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Tissue reaction to middle ear prostheses: in vivo observation (rabbit ear lobe) of polyethylene tube, stainless steel wire and absorbable gelatin sponge used in middle ear surgery.

Over the past ten years, polyethylene tube, stainless steel wire and absorbable gelatin sponge have come to be used in middle ear surgery. A modified Williams' steel chamber with a transparent central area was embedded in a rabbit ear lobe surgically, and cross-sectioned polyethylene tube, stainless steel wire or absorbable gelatin sponge were inserted respectively. The in vivo tissue reaction to each of these installed materials was observed daily microscopically. Finally, in the case of both the cross-sectioned polyethylene tube and the stainless steel wire, the chambers were fixed with 10% formalin solution and the contents stained for histological study. The results were as follows: Absorbable gelatin sponge was absorbed completely by phagocytosis in 62 days. Polyethylene tube was encapsulated by a layer of fibroblasts by day 110 in one case and by day 140 in another case; these findings were confirmed histologically on day 110 and 281. Almost all the surface of the stainless steel wire was encapsulated by a layer consisting of giant cells, on which a dense fibrous layer was superimposed by day 82. It is concluded that polyethylene tube, stainless steel wire, and absorbable gelatin sponge should be well tolerated in middle ear surgery.

Absorption

Patulous Eustachian tube. A new treatment with infusion of absorbable gelatin sponge solution.

For the treatment of abnormally patent Eustachian tube, we had previously employed repeated tubal insufflation of salicylic acid-boric powder (1:4) through a Eustachian tube catheter. Such treatments, however, usually were associated with uncertain results and numerous complications. Therefore, treatment of this condition was changed to employment of an infusion of absorbable gelatin sponge solution directly into the Eustachian tube. Twenty-two ears in 16 patients recovered successfully when this method was used.

Adult

Alternatives to packing in septorhinoplasty.

Nasal packing is considered routine by most physicians and patients at the completion of nasal and septal surgery. Yet the rationale for this maneuver is not clearly defined by reported investigation or logical analysis. We discuss 75 consecutive nasal surgical procedures completed without packing. There were two postoperative episodes of bleeding, both from pyriform aperture incisions for lateral osteotomy and both managed in the recovery room with an absorbable gelatin sponge. Technical refinements such as scrupulous preoperative history taking, through-and-through suturing of the entire septal flaps, small-caliber osteotomy, meticulous closure of all intranasal incisions, and proper application of a conforming dressing are essential for hemostasis. We offer specific procedural guidance to minimize the risk of postoperative nasal bleeding.

Adolescent

Esophagogastric variceal hemorrhage: its treatment by percutaneous transephatic coronary vein occlusion.

The angiographic technique percutaneous transhepatic coronary vein occlusion was used to treat esophagogastric variceal bleeding in 38 patients. There were two categories of patients: those actively bleeding who had not been controlled by continuous vasopressin infusion and/or Blakemore tube tamponade, and those with portal hypertension who were not actively bleeding at the time of transhepatic portal venography but who were at high risk for recurrent variceal hemorrhage. Coronary vein occlusion was achieved in 33 patients by (1) metal clip and cotton devices(one); (2) balloon catheter occlusion (two); (3) heat-treated autogenous clot and powdered absorbable gelatin sponge (Gelfoam) (13); and (4) Gelfoam strips soaked in sodium tetradecyl sulfate (17). Percutaneous coronary vein occlusion was effective in controlling 81% of the patients with actively bleeding varices. In patients who were not actively bleeding, percutaneous transhepatic coronary vein occlusion seemed to afford good protection for recurrent variceal hemorrhage.

Coronary Vessels

Transcatheter embolization of traumatic renal arteriovenous fistula.

An iatrogenic renal arteriovenous fistula was treated by transcatheter embolization with particles of absorbable gelatin sponge. Recurrent massive hematuria was successfully controlled. The procedure was easily accomplished with minimal loss of renal parenchyma. Surgery, which usually requires partial or total nephrectomy, was avoided.

