Prospective, randomized, controlled trial of a hemostatic sealant in children undergoing adenotonsillectomy.

OBJECTIVES: To evaluate the efficacy of Floseal as a hemostatic sealant compared to traditional electrocautery hemostasis after cold knife adenotonsillectomy. STUDY DESIGN: Prospective, randomized, controlled trial of 68 consecutive patients undergoing cold steel adenotonsillectomy. Patients were randomized to receive either Floseal (FS) or electrocautery (EC) for hemostasis. RESULTS: FS patients had shorter operative times than EC patients (16 min vs 31.2 min, P < 0.0001) and less blood loss (49.2 mL vs 70.8 mL, P < 0.05). Four EC patients were crossed over to Floseal when adequate hemostasis could not be achieved in the adenoid bed. No Floseal patients were crossed over. FS patients had significantly less pain on postoperative days two through 11 (P < 0.05) and less use of narcotic pain medications over the first 10 postoperative days (P < 0.05). FS patients also had a faster return to regular diet (5.5 days vs 7.9 days, P < 0.01) and activity (5.3 days vs 7.8 days, P < 0.01) as compared to the EC patients. There were no significant complications in either group. CONCLUSIONS: Floseal is safe and efficacious, and decreases postoperative morbidity as compared to electrocautery hemostasis after cold steel adenotonsillectomy. SIGNIFICANCE: This study demonstrates the safety and efficacy of Floseal as a hemostatic method in children undergoing adenotonsillectomy.

Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in patients with acute anterior epistaxis.

OBJECTIVES: 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. STUDY DESIGN: Institutional review board-approved, prospective, randomized, controlled, nonblinded, crossover clinical trial. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Asymptomatic near-total airway obstruction by a cylindrical tracheal foreign body.

OBJECTIVES/ HYPOTHESIS: The objective was to present the unique case of previously unreported asymptomatic cylindrical tracheal foreign body causing near-total airway obstruction. The asymptomatic nature of the case made diagnosis and management challenging. STUDY DESIGN: A retrospective case review at an urban health maintenance organization medical center. METHODS: A 3.5-year-old asymptomatic boy was incidentally discovered to have a metallic foreign body in his mid trachea on a screening scoliosis roentgenogram. He underwent rigid bronchoscopic retrieval the following day. RESULTS: The foreign body was found to be a corroded, 9 x 6-mm metallic cylinder with a narrowed luminal diameter of 2.0 mm. Intubation was maintained in the pediatric intensive care unit for 48 hours, and extubation was performed in the operating room under direct bronchoscopy. Mitomycin C was applied to a circumferential area of denuded tracheal mucosa. CONCLUSION: Tracheal foreign bodies are distinctly different clinical entities from bronchial foreign bodies. Asymptomatic bronchial foreign bodies are relatively common, but to the authors' knowledge, an asymptomatic tracheal foreign body had not been reported previously. Discussion focused on pathophysiology with reference to Poiseuille's law, diagnosis, and management of asymptomatic tracheal foreign bodies, including the possibility of elective bronchoscopic retrieval.

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

PROBLEM ADDRESSED: 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. METHODS AND MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.

Craniofacial and skull base trauma.

BACKGROUND: Traumatic craniofacial and skull base injuries require a multidisciplinary team approach. Trauma physicians must evaluate carefully, triage properly, and maintain a high index of suspicion to improve survival and enhance functional recovery. Frequently, craniofacial and skull base injuries are overlooked while treating more life-threatening injuries. Unnoticed complex craniofacial and skull base fractures, cerebrospinal fluid fistulae, and cranial nerve injuries can result in blindness, diplopia, deafness, facial paralysis, or meningitis. Early recognition of specific craniofacial and skull base injury patterns can lead to identification of associated injuries and allow for more rapid and appropriate management. CONCLUSION: Early detection and treatment of craniofacial and skull base traumatic injuries should lead to decreased morbidity and mortality. This review discusses the most common of these injuries, their possible complications, and treatment.

Endoscopically placed nasogastrojejunal feeding tubes: a safe route for enteral nutrition in patients with hepatic encephalopathy.

Patients with hepatic encephalopathy are at particular risk for aspiration when given oral or gastric feedings. An ideal strategy might combine distal enteral feeding with proximal gastric decompression, which is offered by a nasogastrojejunal (NGJ) feeding tube. One objective was to determine the efficacy and safety of endoscopically placed NGJ feeding tubes in patients with hepatic encephalopathy. Charts of patients who underwent NGJ tube placements between April 1997 and January 2000 were retrospectively reviewed. Two endoscopic techniques ("push" and "pull") were used. Eighteen patients (nine male and nine female) underwent 32 procedures. Twelve patients had undergone liver transplantation, four had decompensated cirrhosis, and two had fulminant hepatic failure. Twenty procedures used the push technique and 12 required the pull technique. The insertion time was shorter for the push technique compared with the pull technique (21.8 vs 39.6 min, P < 0.05). Enteral feedings were begun at an average of 5.2 hours after tube placement. The tubes remained in place for an average of 13.9 days. Complications related to the NGJ tubes included self-removal in eight, tube clogging in five, proximal migration in four, and intraduodenal migration of the gastric port in one. No aspiration episodes occurred. We conclude that NGJ feeding tubes may be placed endoscopically as a bedside procedure for patients with hepatic encephalopathy and provide a safe, efficacious, and rapid route for enteral nutrition in these patients.