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Biocompatibility analysis of poly(glycerol sebacate) as a nerve guide material
Sundback, C. A., J. Y. Shyu, et al. (2005), Biomaterials 26(27): 5454-64.
Abstract: No satisfactory method currently exists for bridging neural defects. Autografts lead to inadequate functional recovery, and most available artificial neural conduits possess unfavorable swelling and pro-inflammatory characteristics. This study examined the biocompatibility of a novel biodegradable elastomer, poly(glycerol sebacate) (PGS), for neural reconstruction applications, as the material possesses favorable mechanical property and degradation characteristics. The effect of PGS on Schwann cell metabolic activity, attachment, proliferation, and apoptosis were examined in vitro in comparison with poly(lactide-co-glycolide) (PLGA), a biomaterial widely utilized for tissue engineering applications. The in vivo tissue response to PGS was compared with PLGA implanted juxtaposed to the sciatic nerve; the physical changes in the implant material were measured during the degradation process. PGS had no deleterious effect on Schwann cell metabolic activity, attachment, or proliferation, and did not induce apoptosis; the in vitro effects of PGS were similar to or superior to that of PLGA. In vivo, PGS demonstrated a favorable tissue response profile compared with PLGA, with significantly less inflammation and fibrosis and without detectable swelling during degradation. PGS is an excellent candidate material for neural reconstruction applications given its lack of in vitro Schwann cell toxicity and minimal in vivo tissue response.

Biocompatibility and degradation of poly(DL-lactic-co-glycolic acid)/calcium phosphate cement composites
Ruhe, P. Q., E. L. Hedberg, et al. (2005), J Biomed Mater Res A 74(4): 533-44.
Abstract: Injectable calcium phosphate (Ca-P) cement materials exhibit favorable osteocompatible behavior but are resorbed slowly because of a lack of a bone ingrowth-enabling macroporosity. In this study, poly(DL-lactic-co-glycolic acid) (PLGA) microparticles (average size 66 +/- 25 microm) were incorporated into Ca-P cement to obtain a macroporous Ca-P cement scaffold after PLGA hydrolysis in vivo. Preset PLGA/Ca-P cement composite discs of various weight ratios (0/100, 15/85, 30/70, and 50/50) were implanted subcutaneously and in cranial defects in rats for 12 weeks. Histological analysis revealed that all macropores in the PLGA-containing composites (average pore size 73 +/- 27 microm) were filled with fibrous tissue and blood vessels (subcutaneous implants) and/or bone (cranial implants). Histologically, bone formation appeared most abundant and most consistent in the 30/70 PLGA/Ca-P cement composites. Histomorphometrical evaluation revealed a significant increase in defect fill in the 15/85 and 30/70 PLGA/Ca-P cement composites. Finally, subcutaneous and cranial 50/50 PLGA/Ca-P cement composites had degraded to a large extent, without adequate replacement by bone in the cranial implants. Therefore, we conclude that PLGA/Ca-P cement composites enable tissue ingrowth and show excellent osteocompatibility in weight ratios of 15/85 and 30/70 PLGA/Ca-P cement. In this model, 30/70 PLGA/Ca-P cement composites showed the most favorable biological response.

