Author Contributions: Dr Bennett-Guerrero had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Bennett-Guerrero, Ferguson, Lin, Mark, Corey.
Acquisition of data: Lin, Scavo, Kouchoukos, Richardson, Pridgen, Corey.
Analysis and interpretation of data: Bennett-Guerrero, Lin, Garg, Mark, Kouchoukos, Corey.
Drafting of the manuscript: Bennett-Guerrero, Lin, Corey.
Critical revision of the manuscript for important intellectual content: Ferguson, Lin, Garg, Mark, Scavo, Kouchoukos, Richardson, Pridgen, Corey.
Statistical analysis: Lin, Garg.
Administrative, technical, or material support: Ferguson, Mark, Kouchoukos, Richardson, Pridgen.
Study supervision: Bennett-Guerrero, Ferguson, Kouchoukos, Corey.
Financial Disclosures: Dr Bennett-Guerrero reported that he is in discussions with Excited States LLC regarding entering into a consulting agreement to advise on a clinical trial involving surgical wound infection prevention. Dr Ferguson reported receiving honoraria from Innocoll Technologies Ltd (the study's sponsor) for participating on the steering committee.
Funding/Support: The study was sponsored by Innocoll Technologies Ltd and coordinated by the Duke Clinical Research Institute, a department of Duke University, Durham, North Carolina. Each coauthor received research funding and support from the Innocoll Technologies Ltd. None of the coauthors is or has been employed by Innocoll Technologies Ltd.
Role of the Sponsor: The sponsor, Innocoll Technologies Ltd, designed the study and wrote the protocol in conjunction with the Duke Clinical Research Institute and an external member of the steering committee (Dr Ferguson, East Carolina Heart Institute). The sponsor was not involved in collection or management of the data. The sponsor did not conduct any statistical analyses, but did assist in analyzing and interpreting the data. The sponsor did not prepare the manuscript. Drs Bennett-Guerrero and Corey wrote the first draft of the manuscript. The sponsor reviewed the manuscript and provided minor comments. The study agreement provided Duke University freedom to publish the trial results without sponsor approval; therefore, the sponsor did not formally approve the manuscript. The Duke Clinical Research Institute wrote the protocol, gathered the data, maintained and controlled the database, analyzed the data, vouches for the data and analysis, wrote the manuscript, and decided to publish the manuscript.
Independent Statistical Analysis: Dr Lin, a Duke University faculty member and a coauthor, analyzed the data and has verified that the results presented in this article were provided by her.
SWIPE-1 Trial Group: Norbert E. Baumgartner, MD, FACS (Michigan Cardiovascular Institute), William Brinkman, MD, FAAP (Medical City Dallas Hospital), Clay M. Burnett, MD (Olathe Medical Center), John B. Casterline, MD (Cardio-Thoracic Surgeons, PC), Manuel R. Castresana, MD, FCCM (Medical College of Georgia Research Institute), Ramesh B. Cherukuri, MD (Michigan Cardiovascular Institute), Thomas Christopher, MD (Chippenham Medical Center), Allonso Collar, MD, FACS (Thoracic and Cardiovascular Healthcare Foundation), Charles Cousar, MD (Jacksonville Center for Clinical Research), Tracy Dorheim, MD (Nebraska Medical Center/Heart Consultants, PC), David Duncan, MD (Forsyth Medical Center), Richard Engelman, MD (Baystate Medical Center), N. Martin Giesecke, MD (Texas Heart Institute), Allen Graeve, MD (Multicare Health System), Chiwon Hahn, MD, FACS (Henrico Doctors Hospital), Stephen Hazelrigg, MD (Southern Illinois University School of Medicine), Robert Holmes, MD, FACS (Michigan Cardiovascular Institute), Robert Kamienski, MD (Akron General Medical Center), Marc Kanchuger, MD (New York University Medical Center), Gregory Keagy, DO (Genesis Health Care System), Dean Kereiakes, MD, FACC (Lindner Clinical Trial Center), William Killinger Jr, MD (Carolina Cardiovascular Surgical Associates), Nicholas Kouchoukos, MD (Missouri Baptist Medical Center), Alan Kypson, MD (Brody School of Medicine, East Carolina University), John Laschinger, MD, FACS (Midatlantic Cardiovascular Associates), Stanley Lochridge, MD (Medical Center East), George Maier, MD (Gaston Memorial Hospital), Joseph Mathew, MD, FASE (Duke University Medical Center), Charles McCoy, MD (Wesley Medical Center), Thomas Militano, MD (Washington Adventist Hospital), Diane Miller, MD (Portland VA Medical Center), Harold Minkowitz, MD (Memorial Hermann Healthcare System), Stephen Olenchock Jr, DO (Saint Luke's Hospital-Allentown), Timothy Osborn, MD (Tomball Regional Hospital), Ganga Prabhakar, MD (Iowa Heart Center), Michael J. Reardon, MD (The Methodist Hospital), John Richardson Jr, MD (Saint Vincent's Hospital), Gary Roach, MD (Kaiser Foundation Hospital), Ronald Roddy, PhD (Duke Clinical Research Institute), Russell Ronson, MD (Brookwood Ambulatory Care Center), Chittoor B. Sai-Sudhakar, MBBS, FACS, FRCS (Ohio State University Medical Center), Vincent Scavo, MD (Indiana/Ohio Heart), Alvaro Segura-Vasi, MD (Eliza Coffee Memorial Hospital), Ravi Sharma, MD (Regional Medical Center-Bayonet Point), Linda M. Sundt, MD (Thomas Jefferson University Hospital), Terrill E. Theman, MD (Saint Luke's Hospital and Health Network), James C. Todd III, MD (CV Surgical Associates, PA), Joseph T. Wingard, MD (Jacksonville Center for Clinical Research), and Hongqiu Yang, PhD (Duke Clinical Research Institute).
Additional Contributions: We thank the Duke Clinical Research Institute coordinating center and staff, Susan Cusack, BSN (regulator for Premier Research), and the following members of the data and safety monitoring board: Daniel Sexton, MD (chairman, Department of Medicine, Division of Infectious Disease, Duke University, Durham, North Carolina), John W. Hammon Jr, MD (Department of Cardiothoracic Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina), Shein Chung Chow, PhD (Duke University, Department of Biostatistics and Bioinformatics, Durham, North Carolina). Members of the data and safety monitoring board received financial compensation from Innocoll Technologies Ltd for their contributions.