Status:
COMPLETED
Monitoring of Tissue Transfer Flaps by Modulated Imaging (MI) Spectroscopy
Lead Sponsor:
University of California, Irvine
Conditions:
Reconstructive Surgical Procedures
Tissue Transplantation
Eligibility:
All Genders
18+ years
Brief Summary
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 detache...
Detailed Description
Objectives: 1. To develop a safe, non-contact, intra-operative \& post-operative device, which can be used as an adjunct to the clinical evaluation of tissue transfer flaps after reconstructive surge...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 15 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00633503
Start Date
January 1 2011
End Date
January 15 2020
Last Update
April 5 2021
Active Locations (2)
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1
Aesthetic and Plastic Surgery Institute
Orange, California, United States, 92868
2
The University of California Irvine
Orange, California, United States, 92868