Biocompatibility and recellularization potential of an acellular porcine heart valve matrix
Wilcox, H. E., S. A. Korossis, et al. (2005), J Heart Valve Dis 14(2): 228-36; discussion 236-7.
Abstract: BACKGROUND AND AIM OF THE STUDY: Tissue-engineered heart valves have the potential to overcome the limitations of present heart valve replacements. The study aim was to investigate the biocompatibility and recellularization potential of an acellular porcine valve matrix. METHODS: Acellular porcine valve matrix contact and extract cytotoxicity was tested against porcine fibroblasts and smooth muscle cells (SMC). Porcine cells were incubated with decellularized aortic valve leaflets and aortic wall, and then assessed for changes in morphology and contact inhibition of growth. Soluble tissue extracts were prepared from decellularized leaflets and aortic wall, and assessed for their effect on the viability of cultured porcine cells. Acellular leaflets were seeded with either fibroblasts or SMC at 1 x 10(3) to 1 x 10(6) cells/cm2 for 24 h, or 5 x 10(4) cells/cm2 for 1-4 weeks. Cell attachment onto, and migration into, the acellular matrix was assessed by scanning electron microscopy and histology. RESULTS: No contact inhibition of growth, or changes in fibroblast or SMC morphology, were observed following contact with the acellular valve matrix. No soluble extract cytotoxicity was found. Intermediate cell-seeding densities (2.5 x 10(4) to 7.5 x 10(4) cells/cm2) of both cell types produced confluent cell attachment; at the lowest concentration (1 x 10(3) cells/cm2) cell attachment was sparse, and at the highest (1 x 10(6) cells/cm2) it was multilayered. The SMC migrated throughout the leaflet matrix over four weeks, but there was no fibroblast migration into the matrix. CONCLUSION: The absence of contact and extract cytotoxicity indicated that the acellular valve matrix was biocompatible in vitro. The failure of porcine fibroblasts to grow on, or infiltrate into, the matrix suggested that the SMC may be the preferred cell type for future leaflet recellularization studies in the development of a tissue-engineered heart valve replacement.

Biocompatibility and stability of disulfide-crosslinked hyaluronan films
Liu, Y., X. Zheng Shu, et al. (2005), Biomaterials 26(23): 4737-46.
Abstract: Hyaluronan (HA) can be chemically modified to engineer robust materials with pre-selected mechanical properties and resorption rates that can be dictated by the intended clinical use. Disulfide-crosslinked HA films were prepared by air oxidation of thiol-modified HA, followed by treatment with 0.3% hydrogen peroxide. The degradation of the disulfide-crosslinked films in vitro was very slow (<10% in 7 days) in buffer alone and shorter (t1/2=3-5 days) in the presence of hyaluronidase (HAse). The cytocompatibility of the disulfide-crosslinked HA films was determined using two separate conditions: (i) in vitro culture of mouse fibroblasts in indirect contract with the films, and (ii) in vitro culture of fibroblasts directly on films coated with poly d-lysine. Excellent cytocompatibility was observed in murine fibroblasts that were cultured in indirect contact with thiolated HA films. Although cells were unable to attach and spread on thiolated HA films, pre-coating the thiolated HA films with poly D-lysine resulted in attachment and spreading equivalent to that observed on polystyrene. Rates of resorption in vivo were obtained by subcutaneous implantation of disulfide-crosslinked HA films into the backs of Wistar rats. Biocompatibility in vivo was determined in both subcutaneous flank and peritoneal cavity implantation of the films in Wistar rats. The disulfide-crosslinked HA films were less than 30% resorbed after 42 days in vivo, and histochemical and cytochemical analysis indicated that the films were well-tolerated with mild inflammatory response at both sites of implantation.

Biocompatibility evaluation of different alginates and alginate-based microcapsules
Orive, G., A. M. Carcaboso, et al. (2005), Biomacromolecules 6(2): 927-31.
Abstract: Biocompatibility of biomaterials and biomaterial-based medical devices is a critical issue for the long-term function on multiple therapeutic systems. In the past few years, there has been an increasing interest in producing more biocompatible biomaterials and in developing novel assays to analyze the quality of the products. In this study, a battery of in vitro techniques to assess the biocompatibility of alginates with different compositions and purities and alginate-based microcapsules is presented. Study of the protein and polyphenol content of the alginates revealed clear differences between the nonpurified and the purified alginates. A similar behavior was observed when the mitogenic activity and the tumor necrosis factor-alphasecretion induced by the alginates were assessed. Interestingly, when the latter two techniques were adapted to evaluate the different alginate microcapsules, a correlation with the results obtained for the alginate samples was observed. These results reinforce the idea of using the full battery of assays here reported to screen alginates and alginate-based microcapsules before implantation.

