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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Craig W. Senders, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584272
First received: December 26, 2007
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition
Cleft Palate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Estimated Enrollment: 500
Study Start Date: March 2007
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

UCDMC pediatric clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584272

Locations
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Craig W. Senders, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Craig W. Senders, MD, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00584272     History of Changes
Other Study ID Numbers: 200715210-1
Study First Received: December 26, 2007
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
cleft palate
suture materials

Additional relevant MeSH terms:
Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
 Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on June 18, 2013