Medical Devices; General and Plastic Surgery Devices; Classification of the Non-Absorbable, Hemostatic Gauze for Temporary Internal Use. Final order.

The Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non-absorbable, hemostatic gauze for temporary internal use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Biologic dressing in burns.

Advances in cellular biology and knowledge in wound healing and growth factors have given us a wide variety of choices to attack the problem of the complex burn wound. Split-thickness skin grafting with autograft is at present the standard of care. It, however, is not an ideal substitute and frequently is not available for full-burn coverage. This article will review honey, human amnion, xenograft, allograft, cultured epithelial autograft, and various engineered commercial products for use in the biologic treatment of burn wounds.

Prevention and management of outpatient pediatric burns.

Burns are common injuries in the pediatric population, with an estimated 250,000 pediatric burn patients seeking medical care annually. A relative few require inpatient management. This article discusses suggestions for burn prevention, as well as acute burn care and long-term management of small burns.

Evaluación in vitro de las propiedades de seis apósitos para la cura en ambiente húmedo de heridas exudativas / Evaluation in vitro of the properties of six dressings for the healing wet environments of exudative wounds

Introducción: Dentro de los apósitos destinados a la cura en ambiente húmedo,las espumas constituyen un tipo de apósito especialmente indicadopara el tratamiento de heridas altamente exudativas debido a su gran capacidadde absorción. Son apósitos atraumáticos que protegen la zona perilesionaly mantienen el lecho húmedo favoreciendo la epitelización y aliviandoel dolor, por lo que ocupan un espacio muy específico en el cuidado de lasúlceras vasculares y por presión. Material y método: Estudio experimentalin vitro para evaluar las características de 6 tipos de apósitos de espuma polimérica:SKINFOAM no adhesivo (SF1) y adhesivo (SF2), ALLEVYN noadhesivo (A1) y adhesivo (A2) y BIATAIN no adhesivo (B1) y adhesivo(B2). Las características valoradas fueron: capacidad de absorción y controlde exudados, caracterización de la superficie en contacto, capacidad de transpiración,conformabilidad y protección antimicrobiana. Resultados: Laspruebas de absorción y control de exudados muestran cómo los apósitosSF1 y SF2 obtienen la mayor absorción por unidad de peso mientras quelos modelos B1 y B2 se deforman de manera evidente; incluso en el casodel apósito adhesivo B2 la almohadilla de foam se despegó del film adhesivo.El experimento por goteo no pudo realizarse con los apósitos A1 y A2por no retener las gotas de solución, ya que la capa adherente de contactointerna evita la retención. Las medidas de rugosidad mostraron la excelentesuavidad de los apósitos SF1 y SF2, comportamiento que influirá directamentesobre el síntoma del dolor. Las tasas de transpiración de vapor deagua, más altas, particularmente para los modelos adhesivos, fueron paralos apósitos SF2 y B1. El apósito más fácilmente extensible fue el SF1 y laprotección bacteriana fue similar en todos los apósitos. Conclusiones: Losresultados muestran que los apósitos SF1 entre los no adhesivos y SF2 entrelos adhesivos (modelos SKINFOAM) son los que mejor comportamientoglobal tienen de las propiedades estudiadas. Respecto a los otros modelos,cabe destacar la capacidad de absorción por unidad de superficie de los modelosA1 y B2, la retención de exudados bajo presión y la mínima cantidadde agua libre del modelo B1 y los resultados en la prueba de transpiración del modelo A2 (AU)

Introduction: Of the dressings used for healing in wet environments, foam is a typeof dressing that is particularly indicated for the treatment of highly exudativewounds due to its great absorption capacity. They are atraumatic dressings that protectthe perilesional area and keep the bed moist promoting epithelialization andproviding pain relief, thus occupying a very specific space in the care of vascular andpressure ulcers. Material and method: In vitro experimental study to evaluate thecharacteristics of 6 types of polymeric foam dressings: Non-adhesive (SF1) and adhesive(SF2) SKINFOAM, non-adhesive (A1) and adhesive (A2) ALLEVYN andnon-adhesive (B1) and adhesive (B2) BIATAIN. The characteristics assessed were:exudate absorption and control capacity, characterisation of the contact surface,transpiration, conformability and antimicrobial protection capacity. Results: Theexudate absorption and control tests show how dressings SF1 and SF2 obtain greaterabsorption per unit of weight while models B1 and B2 are evidently deformed,and even in the case of the adhesive B2 dressing, the foam padding detached fromthe adhesive film. The drip experiment could not be carried out with dressings A1and A2 as the drops of solution could not be retained since the internal contact adherencelayer prevents retention. The roughness measurements demonstrated the excellentsoftness of the SF1 and SF2 dressings, a behaviour that will have a directimpact on pain symptoms. The highest water vapour transpiration rates, particularlyfor adhesive models, were for dressings SF2 and B1. The easiest-to-extend dressingwas the SF1, and bacterial protection was similar in all the dressings. The dressingswith the greatest absorption capacity were model B1 by unit of surface andmodel A1 by unit of weight. The maximum exudate retention under pressure wasthat of dressing C1 among the non-adhesives (96.79%) and A2 among the adhesives(97.13%). Dressings C1 and C2 presented the lowest amount of free water. Thehighest rates of water vapour transpiration corresponded to dressings C1 and A2,respectively. Dressing A1 presented the best surface characteristics. All the modelshad a similar behaviour in all the microbiological tests. Conclusions: The resultsshow that the SF1 dressings from among the non-adhesives and the SF2 fromamong the adhesives (Skinfoam models) present the best overall behaviour in termsof the properties studied. Regarding the other models, mention must be made of theabsorption capacity per unit of surface of models A1 and B2, the retention of exudatesunder pressure and the minimum amount of free water of model B1 and theresults of model A2 in the transpiration test (AU)