Biocompatibility of a bicarbonate/lactate-buffered PD fluid tested with a double-chamber cell culture system
Fusshoeller, A., J. Baehr, et al. (2005), Perit Dial Int 25(4): 387-93.
Abstract: OBJECTIVE: In peritoneal dialysis (PD), neutrally buffered PD fluids with lower concentrations of glucose degradation products (GDP) have tested superior to conventional fluids in terms of biocompatibility. However, conventional in vitro studies provoke debate because, due to the lack of subsequent equilibration with the blood, they do not resemble the true intraperitoneal situation of PD. METHODS: We established a double-chamber cell culture system with peritoneal mesothelial cells seeded on top of a permeable membrane, with a physiological buffer below. Thus adequately reflecting the in vivo equilibration pattern, we compared a conventional fluid with a neutral bicarbonate/lactate-buffered PD solution. Using an exchange pattern adapted from an 8-hour continuous ambulatory PD regimen, cell viability was assessed with an MTT assay, and cell function via constitutive and stimulated interleukin (IL)-6 release. As an indicator of potential induction of fibrosis and as a parameter of mesothelial cell integrity, respectively, transforming growth factor-beta 1 (TGF-beta1) generation and cancer antigen 125 (CA125) release were measured. RESULTS: The conventional solution significantly compromised mesothelial cell viability and function in terms of mitochondrial activity (p < 0.05) and stimulated IL-6 release (p < 0.05). The bicarbonate/lactate fluid had no effect on cell viability or IL-6 release and turned out to be equivalent to the properties of the growth medium. Whereas lactate-incubated cells did not respond to IL-1beta stimulation, bicarbonate/lactate-treated cells adequately increased IL-6 release after stimulation (p < 0.0005). Release of TGF-beta1 and CA125 did not differ between the different fluids and the control. CONCLUSIONS: Due to the sustained equilibration process, the double-chamber cell culture model allows a more realistic insight into mesothelial cell viability and function in terms of PD. As in classic in vitro studies, an adverse effect of conventional PD solutions on mesothelial cells was overt in the present cell culture system. The neutral bicarbonate/lactate-buffered fluid with low GDP content, however, did not interfere with mesothelial cell vitality or function, indicating superior biocompatibility.

Biocompatibility of a nonpenetrating synthetic cornea in vascularized rabbit corneas
Stoiber, J., V. Fernandez, et al. (2005), Cornea 24(4): 467-73.
Abstract: PURPOSE: This study was designed to assess feasibility and biocompatibility of a lamellar, nonperforating supraDescemetic Synthetic Cornea (sDSC) implanted in rabbit eyes after a corneal injury. METHODS: Corneal vascularization and scarring was induced in the right eye of 15 rabbits by application of 1-heptanol and complete surgical removal of the limbus. An sDSC (7-mm diameter, 450-microm-thick optical zone, 100-microm-thick outer flange) was implanted after 45 +/- 5 days. The keratoprostheses were implanted with their central optic part positioned on a completely exposed Descemet's membrane (DM) while the outer flange was located in deep stroma. Three different materials were tested: hydrophobic PMMA (n = 5) and hydrophilic HEMA-MMA (n = 5) and HEMA-NVP (n = 5) with a water content of 34% and 75%, respectively. The corneal surface was covered with a conjunctiva-Tenon flap. Central flap trephination was performed after 63 +/- 7 days. DM vascularization and scarring was assessed and graded after flap opening and weekly thereafter. RESULTS: In all 15 consecutive cases implantation could be completed successfully without perforation of DM. Repair of the conjunctival flap had to be performed in five rabbits. Four months postoperatively, the flaps were opened. Four of five corneas (80%) with a PMMA implant and three of five (60%) with a HEMA-NVP75 implant had retained their original transparency. The others had developed significant neovascularization in the Descemet-sDSC optic interface. All corneas (100%) that received an sDSC made of HEMA-MMA34 displayed a completely clear DM without any vessels or scarring. DM was found firmly attached to the posterior surface of the optic. CONCLUSION: Implantation of a nonperforating synthetic cornea on top of an exposed DM is feasible. HEMA-MMA34 showed the most promising results. Because opening of the anterior chamber is not required, a lamellar supraDescemetic Synthetic Cornea would theoretically reduce some of the risks attributed to penetrating keratoprostheses.

