A retrospective clinical study of 188 consecutive patients to examine the effectiveness of a biologically active cryopreserved human skin allograft (TheraSkin®) on the treatment of diabetic foot ulcers and venous leg ulcers

A biologically active human skin allograft, currently distributed under the brand name TheraSkin(?), was examined for safety and efficacy in the treatment of venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). The objective was to determine if TheraSkin could serve as a safe and effective alternative to bioengineered skin substitutes such as Apligraf(?) and Dermagraft(?). The authors conducted a retrospective study of 214 consecutive patients seen at the Inova Wound Center (Mt Vernon, Virginia), with either a DFU or a VLU. After excluding patients who did not meet the study criteria, the final eligible cohort consisted of 188 subjects, with 134 VLUs and 54 DFUs. Multivariate logistic regression was used to evaluate the relationship between baseline wound size and the proportion of healed wounds after 12 and 20 weeks from initial allograft application. The authors found that by the 12th week, DFUs closed 60.38% of the time and VLUs closed 60.77% of the time. After 20 weeks, the number of closed DFUs increased to 74.1% and the number of VLUs increased to 74.6%. The mean wound size in the DFU group was 6.2 cm(2) (±11.8) and 11.8 cm(2) (±22.5) in the VLU group. The mean number of TheraSkin allografts required ranged from 1 to 8, with an average of 2.03 (±1.47) at the 12-week point and an average of 3.23 (±2.77) at the 20-week point. Multivariate logistic regression was used to calculate the odds of wound healing by week 12 and week 20 in each group. The authors also analyzed adverse events and found TheraSkin to be noncontributory to any adverse events, verifying the safety of TheraSkin in this study population. In this study, TheraSkin has been shown to be highly effective for the treatment of both VLUs and DFUs with an acceptable safety profile.     

The impact of work hour restrictions on surgical resident education

OBJECTIVE: Resident work-hour restrictions were instituted in July 2003 based on ACGME mandates. The American Board of Surgery In-Training Examination (ABSITE), American Board of Surgery Qualifying Examination (ABSQE), and operative volume traditionally have been measures of surgical resident education and competency. The objective of this study was to determine the effect of reduced work hours on resident standardized test scores and operative volume at our institution. DESIGN: We reviewed ABSITE scores, ABSQE scores, and operative logs from 1997 to 2005 of all general surgery residents. Linear mixed-effects models were fitted for each component ABSITE score (total, basic science, and clinical management), and they were compared using a chi-squared likelihood ratio. Operative logs of graduating residents were compared before and after the work restrictions and were evaluated for association with ABSITE score. p-values less than 0.05 were considered significant. RESULTS: The program was compliant with ACGME mandates within 6 months of institution. ABSITE scores improved significantly after the restriction of work hours in both basic science (p = 0.003) and total score (p = 0.008). Clinical management scores were not affected. The number of major cases recorded by graduating residents did not change. A positive correlation was found between number of cases performed during residency and clinical management ABSITE scores (p = 0.045). ABSQE scores were not impacted by operative volume during residency. CONCLUSIONS: ABSITE scores improved significantly after the restriction of resident work hours. Resident operative experience was not affected. An unexpected consequence of work-hour restrictions may be an improvement in surgical resident education.     

Pain after percutaneous radiofrequency ablation of renal tumors

BACKGROUND AND PURPOSE: Most patients have minimal pain after percutaneous radiofrequency ablation (RFA) of a renal tumor. However, anecdotally, there is some variation in the amount of patient discomfort. Our goal was to identify relevant patient factors and characteristics of their renal tumors that may influence pain after percutaneous RF ablation. PATIENTS AND METHODS: We performed a retrospective chart review of 59 sequential patients who received percutaneous RFA between 2001 and 2005 at a single institution. Data on patient age, sex, body mass index (BMI), and narcotic administration in the periprocedural period were available for 46 patients. Preoperative imaging (CT or MRI) was reviewed to determine tumor size and location, as well as the shortest distance of the mass to the body-wall musculature. RESULTS: The distance from the renal mass to the body-wall musculature was significantly correlated with the total narcotics received in the periprocedural period. This measured distance did not correlate with the patient's BMI. No other relations between patient factors or tumor characteristics and peri-procedural narcotic usage were identified. CONCLUSION: Patients whose tumors lie close to their body-wall musculature have greater narcotic requirements in the periprocedural period. Knowledge of this correlation should result in better patient counseling and help anticipate periprocedural analgesia requirements.     

