Study protocol and statistical analysis plan for a randomized, double-blind, controlled trial evaluating recombinant human platelet-derived growth factor B (rhPDGF) in the reconstruction of complex head or neck defects following skin cancer excision.
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| Title: | Study protocol and statistical analysis plan for a randomized, double-blind, controlled trial evaluating recombinant human platelet-derived growth factor B (rhPDGF) in the reconstruction of complex head or neck defects following skin cancer excision. |
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| Authors: | Clark CR; Vanderbilt Institute of Clinical and Translational Research, Vanderbilt Health, Nashville, Tennessee, United States of America., Blette BS; Department of Biostatistics, Vanderbilt Health, Nashville, Tennessee, United States of America., Guzman RAT; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America., Lempicki MD; Vanderbilt Institute of Clinical and Translational Research, Vanderbilt Health, Nashville, Tennessee, United States of America., Karamitros G; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America., Gergoudis F; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America., Gutama BW; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America., O'Neill DR; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America., Savitz B; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America., Smith J; Vanderbilt Institute of Clinical and Translational Research, Vanderbilt Health, Nashville, Tennessee, United States of America., Shirey-Rice JK; Vanderbilt Institute of Clinical and Translational Research, Vanderbilt Health, Nashville, Tennessee, United States of America., Pulley JM; Vanderbilt Institute of Clinical and Translational Research, Vanderbilt Health, Nashville, Tennessee, United States of America., Lynch SE; Lynch Regenerative Medicine, Franklin, Tennessee, United States of America., McGonigle TW; Department of Biostatistics, Vanderbilt Health, Nashville, Tennessee, United States of America., Thayer WP; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America. |
| Source: | MedRxiv : the preprint server for health sciences [medRxiv] 2026 May 04. Date of Electronic Publication: 2026 May 04. |
| Publication Type: | Journal Article; Preprint |
| Journal Info: | Country of Publication: United States NLM ID: 101767986 Publication Model: Electronic Cited Medium: Internet NLM ISO Abbreviation: medRxiv Subsets: PubMed not MEDLINE |
| Database: | MEDLINE Ultimate |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 42145621 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Study protocol and statistical analysis plan for a randomized, double-blind, controlled trial evaluating recombinant human platelet-derived growth factor B (rhPDGF) in the reconstruction of complex head or neck defects following skin cancer excision. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Clark+CR%22">Clark CR</searchLink>; Vanderbilt Institute of Clinical and Translational Research, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22Blette+BS%22">Blette BS</searchLink>; Department of Biostatistics, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22Guzman+RAT%22">Guzman RAT</searchLink>; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22Lempicki+MD%22">Lempicki MD</searchLink>; Vanderbilt Institute of Clinical and Translational Research, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22Karamitros+G%22">Karamitros G</searchLink>; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22Gergoudis+F%22">Gergoudis F</searchLink>; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22Gutama+BW%22">Gutama BW</searchLink>; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22O'Neill+DR%22">O'Neill DR</searchLink>; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22Savitz+B%22">Savitz B</searchLink>; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22Smith+J%22">Smith J</searchLink>; Vanderbilt Institute of Clinical and Translational Research, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22Shirey-Rice+JK%22">Shirey-Rice JK</searchLink>; Vanderbilt Institute of Clinical and Translational Research, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22Pulley+JM%22">Pulley JM</searchLink>; Vanderbilt Institute of Clinical and Translational Research, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22Lynch+SE%22">Lynch SE</searchLink>; Lynch Regenerative Medicine, Franklin, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22McGonigle+TW%22">McGonigle TW</searchLink>; Department of Biostatistics, Vanderbilt Health, Nashville, Tennessee, United States of America.<br /><searchLink fieldCode="AU" term="%22Thayer+WP%22">Thayer WP</searchLink>; Department of Plastic Surgery, Vanderbilt Health, Nashville, Tennessee, United States of America. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22101767986%22">MedRxiv : the preprint server for health sciences</searchLink> [medRxiv] 2026 May 04. <i>Date of Electronic Publication: </i>2026 May 04. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Preprint – Name: TitleSource Label: Journal Info Group: Src Data: <i>Country of Publication: </i>United States <i>NLM ID: </i>101767986 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>NLM ISO Abbreviation: </i>medRxiv <i>Subsets: </i>PubMed not MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=42145621 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.64898/2026.05.01.26352276 Languages: – Code: eng Text: English Titles: – TitleFull: Study protocol and statistical analysis plan for a randomized, double-blind, controlled trial evaluating recombinant human platelet-derived growth factor B (rhPDGF) in the reconstruction of complex head or neck defects following skin cancer excision. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Clark CR – PersonEntity: Name: NameFull: Blette BS – PersonEntity: Name: NameFull: Guzman RAT – PersonEntity: Name: NameFull: Lempicki MD – PersonEntity: Name: NameFull: Karamitros G – PersonEntity: Name: NameFull: Gergoudis F – PersonEntity: Name: NameFull: Gutama BW – PersonEntity: Name: NameFull: O'Neill DR – PersonEntity: Name: NameFull: Savitz B – PersonEntity: Name: NameFull: Smith J – PersonEntity: Name: NameFull: Shirey-Rice JK – PersonEntity: Name: NameFull: Pulley JM – PersonEntity: Name: NameFull: Lynch SE – PersonEntity: Name: NameFull: McGonigle TW – PersonEntity: Name: NameFull: Thayer WP IsPartOfRelationships: – BibEntity: Dates: – D: 04 M: 05 Text: 2026 May 04 Type: published Y: 2026 Titles: – TitleFull: MedRxiv : the preprint server for health sciences Type: main |
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