Management of the radial forearm free flap donor site with the vacuum-assisted closure (VAC) system.

INTRODUCTION: The radial forearm free flap is a popular reconstructive flap in modern head and neck surgery. Poor wound healing at the forearm donor site is common and frequently results in tendon exposure. The Vacuum-Assisted Closure (VAC) system (Kinetic Concepts Inc., San Antonio, TX) is a topical negative pressure dressing that has been shown to improve skin graft viability when used as a bolster dressing. In this study, we investigated the use of the VAC system in the management of the radial forearm free flap donor site. METHODS: A retrospective chart review was performed on all subjects who underwent a radial forearm free flap reconstruction in which the VAC system was used as a bolster dressing at the donor site from January 1, 2003, through March 31, 2005. RESULTS: Thirty-four consecutive subjects were included in the study. Exposed tendon did not occur in 14 (0%) subjects in which the VAC bolster was used for a minimum of 6 days. Eleven of the 20 subjects (55%) who used the VAC bolster for 5 days demonstrated small amounts of tendon exposure (<2 cm) on follow-up clinic examination. The minimum follow up for all subjects was 4 months. CONCLUSION: This study demonstrates that the VAC system is a feasible alternative to conventional bolster dressing in the management of the radial forearm free flap skin-grafted donor site. Based on this study, when used for a minimum of 6 days, the VAC bolster dressing eliminated tendon exposure at the forearm donor site.

Wound dressings for office-based surgery.

Since the turn of the 20th century, our understanding of wound healing has changed completely. Because of this, we now realize that wounds heal better under occlusive or semi-occlusive conditions. This revelation has led to the creation of a vast array of wound-dressing techniques and products that any office-based surgeon must use on a daily basis. This article reviews these techniques and products and offers the reader a framework of techniques that will help to achieve optimal surgical outcomes while at the same time maximize patient comfort and convenience.

Clinical and scientific data of a hydropolymer range of dressings.

The Tielle trade mark family (Johnson and Johnson Medical) is a range of hydropolymer foam dressings that come in a variety of shapes and sizes, and are designed to fit the different types and locations of wounds that occur in practice. There are three types: Tielle, Tielle Lite and Tielle Plus. Each can be based on the characteristics of the primary dressing, if any, and on the degree of exudate that the wound is producing. This article aims to give an overview of the range and a summary of research-based clinical and scientific evidence to support clinical practice.

[One catches not only mice with bacon. An atraumatic treatment for cutaneous myiasis]. / Mit Speck fängt man nicht nur Mäuse - Eine atraumatische Behandlungsmethode der kutanen Myiasis -

HISTORY AND ADMISSION FINDINGS: A 37 year old patient was admitted because of four prurigous furunculoid swellings on his right upper knee. The patient had a history of traveling in Brasil for 6 weeks, returning 2 weeks before admission. The nodular skin lesions, 2.5 cm in diameter, had a central opening, from where under little pressure a seropurulent fluid discharged. In the central opening moving, whitish structures were visible. TREATMENT AND COURSE: A piece of raw bacon, serving as occlusion-material, was fixated on the affected skin for two hours. The larvae emerged due to oxygen deficiency. After retraction of the bacon it was possible to grasp the emerged end of the larvae with tweezers and pull them out completely. The larvae were identified as third instar of dermatobia hominis. CONCLUSION: Cutaneous myiasis is a worthy differential diagnosis in patients presenting with furunculoid skin lesions after traveling to endemic areas. The treatment with bacon as an occlusion-material offers an atraumatic alternative to surgical excision.

General and plastic surgery devices; classification of the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is classifying the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing into class I (general controls). FDA is also exempting these devices from premarket notification procedures. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Investigación de la técnica de percutánea / Research on percutaneous technique

En el presente trabajo se presenta un estudio de comparación entre dos técnicas distintas de curación de la herida de punción por percutánea en neonatos. El interés se centró en comparar la duración de la percutánea y el número de complicaciones entre ambas curaciones

Investigación de la técnica de percutánea / Research on percutaneous technique

En el presente trabajo se presenta un estudio de comparación entre dos técnicas distintas de curación de la herida de punción por percutánea en neonatos. El interés se centró en comparar la duración de la percutánea y el número de complicaciones entre ambas curaciones (AU)