The effects of different packing materials on healing and hearing after trauma to middle ear mucosa, an experimental study in rats.

PURPOSE: To compare the performance of Spongostan, Otopore, Spongostan soaked with dexamethasone and Spongostan soaked with Hyaluronic acid (HA) as middle ear packing material after mucosal trauma. METHODS: Twenty rats were divided into 4 groups. In control group (group 1), the middle ear cavities of animals were bilaterally packed with Spongostan; in group 2, with Otopore; in group 3, with Spongostan soaked with dexamethasone; and in group 4, with Spongostan soaked with HA. Auditory brainstem responses (ABRs) were performed preoperatively and 1 and 6 weeks postoperatively. Histological analyses were performed to evaluate the inflammatory reaction and wound healing in the middle ear cavity. RESULTS: ABR recordings demonstrate that threshold level changes from baseline were minor in Otopore and Spongostan soaked with dexamethasone packed ears. Threshold levels were higher in the Spongostan and Spongostan soaked with HA packed ears compared with both Otopore and Spongostan soaked with dexamethasone packed ears. Histological analyses showed that Spongostan caused inflammation more intense than Otopore and Spongostan soaked with dexamethasone. Residual material at postoperative week 6, new bone formation and adhesion were common in the Spongostan group compared with other groups. Fibrosis was more common in Spongostan group compared with other groups but the difference was not significant. CONCLUSION: Otopore appears to be safe and effective for use in otologic surgery. The inflammation, adhesion and new bone formation decreased when Spongostan was used with steroid or HA, when compared to Spongostan alone.

Antiseptic effect of low-concentration povidone-iodine applied with a depot device in the conjunctiva before cataract surgery.

PURPOSE: Examine the antiseptic effect of long-term low-concentration (0.3%) povidone-iodine (PI) before cataract surgery. SETTING: St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. DESIGN: Single-armed prospective clinical study. METHODS: Repeated measure of preoperative conjunctival samples from 51 participants were obtained the day before surgery (T1), the day of surgery after treatment with ophthalmic NSAID (T2), and after additional treatment with low-concentration PI (T3) given by placing a pledget soaked in a mix of eye-drops in fornix inferior for 20 min. RESULTS: Before surgery, and before any type of treatment (T1), bacterial growth (≥5 BC) in the conjunctiva was identified in 36 (66.7%) of the participants. After treatment with ophthalmic NSAID (T2), and after additional treatment with low-concentration PI (T3), bacteria were identified in 31 (60.8%) and 12 (23.4%) participants, respectively. All except one of the participants with a measurable change from T2 to T3 (n = 31, 60.8% of total sample), experienced a decrease in number of bacterial colonies (BC) after treatment with low-concentration PI (96.8 vs. 3.2%, p < 0.001). A complete removal of bacteria was seen in 20 (n = 31, 64,5%) of the colonized participants after treatment with PI. CONCLUSIONS: Preoperative treatment with long-term, low-concentration PI applied via a depot device in fornix inferior, seem to be an easy and effective way to reduce the number of BC in the conjunctiva.

Effect of Methyl Palmitate on the Formation of Epidural Fibrosis in an Experimental Epidural Fibrosis Model.

AIM: To investigate the effects of local and systemic administration of methyl palmitate on the formation of epidural fibrosis. MATERIAL AND METHODS: Twenty-eight rats were randomly divided into four equal groups (control, Spongostan, local methyl palmitate and orally methyl palmitate) and laminectomy was performed between T11 and L1 in all rats. Local methyl palmitate (300 mg/kg) was applied with Spongostan; methyl palmitate (300 mg/kg) was given orally three times per week on different days for a total period of 4 weeks. Four weeks later, the vertebral column from T9 to L3, including the paraspinal muscles and epidural scar tissue, was removed en bloc and epidural fibrosis and arachnoidal involvement was graded and evaluated histopathologically. Kruskal-Wallis and Pearson Chi-Square test were used for statistical analysis. A statistically significant p-value was determined as p < 0.05. RESULTS: The grading of epidural fibrosis was lower at a statistically significant level in orally-administrated methyl palmitate groups compared to the control and spongostan groups (p < 0.05). CONCLUSION: The findings of this study show that oral methyl palmitate decreases the formation of epidural fibrosis and that this effect of methyl palmitate could be mediated by reducing the functions of inflammatory cells such as macrophages, neutrophils and fibroblasts, including anti-inflammatory and antioxidant effects.

Comparative analysis of Cutanplast and Spongostan nasal packing after endoscopic sinus surgery: a prospective, randomized, multicenter study.

