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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: October 22, 2014
Last verified: October 2014
  Purpose

Tissue transfer flaps are a method of moving tissue from a donor location to a recipient location. In the case of a free tissue transfer flaps, the blood vessels to the transferred tissues are detached and then re-attached to different arteries and veins at the recipient site. The process of reconstructive surgery using tissue transfer flaps is not without complications. These complications may include acute arterial or venous occlusion, as well as the development of late complications such as fat necrosis and flap atrophy.


Condition Intervention
Other Reconstructive Surgery
Device: Modulated Imaging

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:


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

Primary Outcome Measures:
  • Transfer Skin flap [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2007
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tissue transfer skin flap
Modulated Imaging Spectroscopy
Device: Modulated Imaging
Modulated Imaging Spectroscopy

Detailed Description:

The researchers developed a safe, non-contact, intra-operative and post-operative device called Modulated Imaging, can detect changes in a flap's optical properties and can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy.

  Eligibility

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

Study population will be selected from Surgical Department as outpatients and in-patient bases that require reconstructive surgery using a pedicle or free tissue transfer flap.

Criteria

Inclusion Criteria:

  • Adult 18 years and older planned to undergo reconstructive surgery

Exclusion Criteria:

  • All emergency reconstructive surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792792

Locations
United States, California
University of California Medical Center
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: NIH/LAMMP WIFI-RR-01192-29
Study First Received: November 14, 2008
Last Updated: October 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
tissue transfer

ClinicalTrials.gov processed this record on November 25, 2014