Biocompatibility of a xenogenic elastin-based biomaterial in a murine implantation model: the role of aluminum chloride pretreatment
Hinds, M. T., D. W. Courtman, et al. (2004), J Biomed Mater Res A 69(1): 55-64.
Abstract: We have investigated the long-term effect of aluminum chloride (AlCl(3)) treatment on the calcification and inflammatory reaction of a porcine elastin-derived biomaterial (PEB) in a novel subdermal adult mouse model. Untreated PEB disks and PEB treated with AlCl(3) were implanted subdermally in BALB/c mice for 30, 60, and 180 days. The calcification of the elastin disks was examined with histological analysis and atomic absorption analysis of calcium content. The inflammatory reaction was evaluated both with histological analysis of explants and by an enzyme-linked immunosorbent assay of the serum in each mouse to determine the production of antielastin antibodies. Robust calcification was evident in all untreated PEBs with calcium levels of 107.1 +/- 11.8, 151.4 +/- 14.4, and 227.2 +/- 23.8 microg/mg for 30, 60, and 180 days, respectively. AlCl(3) treatment only temporarily prevented the calcification of the elastin disks for 30 days. By 60 and 180 days, the AlCl(3)-treated materials had significant calcification with 88.7 +/- 17.4 and 105.3 +/- 27.0 microg/mg calcium, respectively. The inflammatory reaction was moderate for both types of implants. The AlCl(3)-treated implants displayed significantly more macrophage and lymphocyte infiltration at 180 days after implantation, and a trend to higher humoral responses at 30 and 60 days when compared with untreated PEBs. We conclude that PEBs extensively calcify in the adult mice model. AlCl(3) treatment of elastin enhances the long-term immunological response to xenogenic elastin implants and merely delays the onset of calcification.

Biocompatibility of alginate
Wandrey, C. (2004), Artif Cells Blood Substit Immobil Biotechnol 32(4): 503-5; author reply 506-8.

Biocompatibility of EDTA, EGTA and citric acid
Sousa, S. M., C. M. Bramante, et al. (2005), Braz Dent J 16(1): 3-8.
Abstract: This in vivo study evaluated, through the physicochemical assay method for quantification of enhanced vascular permeability, the irritating potential of EDTA, EGTA, citric acid and saline. Thirty-two male Wister rats were anesthetized and four experimental sites were demarcated on their backs. Injections of 2% Evans blue (20 mg/kg) were administered intravenously into the lateral caudal vein. The test solutions were immediately injected intradermally (0.01 mL) into the experimental sites. The animals were killed 30 min, 1, 3 and 6 h after injection of the solutions and each piece of skin was submerged in formamide and incubated at 45 masculineC for 72 h. After filtration, the optical density was measured in a spectrophotometer and the total amount of dye extracted from the samples was calculated by means of a standard calibration curve. Data were analyzed statistically by two-way ANOVA and Tukey's HSD test. Compared to control, EDTA had the greatest volume of dye followed by EGTA and citric acid, for all time periods. There were statistically significant differences between all solutions (p<0.01). Considering the periods assessed, a significant difference was observed between the 3- and 6-h groups (p<0.05), but not between the 30-min and 1-h groups. Among the organic acids evaluated in this study, citric acid yielded the lowest amount of extracted dye. This indicates that the citric acid was the least irritating solution.

