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| Tracking Information | |||||
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| First Received Date ICMJE | December 26, 2007 | ||||
| Last Updated Date | December 26, 2007 | ||||
| Start Date ICMJE | March 2007 | ||||
| Estimated Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials | ||||
| Official Title ICMJE | Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials | ||||
| Brief Summary | Investigator initiated retrospective chart review to study the effects of changing suture material on the healing and outcome of cleft palate surgery were. |
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| Detailed Description | This study aims to show what the effects of changing suture material were on the healing and outcome of cleft palate surgery. The study will be considered successful if we find that either there is an effect on the healing after surgery, one of the suture materials seems to promote better healing and final outcome, or that there is no difference between the suture materials. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Retrospective | ||||
| Condition ICMJE | Cleft Palate | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | March 2008 | ||||
| Estimated Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Year to 10 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00584272 | ||||
| Responsible Party | Craig W. Senders, MD, University of California Davis | ||||
| Study ID Numbers ICMJE | 200715210-1 | ||||
| Study Sponsor ICMJE | University of California, Davis | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of California, Davis | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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