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PubMed1999

Formulation and in vivo evaluation of ocular insert containing phenylephrine and tropicamide.

A Gelfoam based ocular device containing 1.7 mg of phenylephrine and 0.6 mg of tropicamide was formulated and evaluated for pupillary dilation in rabbits. The manufacturing procedure is fairly simple and the required excipients are inexpensive. The in vivo results show that the mydriatic response produced by the proposed device is larger and longer lasting than that produced by eyedrops with an equivalent amount of phenylephrine and tropicamide. The results reported in this study, along with those of previous studies, imply that Gelfoam(R) is a versatile drug carrier for either local or systemic drug delivery via the ophthalmic route.

Animals↗
PubMed1998

Round window administration of gentamicin: a new method for the study of ototoxicity of cochlear hair cells.

Damage to inner ear sensory hair cells after systemic administration of ototoxic drugs has been documented in humans and animals. Birds have the ability to regenerate new hair cells to replace those damaged by drugs or noise. Unfortunately, the systemic administration of gentamicin damages both ears in a variable fashion with potentially confounding systemic drug effects. We developed a method of direct application of gentamicin to one cochlea of hatchling chickens, allowing the other ear to serve as a within-animal control. We tested variables including the vehicle for application, location of application, dosage, and duration of gentamicin exposure. After 5 or 28 days survival, the percent length damage to the cochlea and regeneration of hair cells was evaluated using scanning electron microscopy. Controls consisted of the opposite unexposed cochlea and additional animals which received saline instead of gentamicin. Excellent damage was achieved using gentamicin-soaked Gelfoam pledgets applied to the round window membrane. The percent length damage could be varied from 15 to 100% by changing the dosage of gentamicin, with exposures as short as 30 min. No damage was observed in control animals. Regeneration of hair cells was observed in both the base and apex by 28 days survival.

Animals↗
PubMed1998

Effects of columella removal on inner ear morphology in the chick.

We are currently removing the single middle ear bone (columella) in the domestic chick to introduce chemical agents directly into the inner ear. Since we are interested in the effect of these agents on neural structures within the avian basilar papilla (BP), we are concerned about any subtle changes that might result from the surgical procedure of columella removal alone. The purpose of this study was to use light and transmission electron microscopy to analyze morphological changes in the inner ear after columella removal. Fifteen-day-old chicks underwent a unilateral, bilateral or a sham removal of the columella. After columella removal, the oval window was either plugged with Gelfoam or Kimwipe (standard accepted procedure to prevent possible perilymph leak) or left uncovered. After a 5-day survival period, morphological changes were observed in the tegmentum vasculosum (TV) of all ears receiving a columella removal as compared to unoperated ears. Further, ears with Gelfoam plugging the oval window also had damage to the hair cells and support cells of the basilar papilla. In contrast, there were no observable differences in either auditory afferent or efferent nerve terminals on hair cells in the BP from any ears that had the columella removed compared to those from unoperated ears. These results suggest that columella removal alone may produce morphological changes to the TV within 5 days of surgery but not to structures within the BP. On the other hand, columella removal with a Gelfoam plug results in damage not only to the TV but also to cells within the basilar papilla during this same survival time. Despite damage to other structures within the inner ear, cochlear efferent and afferent terminals on surviving hair cells were unaffected by columella removal with or without plugging.

Animals↗
PubMed2003

Improved outcomes with early vocal fold medialization for vocal fold paralysis after thoracic surgery.

