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North Attleboro, MA, United States

Voigt J.,Medical Device consultants | Driver V.R.,Boston University
Wound Repair and Regeneration

Hyaluronic acid (HA) is a polysaccharide common to most species and is found in many sites in the human body, including the skin and soft tissue. A systematic review of the literature and meta-analysis was performed to identify randomized controlled trials, evaluating the use of HA derivatives in healing burns, epithelial surgical, and chronic wounds. Nine studies were identified, which met the search criteria and clinical endpoints of complete healing and percent wound size reduction when using HA vs. either an active or passive comparator. It was found in the vast majority of randomized controlled trials (eight of nine) that HA derivatives significantly improved the healing of wounds vs. traditional therapies or placebo (either via complete healing or a significant reduction in wound size) occurring from burns, venous insufficiency, diabetes, neuropathic insufficiency, and surgical removal of the epithelial layer (for tattoo removal). In the other remaining trial, one formulation of HA was compared with another, with the higher concentration showing improved application characteristics. Further, it was found in a meta-analysis in subsets of patients with diabetic foot ulcers (neuropathic) that HA derivatives healed these types of wounds significantly faster than standard of care. These studies in aggregate show that HA derivatives accelerate the healing process in burns, epithelial surgical wounds, and chronic wounds. © 2012 by the Wound Healing Society. Source

The cost of primary total hip replacement products approaches 65% of the total reimbursement. Durability of total hip replacement resides with the acetabular component. This systematic review and meta-analysis determined if the outcomes of durability, function, and adverse events associated with cemented all-polyethylene acetabular components was similar to other acetabular designs, holding other variables constant. Randomized controlled trials only were evaluated. Two independent reviewers collected the data from 6 randomized controlled trials. Appropriate statistical analysis was performed. There was no statistical difference in regard to the outcomes at various time points (≤3, 4-8, and ≥10 years) in the 907 implants evaluated. There does, however, appear to be a trend toward abject failure with cemented all-polyethylene acetabular component implants consistent with findings of increased radiolucencies more than 10years out. The issue of increased radiolucencies over time and failure with these types of implants bears closer scrutiny. © 2012 Elsevier Inc.. Source

Darouiche R.,Baylor College of Medicine | Mosier M.,Washburn University | Voigt J.,Medical Device consultants
PACE - Pacing and Clinical Electrophysiology

Background: Surgical site infections (SSIs) resulting from cardiac implantable electronic device (CIED) implantation cause significant morbidity and mortality, and are increasing at a disproportionately higher rate than the rate of CIED implantation. The prophylactic administration of antibiotics and antiseptics can reduce this infection rate. The objective of this systematic review and meta-analysis was to determine whether the prophylactic administration of antibiotics and antiseptics in patients undergoing CIED implantation reduces the incidence of SSI in randomized controlled trials. We searched the Cochrane Wounds Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2), Ovid MEDLINE, Ovid EMBASE, and EBSCO CINAHL. No date or language restrictions were applied. Methods: Two review authors independently screened papers for inclusion, assessed risk of bias, and extracted data using a data collection form. Data were pooled where appropriate. Results: Fifteen studies (3,970 participants) were included in this review. For patients undergoing a CIED implant, perioperative systemic antibiotics (PSA) plus antiseptics delivered 1 hour before the procedure significantly reduced the incidence of SSI compared with no antibiotics (risk ratio [RR] 0.13; 95% confidence interval [CI] 0.05-0.36; P value < 0.00001). Furthermore, PSA plus antiseptics significantly reduced the incidence of postoperative infection compared to antibiotics delivered postoperatively (RR 0.14; 95% CI 0.03-0.60; P value 0.008). Conclusion: The evidence strongly suggests that antibiotic prophylaxis within 1 hour before CIED implantation is effective at reducing SSI. (PACE 2012; 35:1348-1360) © 2012, The Authors. Journal compilation © 2012 Wiley Periodicals, Inc. Source

It has been assumed that less intense levels of care for managing heart failure result in a lowering of the overall costs for this care in the United States. The objective of this review was to determine whether this assumption is correct. A systematic review was performed using Medline, technology assessment Web sites, and relevant cardiovascular and heart failure journals from the year 2000 to the present. US randomized controlled trials where costs were evaluated as one of the endpoints were included. Data were collected using Cochrane Review characteristics of included studies and risk of bias assessment forms. Cost data from each trial were converted to a uniform cost definition and year. Meta-analysis was performed where appropriate. Ten trials were identified evaluating costs at various time points (3, 6, and 12 months). Meta-analysis of trials demonstrated no difference in costs for care, no matter the patient condition or settings. In high-quality trials examining costs, there may be a shifting in costs from more expensive care settings to less expensive care settings without savings to the healthcare system. Larger and longer-term trials should be undertaken to understand this issue.© 2012 Wiley Periodicals, Inc. Source

Voigt J.,Medical Device consultants | Mosier M.,Washburn University
Journal of Clinical Pathology

A significant number of bone marrow biopsies are performed annually. Outcomes of patient pain and sample size of biopsy are important issues as perception of patient pain is underestimated by clinicians and sample size assists in accurate diagnosis. Manual extraction of marrow biopsy is the main method used. Recently a powered system has been introduced. The objectives of this systematic review and meta-analysis were to determine if the powered system reduces patient pain and improves sample capture. A PubMed and Cochrane search for randomised controlled trials was undertaken comparing the powered system with manual methods. Risk of bias assessment and meta-analysis of outcomes using appropriate statistical methods were performed. Five randomised controlled trials were identified. Patient pain (measured via visual analogue scale (VAS)-100 point scale) was significantly reduced using the powered system: mean difference=-6.57; 95% CI -12.93 to -0.22; p=0.04. The relative reduction in pain was 17%-25% with the powered system. Sample biopsy size (length in mm) was also significantly increased with the powered system: mean difference=3.65 mm; 95%; CI 1.61 mm to 5.68 mm; p=0.0005. The relative increase in sample size was 33% with the powered system. Operator ease of use (as measured via VAS) and adverse events were similar. Despite limited operator experience, patients experienced less pain and sample sizes were increased without an increase in adverse events with the powered system. The powered system may offer an option in obtaining samples from patients whose pain is compromised by disease and may reduce redos. Source

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