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Monitoring of Tissue Transfer Flaps by Modulated Imaging

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00792792
First received: November 14, 2008
Last updated: December 26, 2012
Last verified: December 2012
History of Changes
  Purpose

The researchers at Beckman Laser Institute, UCI developed a safe, non-contact, intra-operative & post-operative device called Modulated Imaging (MI), to the clinical evaluation of tissue transfer flaps after reconstructive surgery.


Condition
Other Reconstructive Surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-contact, Intra-operative & Post-operative Device, Evaluation of Tissue Transfer Flaps After Reconstructive Surgery.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • a correlation between the immediate post-operative optical properties of tissue transfer flaps and the development of late complications. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2007
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
tissue transfer
reconstructive surgery

Detailed Description:

The MI device collect data regarding the optical properties of the tissue transfer flaps, to detect acute post-operative occlusion of the artery or of the vein going to and from the tissue transfer flap.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • Adult 18 years and older planned to undergo reconstructive surgery at UCIMC

Exclusion Criteria:

  • All emergency reconstructive surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792792

Locations
United States, California
Beckman Laser Medical clinic, UCI
Irvine, California, United States, 92612
UCIMC
Orange, California, United States, 92868
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Evans R Gregory, PhD Aesthetic & Plastic Surgery Institute, UCIMC
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00792792     History of Changes
Other Study ID Numbers: LAMMP WIFI-RR-01192-29
Study First Received: November 14, 2008
Last Updated: December 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
tissue transfer

ClinicalTrials.gov processed this record on May 22, 2013