 days (43% vs 69%). Finally, 3 patients in the cautery group (n = 35) were crossed over to the Floseal group. Floseal resulted in a cost savings of $104/operation. Conclusion: Floseal sealant is a safe, effective, easy, and cost-conscious technique for obtaining hemostasis in children undergoing adenoidectomy. Significance: Floseal sealant is a good tool in the armamentarium of surgeons who encounter heavy bleeding during adenoidectomy. Support: None reported.

Sealing Percutaneous Nephrolithotomy Tracts With Gelatin Matrix Hemostatic Sealant: Initial Clinical Use

Tubeless percutaneous nephrolithotomy (PCNL) has been performed at several centers with good success. However, these cases have been carefully selected with regard to short duration and smaller stone burden to prevent complications associated with the loss of access to the collecting system. We describe the use of gelatin matrix hemostatic sealant (FloSeal Baxter Medical, Fremont, California) as an adjunct to tubeless percutaneous nephrolithotomy to help preclude bleeding complications. Two patients were treated with PCNL through a single nephrostomy tract. At the satisfactory conclusion of the cases the tract was occluded retrograde with an occlusion balloon catheter and gelatin matrix hemostatic sealant was injected down the nephrostomy tract. An indwelling stent and bladder catheter were placed following which all guidewires were removed and skin sutures were placed. The operative times were 75 and 180 minutes, respectively. Both patients had stable postoperative hemoglobin and no evidence of bleeding or obstruction on postoperative computerized tomography. Injection of gelatin matrix hemostatic sealant into the nephrostomy tract may be of value in preventing bleeding after PCNL. In this pilot experience it provided immediate and effective hemostasis.

FloSeal Matrix: new generation topical hemostatic sealant.

Application of direct pressure at a bleeding site frequently provides either complete control of bleeding or adequate control to enable more definitive measures to be taken. However, this method of controlling bleeding may not be sufficient when the source of bleeding is hard to identify, as may be the case for diffuse venous bleeding, or when an inherent coagulopathy is present. Intraoperative coagulopathy, which can be induced by a variety of factors including hemodilution1-4 and hypothermia,1,5,6 may be treated with active hemostatic agents. Hemostasis is also compromised due to the presence of antiplatelet and anticoagulation agents, especially in patients undergoing cardiac or vascular surgery, as well as from changes associated with cardiopulmonary bypass.7-10 In such cases topical hemostatic agents become useful adjuncts to the conventional methods of achieving hemostasis. A comprehensive list of currently available topical hemostatic agents, together with their key attributes is presented in Table 1. The present article discusses the properties and uses of one such topical hemostatic agent, FloSealTM Matrix Hemostatic Sealant (FloSeal), which has proved its utility in addressing problematic bleeding during surgery in a variety of procedures and anatomical sites.11-15 FloSeal represents the new generation of topical hemostatic agents made from collagen or gelatin. FloSeal is prepared by mixing together a proprietary gelatin matrix and topical thrombin im-

The effect of 2 sealants (FloSeal and Tisseel) on fasciocutaneous flap revascularization.

Fasciocutaneous tissue transfer is one of the most common procedures performed in head and neck reconstructive surgery. These composite tissues can be transferred as either a free flap or a pedicled flap. Free tissue transfer has become the reconstructive modality of choice following head and neck oncologic ablation. Synthetic tissue adhesives and hemostatic agents are rapidly gaining popularity in reconstructive surgery. Their ability to decrease bleeding and promote flap sealing and healing has led to a proliferation in their use. To our knowledge, the short-term effect of these substances on healing, as measured by flap revascularization, has not been systematically investigated. Fifty-six male Sprague-Dawley rats were divided into 3 groups: a control group, a matrix hemostatic sealant (FloSeal) group, and a 2-component fibrin sealant (Tisseel) group. In each group, the rats had a 3 x 6-cm fasciocutaneous flap based on the inferior epigastric artery elevated and exposed to 2 hours of primary ischemia. In the control group, 0.2 mL of isotonic sodium chloride solution was placed between the flap and its bed, while in the experimental groups, 0.5 mL of FloSeal or 0.2 mL of Tisseel was applied to the wound before closure. Each group was then divided into groups of 5 rats. Each of these groups then had their pedicle divided on postischemic day 4, 5, 6, or 7. The percentage survival of the flap was measured 7 days after pedicle ligation. There was no statistical difference in flap survival of rats treated with isotonic sodium chloride solution, Tisseel, or FloSeal. Ligation of the flap pedicle on days 4, 5, 6, or 7 did not result in any difference in flap survival among the 3 groups. The FloSeal and Tisseel demonstrate no short-term detrimental effect on flap survival nor do they seem to affect revascularization in a fasciocutaneous free flap model.

Use of FloSeal Hemostatic Sealant in Transsphenoidal Pituitary Surgery: Technical Note

Bleeding during transsphenoidal pituitary surgery can lead to a variety of operative difficulties. When the endonasal transsphenoidal approach is used, even mild intraoperative hemorrhage can lessen visibility in the confined operative field of view. This technical note describes the use of a hemostatic agent we have found of benefit in obtaining prompt hemostasis during this operation. Operative records were reviewed for an 18-month period for all patients who underwent transsphenoidal surgery since we began using FloSeal hemostatic sealant in January 2000. During the study period, 293 transsphenoidal operations were performed for pituitary lesions. Of these, 20 procedures involved vigorous or persistent bleeding. When the standard techniques for hemostasis failed or were inadequate, FloSeal, a sterile mixture of a gelatin matrix and thrombin component mixed at the time of use, was applied to the site of hemorrhage by use of a 14-gauge angiocatheter to reach the sella. We observed complete hemostasis immediately on application of FloSeal in all cases except one, which required a second application. Hemostasis was obtained immediately after the second application. No operations were aborted during this period as a consequence of undue bleeding. We detail the method in which we use FloSeal in transsphenoidal surgery and report our impression of its effectiveness. FloSeal has been demonstrated to be safe and biocompatible as compared with hemostatic agents currently in use.

Use of FloSeal Hemostatic Sealant in Transsphenoidal Pituitary Surgery: Technical Note

Bleeding during transsphenoidal pituitary surgery can lead to a variety of operative difficulties. When the endonasal transsphenoidal approach is used, even mild intraoperative hemorrhage can lessen visibility in the confined operative field of view. This technical note describes the use of a hemostatic agent we have found of benefit in obtaining prompt hemostasis during this operation.Operative records were reviewed for an 18-month period for all patients who underwent transsphenoidal surgery since we began using FloSeal hemostatic sealant in January 2000.During the study period, 293 transsphenoidal operations were performed for pituitary lesions. Of these, 20 procedures involved vigorous or persistent bleeding. When the standard techniques for hemostasis failed or were inadequate, FloSeal, a sterile mixture of a gelatin matrix and thrombin component mixed at the time of use, was applied to the site of hemorrhage by use of a 14-gauge angiocatheter to reach the sella. We observed complete hemostasis immediately on application of FloSeal in all cases except one, which required a second application. Hemostasis was obtained immediately after the second application. No operations were aborted during this period as a consequence of undue bleeding.We detail the method in which we use FloSeal in transsphenoidal surgery and report our impression of its effectiveness. FloSeal has been demonstrated to be safe and biocompatible as compared with hemostatic agents currently in use.