Data Requirement for Animal-Derived Wound Care Devices: Limitations of the 510(k) Regulatory Pathway.

BACKGROUND: Device classification and preclinical data requirements for animal-derived wound care products were recently reviewed by the FDA. Given the possible performance differences for these products, we evaluated the FDA data requirements as well as the published literature for all animal-derived wound care products ever cleared through the FDA. STUDY DESIGN: The publicly available online database was queried for all animal-derived wound products; premarket data requirements for each product were recorded. A PubMed search was conducted to determine the number of published clinical studies for each product, and manufacturer websites were accessed to obtain the price for each product. RESULTS: A total of 132 animal-derived wound products have been cleared by the FDA since the Center for Devices and Radiological Health was established in 1976. Of these, 114 had a publicly available clearance statement online. Preclinical biocompatibility testing was performed in 85 products (74.6%) and referenced in 10 (8.8%). Preclinical animal wound healing testing took place in 17 (14.9%). Only 9 products (7.9%) had clinical safety testing, and no products had clinical effectiveness data. We found no published peer-reviewed clinical data for 97 products (73%). Cost was infrequently available but ranged from $4.79 to $2,178 per unit. CONCLUSIONS: Although the current pathway is appropriate for efficiently clearing new wound care products, clinical effectiveness is not included in the regulatory review process. Wound care products are primarily evaluated by the FDA for safety and biocompatibility. Thus, any claims of clinical effectiveness require independent validation, which is often lacking.

Social media use and impact on plastic surgery practice.

BACKGROUND: Social media platforms have revolutionized the way human beings communicate, yet there is little evidence describing how the plastic surgery community has adopted social media. In this article, the authors evaluate current trends in social media use by practicing plastic surgeons. METHODS: An anonymous survey on the use of social media was distributed to members of the American Society of Plastic Surgeons. Prevalent patterns of social media implementation were elucidated. RESULTS: One-half of respondents were regular social media users. Reasons for using social media included the beliefs that incorporation of social media into medical practice is inevitable (56.7 percent), that they are an effective marketing tool (52.1 percent), and that they provide a forum for patient education (49 percent). Surgeons with a primarily aesthetic surgery practice were more likely to use social media. Most respondents (64.6 percent) stated that social media had no effect on their practice, whereas 33.8 percent reported a positive impact and 1.5 percent reported a negative impact. CONCLUSIONS: This study depicts current patterns of social media use by plastic surgeons, including motivations driving its implementation and impressions on its impact. Many feel that social media are an effective marketing tool that generates increased exposure and referrals. A small number of surgeons have experienced negative repercussions from social media involvement. Our study reveals the presence of a void. There is a definite interest among those surveyed in developing best practice standards and oversight to ensure ethical use of social media platforms throughout the plastic surgery community. Continuing discussion regarding these matters should be ongoing as our experience with social media in plastic surgery evolves.

Comparison of implant-based immediate breast reconstruction with and without acellular dermal matrix.

BACKGROUND: Acellular dermal matrix is frequently used in implant-based breast reconstruction to cover the inferior aspect of the breast pocket. Its performance profile remains equivocal. The authors studied whether adding it in implant-based immediate breast reconstruction improved outcomes when compared with non-acellular dermal matrix reconstruction. METHODS: Patients undergoing implant-based immediate breast reconstruction at a single academic medical center were evaluated. Aesthetic outcomes and postoperative complications were assessed and direct comparisons were made between acellular dermal matrix and non-acellular dermal matrix cohorts. RESULTS: A total of 203 patients underwent 337 immediate expander-based breast reconstructions [with acellular dermal matrix, n=208 (61.7 percent); without, n=129 (38.3 percent)]. Patient characteristics, including age at time of reconstruction (mean, 49±11 versus 47±10 years) and body mass index (mean, 23±5 versus 23±3 kg/m) were similar between groups (p>0.05). Complications occurred in one-third of patients (33.5 percent). In univariate analyses, acellular dermal matrix use had fewer overall complications (odds ratio, 0.61; 95 percent CI, 0.38 to 0.97). The incidences of seroma/hematoma (p=0.59), infection (p=0.31), and wound complications (p=0.26) did not differ. Aesthetic outcomes were higher in the acellular dermal matrix group. In multivariate logistic regression, acellular dermal matrix use was associated with less capsular contracture (odds ratio, 0.18; 95 percent CI, 0.08 to 0.43) and mechanical shift (odds ratio, 0.23; 95 percent CI, 0.06 to 0.78). CONCLUSIONS: Optimizing the inframammary fold with acellular dermal matrix creates a superior aesthetic result. Its use appears safe and is associated with less capsular contracture and mechanical shift and improvement in the inframammary fold appearance, without increasing postoperative complications. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Arterial allograft allows in-line reconstruction of prosthetic graft infection with low recurrence rate and mortality.