Adult

Treatment of uncontrolled hypertension by therapeutic renal infarction.

Certain hemodialysis patients need to be made anephric, either surgically or physiologically. Bilateral renal infarction with shredded absorbable gelatin sponge (Gelfoam) was performed on a woman with malignant hypertension being maintained on chronic center dialysis who was too great a surgical risk for bilateral nephrectomy. Peripheral embolization complicated the procedure resulting in a forefoot amputation for dry gangrene two months later. Her postinfarction peripheral plasma renins remained elevated, and she remained hypertensive but was more easily managed with fewer drugs. This technique has been successfully used by others in 1 patient with chronic renal failure and heavy proteinuria and another with hypertension and a solitary kidney. If, as in our case, postinfarction plasma renins remain elevated and hypertension persists, bilateral nephrectomy could be performed at a later date or infarction could be repeated.

Adult

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

Treatment of carcinoid liver metastases by hepatic-artery embolisation.

Two patients with multiple hepatic carcinoid metastases experienced considerable symptomatic relief after the hepatic artery was embolised with fragments of absorbable gelatin sponge administered through a percutaneous arterial catheter. With adequate pharmacological cover the technique is a safe, effective, and relatively painless treatment for a condition which is usually very difficult to manage.

Adult

Spinal cord infarction following therapeutic renal artery embolization.

A patient with dialysis cachexia became paraparetic within hours of therapeutic renal artery embolization. At autopsy, emboli of absorbable gelatin sponge filled spinal arteries, accompanied by spinal cord infarcts. The renal arteries of patients with end-stage renal disease are smaller than normal becaue of intimal fibrosis associated with prolonged dialysis. Embolic material can reflux more readily in these patients than in patients with renal tumors.

Adult

Antibacterial activity of oxidized regenerated cellulose.

It has been demonstrated that oxidized regenerated cellulose promptly and markedly reduces the bacterial census of ten different strains of common pathogens when exposed to them in vitro. This was not true of two other hemostatic agents tested, namely, absorbable gelatin sponge and topical thrombin. Wounds in guinea pigs in which oxidized regenerated cellulose was placed and infected with one of three pathogens had healing per primum in 39 of 40 instances. In similar control wounds and incisions in which absorbable gelatin sponge was placed, sepsis of the wound developed in 19 of 20 of the control group and in 39 of 40 guinea pigs in the absorbable gelatin sponge group.

Animals

Sterile mediastinal gas mimicking abscess in aortic aneurysm repair.

Six weeks after aortic aneurysm repair, computed tomography (CT) showed mediastinal gas where absorbable gelatin sponge (Gelfoam) was used. A leukocyte scan labeled with indium 111, however, was normal and surgical exploration showed no infection. Sterile gas collections may be seen following absorbable gelatin sponge use many weeks after surgery and 111In-labeled leukocyte scanning may be a useful differential test.

Abscess

Poststapedectomy otitis media and meningitis.

A patient developed acute otitis media, labyrinthitis, and meningitis 16 months after a stapedectomy operation, and 14 similar cases have been collected from the literature. Poststapedectomy otitis media carries an increased risk of labyrinthitis and meningitis and requires prompt antibiotic therapy and regular observation until cured. Should labyrinthitis occur, with or without meningitis, fistula repair must be undertaken as soon as the infection is eliminated. All stapedectomy patients require regular supervision, and must report for urgent treatment if symptoms of otitis media or perilymph fistula occur. Stapedectomy techniques should not employ sharp bevelled prostheses, and autogenous tissue grafts are probably superior to an absorbable gelatin sponge in protecting the inner ear. Eustachian tube problems and recurring or chronic upper-respiratory tract infections can predispose to middle ear infection and are thus contraindications to stapedectomy.

Adult

Brain biocompatibility of a biodegradable, controlled-release polymer in rats.

