A randomized trial of polyurethane and silicone percutaneous endoscopic gastrostomy catheters

Abstract

INTRODUCTIONPercutaneous endoscopic gastrostomy (PEG) catheters are increasingly used to facilitate long-term enteral feeding in patients unable to eat. Their safety pro®le and performance is generally good and the general condition of patients, particularly their weight, is improved in those who cannot be fed otherwise. 1±3 In many patients, feeding through a PEG catheter is a permanent solution for their feeding problems. It can be employed both in an institutional setting and at home with proper instruction and care. 4 When PEG feeding is used as a de®nitive treatment modality, good long-term functioning and a low incidence of PEG-related complications are important features. A wide selection of PEG catheters, mostly made of polyurethane or silicone, are available. Claims regarding the longevity and safety of the different materials used in PEG catheters have not so far been tested in clinical practice. We performed a randomized trial to compare two PEG catheters which were similar in design, but one was made of polyurethane and the other of silicone. These catheters were compared with regard to PEG-related complications and PEG survival. PATIENTS AND METHODSThis study was performed in a non-university teaching hospital, where three experienced gastroenterologists SUMMARY Background: No data are available on differences in complication rate and long-term functioning between polyurethane and silicone percutaneous endoscopic gastrostomy (PEG) catheters. Methods: We randomized patients who quali®ed for PEG placement to receive either a polyurethane or silicone PEG catheter. Patients were prospectively monitored for 28 days after placement for the occurrence of complications. Data on long-term PEG survival were obtained retrospectively from the Hospital and general practitioner's medical records. Results: One hundred and six patients were randomized (polyurethane 50, silicone 56). During the ®rst four weeks of follow-up, major complications occurred twice

Multidisciplinary Practical Guidelines for Gastrointestinal Access for Enteral Nutrition and Decompression From the Society of Interventional Radiology and American Gastroenterological Association (AGA) Institute, With Endorsement by Canadian Interventional Radiological Association (CIRA) and Cardiovascular and Interventional Radiological Society of Europe (CIRSE)

“…That was supported by a well designed prospective randomized study (154) that also demonstrated greater patency and structural integrity of polyurethane gastrostomy tubes. However, in another prospective study, Van Den Hazel et al (155) showed no difference in long-term patency and complications between polyurethane and silicone tubes. In addition, silicone tubes were found to be prone to fungal colonization, resulting in material degradation and tube occlusion (156).…”

Clinical Trial: A Randomized Study Comparing the Durability of Silicone and Latex Percutaneous Endoscopic Gastrostomy Tubes

“…The two randomized studies that compared silicone PEG tubes with polyurethane PEG tubes did not reveal differences in durability. 11,14 However, two published studies 11,13 found that silicone tubes are more susceptible to deterioration related to fungal colonization, a parameter that was not evaluated in the present study. Therefore, we are unable to conclude whether the lower durability of the latex PEG tubes was related to biological factors or to the physical characteristics of the latex.…”

“…Van Den Hazel et al 14 and Blacka et al 11 reported higher complication rates among patients who had silicone PEG tubes compared with polyurethane PEG tubes, a finding that was not reported by Sartori et al 13 The present study evaluated peristomal infection rates, granulated tissue formation, and leakage. No differences were found between the two types of tubes in these parameters, indicating that both tubes can be used with equal safety levels, at least with short follow-up periods.…”

Applications and challenges of using 3D printed implants for the treatment of birth defects

“…The main polymer implant material used in the fabrication of the G-tube is silicone, and now new polymers such as polyurethane are being explored (DeLegge & DeLegge, 2005). Recent studies comparing two types of G-tubes made with either polyurethane or silicone, demonstrate the longer lifetime of polyurethane based implants (lasting for 916 days), compared to silicone-based implants (lasting for 354 days) (Van Den Hazel, Mulder, Den Hartog, Thies, & Westhof, 2000). However, both high biocompatibility and flexibility are still remarkable advantages provided by siliconebased materials in biomedical devices, therefore, new research directions involving the development of new silicone and polyurethane copolymers are currently ongoing (DeLegge & DeLegge, 2005).…”