NCT00658242

Brief Summary

Craniofacial reconstruction procedures are undertaken in young children to improve appearance, prevent functional disturbances, and enhance psychosocial development. These procedures involve wide scalp dissections and multiple osteotomies and have been associated with significant morbidity. The most commonly seen perioperative complications are associated with the rate and extent of blood loss. This prospective observational registry will be a research tool which will provide a means to evaluate perioperative management of these children at CHOP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

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, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

4.3 years

First QC Date

April 8, 2008

Last Update Submit

August 7, 2013

Conditions

Craniotomy

Keywords

craniofacialmaxillofacialosteotomycraniectomycraniotomy

Outcome Measures

Primary Outcomes (1)

  • To create a research tool that prospectively captures perioperative data in the craniofacial surgical patient population that may provide insights into the perioperative management and help guide clinical decision making.

    2.5 years

Study Arms (1)

I

Subjects having Craniofacial surgery

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects presenting for craniofacial surgery

You may qualify if:

  • Males or females with ages from birth to 18 years.
  • Patients undergoing surgical procedures on the craniofacial region performed by plastic surgeons, neurosurgeons, or by plastic surgeons in concert with neurosurgeons.
  • Patients undergoing plastic surgical procedures involving a craniotomy, craniectomy, maxillofacial osteotomy, strip craniectomy, or other plastic surgical procedure involving bones of the head and face.
  • Parental/guardian permission (informed consent) and if appropriate, child assent.

You may not qualify if:

  • Patients undergoing craniofacial plastic surgical procedures not involving bones of the head and face.
  • Patients not admitted to the intensive care unit following surgery.
  • Patients undergoing procedures only involving the mandible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital Of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Paul A Stricker, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2008

First Posted

April 14, 2008

Study Start

March 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

US(1)