Surgical management of infected prosthetic vascular grafts is associated with a significant risk of recurrent infection, limb loss, and mortality. Treatment options include graft excision with extra-anatomic bypass and in-line repair with prosthetic graft, vein, or artery. We hypothesized that in-line reconstruction using cryopreserved arterial allografts would be associated with a lower recurrent infection rate, limb loss, and mortality than other alternatives. We reviewed all cases where adults underwent surgical management of infected prosthetic aortic, iliac, or femoral bypass grafts with cryopreserved arterial allograft at our medical center from 2001 to 2008. Cryopreserved arterial allografts were used in 21 patients. There were nearly equal number of men (n = 11, 52%) and women (n = 10, 48%). The median age was 63 years and median time since cryoartery repair was 4 years. There have been no deaths in the follow-up period. Complications (19%) included colon perforation (n = 1), lower extremity compartment syndrome (n = 1), limb ischemia (n = 1), and reinfection with pseudoaneurysm and subsequent limb amputation (n = 1). These positive findings of low morbidity and absence of mortality in high risk patients have resulted in a shift at our institution to the preferential use of cryopreserved arterial allograft with in-line reconstruction for infected prosthetic grafts.

Molecular mediators of liver ischemia and reperfusion injury: a brief review.

Ischemia and reperfusion injury is a dynamic process that involves multiple organ systems in various clinical states including transplantation, trauma, and surgery. Research into this field has identified key molecular and signaling players that mediate, modulate, or augment cellular, tissue, and organ injury during this disease process. Further elucidation of the molecular mechanisms should provide the rationale to identify much-needed novel therapeutic options to prevent or ameliorate organ damage due to ischemia and reperfusion in clinics.

Light-assisted stab phlebectomy: report of a technique for removal of lower extremity varicose veins.

We report a new technique to remove varicose veins and reduce recurrence from missed veins. A rigid cannula with a light source injects tumescent solution and transilluminates under veins. Varicose veins are removed with stab phlebectomy using a modified crochet hook and mosquito clamp. Additional tumescent solution flushes hematomas and compresses empty vein channels, resulting in less pain, bleeding, and pigmentation. More than 200 patients have undergone light-assisted stab phlebectomy at the Gonda Vascular Center, with high patient and surgeon satisfaction. This sutureless technique allows complete and rapid varicose branch vein removal with few missed varicose veins, little bruising, and an excellent cosmetic result.

Light-assisted stab phlebectomy: early postoperative experience.

Light-assisted stab phlebectomy (LASP) is a technique that we have developed for treatment of lower extremity varicose veins. It combines powered and stab phlebectomy with minimally invasive surgical instruments to optimize intraoperative visualization of varicose veins and to remove branch veins with minimal bruising, hematoma, or pain. The early experience with this technique has not been reported. We conducted a retrospective review of all patients who underwent LASP to characterize the associated perioperative experience and to identify postoperative factors that indicated a successful outcome. From 2004 to 2006, LASP was performed on 268 limbs to remove lower extremity branch veins. The majority of patients were women (75%), and the mean age was 52 years. A group of 184 patients underwent LASP in combination with another procedure, and 49 patients underwent LASP alone. Nearly all patients had conscious sedation for anesthesia (99%); operating room time averaged 44 minutes, and blood loss averaged 88 cc. Immediate postoperative complications were infrequent, occurring in 10 per cent of patients, and included unresected or missed veins, hematoma, and cellulitis. LASP provides improved visualization of branch veins and allows varicose veins to be removed with a short operating room time and minor postoperative complications.

Incidentally discovered tumors of the endocrine glands.

Clinically inapparent masses, or 'incidentalomas' of the endocrine glands are increasingly common owing to continued advancements in medical imaging. Incidentalomas of the adrenal glands have received substantial attention in the literature, whereas lesions of the thyroid and endocrine pancreas, though frequently encountered in the clinic, have received relatively little attention. We review the detection and subsequent management of incidentalomas of the thyroid, adrenal and pancreas, with specific attention paid to the mode of detection and risk stratification of lesions.

Incisional hernia after liver transplantation.

BACKGROUND: Incisional hernia is a potential complication of orthotopic liver transplantation (OLT), with various options for repair. STUDY DESIGN: We conducted a retrospective review of a series of adult patients with incisional hernias after OLT to identify risk factors and to compare methods of repair. RESULTS: Incisional hernia repair was performed in 44 of 959 patients (4.6%) who underwent OLT from 1999 to 2005. Mean age at time of OLT was 53 years, and 73% were men. One or more complications of OLT occurred in 33 patients (75%) and included reoperation for bile leak or hemoperitoneum (34%), pulmonary problems (27%), early acute rejection (7%), and severe ascites and retransplantation (5% each). Incisional hernia was diagnosed at 419 days (range 62 to 1,524 days) and repaired at 471 days (range 109 to 1,581 days) after OLT. Presentation included pain or discomfort (78%) and incarceration or strangulation (5%); 17% were asymptomatic. Herniorrhaphy techniques included fascial repair with onlay polypropylene mesh reinforcement (n=25, 57%); fascial repair only (n=15, 34%); or inlay mesh sewn to fascial edges (n=4, 9%). Complications of repair included recurrence in seven patients (16%) and wound infection and seroma in one patient each. Recurrence occurred in five patients with primary repair and two with mesh techniques (33% versus 6%, p=0.04). CONCLUSIONS: Incisional hernia is a late complication of OLT for which male gender and early post-OLT complications are risk factors. Repair is safe when undertaken after acute problems have resolved and is best accomplished using mesh reinforcement of autologous tissue.