OBJECTIVE: To determine the clinical impact of early versus late surgical therapy for new onset unilateral vocal cord paralysis (UVCP) after thoracic surgery. STUDY DESIGN: Patients diagnosed with new onset UVCP after esophagectomy, pneumonectomy or pulmonary lobectomy were reviewed to determine the incidence of pneumonia, need for postoperative bronchoscopy and length of stay (LOS). Comparisons were made between patients undergoing early (< or = 4 days after thoracic procedure) versus late rehabilitation (> or = 5 days after thoracic procedure) of their UVCP with vocal cord medialization. RESULTS: Some 86 patients (27 esophagectomies, 43 pneumonectomies and 16 lobectomies) with new onset UVCP were examined. A total of 32 patients (37.2%) underwent early vocal cord medialization and 54 (62.8%) underwent late repair. The pneumonia rate for patients undergoing early vocal cord medialization (6.3%) was significantly lower than the rate for vocal cord medialization (37.0%, P=0.001, chi(2)). Early medialization patients required fewer postoperative bronchoscopies (mean number of bronchoscopies, 0.26) than late medialization patients (mean bronchoscopies, 0.94, P=0.013). The median LOS was significantly decreased for early versus late medialization patients in both pneumonectomy (reduction in LOS of 8 days) and lobectomy groups (reduction in LOS of 7 days). CONCLUSIONS: Early vocal cord medialization decreases the pneumonia rate, the requirement for postoperative bronchoscopies and the LOS for patients suffering from new onset UVCP after thoracic surgery. SIGNIFICANCE: Consideration should be given to early medialization for new onset UVCP when medically sound.

Bronchoscopy↗
PubMed1999

A simple HPLC method using a microbore column for the analysis of doxorubicin.

Doxorubicin is one of the most potent anti-tumor agents generally used in the treatment of bone cancer. A simple and sensitive HPLC method was developed and validated for the assay of doxorubicin. The method used a C18 Luna microbore column (50 x 1 mm) with a fluorescent detector (505 nm Ex. and 550 nm Em.). The mobile phase consisted of water-acetonitrile-acetic acid (80:19:1, v/v/v, pH 3.0) and the flow rate was 0.1 ml min(-1). Daunomycin was used as the internal standard. This isocratic system required a 10-min run-time, giving a detection limit of 0.02 ng (0.035 pmol per injection). Standard curves were linear over the concentration range of 0.01-0.1 microg ml(-1). Relative standard deviations (R.S.D.) for the within-day, day-to-day precision, and the accuracy measurement for the assay were less than 4.0, 3.2, and 4.1%, respectively. This HPLC method was used to study the in vitro release characteristics of doxorubicin from implantable drug delivery system.

Acetic Acid↗
PubMed2003

Prospective randomized multicenter trial of fibrin sealant versus thrombin-soaked gelatin sponge for suture- or needle-hole bleeding from polytetrafluoroethylene femoral artery grafts.

OBJECTIVE: We evaluated the safety and efficacy of the fibrin sealant Beriplast P (FSBP; Aventis-Behring) for hemostasis in anastomosis of polytetrafluoroethylene (PTFE) grafts to the femoral artery. METHODS: In a single-blinded randomized prospective multicenter clinical trial, FSBP was compared with thrombin-soaked gelatin sponge (TSG) for efficacy in stopping bleeding from needle or suture holes in PTFE grafts after anastomosis to the femoral artery. Patients were randomized to FSBP application, which requires a 3-minute period of arterial clamping to enable the fibrin clot to adhere, or to TSG application, which requires pressure from gauze sponges, after completion of the femoral artery anastomosis. The primary end point was hemostasis, defined as absence of any detectable bleeding as judged by the operating surgeon, by 4 minutes after randomization. Secondary end points included actual time from randomization to hemostasis, time to beginning of wound closure, measured blood loss (weighed sponges), incidence of recurrent bleeding, stay in the intensive care unit, and hospital length of stay. Data were analyzed with the intention-to-treat method. RESULTS: Two hundred thirty-five subjects were enrolled at 26 medical centers; 34 were subsequently excluded from the study. Of the 201 randomized subjects, 100 received FSBP and 99 received TSG. Hemostasis was achieved by 4 minutes in 64 subjects (63%) in the FSBP group and 40 subjects (40%) in the TSG group (P =.0018). In the FSBP group, compared with the TSG group, time to hemostasis was shorter (median, 4.0 minutes; 95% confidence interval [CI], 3.8-4.18 minutes vs median, 5.6 minutes, 95% CI, 4.5-7.0; P =.008), blood loss was less (mean, 4.0 +/- 29.7 g vs mean, 15.6 +/- 28.4 g; P <.0001), and time to wound closure was shorter (median, 15 minutes; 95% CI, 10.47-18.67 minutes vs median, 22.8 minutes; 95% CI, 18.67-30.67; P =.005). There were no differences in recurrent bleeding or any other adverse events. There was no significant difference in ICU stay, but hospital length of stay was shorter in the FSBP group compared with the TSG group, and the difference approached significance (median, 6.5 days; 95% CI, 5.00-7.00 days vs median, 7.0 days; 95% CI,. 6.00-8.00 days; P =.0565). CONCLUSION: FSBP is more effective than TSG for achieving hemostasis of needle or suture hole bleeding from PTFE femoral artery grafts.

