NCT00584272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

8.1 years

First QC Date

December 26, 2007

Last Update Submit

June 19, 2017

Conditions

Cleft Palate

Keywords

cleft palatesuture materials

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

UCDMC pediatric clinic

You may qualify if:

  • Cleft palate repair performed at UCDMC between 1/1996 and 6/2006

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMouth AbnormalitiesMouth DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Craig W. Senders, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 2, 2008

Study Start

March 1, 2007

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations

US(1)