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

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

This study is ongoing, but not recruiting participants.

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

Genetics Home Reference related topics:

Baller-Gerold syndrome Crouzon syndrome

MedlinePlus related topics:

Cleft Lip and Palate

U.S. FDA Resources

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

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

Responsible Party:	University of California Davis ( Craig W. Senders, MD )
Study ID Numbers:	200715210-1
First Received:	December 26, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00584272
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 Abnormalities

Jaw Diseases

Stomatognathic System Abnormalities

Jaw Abnormalities

ClinicalTrials.gov processed this record on August 20, 2008