Commercial gelatin-based packing materials are available under different names and compositions to be used after endoscopic sinus surgery (ESS). The purpose of this study was to investigate the efficacy of Spongostan and Cutanplast nasal packing on patients' subjective symptoms, hemostasis, and wound healing following ESS. One hundred adult patients with chronic sinusitis requiring the same extent of ESS were included. Following surgery, one nasal cavity was packed with Cutanplast and the other one with Spongostan. Patients' subjective symptoms while the packing was in situ, hemostatic properties, degree of remaining amount of packing materials, postoperative wound healing, and the cost of the pack were evaluated. Cutanplast and Spongostan are equally effective in the control of postoperative bleeding following ESS. However, Cutanplast packing was significantly more comfortable than Spongostan for nasal obstruction, postnasal drip, rhinorrhea, and headache. Furthermore, the Cutanplast packing was significantly less painful at all time points. The remaining amount of the pack was significantly lower in the Cutanplast than Spongostan packing. Spongostan packing appears to impair wound healing within the sinus cavities up to 3 months postoperatively. Cutanplast was less expensive than Spongostan as used in this study. Cutanplast may be more useful gelatin-based packing material than Spongostan in terms of efficacy and cost-benefit after ESS.

Incidental durotomy in lumbar spine surgery--a three-nation survey to evaluate its management.

BACKGROUND: Although it is generally accepted that incidental durotomies (ID) should be primarily repaired, the current literature shows no consensus regarding the peri- and postoperative management in case of ID during lumbar spine surgery. Because ID is a rather frequent complication and may be associated with significant disability, we were interested to analyze the current handling of ID in three European countries. METHODS: In March 2014, members of the Swiss, German, and Austrian neurosurgical and spine societies were asked to complete an online questionnaire regarding the management of ID during and after lumbar spine surgery. Two, respectively 4 weeks after the first invitation, reminder requests were sent to all invitees, who had not already responded at that time. RESULTS: There were 175 responses from 397 requests (44.1 %). Responders were predominantly neurosurgeons (89.7 %; 10.3 % were orthopedic surgeons), of which 45.7, 40.0, and 17.8 % work in a non-university hospital, university hospital, and private clinic, respectively. As for the perioperative management of ID, 19.4 % of the responders suggest only bed rest, while, depending on the extent of the ID, 84.0 % suggest additional actions, TachoSil/Spongostan with fibrin glue or a similar product and single suture repair being the most mentioned. Concerning epidural wound drainage in case of ID, 37.2 % desist from placing an epidural wound drainage with or without aspiration, 30.9 % place it sometimes, and 33.7 % place it regularly, but only without aspiration. Most responders prescribe bed rest for 24 (34.9 %) or 48 h (28.0 %), with much fewer prescribing bed rest for 72 h (6.3 %) and none more than 72 h, and 14.9 % of participants never prescribe bed rest. The vast majority of physicians (82.9 %, n = 145) always inform their patients after the operation in case of ID. CONCLUSIONS: There is substantial heterogeneity in the management of incidental durotomies. The majority of spine surgeons today aim at complete/sufficient primary repair of the ID with varying recommendations concerning postoperative bed rest. Still, there is a trend towards early mobilization if the incidental durotomy has been closed completely/sufficiently with no participant favoring bed rest for more than 72 h.

Placement of bupivacaine-soaked Spongostan in episiotomy bed is effective treatment modality for episiotomy-associated pain.