Ten-year follow up after laparoscopic Nissen fundoplication for gastroesophageal reflux disease

Laparoscopic Nissen fundoplication was first undertaken in the early 1990s. Appreciable numbers of patients with 10-year follow up are only now available. This study assesses long-term outcome and durability of outcome after laparoscopic Nissen fundoplication for treatment of gastro-esophageal reflux disease. Since 1991, 829 patients have undergone laparoscopic fundoplications and are prospectively followed. Two hundred thirty-nine patients, 44 per cent male, with a median age of 53 years (+/- 15 standard deviation) underwent laparoscopic Nissen fundoplications at least 10 years ago; 28 (12%) patients were "redo" fundoplications. Before and after fundoplication, among many symptoms, patients scored the frequency and severity of dysphagia, chest pain, vomiting, regurgitation, choking, and heartburn using a Likert scale (0 = never/not bothersome to 10 = always/very bothersome). Symptom scores before versus after fundoplication were compared using a Wilcoxon matched-pairs test. Data are reported as median, mean +/- standard deviation, when appropriate. After fundoplication, length of stay was 2 days, 3 days +/- 4.8. Intra-operative inadvertent events were uncommon and without sequela: 1 esophagotomy, 1 gastrotomy, 3 cardiac dysrhythmias, and 3 CO2 pneumothoraces. Complications after fundoplication included: 1 postpneumonic empyema, 3 urinary retentions, 2 superficial wound infections, 1 urinary tract infection, 1 ileus, and 1 intraabdominal abscess. There were two perioperative deaths; 88 per cent of the patients are still alive. After laparoscopic Nissen fundoplication, frequency and severity scores dramatically improved for all symptoms queried (P < 0.001), especially for heartburn frequency (8, 8 +/- 3.2 versus 2, 3 +/- 2.8, P < 0.001) and severity (10, 8 +/- 2.9 versus 1, 2 +/- 2.5, P < 0.001). Eighty per cent of patients rate their symptoms as almost completely resolved or greatly improved, and 85 per cent note they would again have the laparoscopic fundoplication as a result of analysis of our initial experience, thereby promoting superior outcomes in the future. Nonetheless, follow up at 10 years and beyond of our initial experience documents that laparoscopic fundoplication durably provides high patient satisfaction resulting from long-term amelioration of the frequency and severity of symptoms of gastroesophageal reflux disease. These results promote further application of laparoscopic Nissen fundoplication.     

The practice of venous thromboembolism prophylaxis in the major trauma patient

BACKGROUND: The incidence of venous thromboembolism (VTE) without prophylaxis is as high as 80% after major trauma. Initiation of prophylaxis is often delayed because of concerns of injury-associated bleeding. As the effect of delays in the initiation of prophylaxis on VTE rates is unknown, we set out to evaluate the relationship between late initiation of prophylaxis and VTE. METHODS: Data were derived from a multicenter prospective cohort study evaluating clinical outcomes in adults with hemorrhagic shock after injury. Analyses were limited to patients with an Intensive Care Unit length of stay >or=7 days. The rate of VTE was estimated as a function of the time to initiation of pharmacologic prophylaxis. A multivariate stepwise logistic regression model was used to evaluate factors associated with late initiation. RESULTS: There were 315 subjects who met inclusion criteria; 34 patients (11%) experienced a VTE within the first 28 days. Prophylaxis was initiated within 48 hours of injury in 25% of patients, and another one-quarter had no prophylaxis for at least 7 days after injury. Early prophylaxis was associated with a 5% risk of VTE, whereas delay beyond 4 days was associated with three times that risk (risk ratio, 3.0, 95% CI [1.4-6.5]). Factors associated with late (>4 days) initiation of prophylaxis included severe head injury, absence of comorbidities, and massive transfusion, whereas the presence of a severe lower extremity fracture was associated with early prophylaxis. CONCLUSIONS: Clinicians are reticent to begin timely VTE prophylaxis in critically injured patients. Patients are without VTE prophylaxis for half of all days within the first week of admission and this delay in the initiation of prophylaxis is associated with a threefold greater risk of VTE. The relative risks and benefits of early VTE prophylaxis need to be defined to better direct practice in this high-risk population.     

