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Results of gelfoam technic in stapedectomy.
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Transcatheter embolization for control of bleeding after prostatic biopsy.
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Safety of anterior cement fixation in the cervical spine: in vivo study of dog spine.
There is increased use of methylmethacrylate in the treatment of neoplastic lesions of the spine. The advantage of this treatment is immediate stabilization, thus avoiding prolonged immobilization. In vivo study using a dog model showed that anterior fixation with cement, with or without Gelfoam as insulation material, produced no spinal cord injury.
Prevention of nerve root adhesions after laminectomy.
In repeat lumbar surgery for failure of the original operation to provide lasting relief, well-organized fibrous tissue is often noted binding together the dura, nerve roots, and erector spinae muscles. Lumbar laminectomy was carried out in 46 dogs and seven groups of animals studied. Gelfoam failed to prevent fibrosis. Free fat grafts prevented fibrosis whether the graft was placed at the laminectomy site or around the nerve roots. Vascularization of the grafts was demonstrated by injection of India ink before sacrifice. Ligamentum nuchae, which is similar to ligamentum flavum in its high elastic content, was also effective in preventing scar formation. The operative biopsy findings at reexploration in four patients who had free fat grafts following laminectomy are presented.
Control of postlaminectomy scar formation: an experimental and clinical study.
Scar formation after laminectomy was evaluated in dogs treated with hemostatic agents, antiinflammatory drugs, or mechanical barriers. Microfibrillar collagen was found to be superior to gelatin foam. The antiinflammatory drugs delayed healing and frequently resulted in abscess formation, and eventually scar filled the defect. The fat grafts formed a viable mechanical barrier. Gelatin foam sponge was compared with microfibrillar collagen for hemostasis with free fat grafts in a clinical series of 50 patients. The latter technique was clearly superior.
Vertebral hemangioma with compression fracture and paraparesis treated with preoperative embolization and vertebral resection.
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Effects of sodium hyaluronate on peridural fibrosis after lumbar laminotomy and discectomy.
Sodium hyaluronate, 1.9% solution, was evaluated for its ability to retard peridural fibrosis after unilateral lumbar hemilaminotomy, anular fenestration, and nuclectomy in dogs. Three materials: fat grafts, gelfoam, and sodium hyaluronate, were compared with empty controls for their ability to inhibit peridural fibrosis. Each dog served as his own internal control and the formation of fibrosis was evaluated at 2, 4, 12, and 26 weeks. Sodium hyaluronate was found to inhibit fibrosis more than the other materials on both a macroscopic and microscopic level. The area of fibrosis and tenacity of the adhesions on dissection were notably less in the sodium hyaluronate group. Microscopically, the thickness of collagen and number of fibroblasts were decreased with the use of 1.9% sodium hyaluronate. The peridural fibrosis occurred equally both anteriorly and posteriorly to the nerve roots and correlated with the area of surgical dissection. Fat grafts were not effective in preventing fibrosis anteriorly, especially in the region of the exiting nerve roots. Gelfoam did not inhibit but actually appeared to increase fibrosis formation. Interposition materials currently used in humans to prevent scar formation such as gelfoam and fat grafts have only addressed the posterior scar formation, which do little to alter the fibrosis anteriorly. The adhesions between the nerve root and the anulus fibrosus bind the nerve root down anteriorly, making it more vulnerable to recurrent disc herniation. Sodium hyaluronate, 1.9% solution, with its viscous semifluid properties, coats the nerve roots and dura anteriorly and posteriorly.(ABSTRACT TRUNCATED AT 250 WORDS)
Lamina repair and replacement to control laminectomy membrane formation in dogs.
This study examined the efficacy of lamina repair by the use of various techniques to prevent postlaminectomy scar formation in a canine system. Five-level noncontiguous laminectomies were performed on six adult canines. The most caudal (Site 1) was left uncovered and served as the control. Exposed dura at each of the remaining four levels was covered with one of the following: Site 2, free autogenous laminar bone graft; Site 3, polymethylmethacrylate; Site 4, Teflon-Proplast composite; Site 5, collagen gel. The dogs used in the study were killed 16 weeks after surgery. Three specimens were examined by plain roentgenography and computerized tomography, two specimens were examined histologically, and the remaining four specimens were graded according to scar volume and scar adherence, as detected during gross dissection of the postlaminectomy scar. No repair technique interfered with roentgenography evaluation. The least scar and fewest adhesions were present under the free bone graft repair site. The Teflon-Proplast composite and polymethylmethacrylate both limited the amount and adherence of scar. Collagen gel and control sites were indistinguishable in this study. It is concluded that lamina repair with a solid material covering exposed dura significantly reduces the formation of postlaminectomy membrane and scar.
Gelfoam-induced acute quadriparesis after cervical decompression and fusion.