We report the biocompatibility in the rat brain of a controlled-release, biodegradable polymer, the polyanhydride poly-[bis(p-carboxyphenoxy)propane-sebacic acid] copolymer (PCPP-SA) in a 20:80 formulation. The biodegradable polyanhydride can be used for drug delivery directly into the brain, circumventing the difficulties posed by the blood-brain barrier and avoiding the consequences of having to administer toxic doses systematically to reach therapeutic doses in the central nervous system. The tissue reaction in the presence of PCPP-SA was compared to that seen with other standard neurosurgical implants. Fifty-six adult Sprague-Dawley rats were assigned to one of seven groups and underwent bilateral frontal lobe implantation of PCPP-SA (42 hemispheres), Surgicel (oxidized regenerated cellulose) (35 hemispheres), or Gelfoam (absorbable gelatin sponge) (35 hemispheres). None of the animals showed any behavioral changes or neurological deficits suggestive of either systemic or localized toxicity from the biodegradable polyanhydride, all surviving to the scheduled data of sacrifice. PCPP-SA evoked a well localized inflammatory reaction, comparable to that of Surgicel, which resolved as the PCPP-SA polymer degraded over five weeks. The biodegradable polyanhydride has been shown in this study to be nontoxic and biocompatible in the rat brain, when compared to standard neurosurgical implants.

Animals

Use of methylene blue and selective embolization of the pudendal artery for high flow priapism refractory to medical and surgical treatments.

High flow priapism is often treated effectively with intracavernous vasoconstrictive agents or surgical shunting. If these maneuvers fail treatment is unclear. A 21-year-old black man, who had failed previous pharmacological and surgical therapies, temporarily (8 hours) responded to intracavernous methylene blue, which is known to antagonize endothelial derived relaxation factor. Recurrent priapism was managed successfully by embolization of the left internal pudendal artery with absorbable gelatin sponge. Review of the literature reveals that only 7 patients have been managed with arterial embolization and our case represents the first in which intracavernous methylene blue produced detumescence.

Adult

Treatment of hypersplenism by embolus placement in the splenic artery.

In a patient with liver cirrhosis and severe hypersplenism resistent to corticosteroids splenectomy was attempted but proved impossible. Embolisation of the splenic artery with tiny fragments of absorbable gelatin sponge induced gradual restitution of haematological function to normal after 6 wk. Abdominal pain, paralytic ileus of short duration, transient pyrexia, and pleural effusion ensued but were well tolerated. The patient has remained well, 2 1/2 mo later. It is suggested that this simple method may prove rewarding and could safely be used, if necessary, more than once in patients for whom other treatments are unsuitable or have failed.

Angiography

Biocompatibility of a biodegradable, controlled-release polymer in the rabbit brain.

The biodegradable polyanhydrides are a new class of controlled release polymers developed for the interstitial delivery of drugs to their target site in the brain or other organs over periods ranging from days to years. These polymers can release molecules of any size in a predictable fashion. Their degradation products are non-cytotoxic and biocompatible. The biocompatibility of a biodegradable polyanhydride, the copolymer of poly[bis(p-carboxyphenoxy)propane] anhydride and sebacic acid (PCPP-SA) in a 50:50 formulation, was studied in the rabbit brain. Twenty adult New Zealand White male rabbits underwent implantation of PCPP-SA in a frontal lobe and absorbable gelatin sponge (Gelfoam) in the other frontal lobe. The animals were evaluated daily until the time of sacrifice. Groups of four animals were sacrificed sequentially on post-operative days 1, 3, 7, 21, and 60, and the brains processed for histological evaluation. None of the animals showed behavioral changes or neurological deficits suggestive of toxicity and all that received implants survived to their date of sacrifice. The histological examination showed no significant differences between the tissue reaction from PCPP-SA compared to Gelfoam. The polymers were also tested in the rabbit cornea bioassay and did not induce an inflammatory response. We conclude that PCPP-SA (50:50), a new biodegradable polymeric matrix that can be surgically implanted for the interstitial delivery of drugs in the brain, is biocompatible in the rabbit brain.

Animals