Ultraviolet lighting during orthopaedic surgery and the rate of infection

BACKGROUND: Ultraviolet lighting is an alternative to laminar airflow in the operating room that may be as effective for lowering the number of environmental bacteria and possibly lowering infection rates by killing the bacteria rather than simply reducing the number at the operative site. The purpose of the present study was to compare the infection rates following joint replacement procedures performed by one orthopaedic surgeon with and without the use of ultraviolet lighting. METHODS: From July 1986 to July 2005, one surgeon performed 5980 total joint replacements at one facility. In September 1991, ultraviolet lighting was installed in the operating rooms. All procedures that were performed before the installation of the ultraviolet lighting utilized horizontal laminar airflow, whereas all procedures that were performed after that date utilized ultraviolet lighting without laminar airflow. Factors associated with the rate of infection were analyzed. RESULTS: Over a nineteen-year period, forty-seven infections occurred following 5980 joint replacements. The infection rate without ultraviolet lighting (and with laminar airflow) was 1.77%, and the infection rate with ultraviolet lighting was 0.57% (p < 0.0001). The odds of infection were 3.1 times greater for procedures performed without ultraviolet lighting (and with laminar airflow) as compared with those performed with only ultraviolet lighting (p < 0.0001). The infection rate associated with total hip replacement decreased from 1.03% to 0.72% (p = 0.5407), and the infection rate associated with total knee replacement decreased from 2.20% to 0.50% (p < 0.0001). Revision surgery, previous infection, age, total body mass index, use of cement, disease, and diagnosis were not associated with an elevated infection rate. CONCLUSION: When appropriate safety precautions are taken, ultraviolet lighting appears to be an effective way to lower the risk of infection in the operating room during total joint replacement surgery.     

Applying peripheral vascular injury guidelines to penetrating trauma

Introduction

Treatment of traumatic vascular injury is evolving because of endovascular therapies. National guidelines advocate for embolization of injuries to lower extremity branch vessels, including pseudoaneurysms or arteriovenous fistulas, in hemodynamically normal patients without hard signs of vascular injury. However, patient stability and injury type may limit endovascular applicability at some centers. We hypothesized that for penetrating trauma, indications for endovascular treatment of peripheral vascular injuries, as outlined by national guidelines, are infrequent.

Methods

We reviewed records of patients sustaining penetrating peripheral vascular injuries treated at our university-based urban trauma center from 2006–2010. Patient demographics and outcomes were analyzed.

Results

In 92 patients with penetrating peripheral vascular injuries, 82 were managed operatively and 10 were managed nonoperatively. Seventeen (18%) were hemodynamically unstable on arrival, 44 (48%) had multiple vessels injured, and 76 (83%) presented at night and/or on the weekend. No pseudoaneurysms or arteriovenous fistulas were seen initially or at follow-up. Applying national guidelines to our cohort, only two patients (2.2%) met recommended criteria for endovascular treatment.

Conclusions

According to national guidelines, indications for endovascular treatment of penetrating peripheral vascular injury are infrequent. Nearly two-thirds of patients with penetrating peripheral vascular injuries were hemodynamically unstable or had multiple vessels injured, making endovascular repair less desirable. Additionally, over 80% presented at night and/or on the weekend, which could delay treatment at some centers due to mobilization of the endovascular team. Trauma centers need to consider their resources when incorporating national guidelines in their treatment algorithms of penetrating vascular trauma.     

Postmarketing safety of biologics and biological devices

Background contextRegardless of study design, the approval process of biologics and biological devices cannot identify every possible safety concern. Postmarketing safety surveillance can provide information based on real-world use of medical products in heterogeneous populations and is critical for identifying potentially serious adverse events, events that are too rare to be detected during premarketing studies, late complications, and events involving individuals or uses that were not evaluated in clinical trials.PurposeTo review why adverse event reporting is important and how the information is used, with emphasis on the points that are most applicable for surgeons and other spine professionals.MethodsThis is an overview of postmarketing safety surveillance.ResultsReview of adverse event reports has resulted in safety notifications, label changes, and publications regarding the safety of biologics and biological devices, such as the risk of airway compromise after the use of recombinant human bone morphogenetic protein in cervical spine fusion, the occurrence of a fatal air embolism after the use of a fibrin sealant that had been applied with a spray device, and infections after allograft transplantation of human tissues.ConclusionsIn light of the rapid development of new biologics, postmarketing surveillance is imperative for ensuring that these products are as safe as possible. By reporting adverse events, surgeons and other health care professionals play a key role in improving and refining our understanding of the safety of biologics.