Biocompatibility of poloxamer hydrogel as an injectable intraocular lens: a pilot study
Kwon, J. W., Y. K. Han, et al. (2005), J Cataract Refract Surg 31(3): 607-13.
Abstract: PURPOSE: To induce irreversible gelation of poloxamer, a thermosensitive polymer hydrogel, by using a photoinitiator and ultraviolet (UV) irradiation and to verify the biocompatibility and use of poloxamer as an injectable intraocular lens (IOL) material. SETTING: Department of Ophthalmology, Seoul National University College of Medicine, Seoul Artificial Eye Center, Clinical Research Institute, Seoul National University Hospital, Seoul, Korea. METHODS: In 10 rabbits, endocapsular phacoemulsification was performed and a poloxamer-photoinitiator mixture was injected into the capsular bag through a small capsulorhexis site. In 1 eye, the capsulorhexis site was closed with a small plug and the entire eye was irradiated with UV light for 5 minutes. Postoperatively, poloxamer transparency and effect on the conjunctiva, cornea, iris, vitreous, and retina were observed. RESULTS: A mixture comprising 25% poloxamer and 0.01% photoinitiator produced a poloxamer that remained transparent in the lens capsule for up to 6 months. No inflammatory response or toxicity was observed in the conjunctiva, cornea, iris, vitreous, or retina. CONCLUSION: Poloxamer is a potentially suitable material for an injectable IOL. Further study is needed.

Biocompatibility of poly(carbonate urethane)s with various degrees of nanophase separation
Hsu, S. H. and Y. C. Kao (2005), Macromol Biosci 5(3): 246-53.
Abstract: Nanophase separation has been suggested to influence the biological performance of polyurethane. In a previous work, six different 4,4'-diphenylmethane diisocyanate (MDI)-based poly(carbonate urethane)s (PCUs) that exhibited various degrees of nanophase separation were synthesized and characterized. In the present work, these PCUs were used as a model system to study the effect of nanometric structures on the biocompatibility of polyurethane. Human blood platelet activation, monocyte activation, protein adsorption, and bacterial adhesion on PCU were investigated in vitro. It was found that human blood platelets as well as monocytes were less activated on the PCU surfaces with a greater degree of nanophase separation in general. This phenomenon was closely associated with the lower ratio of human fibrinogen/albumin competitively adsorbed on these surfaces. Bacterial adhesion was also inhibited in some nanophase-separated PCUs. [diagram in text].

Biocompatibility of Poly(epsilon-caprolactone) scaffold modified by chitosan--the fibroblasts proliferation in vitro
Mei, N., G. Chen, et al. (2005), J Biomater Appl 19(4): 323-39.
Abstract: In this study, the surface of poly(epsilon-caprolactone) (PCL) scaffold was modified by chitosan (CS) in order to enhance its cell affinity and biocompatibility. It is demonstrated by scanning electronic microscopy (SEM) that when 0.5-2.0 wt% chitosan solutions are used to modify the PCL scaffold, the amount of adhesion of the fibroblasts on the chitosan-modified PCL scaffolds dramatically increase when compared to the control after 7 days cell culture. The results indicate that the chitosan-modified PCL scaffolds are more favorable for cell proliferation by improving the scaffold biocompatibility. The improvement may be helpful for the extensive applications of PCL scaffold in heart valve and blood vessel tissue engineering.

Biocompatibility of thermosensitive chitosan-based hydrogels: an in vivo experimental approach to injectable biomaterials
Molinaro, G., J. C. Leroux, et al. (2002), Biomaterials 23(13): 2717-22.
Abstract: Chitosan, an amino-polysaccharide obtained from the alkaline deacetylation of chitin, presents an interest as a drug vehicle. Indeed, chitosan solutions containing glycerol-2-phosphate (beta-GP) undergo sol-gel transition at a temperature close to 37 degrees C, which make them suitable for the parenteral administration of drugs. However, before using these chitosan derivatives for biomedical applications, it is important to evaluate their biocompatibility, and particularly to test their inflammatory effects. When injected in the hindpaw of the rat, we have shown that: (i) four chitosan/beta-GP solutions tested triggered a non-specific response, with solutions prepared with chitosans of higher deacetylation degrees yielding a lesser inflammatory reaction and (ii) systemic pretreatment of animals with icatibant, apafant and diphenhydramine did not significantly diminish this response; dexamethasone practically abolished it for all solutions and ketanserine only slightly decreased it in one preparation at two different times. In conclusion, it appears that a higher degree of deacetylation of the chitin chain is desirable for superior biocompatibility.