STUDY OBJECTIVE: To investigate the efficacy of placing bupivacaine-soaked Spongostan (Ferrosan, Soeborg, Copenhagen, Denmark) in episiotomy beds for relief of postpartum pain. DESIGN: Randomized, controlled study (Canadian Task Force classification I). SETTING: University medical school. PATIENTS: Women with mediolateral episiotomy. INTERVENTIONS: Patients were recruited and randomized into 2 groups by using a random number table. Group I (control group) received local lignocaine infiltration 1% up to 20 mL. For group II (Spongostan group), in addition to local lignocaine infiltration, bupivacaine-soaked Spongostan was placed in the episiotomy bed. All patients received routine postpartum perineal care in addition to the regular pain drugs (75 mg of diclofenac every 4 hours if needed). The primary outcome for the study was severity of pain, rated on a 10-cm visual analog scale from 0 to 10. Rating was recorded at 0, 1, 1.5, 2, 6, and 24 hours after delivery. MEASUREMENTS AND MAIN RESULTS: In all, 48 women were randomized to group I (local lignocaine alone) and 51 women to group II (local lignocaine plus Spongostan). The Spongostan and control groups were similar with respect to maternal age, parity, gestational age, maternal weight, and neonatal birth weight (p >.05; CI for difference: -2.6/10, 0.1/0.3, 0.3/0.7, 6.9/1.7, and -7/1.9, respectively). Episiotomy length (both vaginal and perineal) and episiotomy depth were higher in Spongostan group than control group (p <.05; 95% CI: -0.9/0, -0.8/-0.1, and -0.6/0, respectively). However, episiotomy reconstruction time of both groups was similar (p >.05; CI: 1.7/6.2). The pain score of Spongostan group was lower than control group and it was statistically significant at all time intervals (0, 1, 1.5, 2, 6, and 24 hours) between the Spongostan and control groups (p <.05; CI: 0.6/1.9, 1.1/2.4, 1.0/2.5, 0.9/2.4, 0.3/1.9, and 0.5/1.8, respectively). Postpartum total analgesic requirement (mg/person) again was significantly lower in the Spongostan group than control group (p <.01; CI: 0.1/0.4). CONCLUSION: Placement of bupivacaine-soaked spongostan into the episiotomy bed resulted in decreased postpartum pain and drug requirement. It may be attributed to a higher drug concentration at episiotomy bed and prolonged drug effect.

Use of gelatin powder added to rifamycin versus bone wax in sternal wound hemostasis after cardiac surgery.

Bone wax is the substance which has been used for hemostasis in different surgical fields for up to one hundred years and historically used in our center to prevent sternal bleeding and subsequent complications. Recently, reabsorbable gelatin powder has come into use. Up to now there are no clinical studies that compare these two substances. Between 1st January and 31st December 2004, 1249 subsequent patients have been operated on for different cardiac surgical procedures in our center, of them 557 were enrolled in a randomized perspective monocentric study. They have been divided into two similar subgroups: one treated with swine gelatin plus rifamycin (group one) and the other with bone wax (group two). The two hemostatic products have been applied just after the sternotomy and before the chest closing. Each patient was evaluated for bleeding, sternal infections and was followed-up for two months for bone and wound healing. Postoperative bleeding at the tenth hour was 315 ml+/-269 (mean+/-S.D.) in the first group and 395 ml+/-265 in the second (P<0.001). In the 10th-20th hour interval time bleeding was 120 ml+/-74 and 205 ml+/-132, respectively (P<0.001). Total bleeding was 415 ml+/-87 in group one and 580 ml+/-150 in group two (P<0.001). Chest reopening for bleeding not due to surgical problems was carried out in 14 patients (4.7%) (group one) and 19 (7.3%) (group two) (n.s.). Superficial sternal wound infection occurred in two patients (0.7%) in group one and three patients (1.1%) in group two (n.s.). There were no deep sternal wound infections. Bleeding was significantly higher in patients treated with bone wax compared to those with absorbable gelatin plus rifamycin.

Surgifoam and mitoxantrone in the glioblastoma multiforme postresection cavity: the first step of locoregional chemotherapy through an ad hoc-placed catheter: technical note.

OBJECTIVE: To investigate the safety and feasibility of a novel form of treatment offered by the direct intraoperative application of a Surgifoam-mitoxantrone mix into a glioblastoma multiforme postresection cavity. A technique for the placement of an intracavity catheter connected with a subcutaneous reservoir for further locoregional mitoxantrone administration is also described. METHODS: Between January and December 2004, 22 consecutive recurrent glioblastoma multiforme patients (14 men, 8 women; age, 56-72 yr; average, 64 yr; median, 65 yr) were enrolled in this study. All patients underwent image-assisted gross total resection of the pathological tissue. A Surgifoam-mitoxantrone mix (1 g Surgifoam powder, 3 ml physiological solution, and 12 mg mitoxantrone in 6 ml) was used to fill the surgical cavity. A ventricular catheter, connected to a Rickham subcutaneous reservoir, was then positioned in the surgical cavity for future mitoxantrone administration. RESULTS: Toxic effects caused by mitoxantrone administration were not observed in any patients during the first postoperative month. On postoperative Days 1, 7, and 30, computed tomographic scans excluded surgical complications. In three patients, residual tumor was disclosed. CONCLUSION: A mix of Surgifoam and mitoxantrone could be safely applied intraoperatively into the post-glioblastoma multiforme resection cavity without any observable side effects. This technique may benefit both the surgeon and the patient by taking advantage of the drug's hemostatic and cytostatic properties.

Selective embolization of a pulmonary artery rupture caused by a Cournand catheter.

