Document Type
Article
Publication Date
5-2011
Publication Source
BMC Medical Research Methodology
Abstract
Background: Energy-based surgical scalpels are designed to efficiently transect and seal blood vessels using thermal energy to promote protein denaturation and coagulation. Assessment and design improvement of ultrasonic scalpel performance relies on both in vivo and ex vivo testing. The objective of this work was to design and implement a robust, experimental test matrix with randomization restrictions and predictive statistical power, which allowed for identification of those experimental variables that may affect the quality of the seal obtained ex vivo.
Methods: The design of the experiment included three factors: temperature (two levels); the type of solution used to perfuse the artery during transection (three types); and artery type (two types) resulting in a total of twelve possible treatment combinations. Burst pressures of porcine carotid and renal arteries sealed ex vivo were assigned as the response variable.
Results: The experimental test matrix was designed and carried out as a split-plot experiment in order to assess the contributions of several variables and their interactions while accounting for randomization restrictions present in the experimental setup. The statistical software package SAS was utilized and PROC MIXED was used to account for the randomization restrictions in the split-plot design. The combination of temperature, solution, and vessel type had a statistically significant impact on seal quality.
Conclusions: The design and implementation of a split-plot experimental test-matrix provided a mechanism for addressing the existing technical randomization restrictions of ex vivo ultrasonic scalpel performance testing, while preserving the ability to examine the potential effects of independent factors or variables. This method for generating the experimental design and the statistical analyses of the resulting data are adaptable to a wide variety of experimental problems involving large-scale tissue-based studies of medical or experimental device efficacy and performance.
Inclusive pages
1-6
ISBN/ISSN
1471-2288
Document Version
Published Version
Copyright
Copyright © 2011, Diestelkamp et al.; licensee BioMed Central Ltd.
Publisher
BioMed Central
Volume
11
Peer Reviewed
yes
Issue
75
eCommons Citation
Diestelkamp, Wiebke; Krane, Carissa M.; and Pinnell, Margaret, "Design of a Factorial Experiment with Randomization Restrictions to Assess Medical Device Performance on Vascular Tissue" (2011). Biology Faculty Publications. 140.
https://ecommons.udayton.edu/bio_fac_pub/140
Included in
Biology Commons, Biotechnology Commons, Cell Biology Commons, Genetics Commons, Microbiology Commons, Molecular Genetics Commons
Comments
This document is provided for download in compliance with the publisher's policy on self-archiving. Permission documentation is on file.