Effect of Changing Surgical Instruments Before Wound Closure to Prevent Wound Infection in Lower GI Surgery: A Randomized Controlled Trial.

BACKGROUND: Surgical site infection is a major surgical complication and has been studied extensively. However, the efficacy of changing surgical instruments before wound closure remains unclear. OBJECTIVE: The aim of this study was to investigate the efficacy of changing surgical instruments to prevent incisional surgical site infection during lower GI surgery. DESIGN: This was a randomized controlled trial. SETTINGS: This study was conducted at the Hyogo College of Medicine in Japan. PATIENTS: Patients undergoing elective lower GI surgery with open laparotomy were included. INTERVENTIONS: Patients were randomly assigned to 1 of 2 groups. In group A, the surgeon changed surgical instruments before wound closure, and in group B, the patients underwent conventional closure. MAIN OUTCOME MEASURES: The primary end point was the incidence of incisional surgical site infection. The secondary end point was the incidence of surgical site infection restricted to clean-contaminated surgery. RESULTS: A total of 453 patients were eligible for this trial. The incidence of incisional surgical site infection was not significantly different between group A (18/213; 8.5%) and group B (24/224; 10.7%; p = 0.78). In the clean-contaminated surgery group, the incidence of incisional surgical site infection was 13 (6.8%) of 191 in group A and 9 (4.7%) of 190 in group B (p = 0.51). LIMITATIONS: This was a single-center study. CONCLUSIONS: Changing surgical instruments did not decrease the rate of incisional surgical site infection in patients undergoing lower GI surgery in either all wound classes or clean-contaminated conditions. See Video Abstract at http://links.lww.com/DCR/B701. EFECTO DE REALIZAR CAMBIO DE LOS INSTRUMENTOS QUIRRGICOS ANTES DEL CIERRE DE LA INCISIN EN LA INFECCIN DE LA HERIDA DEL SITIO QUIRRGICO EN CIRUGA DEL TUBO DIGESTIVO BAJO ESTUDIO ALEATORIO CONTROLADO: ANTECEDENTES:La infección del sitio quirúrgico es una complicación importante y se ha estudiado ampliamente. Sin embargo, la eficacia de cambiar los instrumentos quirúrgicos antes del cierre de la herida sigue sin estar clara.OBJETIVO:El objetivo de este estudio es investigar la eficacia de cambiar el instrumental quirúrgico en la prevención de la infección del sitio quirúrgico en cirugía gastrointestinal inferior.DISEÑO:Estudio aleatorio controlado.AJUSTE:Este estudio se realizó en la Facultad de Medicina de Hyogo en Japón.PACIENTES:Se incluyeron pacientes sometidos a cirugía electiva de tubo digestivo bajo con laparotomía abierta.INTERVENCIONES:Los pacientes fueron asignados aleatoriamente a uno de dos grupos. En el grupo A, el cirujano cambió el instrumental quirúrgico antes del cierre de la herida, y en el grupo B, los pacientes se sometieron a un cierre convencional.PRINCIPALES MEDIDAS DE RESULTADO:El criterio de valoración principal fue la incidencia de infección del sitio quirúrgico de la incisión. El criterio de valoración secundario fue la incidencia de infección del sitio quirúrgico restringida a la cirugía limpia contaminada.RESULTADOS:Un total de 453 pacientes fueron elegibles para este ensayo. La incidencia de infección del sitio quirúrgico no fue significativamente diferente entre el grupo A (18/213; 8,5%) y el grupo B (24/224; 10,7%) (p = 0,78). En el grupo de cirugía limpia-contaminada, la incidencia de infección del sitio quirúrgico incisional fue 13/191 (6,8%) en el grupo A y 9/190 (4,7%) en el grupo B (p = 0,51).LIMITACIÓN:Estudio de un solo centro.CONCLUSIÓNES:El cambio de instrumentos quirúrgicos no disminuyó la tasa de infección del sitio quirúrgico en todas las clases de heridas o condiciones limpias-contaminadas. Consulte Video Resumen en http://links.lww.com/DCR/B701.

A survey of healthcare industry representatives' participation in surgery: some new ethical concerns.

