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Reduction in the incidence of alveolar osteitis in patients treated with the SaliCept patch, containing Acemannan hydrogel.

PURPOSE: In the present study, we compared the incidence of alveolar osteitis (AO) in patients treated with either clindamycin-soaked Gelfoam (Pharmacia and Upjohn Co, Kalamazoo, MI) or SaliCept Patches (Carrington Laboratories, Inc, Irving, TX). The SaliCept Patch is a freeze-dried pledget that contains Acemannan Hydrogel (Carrington Laboratories) obtained from the clear inner gel of Aloe vera L. PATIENTS AND METHODS: A retrospective evaluation was performed of the records of 587 patients (1,031 sockets) whose extraction sites had been treated with clindamycin-soaked Gelfoam. A prospective trial was conducted in which 607 patients (1,064 sockets) had 2 SaliCept Patches placed immediately after extraction. The same surgeon treated all patients. RESULTS: Analysis restricted to mandibular third molar sites showed that 78 of 975 sites (8.0%) in the Gelfoam group developed AO, whereas only 11 of 958 sites (1.1%) in the SaliCept group developed AO (P <.0001). Further analysis of all extraction sites revealed that the incidence of AO in the Gelfoam group was 7.6% compared with 1.1% in the SaliCept-treated group (P <.0001). CONCLUSIONS: The study results suggest that the SaliCept Patch significantly reduces the incidence of AO compared with clindamycin-soaked Gelfoam.

Adolescent↗

Embolization of superior mesenteric artery branches in dogs. Ischemic bowel changes depend on location of vessel occlusion and embolic materials.

OBJECTIVE: To evaluate the degree of ischemic changes of the small intestine after arterial embolization of proximal or distal arteries with Gelfoam particles and coils in dogs. METHODS: Superselective arterial embolization in 18 dogs was performed using a coaxial catheter system. Gelfoam occlusion of the proximal level of ileal or jejunal arteries was performed in four dogs (group A). Gelfoam occlusion of the distal level was performed in four dogs (group B). Coil occlusion of the proximal level was performed in five dogs (group C). Coil occlusion of the distal level was performed in five dogs (group D). All 18 dogs were killed 1 day after the procedure. Gross and microscopic findings were evaluated. RESULTS: The embolizations were successful in all dogs. In group B, significant mucosal destruction, lymphocyte proliferation of the submucosa and mucosa, and diffuse swelling in all layers of the intestine were found in all four dogs. Three revealed diffuse ischemic changes and one showed focal ischemic changes. In groups A and C, all the layers of the intestine were intact and did not show any ischemic changes. In group D, one dog showed erosion of a small portion of mucosa and lymphocytic infiltration. The other dogs showed nonspecific findings in all layers of the intestine. CONCLUSIONS: Proximal embolization with Gelfoam and coils as well as distal embolization with coils did not cause ischemia. However, ischemic changes in the intestinal wall could be observed after distal embolization with Gelfoam.

Angiography↗

Otologic effects of topical mitomycin C: phase I-evaluation of ototoxicity.

HYPOTHESIS: To determine ototoxicity of topical mitomycin C when placed in the middle ear at varying concentrations. BACKGROUND: Despite meticulous surgical technique and diligent postoperative care, some patients develop excessive scar and granulation tissue in the middle ear or mastoid cavity. Poor wound healing may result in infection, tympanic membrane perforation, or conductive hearing loss, which may necessitate further surgery. Use of topical mitomycin C in the ear may be beneficial in reducing scar and granulation tissue formation. This phase of the study was developed to determine the safety of topical mitomycin C in the rat model relative to ototoxicity. METHODS: Twelve Sprague-Dawley rats were evaluated with auditory brainstem response testing before and after treatments. Topical mitomycin C was injected in the middle ear of the right ear of eight animals. Varying concentrations of 0.125 to 0.5 mg/ml were used. Saline was injected in the left ear of each animal to serve as a control. Four separate animals were evaluated with placement of topical mitomycin C on Gelfoam into the middle ear. In two animals, Gelfoam was placed in the middle ear for 1 minute and then removed. In two animals, Gelfoam was placed in the middle ear and left in place. Auditory brainstem response testing was performed at 4 weeks and at 8 weeks. RESULTS: Using a high concentration of mitomycin C (>0.25 mg/ml) resulted in ototoxicity, with an increase in the auditory brainstem response threshold at 4 weeks and at 8 weeks. At low concentrations (<0.20 mg/ml), no change in auditory brainstem response threshold was noted. Animals treated with Gelfoam soaked in mitomycin C showed no change in auditory brainstem response threshold. CONCLUSION: The results of this study indicate that topical mitomycin C on Gelfoam applied in the middle ear appears safe when low concentrations are used, even in the rat, which has a higher susceptibility to gentamycin toxicity than humans. Higher concentrations may lead to ototoxicity based on changes in Wave V on auditory brainstem response. This treatment may prove to be an important option for patients suffering from chronic granulation tissue or scar tissue in the external or middle ear.