Management of hepatitis C-infected liver transplant recipients at large North American centres: changes in recent years.

Large (>or=45 transplants per year) North American liver transplant centres were surveyed regarding management of hepatitis C virus (HCV). A total of 25/41 (59%) and 28/48 (58%) of centres responded to the surveys in 1998 and 2003, respectively, with 17 centres participating in both surveys. HCV was the most common indication for transplantation. Use of protocol liver biopsies was higher in 2003 and 60% used them to monitor HCV disease. Fewer centres reported modifying primary immunosuppression (IMS) for HCV-positive (vs. non-HCV) patients in 2003 (26%) vs. 1998 (56%). IMS was most frequently tacrolimus-based, but mycophenolate mofetil use increased in 2003 (52% vs. 23% in 1998). In both years, approximately 40% treated allograft rejection differently in HCV-positive recipients, with less use of OKT3 in 2003. Combination anti-HCV therapy for 12 months or more was the treatment of choice and growth factor use was common (68%). HCV-positive recipients were considered candidates for retransplantation but HCV-specific criteria were used in decision-making. Practice of centres changed over time with an increase in HCV transplantation and use of protocol liver biopsies, and a trend towards lesser modification of IMS in HCV-positive recipients. We conclude that there is considerable variability in the management of HCV among transplant programs and over time.

Injectable fibrin scaffold improves cell transplant survival, reduces infarct expansion, and induces neovasculature formation in ischemic myocardium.

OBJECTIVES: In this study, we determined whether fibrin glue improves cell transplant retention and survival, reduces infarct expansion, and induces neovasculature formation. BACKGROUND: Current efforts in restoring the myocardium after myocardial infarction (MI) include the delivery of viable cells to replace necrotic cardiomyocytes. Cellular transplantation techniques are, however, limited by transplanted cell retention and survival within the ischemic tissue. METHODS: The left coronary artery of rats was occluded for 17 min followed by reperfusion. One week later, bovine serum albumin (BSA), fibrin glue, skeletal myoblasts in BSA, or skeletal myoblasts in fibrin glue were injected into the infarcted area of the left ventricle. The animals were euthanized five weeks after injection, and their hearts were excised, fresh frozen, and sectioned for histology and immunohistochemistry. RESULTS: After five weeks, the mean area covered by skeletal myoblasts in fibrin glue was significantly greater than the area covered by myoblasts injected in BSA. Myoblasts within the infarct were often concentrated around arterioles. The infarct scar size and myoblasts in the fibrin group were significantly smaller than those in the control and BSA groups. Fibrin glue also significantly increased the arteriole density in the infarct scar as compared with the control group. CONCLUSIONS: This study indicates that fibrin glue increases cell transplant survival, decreases infarct size, and increases blood flow to ischemic myocardium. Therefore, fibrin glue may have potential as a biomaterial scaffold to improve cellular cardiomyoplasty treat and MIs.

Hepatitis C etiology of liver disease is strongly associated with early acute rejection following liver transplantation.

Although recurrent hepatitis C (HCV) occurs universally after liver transplantation (LT), its tempo and severity are variable and unpredictable. Diagnosis and treatment of early acute rejection (EAR) likely affect the course of recurrent HCV disease. We have studied a contemporary cohort of LT recipients to reexamine risk factors for EAR. We hypothesized that HCV etiology may represent a significant risk factor for EAR for many reasons. First, recurrent disease commonly causes biochemical abnormalities prompting allograft biopsy. Second, overlapping histologic features of acute rejection and recurrent HCV ambiguity may result in diagnostic ambiguity. Finally, the biology of hepatitis may precipitate an antidonor response in addition to an antiviral response. Records of 285 adult recipients undergoing primary LT for cirrhosis between January 1, 1999, and December 31, 2002, were retrospectively reviewed. EAR was defined as a biopsy-proven or an empirically treated episode within 6 months of LT. Cox proportional hazards analysis identified donor, recipient, transplant, and posttransplant characteristics associated with EAR; Kaplan-Meier analysis was used to assess rejection by etiology. HCV cirrhosis was the etiology for 51% of all LT recipients. There were 135 episodes of EAR (127 biopsy proven) in 117 recipients for an overall incidence of 41%. Patient groups with HCV and cholestatic / autoimmune disease groups exhibited the highest incidence of rejection at 49%. Recipient gender, ethnicity, etiology, LT year, and posttransplant immunosuppression levels were risk factors for EAR in univariate analysis; HCV etiology and female gender remained robust risk factors in multivariate analysis. Interferon-based therapy did not impact the incidence or timing of EAR. In conclusion, HCV etiology is strongly associated with EAR. HCV allograft reinfection may create an immunologic environment predisposed to EAR. Alternatively, the association of HCV and EAR may result from an increased frequency of allograft biopsy and may be further exacerbated by inability to accurately diagnose EAR in the setting of recurrent HCV.