Expired Study
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Sacramento, California 95817


Purpose:

Investigator initiated retrospective chart review to study the effects of changing suture material on the healing and outcome of cleft palate surgery were.


Study summary:

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.


Criteria:

Inclusion Criteria: - Cleft palate repair performed at UCDMC between 1/1996 and 6/2006 Exclusion Criteria: - Those who do not meet the inclusion criteria


Study is Available At:


Original ID:

200715210


NCT ID:

NCT00584272


Secondary ID:


Study Acronym:


Brief Title:

Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials


Official Title:

Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

1 Year


Maximum Age:

10 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Davis


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

88


Enrollment Type:

Actual


Overall Contact Information

Official Name:Craig W. Senders, MD
Principal Investigator
University of California, Davis

Study Dates

Start Date:March 2007
Completion Date:April 2015
Completion Type:Actual
Primary Completion Date:April 2015
Primary Completion Type:Actual
Verification Date:June 2017
Last Changed Date:June 19, 2017
First Received Date:December 26, 2007

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Davis

Samples and Retentions

Study Population: UCDMC pediatric clinic
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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