Aged↗
PubMed1999

Hemostatic efficacy of fibrin sealant (human) on expanded poly-tetrafluoroethylene carotid patch angioplasty: a randomized clinical trial.

PURPOSE: The efficacy of solvent-detergent-treated fibrin sealant (human [FSH]) for controlling anastomotic bleeding from expanded polytetrafluoroethylene (ePTFE) patch angioplasty during carotid endarterectomy was evaluated, and FSH was compared with thrombin-soaked gelatin sponge (Gelfoam; TSG). METHODS: The study was of a randomized, open-label, single-site, single-treatment, parallel design that took place in a referral center with hospitalized patients. Forty-seven adult patients (33 men, 14 women) underwent elective carotid endarterectomy. Patients were randomized to receive either FSH (N = 24) or TSG (N = 23). FSH was obtained as an investigational new drug. FSH was applied as a liquid by means of a dual-syringe technique. Heparin anticoagulation, patch thickness, and suture type were standardized. Two different needle sizes were used (CV-6, PT-13: N = 21 [FSH: N = 10, TSG: N = 11]; CV-6, PT-9: N = 26 [FSH: N = 14, TSG: N = 13]). The FSH or TSG was applied to the ePTFE patch, and then blood flow was restored through the carotid artery. Degree of anticoagulation was assessed by anti-factor Xa activity. The time from restoration of carotid blood flow until achieving hemostasis was recorded. The blood loss from patch suture hole bleeding was measured. Completion intraoperative duplex ultrasound scanning was performed in all cases. Heparin was reversed with protamine sulfate. The primary end point was successful hemostasis within 15 minutes of restoration of carotid blood flow. The secondary end points were the amount of blood loss caused by suture line bleeding and the time to achieve hemostasis. RESULTS: There was no difference in the number of patients with complete hemostasis at 15 minutes (TSG, 13 of 23; FSH, 12 of 24; P =.77). The measured blood loss was 99.0 +/- 119.9 (SD) mL for TSG, and 105.0 +/- 107.9 mL for FSH (P =.86). The time to hemostasis was the same for both groups (TSG, 16.5 +/- 16.5 minutes; FSH, 16.6 +/- 14.2 minutes; P =.97). Within both treatment groups, the use of larger needles (PT-13) was associated with greater blood loss (FSH, 169.7 +/- 124.2 mL; TSG, 172.7 +/- 151.5 mL) than was the use of smaller needles (PT-9; FSH, 58.8 +/- 66.3 mL; TSG, 34.1 +/- 25.6 mL; P =.036, P =.001, respectively). There were no postoperative strokes or bleeding complications in either group. No abnormalities were shown in either group by means of completion carotid duplex ultrasound scanning. CONCLUSION: FSH was equivalent, but not superior to, TSG in achieving hemostasis during carotid endarterectomy performed with ePTFE patch angioplasty. Adhesion properties of FSH to ePTFE are possibly different than those to native tissue and warrant additional investigation.