Biocompatibility of vitallium as ossicular reconstruction material in the middle ear: experimental animal study
Ulku, C. H., M. C. Avunduk, et al. (2005), Acta Otolaryngol 125(1): 38-42.
Abstract: CONCLUSION: Although long-term data will be necessary for confirmation, the result of this preliminary study indicates that vitallium may be a good alternative material for ossicular replacement prostheses in the middle ear. OBJECTIVES: To investigate the biocompatibility of vitallium (Co-Cr-Mo) as ossicular reconstruction material in the rabbit middle ear, and to compare the results with those obtained with titanium, well known as a highly biocompatible material, and non-implanted control groups. MATERIAL AND METHODS: Eighteen female New Zealand White rabbits were anesthetized. The tympanomeatal flap was elevated and 12 vitallium and 12 titanium implants were placed in the bulla away from the ossicles in 24 middle ears. Six rabbits were used as non-implanted controls. All animals were sacrificed under general anesthesia on the 180th day after implantation. The temporal bones were removed, fixed in 10% buffered paraformaldehyde and decalcified for a week in EDTA. Tissue samples were then prepared using an Autotechnicon and embedded in paraffin. Sections (30-microm thick) were cut with a microtome, stained with hematoxylin-eosin, von Gieson's stain and fibroblast growth factor (FGF) and examined under a light microscope. The numbers of lymphocytes, collagen fibers and FGF-positive cells were determined in all three groups. RESULTS: There was no significant difference in the numbers of collagen fibers between the groups (p > 0.05). No significant differences were found in the numbers of lymphocytes and FGF-positive cells between the titanium and vitallium groups (p > 0.05). The differences in the numbers of lymphocytes and FGF-positive cells between the control and other groups were found to be significant (p <0.05).

Biocompatibility screening in cardiovascular implants
Sigler, M., T. Paul, et al. (2005), Z Kardiol 94(6): 383-91.
Abstract: BACKGROUND: Interest in information on biocompatibility of implants is increasing. The purpose of this paper is to discuss methods and results of pathological biocompatibility screening of explanted cardiovascular implants. METHODS: Use of standard histology after embedding in paraffin is limited since metallic implants have to be removed during workup with disruption of the specimen. Alternatively, tissue blocks containing an implant can be embedded in methylmethacrylate or hydroxyethylmethacrylate and processed by sectioning with a diamond cutter and grinding, thus leaving the implant in situ and saving the tissue/implant interface for detection of local inflammatory reactions. Another important aspect of evaluation is the progress of thrombus organisation after initial fibrin clotting on the metal surface or in the inner part of occlusion devices. New methacrylate resins and embedding techniques allow for specific immunohistochemical staining of the specimen thus enabling characterisation of tissues surrounding the implant. Information on endothelialisation of the vascular surface of the implant can be obtained by means of immunohistochemistry or by scanning electron microscopy. RESULTS: Illustrating the use of these technologies, we demonstrate findings in tissue specimens from animal studies with different types of devices (i.e. stents, occlusion devices). We present corresponding findings in human specimens with implants that were removed during corrective surgery for congenital heart defects. Early endothelialisation of the vascular surface was seen after implantation in all types of devices. Cells within occlusion devices could be characterised histologically and immunohistochemically as fibromuscular cells as seen in intimal hyperplasia after stent implantation. Inflammatory implant-host reactions ranged from mild to moderate (medical grade stainless steel, nitinol) to severe (polytetrafluoroethylene [PTFE]). CONCLUSIONS: With an optimal work-up of cardiovascular implants, ingrowth and endothelialisation as well as inflammatory reactions in the surrounding tissue can be assessed. This information allows evaluation of individual tissue reactions to the implant and may serve as valuable basis for optimisation of biocompatibility by implant modification.