STUDY DESIGN: Case report. OBJECTIVE: To acknowledge a potential serious complication of Gelfoam use in enclosed space. SUMMARY OF BACKGROUND DATA: The gelatin sponge has been used for hemostasis in spine surgery. Its complication rate is very low, but it has the potential for compression of vital tissues when left next to the spinal cord within an enclosed space. METHOD: Case report. RESULTS: Retained Gelfoam sponges were found in an enclosed space next to the spinal cord. These expanded and compromised the spinal cord. CONCLUSION: There is potential for expansion of the Gelfoam sponge in enclosed spaces after spinal surgery. There is the possibility of neurologic compromise in these cases. Gelfoam should be removed.
A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery.
STUDY DESIGN: A prospective, randomized trial comparing Proceed, a gelatin-based hemostatic sealant (treatment), with Gelfoam-thrombin (control) in stopping intraoperative bleeding during spinal surgery. OBJECTIVES: To determine the effectiveness and safety of Proceed. SUMMARY OF BACKGROUND DATA: Proceed has been tested in animal models to determine its safety and effectiveness as a hemostatic agent. The current study was conducted under a Food and Drug Administration-approved Investigational Device Exemption to evaluate the effectiveness and safety of Proceed in humans. METHODS: For this study, 127 patients undergoing spinal surgery were randomized into either the treatment 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 the hemostatic agent was applied. The application was considered successful if the bleeding stopped within 10 minutes. Follow-up evaluation was performed at 12 to 36 hours, then at 6 to 8 weeks after surgery. RESULTS: Proceed stopped bleeding in 98% of the patients (first bleeding site only) within 10 minutes, as compared with 90% of the control patients (P = 0.001). At 3 minutes, successful hemostasis had been achieved in 97% of the Proceed group, as compared with 71% of the control group (P = 0.0001). There was no difference in the adverse event profile between the two groups. CONCLUSIONS: A significantly larger number of bleeding sites had achieved hemostasis with Proceed than with Gelfoam-thrombin at 1, 2, and 3 minutes after application. Proceed was as safe as Gelfoam-thrombin when used for hemostasis during spinal surgery procedures.
Autologous intervertebral disc cell implantation: a model using Psammomys obesus, the sand rat.
STUDY DESIGN: Work presented here used a small animal model to illustrate the feasibility of autologous disc cell implantation. OBJECTIVES: To develop a small animal model for autologous disc cell implantation. SUMMARY OF THE BACKGROUND DATA: The use of autologous disc cells in the potential treatment of disc degeneration offers attractive possibilities for novel therapies. Results are presented on the use of the sand rat (Psammomys obesus), a small rodent that spontaneously develops disc degeneration during aging, in experimental studies in which cells were harvested from a lumbar intervertebral disc, expanded in monolayer tissue culture, labeled with agents that allow subsequent immunolocalization of these cells, and implanted in a second disc site of the donor animal. METHODS: Tissue culture, disc surgery, histology, and immunocytochemistry were used. Cells were either engrafted in a bioresorbable carrier tested for cell compatibility or injected into the recipient disc. Results were assessed with radiographic examination of the implantation site and with histology and immunocytochemistry. CONCLUSION: Data from 15 animals were obtained with engraftment resident in the animal for up to 33 weeks. Immunocytologic identification of engrafted cells showed that they integrated into the disc and were surrounded by normal matrix at time points up to 8 months postengraftment. Engrafted cells exhibited either a spindle-shaped morphology in the annulus or a rounded chondrocyte-like morphology in the nucleus. Although technically challenging, the authors' experience showed that autologous disc cell implantation can be successful and that the sand rat is a valuable model for autologous disc cell studies.
Chemoembolization of the hepatic artery with BCNU for metastatic uveal melanoma: results of a phase II study.
Uveal melanoma is the most common primary intraocular malignancy in adults and the liver is the most common site for systemic metastases. We conducted a phase II clinical trial for patients with hepatic metastases from uveal melanoma using chemoembolization of the hepatic artery with 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) dissolved in ethiodized oil. Gelatin sponge particles were used as a transiently occlusive agent. The responses in hepatic metastases, overall survival, time to progression and side-effects related to chemoembolization were evaluated. Thirty patients were enrolled. Twenty-four patients completed at least one treatment to all targeted liver metastases and were evaluable for hepatic response. Eighteen of these 24 patients experienced regression or stabilization of hepatic metastases for at least 6 weeks (one complete response in hepatic metastases; four partial responses; 13 stable disease). One of the 13 patients with stable disease was rendered free of disease by surgical removal of metastases after chemoembolization (surgical complete response). The overall response rates (complete and partial responses) for intention-to-treat patients and for patients who were evaluable for response were 16.7 and 20.4%, respectively. The median overall survival of the entire intention-to-treat group of patients was 5.2 months (range, 0.1-27.6 months), for patients with complete or partial response in hepatic metastases 21.9 months (range, 7.4-27.6 months), for patients with stable disease 8.7 months (range, 2.9-14.4 months) and for patients with progressive disease 3.3 months (range, 1.6-5.6 months). Importantly, 13 of the 18 patients who achieved complete response, partial response or stable disease subsequently developed progression of extrahepatic metastases with control of hepatic metastases. Chemoembolization with BCNU is a useful palliative treatment for the control of hepatic metastases in uveal melanoma patients. However, progression in extrahepatic sites after stabilization of hepatic metastases requires further improvement in the therapeutic approach to this disease.
