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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00633503 |
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Date of registration:
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04/03/2008 |
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Primary sponsor: |
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Public title:
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Monitoring of Tissue Transfer Flaps by Modulated Imaging (MI) Spectroscopy
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Scientific title:
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Monitoring of Tissue Transfer Flaps by Modulated Imaging (MI) Spectroscopy |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00633503 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Thomas Scholz, MD |
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Address:
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Telephone:
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714-456-3482 |
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Email:
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tscholz@uci.edu |
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Affiliation:
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Name:
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Gregory RD Evans, MD, FACS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aesthetic and Plastic Surgery Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients planned to undergo reconstructive surgery using either a pedicle or
free tissue transfer flap seen by The Plastic Surgery Service on either an in-patient
or outpatient bases.
- Adult patients that are planned to undergo reconstructive surgery as above and able
to receive information regarding the study and provide informed consent to enrollment
in the study.
Exclusion Criteria
- All emergency reconstructive surgery patients.
- Patients planned to undergo radiation therapy in the region of the reconstructive
surgery within 6 months after surgery.
- Patients who develop hypotension requiring the administration of vasopressors either
intra-operatively or during the post-operative period prior to discharge from the
hospital.
- Patients who develop clinical signs of a surgical site infection at the location of
the tissue transfer flap(s).
- Patients with the development of post-operative anemia requiring a blood transfusion
during the first 72 hours after surgery.
- Patients with tattooing or pigmented lesions on the tissue transfer flap.
- Patients who incur injury to the flaps secondary to trauma within 6 months of the
reconstructive surgery; with trauma defined as either accidental major trauma
resulting in injury to the tissue transfer flap or surgical trauma as a result of
further oncologic resection of tissues in close proximity to the tissue transfer
flap.
- Minor under the age of 18 years of age.
- Patients deemed unable to comprehend and provide informed consent to enrollment into
study due to either a cognitive deficit or medical condition.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Reconstructive Surgical Procedures
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Tissue Transplantation
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Primary Outcome(s)
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detection of flap complications by modulated imaging compared to clinical standards
[Time Frame: as long as hospital stay (baseline before surgery, 72 hours after surgery and before discharge from hospital)]
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Secondary ID(s)
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2007-5891
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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