Administration, Topical↗

Cutting edge: restoration of the ability to generate CTL in mice immune to adenovirus by delivery of virus in a collagen-based matrix.

Viruses are commonly used for the delivery of genes coding for tumor-associated Ags to elicit tumor-specific immune responses. The success of viral vectors has been limited in preclinical and clinical trials in part because of antiviral immunity. We investigated the ability of a collagen-based matrix (Gelfoam; Pharmacia and Upjohn, Kalamazoo, MI) to improve CTL activation by recombinant adenovirus. The data show that coinjection of Gelfoam with type 5 adenovirus recombinant for prostate-specific Ag (Ad5-PSA) enhanced CTL activation. Ad5-PSA priming in Gelfoam also abrogated the inhibitory effects of adenoviral immunity on CTL activation in mice naive to PSA but immune to adenovirus. Finally, Gelfoam enhanced immunization in a self-Ag model using type 5 adenovirus recombinant for membrane-bound OVA (Ad5-mOVA) in rat insulin promoter (RIP)-mOVA-transgenic mice. Thus, Gelfoam enhances CTL activation by recombinant viral vectors in a setting where preformed Ab to the virus is present and also in a tolerant self-Ag model.

Adenoviruses, Human↗

The effect of gelfilm in the prevention of fibrosis in the middle ear of the animal model.

HYPOTHESIS: Gelfilm offers protection against fibrosis in the middle ear when used in combination with Gelfoam. BACKGROUND: Gelfoam is used routinely as a support structure in the middle ear cleft when ossicular reconstruction and tympanic membrane grafts are performed. It has been recognized that fibrosis may occur in this setting if the middle ear mucosa is denuded. Materials have been used to protect the mucosa in an attempt to prevent scar bands, adhesions, and fibrosis and its potential detriment on hearing. These materials have included Teflon, Silastic, and Gelfilm. Concerns have arisen regarding this mode of therapy and its benefit. METHODS: This study looks at the effects of implanting Gelfoam independently and Gelfoam and Gelfilm concurrently in the bulla cavity of the Mongolian Gerbil. The temporal bones were harvested and evaluated histologically using hemotoxylin and eosin staining for fibrosis. RESULTS: Results demonstrated a decrease in the amount of fibrosis in the animals in which Gelfilm was used to protect the denuded mucosa. No evidence of fibroblast ingrowth or scar bands penetrating the Gelfilm was identified. CONCLUSION: These results suggest that Gelfoam can be used safely in the middle ear cleft to support ossicular prosthesis and tympanic membrane grafts when Gelfilm is used to protect denuded mucosa.

Animals↗

Long-term maintenance of liver-specific functions in three-dimensional culture of adult rat hepatocytes with a porous gelatin sponge support.