Pulmonary artery rupture is a rare but often fatal complication of right heart catheterization. We present a case of a ruptured pulmonary artery caused by a Cournand catheter in a high-risk patient with pulmonary hypertension on oral anticoagulation with successful emergency embolization with gelatine foam.

Tissue reaction after implantation of Spongostan, as the carrier of xenogenic bone morphogenetic protein. Experimental study.

Reconstruction or filling of bone defects, especially in the maxillofacial region, often requires use of biomaterials. An implant should fasten healing of the bone gap or it should replace autogenic bone grafts. The combination of bone morphogenetic proteins with suitable carrier may fulfill these requirements. Proteins causing differentiation of mesenchymal cells in chondroblasts and osteoblasts were called Bone Morphogenetic Proteins--BMPs. The authors extracted BMP from bovine bones and placed it into collagen carrier formed from generally accessible hemostatic sponge--Spongostan. The implants were grafted into rat femoral muscle pouches in order to trace the tissue response. Pathologic examinations were performed 3, 6 and 8 weeks after implantation. On the basis on macroscopic and microscopic examinations it was stated that collagen sponge speckled with BMP caused minimal tissue response and evolved characteristic thin connective tissue capsule formation around the implant. The connective tissue penetrated spongious structure of the implant, filling the spaces, which became growing due to sponge resorption. Characteristic hyalinization and sparse chondroblasts were visible 8 weeks after implantation.

Fibrin sealant foam sprayed directly on liver injuries decreases blood loss in resuscitated rats.

OBJECTIVE: The majority of early trauma deaths are attributable to uncontrolled hemorrhage from truncal sites. A hemorrhage-control technique that reduced bleeding in the prehospital phase of treatment without requiring manual compression may improve the outcome of these patients. We conducted this preliminary study to determine whether an expanding fibrin sealant foam (FSF) would reduce bleeding from a severe liver injury even during resuscitation. METHODS: Rats (n = 31; 291 +/- 5 g; 37.4 +/- 0.3 degrees C; mean +/- SEM), underwent a 60 +/- 5% excision of the median hepatic lobe. The animals received one of three treatments: (1) FSF, (2) immunoglobulin G placebo foam (IgGF), or (3) no treatment. All animals were resuscitated with 40 degrees C lactated Ringer's solution at 3.3 mL/ min/kg to a mean arterial pressure of 100 mm Hg. Total blood loss, mean arterial pressure, and resuscitation volume were recorded for 30 minutes. A qualitative measure of foam coverage and adherence to the cut liver edge was recorded. RESULTS: The total blood loss was less (p < 0.01) in the FSF group (21.2 +/- 5.0 mL/kg) than in either IgGF (41.4 +/- 4.3 mL/kg) or the no treatment group (44.6 +/- 4.7 mL/kg), which did not differ. The resuscitation volume was not different. The amount of foam used in the treated groups, 9.1 +/- 1.0 g in the FSF group and 10.0 +/- 1.0 g in the IgGF group, did not differ. Survival for 30 minutes was not different among groups. There was no difference in the amount of cut liver covered by either foam, but the clots were more adherent (p < 0.05) in the FSF group than in the IgGF group. CONCLUSION: In rats with a severe liver injury, spraying fibrin foam directly on the cut liver surface decreased blood loss when compared with placebo foam and no treatment. This pilot study suggests a future possible treatment for noncompressible truncal hemorrhage.

[Survival of 184 patients with hepatocellular carcinoma in cirrhotic liver treated with chemoembolization. A multicenter study]. / La sopravvivenza di 184 pazienti con carcinoma epatocellulare nel fegato cirrotico trattati con chemioembolizzazione. Studio multicentrico.