Biocompatibility study of polymeric biomaterials
Rogero, S. O., S. M. Malmonge, et al. (2003), Artif Organs 27(5): 424-7.
Abstract: Polymeric hydrogels are used as wound dressing material since these materials show advantages such as pain relief, exudates absorption, barrier to microorganisms, permeability, and others. This article shows the results obtained in a study aiming to know the biological performance of different polymeric materials to be used in contact with skin: PVP hydrogels and acrylate adhesive. The biocompatibility was determined by in vitro assay of cytotoxicity and in vivo assay by using the contact test of irritability in rabbits. All the tested samples presented no toxicity and no dermal irritation.

Biocompatibility: the interaction of biomaterials and host response
Gross, U. M. (1988), Int J Oral Implantol 5(1): 37-8.

Biocompatibility--the interaction of biomaterials and host response
Gross, U. M. (1988), J Dent Educ 52(12): 798-803.
Abstract: Future developments for better biocompatibility of dental implants are possible and are discussed here. On each level of local host response, which is subdivided into four phases, improvements of knowledge in basic mechanisms concerning the interaction of biomaterial and host are necessary. For the development of new biomaterials, the limits for load with foreign ions and particles acting on cellular and extracellular matrix should be determined. An example is given for ZrO2-containing glass ceramics. Biochemistry of soft and hard tissue bonding to biomaterials should be investigated. Biomechanical properties of implants could be adapted to individual needs of patients. New composite materials are candidates for the design of long-term functioning implants.

Biocompatible hemodialysis membranes for acute renal failure
Alonso, A., J. Lau, et al. (2005), Cochrane Database Syst Rev(2): CD005283.
Abstract: BACKGROUND: Acute renal failure (ARF) is associated with substantial morbidity and mortality. Some trials have reported a survival advantage among patients dialyzed with biocompatible membranes (BCM) compared to bioincompatible membranes (BICM). These findings were not consistently observed in subsequent studies. OBJECTIVES: To ascertain whether the use of BCM confers an advantage in either survival or recovery of renal function over the use of BICM in adult patients with ARF requiring intermittent hemodialysis. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, in The Cochrane Library - Issue 1, 2004), MEDLINE (1966 to January 2004), EMBASE (1980 to January 2004), the Mexican Index of Latin American Biomedical Journals IMBIOMED (1990 to January 2004), the Latin American and Caribbean Health Sciences Literature Database LILACS (1982 to January 2004), and reference lists of articles. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials comparing the use of a BCM with a BICM in patients > 18 years of age with ARF requiring intermittent hemodialysis. DATA COLLECTION AND ANALYSIS: Two authors extracted the data independently. Cellulose-derived dialysis membranes were classified as BICM, and synthetic dialyzers were considered as BCM. The main outcomes were all-cause mortality and recovery of renal function by type of dialyzer. We further explored these outcomes according to the flux properties (high-flux or low-flux) of each of these dialyzers. A meta-analysis was conducted by combining data using a random-effects model. MAIN RESULTS: Nine studies were included in the primary analysis of mortality, with a total of 1062 patients. None of the pooled RR's reached statistical significance. The pooled relative risk (RR) for mortality was 0.93 (95% confidence interval (CI) = 0.81 to 1.07). The overall RR for recovery of renal function, inclusive of 1038 patients from nine studies was 1.09 (95% CI 0.90 to 1.31). The pooled RR for mortality by dialyzer flux property was 1.03 (95% CI 0.82 to 1.30). The RR for recovery of renal function by flux property was 0.85 (95% CI 0.55 to 1.31). A meta-analysis of mortality of kidney transplant recipients was not possible, but the analysis of recovery of renal function in this patient population was 1.09 (95% CI 0.91to 1.31). Results of sensitivity analyses did not differ significantly from the primary analyses. AUTHORS' CONCLUSIONS: There is no demonstrable clinical advantage to the use of BCM versus BICM in patients with ARF who require intermittent hemodialysis.

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