The three-dimensional culture of adult rat hepatocytes with a porous gelatin sponge (gelfoam) support was investigated. Hepatocytes were immobilized on the surface as well as within the pores of the support. The morphology of the hepatocytes immobilized on the support was close to that observed in vivo. In some parts of the support the spheroids of hepatocytes could be observed. To examine the liver-specific functions of the hepatocytes in the culture, the levels of serum albumin and bile acids secreted into the medium were assessed. The secretion of albumin and bile acids was stable over the course of 12 days, longer than that in collagen-gel culture. To elucidate further the function of hepatocytes immobilized on gelfoam, the metabolic activities of the hepatocytes, as measured by the competency of removal of NH4+ and the synthesis of urea nitrogen, were determined. The rates of ammonium removal and urea nitrogen synthesis were comparable with those in conventional monolayer culture. Albumin secretion was enhanced by the treatment of gelfoam with either heparin or acidic fibroblast growth factor (aFGF), the gelfoam having a high affinity for these substances. DNA synthesis was also enhanced by aFGF. These results demonstrate that gelfoam is a suitable support for the in vitro culture of hepatocytes. Combined with its easy manipulation, it is suggested that the culture system described could be used for both basic and applied studies.

Ammonium Chloride↗

A comparative study of the biologic and immunologic response to medical devices derived from dermal collagen.

We examined collagen materials for soft tissue augmentation [Zyderm Collagen Implant (ZCI), glutaraldehyde cross-linked (GAX) collagen, and Koken Atelocollagen (Atelocollagen)]; hemostatic collagens [Gelfoam Gelatin Powder (Gelfoam), Avitene Microfibrillar Collagen Hemostat (Avitene), and Collastat Collagen Hemostat (Collastat)]; and reconstituted, intact fibrillar collagen from bovine skin in a subcutaneous guinea pig model. After 11, 25, and 39 days in situ, explants from animals injected with GAX collagen demonstrated greater wet-weight persistence than all other materials. Conversely, at all time points, the explants of Atelocollagen were the least persistent. Following 25 days in vivo, explants were examined using differential scanning calorimetry; ZCI and Atelocollagen displayed thermal transition temperatures of 58 degrees C. Avitene and Gelfoam explants displayed transition points of 30 degrees C and 32 degrees C, indicating denatured or cleaved collagen. By contrast, GAX collagen explants had a high (68 degrees C) transition temperature, reflecting its cross-linking. With respect to immunogenicity, day 39 sera from ZCI treated animals showed significantly lower titers in the ELISA to their respective implant collagen than all other groups examined, while antibody activity in the GAX collagen, Gelfoam, Atelocollagen, and intact collagen groups were not significantly different. Collastat elicited antibodies with a greater affinity than observed in these previous groups. Sera from Avitene treated animals demonstrated the highest antibody levels and were the only sera which reacted with bovine serum albumin. Thus, Avitene was the most immunogenic of the collagen materials examined, while GAX collagen demonstrated the greatest persistence and minimal immunogenicity, and ZCI was the least immunogenic.

Animals↗

[Comparative study on the long-term effect of permanent embolization of hepatic artery with Bletilla striata in patients with primary liver cancer].

From May, 1990 to Sept., 1993 106 cases of primary liver cancer were treated by temporary or permanent hepatic arterial embolization with Bletilla striata powders (permanent, 56 cases) or gelfoam powders (temporary, 50 cases) under controlled technical conditions, in term of degree of tumor necrosis, revascularization of tumor, and long-term effect, the results of Bletilla striata group were better as compared with those of gelfoam group. The 1, 2 and 3 year survival rates were 44.9%, 33.6% and 33.6% in Beltilla striata group while the rates were 48.9%, 31.1% and 16.0% in gelfoam group, suggesting that Bletilla striata is superior to gelfoam as an embolizing agent for hepatic carcinoma.

Antineoplastic Agents, Phytogenic↗

Osseous regeneration in the presence of four common hemostatic agents.

The iliac crest is a common site for bone procurement in oral and maxillofacial surgery. The goal of this study was to evaluate the potential for bone regeneration in the presence of four common hemostatic agents in a manner that parallels iliac bone procurement in humans. The agents evaluated were 1) Avitene (microfibrillar collagen; Medchem Products, Inc, Woburn, MA); 2) bone wax (beeswax with isopropyl palmitate; Ethicon, Inc, Somerville, NJ); 3) Gelfoam (absorbable gelatin sponge; The Upjohn Company, Kalamazoo, MI); and 4) Surgicel (oxidized regenerated cellulose; Johnson & Johnson Products, Inc, Patient Care Division, New Brunswick, NJ). Five surgical defects in each of four dogs were created for placement of the four materials; one defect served as an empty control site. The dogs were then allowed to heal over a 2-month period. Radiographic and histologic examination showed new bone formation in the presence of Avitene, Surgicel, and Gelfoam. Residual material incorporated in bone, without foreign-body response, was noted in the Avitene and Gelfoam sites. Bone wax, however, showed an intense foreign-body reaction, characterized by giant cells, plasma cells, fibrous granulation tissue, and lack of bone reformation. On the basis of these initial findings, it was concluded that Surgicel, Avitene, and Gelfoam may be adequate hemostatic agents for use in iliac bone procurement, whereas the use of bone wax appears to be contraindicated.