Adult↗
PubMed1995

G. Paul Moore Lecture--1993. New voices for old.

Otolaryngology and voice science have entered the era of "phonosurgery." Several techniques allow voice professionals to intervene to restore or modify the voice in patients with immobile vocal folds and other problems related to voice production. It is necessary and appropriate that physicians and speech and language pathologists critically examine what has been accomplished and what may yet be possible for further voice improvement.

Collagen↗
PubMed1987

Fibrinolytic alveolitis and its prevention.

This study aimed at testing the clinical efficacy of a topical prevention of FA, the sample comprising 300 cases of extractions. A sponge was inserted in the socket of each of them, dividing the sample into 3 equal groups: group A (gelatine), group B (gelatine + Solcoseryl) and group C (gelatine + Solcoseryl + propyl-hydroxy-benzoic-acid). The global incidence of FA was a comparatively high, 7.6%, which could be related to the pool of patients included in the study as to the presence of teeth and techniques more prone to complications. No specific clinical characteristic has been isolated (distribution within sex, age, teeth, etc.) which could contradict data collected from other authors. The incidence was lower in the groups B (3%) and C (7%) as compared to group A (13%), but only sponges of group B demonstrated a clinical and statistical efficacy, according to the high number of lower third molar extractions. In contrast, the addition of Solcoseryl proves efficient and does not delay healing, according to previous histological studies. This last characteristic has to be confirmed in the experimental conditions described in our study, as has its mode of action. The ultimate mechanism of FA has still, in our opinion, to be better defined well before the restatement of a topical prevention of FA.

Actihaemyl↗
PubMed1988

Effect of a topical drug combination on the early healing of extraction sockets in the vervet monkey.

An animal trial was undertaken in 9 vervet monkeys to test the effect of a medicament combination on extraction socket healing. All 4 third molar teeth were extracted and 2 of the sockets in each animal were packed with Gelfoam sponge impregnated with a medicament containing a local anaesthetic, antiseptic, 2 potent antifibrinolytic agents and metronidazole. The remaining 2 sockets acted as controls: one of the sockets was packed with Gelfoam sponge alone and the other allowed to heal spontaneously with no implant. The healing of these sockets was evaluated histometrically in 4-, 6- and 8-day specimens, and from the results it was concluded that sockets containing the medicament compound showed enhanced early socket healing.

Administration, Topical↗
PubMed2003

The use of polylactic acid/polyglycolic acid copolymer and gelatin sponge complex containing human recombinant bone morphogenetic protein-2 following condylectomy in rabbits.

PURPOSE: To examine the results of a polylactic acid/polyglycolic acid copolymer and gelatin sponge complex (PGS) with or without recombinant human bone morphogenetic protein-2 (rhBMP-2) used to treat condylar defects in rabbits. MATERIAL AND METHODS: Adult male Japanese white rabbits (n=60; 3kg; 12-16 weeks old) were divided into three groups of 20 each. All rabbits underwent condylectomy. In the two implanted groups, PGS with or without 5 microg of rhBMP-2 was implanted to the condylar defect without fixation. No material was implanted into the control group. Animals were sacrificed at 2, 4, 8, 12 and 24 weeks postoperatively, and the temporomandibular joints (TMJs) were examined histologically. RESULTS: Four weeks after implantation, growth of bone and cartilage-like tissue was observed in all rabbits that received PGS implants (with and without rhBMP-2). A cartilage-like layer was derived from the bone marrow at the operated surface. There was no growth of bone tissue in the control rabbits, but they also had a cartilage-like layer directly derived from the operated surface. CONCLUSION: This study demonstrated that PGS with or without rhBMP-2 could induce regeneration of new bone and cartilage-like tissue in the TMJ.

Animals↗
PubMed1989

Utilization of therapeutic embolization in haemorrhage caused by carcinoma of the tongue.