INTRODUCTION: We report the results of a multicenter study of 184 cirrhotic patients with hepatocellular carcinoma (HCC) treated with transcatheter arterial chemoembolization (TACE) and compare our results with those reported in the literature. MATERIAL AND METHODS: We treated 184 cirrhotic FNB-proved HCC patients with TACE in a 2 years' period; 159 were men and 25 women and their mean age was 59 years (range: 46-75 years). TACE was performed with selective or superselective injection of Doxorubicin chlorhydrate (20-50 mg) mixed with Lipiodol Ultrafluid before embolization with Spongostan. This procedure was repeated after 4-6 weeks for at least 3 cycles. Follow-up was performed by means of periodic US, CT and MR scans and by assessment of the clinical status and serum biochemical tests--alpha-fetoprotein, platelet and blood cell counts, protein electrophoresis, bilirubin and other standard liver and renal function tests. TACE results were assessed comparing site, size and local spread of tumor and TACE technique (lobar or segmental, number of performed procedures) with survival in each patient. The lesion was single in 85 (46.2%) and multiple in 99 (53.8%) patients. It exceeded 5 cm in 128 patients (69.5%) and was < 5 cm in 57 (30.5%). RESULTS: Angiography, CT and MRI showed complete necrosis in 148 patients (80.4%) and an unchanged pattern in 36 (19.6%). Overall survival rates were 95.7% at 6 months, 78.3% at 1 year, 46.0% at 2 years, 40.0% at 3 years. The best responses were obtained with lesions < 5 cm--with 100% survival at 6 months, 94.8% at 12 months, 71.4% at 18 months, 54.7% at 24 months and 50.0% at 36 months. Other factors affecting treatment response were singleness of lesion (96.4% at 6 months, 93.9% at 12 months, 71.4% at 18 months, 58.9% at 24 months, and 50.0% at 36 months) and at least 3 cycles of TACE (100% at 6 months, 87.8% at 12 months, 70.1% at 18 months, 48.7% at 24 months and 37.5% at 36 months). Abdominal pain and fever were the most frequent complications, particularly in the first TACE procedure, but both were mild and transient. Lipiodol cholecystitis was found in 3 patients but they were asymptomatic. No patients had evidence of cardiac toxicity or experienced significant leukopenia or thrombocytopenia as a result of systemic toxicity from Doxorubicin. CONCLUSIONS: We can conclude that TACE proves to be an efficacious treatment in the HCC patients who cannot undergo surgery.

Septal reconstruction in nasal septum surgery with a composite-sandwich technique.

The authors describe a technique to reconstruct the medial and posterior portions of the nasal septum during surgical correction. This technique uses a "composite sandwich" made of two thin strips of Spongostan containing autologous crushed bone and cartilage. Thirty patients have been operated using this technique with satisfying results.

[Hemobilia following biliary drainage: percutaneous treatment with arterial embolization and biliary fibrinolysis]. / Emobilia conseguente a drenaggio biliare: trattamento percutaneo con embolizzazione arteriosa e fibrinolisi biliare.

The Authors report a case of haemobilia following the performance of biliary drainage. Angiography of the celiac tripod and superior mesenteric artery was carried out in order to evidence the lesion and to perform, during the same session, embolization of the leaking vessel by means of fibrin sponge particles (Spongostan). Subsequent cholangiographic controls demonstrated the presence of bile ducts clots then treated by loco-regional infusion of urokinase. On the basis of the Authors' personal experience, the combination of loco-regional biliary fibrinolytic treatment and embolisation leads to the resolution of the cause of hematobilia and of retention jaundice.

[Postoperative histologic evaluation of hepatocarcinoma treated using chemo-embolization]. / Valutazione istologica postoperatoria dell'epatocarcinoma trattato mediante chemioembolizzazione.

Transcatheter arterial chemoembolization (TAE) is generally considered to be an effective palliative treatment in patients with inoperable hepatocellular carcinoma (HCC). Recently, TAE has also been performed on operable cases, in order to reduce the chances of recurrence. This study was aimed at evaluating the histopathologic changes following chemoembolization in surgically resected HCCs. Chemoembolization was performed by selective intra-arterial injection of Lipiodol-chemotherapeutic agent (Adriamycin), followed by terminal embolization with Spongostan, in 5 patients with operable HCC. All patients underwent Computed Tomography (CT) follow-up and subsequent partial hepatectomy. CT after chemoembolization accurately demonstrated no increase in tumor size in all patients. In all HCCs a thick fibrous capsule was found. Histopathology of the surgically resected HCCs demonstrated complete necrosis of the primary tumor in 4/5 cases; 1 HCC remained viable and tumor cells were found in a few daughter nodules surrounding the tumor. In 1 case there were viable tumor emboli in the small portal vessels around the tumor. In patients with resectable HCC, TAE was useful in preventing tumor growth and in thickening the capsule, thus making surgery safer and reducing the chances of recurrence.

[Solitary chondromas of the hand: treatment indications]. / Condromi solitari della mano. Indirizzi di trattamento.

The authors report their own experience on eleven cases of solitary chondroma of the hand, that occurred at the orthopaedic and traumatologic clinic of Chieti University. The patients were treated with curettage and spongy-cortical autoplastic bone-grafting or with injection of calcitonin and spongostan. No case had relapsing symptoms and the results obtained showed satisfactory improvements, even though with short-medium follow-up.