Animals↗

Controlled clinical trial of a novel hemostatic agent in cardiac surgery. The Fusion Matrix Study Group.

BACKGROUND: We performed a prospective randomized trial to compare FloSeal Matrix (Fusion Medical Technologies, Inc, Mountain View, CA), a gelatin-based hemostatic sealant, with Gelfoam-Thrombin (Gelfoam, Pharmacia and Upjohn, Kalamazoo, MI; Thrombin, Gentrac Inc, Middeton, WI) (control group) to control perioperative bleeding. METHODS: A total of 93 patients undergoing cardiac operations were randomized into the FloSeal or control group after standard surgical means to control bleeding had failed. The bleeding site was evaluated at 1, 2, 3, 6, and 10 minutes after applying the hemostatic agent. If bleeding stopped within 10 minutes, the application was considered to be successful. In the case of a failure, the surgeon could use any means preferred (except FloSeal) to achieve hemostasis. All bleeding sites in a patient were treated with the hemostatic agent to which the patient was randomized. Follow-up evaluation was performed at 12 to 36 hours and 6 to 8 weeks after operation. RESULTS: FloSeal stopped bleeding in 94% of the patients (first bleeding site only) within 10 minutes, compared to 60% in the control group (p = 0.001). At 3 minutes, successful hemostasis was achieved in 72% of the FloSeal group compared with 23% in the control group (p = 0.0001). There was no difference in the adverse event profile between the two groups. CONCLUSIONS: FloSeal Matrix demonstrated efficacy superior to that of Gelfoam-Thrombin and had a safety profile similar to that of Gelfoam-Thrombin when used as a topical hemostatic agent during cardiac surgery procedures.

Blood Loss, Surgical↗

Immediate percutaneous medialization for acute vocal fold immobility with aspiration.

OBJECTIVES: To determine the efficacy of immediate bedside or office percutaneous, trans-thyroidal injections of a bioabsorbable gelatin material (Gelfoam, Upjohn Co., Kalamazoo, MI) to decrease the risk of aspiration resulting from acute vocal fold immobility. STUDY DESIGN: Retrospective review of patients presenting with acute vocal fold immobility and aspiration or high aspiration risk at an urban, tertiary care university hospital. METHODS: All patients were evaluated by videostroboscopy, functional endoscopic evaluation of swallowing (FEES), and objective voice measures. Patients with acute vocal fold immobility and evidence of aspiration on history or FEES were given the option of medialization by Gelfoam injection. Injections were performed percutaneously in the office or at the bedside under laryngoscopic guidance. FEES was repeated after injection to verify improvement in aspiration. RESULTS: Eleven patients underwent Gelfoam injection for treatment of aspiration and vocal fold immobility. All were significantly improved on post-injection FEES study. All patients were returned to an oral diet, avoiding the need for long-term enteral access. CONCLUSION: Percutaneous Gelfoam injections is a rapid, temporary solution to the common problem of aspiration resulting from acute vocal fold immobility.

Adult↗

Relationship of invasiveness to proliferating activity and to cytoskeletal protein production in human neuroepithelial tumors maintained in an organ culture system: use of human cortex and dura as supporting matrices.