Selective transcatheter arterial embolization, using Gelfoam, was performed in 2 patients with bleeding from tongue arteries due to carcinoma. Though the patients were in poor general condition, being in the terminal stage of cancer, there were no complications and the bleeding was successfully controlled. This method was effective in controlling haemorrhage from the tongue due to carcinoma of the tongue.

Carcinoma↗
PubMed1997

Large arteriovenous high-flow mandibular, malformation with exsanguinating dental socket haemorrhage: a case report.

Arteriovenous malformations (AVMs) of the jaws are extremely rare lesions, which are probably hamartomas of developmental malformations. In this article we present an extremely high-flow AVM of the lower jaw with exsanguinating bleeding from the socket of the exfoliated tooth. Repeated episodic bleedings were controlled with local pressure and packing. Digital subtraction angiography revealed a high-flow, high-shunt AVM. Preoperative embolization and external carotid artery ligation, dental extraction, curettage and packing with Gelfoam were done. Postoperative bleeding stopped, bruit ceased, and it had disappeared completely after 6 months follow-up. On the second follow-up visit, 3 months later, the patient was found to have no problems.

Alveolar Process↗
PubMed1998

Osseous regeneration in the jaws using demineralized allogenic bone implants.

Osseous defects of the jaws following trauma, congenital deformity or pathology may show poor osteogenesis and the affected area may never be completely replaced by bone or will show alveolar height loss. The purpose of the present study was to evaluate the effect of allogenic bone implants (ABI) on the osteogenesis of jaw defects. Fifty-two patients (27 males, 25 females) with cystic lesions of the jaws were randomly divided into two groups: Group A underwent enucleation and packing with adsorbable gelatine sponge. Group B underwent enucleation and grafting with ABI. Both groups were evaluated radiographically. The height of the alveolar process was measured directly on the radiography. The density was measured with a digital densitometer. In Group A, the mandibular height at 6, 12 and 24 months postoperatively was 88%, 80% and 78% of the preoperative heights, respectively. In Group B, the heights were 95%, 93% and 90%, respectively. These differences were significant (P < 0.05-0.01). The density in Group B was significantly greater (P < 0.05-0.01) than in Group A at 6 and 12 months postoperatively. The difference at 24 months was not significant. On the basis of these findings, it can be concluded that ABI grafting of jaw defects enhances osteogenesis and prevents alveolar height loss in the mandible. ABI represent an encouraging alternative to autogenous bone grafting.

Adolescent↗
PubMed2000

Outpatient uterine artery embolization for symptomatic uterine fibroids: experience in 49 patients.

PURPOSE: To assess the feasibility of performing uterine artery embolization as an outpatient treatment for symptomatic uterine fibroids. MATERIALS AND METHODS: Forty-nine consecutive patients (mean age, 44.5 years; range, 28-54 years) underwent uterine artery embolization during a 12-month period. Embolization was performed with 350-500 microm polyvinyl alcohol particles (44 of 49) or Gelfoam pledgets (five of 49). At discharge, patients were given instructions regarding the constitutional symptoms to expect after embolization. A specific medication regimen consisting of prochlorperazine, ketorolac, meperidine, and hydrocodone was prescribed for relief of these symptoms. All patients were telephoned within 24 hours of discharge. During long-term follow-up, a questionnaire was administered to all patients to evaluate the periprocedural experience. Three-month clinical follow-up was available in 26 patients and 6-month imaging follow-up was available in 16 patients. RESULTS: Fourteen patients presented with menorrhagia, six had bulk-related symptoms (abdominal distension, stress incontinence, pelvic pain), and 29 had both. Technical success for bilateral embolization was 98%. Forty-seven of 49 patients were discharged to home 6-8 hours after the procedure; two patients required overnight observation in an ambulatory unit (one because of postprocedure hypertension and one because of a late procedure completion time). At the first follow-up phone call, reported symptoms included pelvic pain/cramping in 83.7% (41 of 49), fatigue in 75.5% (37 of 49), nausea/vomiting in 46.9% (23 of 49), and a nonpurulent vaginal discharge in 18.4% (nine of 49). These symptoms were satisfactorily controlled with discharge medications in 48 of 49 patients. No patients returned to the hospital or visited an emergency room during the first 48 hours after discharge. Forty-six of 49 patients were satisfied with the decision for home discharge. The average uterine volume reduction in 16 patients with 6-month imaging follow-up was 47.5%; 88.5%, of patients (23 of 26) with 3-month clinical follow-up reported improvement or elimination of symptoms. CONCLUSION: With defined telephone follow-up, staff availability, and a protocol designed to alleviate the postprocedure constitutional symptoms, uterine artery embolization is both safe and effective when performed as an outpatient procedure.