OBJECTIVE: To provide preliminary evidence of the types and amount of involvement by healthcare industry representatives (HCIRs) in surgery, as well as the ethical concerns of those representatives. METHODS: A link to an anonymous, web-based survey was posted on several medical device boards of the website http://www. cafepharma.com. Additionally, members of two different medical device groups on LinkedIn were asked to participate. Respondents were self-identified HCIRs in the fields of orthopedics, cardiology, endoscopic devices, lasers, general surgery, ophthalmic surgery, oral surgery, anesthesia products, and urologic surgery. RESULTS: A total of 43 HCIRs replied to the survey over a period of one year: 35 men and eight women. Respondents reported attending an average of 184 surgeries in the prior year and had an average of 17 years as an HCIR and six years with their current employer. Of the respondents, 21 percent (nine of 43) had direct physical contact with a surgical team or patient during a surgery, and 88 percent (38 of 43) provided verbal instruction to a surgical team during a surgery. Additionally, 37 percent (16 of 43) had participated in a surgery in which they felt that their involvement was excessive, and 40 percent (17 of 43) had attended a surgery in which they questioned the competence of the surgeon. CONCLUSIONS: HCIRs play a significant role in surgery. Involvement that exceeds their defined role, however, can raise serious ethical and legal questions for surgeons and surgical teams. Surgical teams may at times be substituting the knowledge of the HCIR for their own competence with a medical device or instrument. In some cases, contact with the surgical team or patient may violate the guidelines not only of hospitals and medical device companies, but the law as well. Further study is required to determine if the patients involved have any knowledge or understanding of the role that an HCIR played in their surgery.

Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery.

BACKGROUND: Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures. METHODS/DESIGN: Our study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study: Stakeholders--federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included. Ethics--beneficence, non-maleficence, autonomy, justice. Economics--scarcity of resources, choices, opportunity costs.For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material. DISCUSSION: The significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy.

Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives.

BACKGROUND: Industry payments to surgeons have received public attention, but little is known about the relationships between surgeons and medical device representatives. Medical device representatives ("device reps") have become an integral part of operating room personnel. The effect of their presence on patient care deserves discussion. STUDY DESIGN: We conducted a qualitative, ethnographic study to explore relationships between surgeons and medical device representatives, and characterize industry involvement in the training of surgeons. We used group and individual open-ended interviews to gain insight into the beliefs, values, and perspectives of surgeons and device reps. We conducted two focus groups, one with ear, nose, and throat surgeons, and one with hospital-based attending orthopedic surgeons. We also conducted individual interviews with three former or current medical device representatives, a director of a surgical residency program at an academic medical center, and a medical assistant for a multi-physician orthopedic practice. RESULTS: While surgeons view themselves as indisputably in charge, device reps work hard to make themselves unobtrusively indispensable in order to establish and maintain influence, and to imbue the products they provide with personalized services that foster a surgeon's loyalty to the reps and their companies. Surgeons view industry-funded training opportunities as a necessary service. Device reps and some surgeons believe that reps benefit patient care, by increasing efficiency and mitigating deficiencies among operating room personnel (including the surgeons themselves). CONCLUSIONS: Our study raises ethical questions about the reliance of surgeons on device reps and device companies for education and surgical assistance and practical concerns regarding existing levels of competence among OR personnel.

Suspensão circular fechada do terço médio da face / Closed circular suspension in the middle third of the face

O tratamento cirúrgico apresentado neste artigo tem inovações táticas e torna o procedimento pouco agressivo. O objetivo é demonstrar uma maneira diferente de executar a suspensão do terço médio da face. O procedimento é realizado com agulhas semicirculares tipo Stocchero, com passagem de fio de náilon 2.0 no plano subcutâneo, na altura da borda anterior da glândula parótida, e fixação do fio na fáscia temporal. Foram operados com emprego desse método 49 pacientes, com obtenção de bons resultados estéticos. Em um paciente, houve necessidade de executar uma cicatriz pré-auricular, para acomodação da pele. O método é seguro, simples, não necessita de internação hospitalar, evita uma cicatriz pré-auricular e o resultado oferece boa satisfação aos pacientes.

The surgical treatment presented here involves technical innovations, making it a less-aggressive procedure. The goal is to demonstrate a different way of executing a suspension of the skin in the medial third of the face. The procedure is performed with semi-circular Stocchero needles with the passage of a 2-0 nylon thread through the subcutaneous plane at the anterior edge of the parotid gland and fixation to the temporal fascia. A total of 49 patients were operated on using this method with good aesthetic results. One patient required a pre-auricular incision to accommodate the skin. This method is safe, simple, does not require hospital inpatient admission, avoids a pre-auricular scar, and provides satisfactory results.