The proliferation and invasiveness of cultured human neuroepithelial tumors were studied. A human malignant astrocytic glioma cell line (U-251 MG) and a medulloblastoma cell line (D283 Med) were maintained for 3 weeks in an organ culture system using adult human brain cortex, dura mater, or Gelfoam sponge as growth matrices. The cells were labeled with bromodeoxyuridine (BrdU) at different time points, and immunohistochemistry was performed for BrdU, glial fibrillary acidic (GFA) protein (in U-251 MG), and neurofilament (NF) protein (in D283 Med). In the U-251 MG line, the cells grew successfully in each matrix, forming a fibrillated solid area and a peripheral zone of invasion. The labeling index (LI) expressed as the percentage of BrdU-labeled cells and the percentage of GFA protein-positive cells in the two zones of the explants were analyzed. The LIs in all cultures were significantly higher in the peripheral than in the central zones. On the other hand, the percentage of GFA protein-positive cells in each matrix was greater in the central zone than in the periphery. The LI was inversely correlated with the percentage of GFA protein-positive cells over the areas counted in each growth matrix. GFA protein production in cells grown on cortex and on dura mater was significantly higher than that in cells grown on Gelfoam. In the D283 Med line, the cells formed an aggregated zone, with peripheral cells infiltrating the Gelfoam. This line showed poor growth on human cortex. Cells grown on the dura demonstrated an LI similar to that on Gelfoam, and cells often infiltrated the dura.(ABSTRACT TRUNCATED AT 250 WORDS)

Brain Neoplasms↗

Matrix embedding alters the immune response against endothelial cells in vitro and in vivo.

BACKGROUND: Endothelial cell (EC) dysfunction represents the first manifestation of atherosclerotic disease. Restoration of endothelium via seeding or transfection is hampered by local alterations in flow, inflammation, and metabolic activation. Perivascular EC matrix implants are shielded from these forces and still control vascular repair. The host immune response to such implants, however, remains largely unknown. We investigated the effect of embedding of ECs within 3-dimensional matrices on host immune responses in vitro and in vivo. METHODS AND RESULTS: We compared expression of major histocompatibility complex (MHC), costimulatory, and adhesion molecules by free aortic ECs or ECs embedded in Gelfoam matrices by flow-cytometry. T-cell proliferation was assessed by [3H] thymidine incorporation. Humoral immune response (ELISA and FACS analysis) and cellular (histopathology) infiltration were investigated after subcutaneous injection of free porcine aortic ECs (PAEs) or of a Gelfoam/EC block, or after concomitant injection of PAEs adjacent to Gelfoam in rats. Aortic ECs embedded in Gelfoam expressed lower levels of MHC class II, costimulatory, and adhesion molecules compared with free ECs (P<0.001), and induced 3-fold less proliferation of human CD4+ T-cells (P<0.0005). Implantation of a Gelfoam/EC block in rats nearly abrogated the immune response with 1.75- to 9.0-fold downregulation in tumor necrosis factor-alpha, interleukin-6, monocyte chemotactic protein-1, and PAE-specific immunoglobulin G (P<0.005) and 3.3- to 4.5-fold reduction in leukocytic tissue infiltration. Injecting PAEs adjacent to Gelfoam induced a significant response comparable to that of free implanted PAEs. CONCLUSIONS: Embedding ECs within 3-dimensional matrices alters the host immune response by inhibiting expression of MHC class II, costimulatory, and adhesion molecules, offering the rationale to develop novel therapies for vascular diseases.

Animals↗

Improved safety of splenoportography by plugging of the needle tract.

Splenoportography, a useful preoperative diagnostic procedure in patients with portal hypertension, has been largely discontinued because of the risk of hemorrhage. We have used both Ivalon and Gelfoam in particle and plug form to plug the needle tract after splenoportography. Initial studies were conducted on six dogs. Plugging of the needle tract by injection of suspensions of small Gelfoam or Ivalon particles resulted in intravasation of these particles into the splenic vein. This was demonstrated by radioactive tagging of particles and the direct collection of splenic blood during the intrasplenic injection. Plugging of the splenic needle tract with compressed Gelfoam caused immediate, complete cessation of bleeding in fully heparinized animals. Because of these experimental results, five humans with decreased platelet counts and severe portal hypertension underwent successful splenoportography without significant hemorrhage. At surgery, successful plugging of the needle tract by Gelfoam was confirmed.

Adult↗

[Experimental and clinical studies on ischemic lesions of the large intestine].