Adult↗
PubMed2001

CT findings after embolization for blunt splenic trauma.

PURPOSE: To determine complications after transcatheter embolization for blunt splenic injury as recognized with computed tomography (CT). MATERIALS AND METHODS: From March 1997 to January 2000, 80 patients underwent transcatheter embolization after blunt splenic injury, of whom 53 underwent abdominal CT examination before and after embolization. Preembolization CT scans were reviewed to determine grade of injury, and postembolization CT scans were reviewed to identify complications secondary to embolization. Arteriography results were reviewed to determine findings and method and location of embolization. RESULTS: Splenic infarcts occurred in 63% of patients after proximal embolization and in 100% of patients after distal embolization. Infarcts after distal embolization tend to be larger and occur just distal to the embolization material, whereas infarcts after proximal embolization tend to be smaller, multiple, and located in the periphery. Most infarcts resolved without sequelae. Seven patients developed gas within an infarct or subcapsular fluid collection. Two collections were drained and found to be sterile and one patient had a splenic abscess at laparotomy. CONCLUSIONS: Infarcts are common after splenic embolization. Gas may be present within an infarct after embolization with Gelfoam; however, the presence of air/fluid level is a better predictor of abscess.

Adult↗
PubMed2002

Segmental transcatheter arterial chemoembolization treatment in patients with cirrhosis and inoperable hepatocellular carcinomas.

PURPOSE: To establish whether segmental transcatheter arterial chemoembolization (TACE) treatment may improve the rates of survival in patients with compensated cirrhosis and inoperable hepatocellular carcinoma (HCC). MATERIALS AND METHODS: Fifty-six patients with compensated cirrhosis and inoperable HCC were treated with segmental TACE. One hundred forty treatments (mean, 2.5 per patient; 30-60 mg Epirubicin, 4-10 mL Lipiodol, and Gelfoam particles) were administered. RESULTS: During the 69-month study, 25 patients (45%) died of tumor progression, 12 (21%) of liver failure, nine (16%) of gastrointestinal hemorrhage, and three (5%) of other causes; seven patients (13%) are still alive. The 3-year rate of survival was 32%. Intention-to-treat analysis determined that patients with Child-Pugh class A disease (n = 44; 79%) or a single <5-cm HCC (n = 21; 37%) had a higher rate of survival than those with Child-Pugh class B disease (n = 12; 21%; P <.002) or a larger HCC (n = 35; 63%; P <.02) and patients (n = 41) who were treated with more than one course of TACE had a higher rate of survival than those who were treated with a single TACE procedure (n = 15; P <.0003). Multivariate analysis was used to predict rates of survival by number of treatments (hazard ratio, 0.6; CI, 0.48-0.86; P <.004), Child-Pugh class (hazard ratio, 2.8; CI, 1.41-5.74; P <.003), and tumor size (hazard ratio, 3.8; CI, 1.81-8.01; P <.001). The 3-year rate of survival in patients with Child-Pugh class A disease and a < or =5-cm-HCC (n = 16) was 56%. This result was similar to the 50% 3-year rate of survival in untreated historic controls with similar characteristics. CONCLUSION: The rate of survival in patients with compensated cirrhosis and inoperable HCC did not appear to improve with use of TACE therapy.

Aged↗