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.

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.

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

The effect of occlusive and semi-occlusive dressings on the healing of acute full-thickness skin wounds on the forelimbs of dogs.

This project compared the effects of hydrocolloid (HC) and hydrogel (HG) occlusive dressings and a polyethylene (PE) semi-occlusive dressing on the healing of acute full-thickness skin wounds on the forelimbs of 10 dogs. All treatments resulted in a similar degree of healing at postoperative days 4 and 7. No significant differences existed in the number of wounds that were more than 90% healed at postoperative day 28 between the group treated with the HG dressing and the group treated with the PE dressing. There were significantly fewer wounds more than 90% healed at postoperative day 28 in the group treated with the HC dressing. Wounds under the HG dressing had the largest mean percentage of contraction at postoperative days 21 and 28. Wounds under the HG dressing also had the largest contraction/re-epithelialization ratio (postoperative days 21 and 28) compared with wounds under the PE and HC dressings. Wounds under the PE dressing had a significantly higher mean percentage of re-epithelialization than wounds under both occlusive dressings on postoperative days 14, 21, and 28. Wounds under the two occlusive dressings had exuberant granulation tissue present more often than wounds under the PE dressing. The two occlusive dressings had significantly higher bacterial counts on wounds compared with wounds under the PE dressing; analysis of variance (ANOVA), P = .0008. Wounds under the HC dressing showed the poorest healing in all parameters.