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.
Anti-adhesion properties of a thrombin-based hemostatic gelatin in a canine laminectomy model: a biomechanical, biochemical, and histologic study.
STUDY DESIGN: An in vivo study on the effects of an agent for scar prevention in a dog laminectomy model. OBJECTIVE: To examine the anti-adhesion properties of a thrombin-based hemostatic gelatin (FLOSEAL; Baxter International Inc., Deerfield, IL). SUMMARY OF BACKGROUND DATA: Postlaminectomy dural adhesion sometimes causes symptomatic problems. Although a new type of hemostatic agent, a thrombin-based hemostatic gelatin, has been developed, its effect on postlaminectomy scar prevention is unknown. METHODS: A 4-level lumbar laminectomy was performed on 11 adult mongrel dogs. There were 2 levels randomly chosen to receive the thrombin-based hemostatic gelatin treatment, while the remaining levels were untreated (control). Dogs were euthanized 8 weeks after surgery. To assess the tenacity of adhesion between the dura and scar, peel-off testing was performed. Gross, biochemical, and histologic analyses were then used to examine the samples. RESULTS: Peel-off stiffness was significantly decreased in the treatment group (64.8% of the control, P = 0.032; 2-tailed unpaired t test). Histologically, there was significantly less scar tissue formation in the treatment group (P = 0.04). The gross analyses showed a trend toward a smaller amount of scar tissue and tenacity of adhesion between the dura and scar in the treatment group. Biochemically, there was a trend toward a lower collagen cross-links content in the treatment group (P = 0.07). CONCLUSIONS: The thrombin-based hemostatic gelatin decreases the tenacity of adhesion between the dura and scar at laminectomy sites.
Cement leakage in percutaneous vertebroplasty: effect of preinjection gelfoam embolization.
STUDY DESIGN: Prospective case series. OBJECTIVES: To determine the safety and feasibility of routine preinjection of gelfoam embolization during percutaneous vertebroplasty. SUMMARY OF BACKGROUND DATA: Percutaneous vertebroplasty has been used effectively in pain relief for vertebral fractures resulting from malignancy and osteoporosis. However, cement extrusion is a common problem and can lead to complications. Gelfoam embolization of venous channels before cement injection has not been widely used as a technique to prevent leakage. METHODS: Thirty-one patients who met the inclusion-exclusion criteria for the study underwent percutaneous vertebroplasty. Venography was first performed to determine the flow pattern in the vertebrae and confirm needle placement. Next, routine gelfoam embolization of venous channels was performed. This was followed by low-pressure, minimal-volume cement injection. The outcome measure of cement leakage was assessed after surgery using radiographs and CT scans. RESULTS: There were no complications. In the 31 patients, 61 levels of vertebroplasty were performed. Overall, there were 16 leaks out of 61 levels in 12 patients (26.2%). In osteoporotic fractures, there were 11 leaks in 49 levels, giving a leakage rate of 22.5%. There was only 1 epidural leak in this group (2%), and this was asymptomatic. Seven leakages were into the adjacent disc, 2 into the body, and 1 into the paravertebral tissues. In malignant fractures, there were 5 leakages out of 12 levels (41.7%). Of these, 2 were epidural leaks (16.7%), which were asymptomatic. CONCLUSIONS: Complications resulting from leakage are the most feared side effect of the procedure. This has resulted in only limited application of vertebroplasty in the United Kingdom. Routine gelfoam embolization together with careful technique has been shown to be a safe and feasible method during vertebroplasty.
De novo grown bone on exposed implant surfaces using photodynamic therapy and recombinant human bone morphogenetic protein-2: case report.
The reconstruction of bone on exposed implant surfaces requires an almost complete elimination of attached bacteria. Only then is new bone growth possible. This case report describes a new way to kill biofilms with photodynamic therapy and to augment bone by using recombinant human bone morphogenetic protein-2. Though the new technique of bone tissue engineering causes some problems, new bone growth on uncovered implant surfaces is successful to a large extent.
Gelatin matrix treatment of complex renal injuries in a porcine model.
PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.