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

This study is ongoing, but not recruiting participants.

First Received: December 26, 2007 No Changes Posted

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00584272

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:	Case-Only, Retrospective
Official Title:	Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials

Resource links provided by NLM:

Genetics Home Reference related topics: Baller-Gerold syndrome Crouzon syndrome

MedlinePlus related topics: Cleft Lip and Palate Surgery

U.S. FDA Resources

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (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:	University of California Davis ( Craig W. Senders, MD )
Study ID Numbers:	200715210-1
Study First Received:	December 26, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00584272 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

cleft palate
suture materials

Study placed in the following topic categories:

Mouth Diseases
Cleft Palate
Musculoskeletal Diseases
Craniofacial Abnormalities

Stomatognathic Diseases
Maxillofacial Abnormalities
Congenital Abnormalities
Musculoskeletal Abnormalities

Additional relevant MeSH terms:

Mouth Diseases
Cleft Palate
Musculoskeletal Diseases
Mouth Abnormalities
Craniofacial Abnormalities
Jaw Diseases

Stomatognathic System Abnormalities
Jaw Abnormalities
Stomatognathic Diseases
Maxillofacial Abnormalities
Congenital Abnormalities
Musculoskeletal Abnormalities

ClinicalTrials.gov processed this record on July 06, 2009