Hemostats, sealants, and adhesives III: a new update as well as cost and regulatory considerations for components of the surgical toolbox.

The hemostat, sealant, and adhesive components of the surgical toolbox continue to evolve and enter clinical practice at a rapid rate. The goal of this comprehensive, sequential review is to update these components to include those now available (February 2012) as well as to explore cost and regulatory factors that impact the development and use of these materials. A unique system of definitions for organizing these components based on group, category, and class is used as a means of improving the understanding and appropriate use of these materials. The system will be used here to present the most recent additions to the toolbox, which are evaluated based on safety, efficacy, usability, and cost. These new additions include pooled human plasma fibrinogen and thrombin embedded in an equine collagen patch for cardiac surgical hemostasis, polyethylene glycol (PEG) and human serum albumin for lung surgical pneumostasis, modified PEG and trilysine amine for spinal sealing, octyl and butyl lactoyl cyanoacrylate for vascular sealing, and a variety of octyl and butyl cyanoacrylates with or without dyes and/or polyester mesh for skin closure with the creation of a bacterial barrier. The system of definitions will also be used to clarify key strategies in the current health care environment for reducing costs and for increasing understanding of Food and Drug Administration regulatory decisions for these materials.

Medical devices; general and plastic surgery devices; classification of tissue adhesive with adjunct wound closure device intended for topical approximation of skin. Final rule.

The Food and Drug Administration (FDA) is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.'' The agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.

General and plastic surgery devices; reclassification of the tissue adhesive for topical approximation of skin device. Final rule.

The Food and Drug Administration (FDA) is reclassifying the device type, tissue adhesive for the topical approximation of skin, from class III (premarket approval) into class II (special controls). Tissue adhesives for non-topical uses remain in class III and continue to require premarket approval applications (PMAs). FDA is proposing this reclassification in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin" that will serve as the special control for the reclassified device type.

Experiments on peeling adhesive tapes from human forearms.

BACKGROUND/PURPOSE: Peeling of adhesive tape from hu-man skin can cause pain and trauma. The effects of the peel angle, peel rate, dwell time, subject, and order of testing were examined. METHODS: Adhesive tape was peeled from the volar forearms of four human subjects. The tape was 25.4-mm-wide Durapore by 3M. The rates ranged from 100 to 10,000 mm/min, the peel angle from 90 degrees to 180 degrees, and the dwell time from one to 15 min. The tensile testing machines'recorded the peel force and the displacement of the end of the tape. RESULTS: A range of maximum and average peel force values was observed. The peel force tended to be minimum for a peel angle around 150 degrees in most cases. As the peel rate was increased, the peel force generally tended to increases lightly, but the relationship was erratic. As the dwell time increased, the peel force increased and then settled down. Of the subjects tested, the skin of the oldest subject experienced the most displacement and highest peel forces(the maximum force over all tests was 3.6 N). The peel force tended to increase with repeated peeling from the same skin site. Compared with peeling from a rigid substrate such as steel, the peel force from skin was lower. CONCLUSION: The results improve understanding of the factors affecting the peel force, which has been correlated previously with trauma caused by peeling adhesive tape from skin.

Scaffold-enhanced albumin and n-butyl-cyanoacrylate adhesives for tissue repair: ex vivo evaluation in a porcine model.

An ex vivo study was conducted in a porcine model to compare the tensile strength of tissue samples repaired by three different repair methods: (i) scaffold-enhanced light-activated albumin protein solder, (ii) scaffold-enhanced n-butyl-cyanoacrylate adhesive, and (iii) conventional sutures. Biodegradable polymer scaffolds of controlled porosity were fabricated with poly(L-lactic-co-glycolic acid) (PLGA) and salt particles using a solvent-casting and particulate-leaching technique. Repairs were conducted on seventeen different tissues including the carotid, femoral, splenic, coronary, and pulmonary arteries, aorta, small intestine, ureter, sciatic nerve, spleen, atrium, kidney, muscle, skin, lung, liver and pancreas. Acute breaking strengths were measured and the data were analyzed by Student's T-test. The resultant repairs using the scaffold-enhanced light-activated adhesive (Group I) were found to yield equivalent tensile strengths to conventional sutures (Group III), with significantly smaller mean standard deviations (8% vs. 25%). The cyanoacrylate-doped scaffold (Group II) repairs performed extremely well with tensile strengths approximately 30% higher for organ tissue and approximately 20% higher for vascular tissue than with the other two repair techniques evaluated in this study. The addition of the polymer scaffold assists in tissue alignment and reduces problems associated with adhesive runaway from the repair site. With appropriate packaging, scaffold-enhanced adhesives offer the potential for quick application in the field by less skilled professionals, paraprofessionals and bystanders in emergency situations--both military and civilian--outside a hospital or clinic setting.

Adhesivo tisular cutáneo (Dermabond (r)) en cirugía cervicofacial: estudio preliminar / Tisular cutaneous adhesive (Dermabond (r)) in cervicofacial surgery: A preliminary study

La búsqueda de una alternativa al método tradicional de sutura de heridas mediante el empleo de un adhesivo tisular no ha ofrecido hasta el momento una herramienta válida en la práctica clínica. Los inconvenientes para la difusión de estos adhesivos pueden verse superados con la reciente introducción del 2-octilcianocrilato (Dermabond(r), Ethicon). No obstante, dado que los estudios realizados hasta el momento sólo demostraban su eficacia en pequeñas incisiones o heridas traumáticas, se hacía imprescindible estudiar su eficacia en el cierre de grandes heridas en la región cervicofacial. Los resultados preliminares recogidos en este estudio muestran su eficacia en la cirugía de glándulas salivales y quistes cervicales. Éstas técnicas fueron escogidas como referencia de cirugía cervicofacial (AU)

[Adhesive substances in medicine--history, present status and perspectives]. / Adhezivní hmoty v medicíne--historie, soucasnost a perspektivy.

In the introduction to this study, present state of the progress of tissue adhesives and their use in medicine is discussed. Synthetic adhesives and the fibrin system are described. The advantages and disadvantages of both types of adhesive are compared. The bioadhesive systems used in medicine must meet certain requirements necessary for their application. The composition and preparation of the fibrin adhesives are analyzed in detail. Their effect on the regeneration of tissue cells and the level of histotoxicity are very important. The characteristics of the fibrin adhesive system result from its physiological origin. The filling of the wound with these adhesives improves the natural processes of healing.