To clarify the pathogenesis and endoscopic features of ischemic lesions of the colon, experimental ischemia was induced in dogs by arterial ligation, gelfoam injection, and clipping. In addition, clinical and endoscopic features of ischemic lesions in ischemic colitis cases in human were studied. In the experimental model, arterial ligation including marginal arteries frequently induced erosions in the large intestine, whereas ligation of the colic artery alone did not induce apparent mucosal lesions of the large intestine. Gelfoam injection to produce thrombi into caudal mesenteric artery or middle colic artery induced ulcers with a high rate of incidence and frequently accompanied by intestinal perforation. Temporal impairment of blood supply by arterial clipping produced erosion, but not ulcers. A high incidence of erosion was obtained in a group that underwent clipping for a prolonged period and a group of receiving Alosenn. Mucosal blood flow measured by the hydrogen gas clearance method was significantly decreased at 1 hr and 4 hr after gelfoam injection compared with those after arterial ligation. In human cases of ischemia following arterial surgery, endoscopic features were similar to those lesions of the experimental ischemia induced by gelfoam injection. These results suggest that thrombi in peripheral small arteries may play a major role in the pathogenesis of ischemic lesions of the large intestine.

Adult↗

[Embolotherapy of craniofacial tumors and vascular diseases: assessing the effect of different embolic agents].

To assess the effect of different embolic agents in curing craniofacial tumors and vascular diseases, 21 patients who were treated by intra-arterial embolization were divided into three groups: gelfoams, bletilla striatas and coils. The results showed that 8 cases of preoperative patients in gelfoams group had a good effect and bleeding were reduced during operation. One patient had vascular recanalization at 1 month after embolization with gelfoam. All patients in bletilla striatas had ideal effect. In coils group, collateral supplying arteries were found in 3 patients at once after embolization and the others had a good effect. In conclusion, craniofacial tumors and vascular diseases were fit to embolotherapy. The selection of embolic agents should be gelfoam in preoperative embolization and bletilla striata in palliative treatment There were not severe complications.

Adolescent↗

[The long-term effect of double embolization of bronchial artery on patients with hemoptysis].

OBJECTIVE: To investigate the long-term effect of bronchial arterial embolization with different material and procedure on patients with hemoptysis. METHOD: Seventy two cases were divided into two groups, one received the double embolization of bronchial artery, the other group used single gelfoam embolization. In double embolization group, the mixture containing gelfoam microspheres (0.5 mm x 0.5 mm), erythromycin and high osmalality sodium chloride were firstly used to embolize the terminal vessels, the gelfoam particle (1 mm x 1 mm) was then used to embolize the main trunk of bronchial artery. RESULT: After 2-4.8 years following up, it turned out that the cure rate and general effectiveness were: the double embolization group 83%, 100% respectively, the single gelfoam embolization group 61%, 95%. By comparison, there were significant difference on cure rate between these two groups(P < 0.05). CONCLUSION: The bronchial arterial double embolization will increase the long-term effect obviously on patients with hemoptysis.

Adolescent↗

Quantitative and qualitative in vivo angiogenesis assay.

We describe the development and optimization of an in vivo angiogenesis assay utilizing gelfoam sponges impregnated with 0.4% agarose and different proangiogenic factors, such as basic fibroblast growth factor (bFGF), vascular epidermal growth factor (VEGF), tumor growth factor-alpha (TGF-alpha), and endothelial growth factor (EGF). The sponges are implanted into the subcutis of mice and harvested after different times. The gelfoam sponges are fixed, sectioned, and stained with fluorescent antibodies against CD31. The median number of CD31+ cells is determined in 10 different 0.159-mm2 fields. Proangiogenic molecules induced significant migration and proliferation of endothelial cells. To demonstrate the utility of this assay for evaluation of an antiangiogenic agent, mice were implanted with gelfoam sponges containing different proangiogenic factors and treated orally with water or PTK 787, a novel tyrosine kinase inhibitor with specific activity against the VEGF-R. PTK 787 significantly inhibited angiogenesis in sponges containing agarose + VEGF but not other proangiogenic molecules. The data show that the implanted gelfoam sponges provide a reliable quantitative assay to study in vivo angiogenesis.

Angiogenesis Inhibitors↗