Monitoring of Tissue Transfer Flaps by Modulated Imaging (MI) Spectroscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of California, Irvine
Sponsor:
Information provided by (Responsible Party):
Gregory R. Evans, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00633503
First received: March 4, 2008
Last updated: November 11, 2012
Last verified: November 2012
  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 & veins at the recipient site. The process of reconstructive surgery using tissue transfer flaps allows for improved results in terms of functionality, aesthetic appearance, and psychological well-being in patients requiring reconstructive surgery after cancer resection or trauma. 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.

The purpose of this pilot study is to determine if a novel, unique, portable, non-contact optical imaging device developed at the Beckman Laser Institute called Modulated Imaging (MI) can detect changes in a flap's optical properties, which can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy. The study would also evaluate if changes in the tissue transfer flap's optical properties, as detected by the device could be employed as a monitoring device in the post-operative period after reconstructive surgery. The MI device's detection of specific optical properties of a tissue flap could also potentially be used as a diagnostic tool to predict the likelihood of the development of fat necrosis or flap atrophy in a delayed fashion several months after reconstructive surgery.

Prior animal and clinical studies using similar devices have demonstrated that changes in the total hemoglobin concentration and percentage of oxygenated hemoglobin in the tissue transfer flap can be used to differentiate between arterial and venous occlusion. These other similar devices have been shown to be able to detect venous occlusion prior to clinical manifestations of venous occlusion using standard monitoring methods. This early detection of venous occlusion has important implications. It is well established that early detection and surgical re-exploration and correction of venous occlusion is associated with improved survival and salvage rates of tissue transfer flaps. It has been suggested in the reconstructive literature that the development of fat necrosis and flap atrophy are caused by a relative arterial or venous insufficiency, which could be detected using the MI device prior to the clinical manifestations of these complications.Patients undergoing reconstructive surgery at UCI Medical Center will be recruited for enrollment into the study. The study design requires following the patients and review their medical records in order to determine the clinical outcomes of their reconstructive surgery. The process of review of the medical record will require the review of both the in-patient medical record during the hospitalization in which the reconstructive surgery takes place and the outpatient medical record after surgery in order to observe for the possible development of the acute and delayed complications of reconstructive surgery.


Condition
Reconstructive Surgical Procedures
Tissue Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring of Tissue Transfer Flaps by Modulated Imaging (MI) Spectroscopy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
A-Observation
All patients undergoing pedicle and free tissue transfer.

  Show Detailed Description

  Eligibility

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

The subjects will be recruited from the pool of the patients seen in the Aesthetic and Plastic Surgery Institute clinics, as well as patients initially seen as in-patient consultations by the Plastic Surgery Service. Patients requiring reconstructive surgery using either a pedicle or free tissue transfer flap(s) will be identified. Patients requiring emergency reconstructive surgery after acute trauma will be excluded from the study as a matter of patient safety. The location and type of tissue transfer flaps enrolled will be dependent on the patient mix that presents during the study enrolment period. After explaining the nature, rationale, objectives, benefits, and risks of the study to the patients, they will be asked to consent to the study.

Criteria

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.
  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: NCT00633503

Contacts
Contact: Thomas Scholz, MD 714-456-3482 tscholz@uci.edu
Contact: Sophia M Ceron 714-456-5471 s2castro@uci.edu

Locations
United States, California
Aesthetic and Plastic Surgery Institute Recruiting
Orange, California, United States, 92868
Contact: Gregory RD Evans, MD, FACS    714-456-5253    gevans@uci.edu   
Contact: Thomas Scholz, MD    714-456-3482    tscholz@uci.edu   
Principal Investigator: Gregory RD Evans, MD, FACS         
The University of California Irvine Recruiting
Orange, California, United States, 92868
Contact: Lavonne Hart    714-456-8728      
Contact: lisa Hayes-Swartz    7144563228      
Principal Investigator: Gregory Evans         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Gregory RD Evans, MD, FACS Aesthetic and Plastic Surgery Institute
  More Information

No publications provided

Responsible Party: Gregory R. Evans, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00633503     History of Changes
Other Study ID Numbers: 2007-5891
Study First Received: March 4, 2008
Last Updated: November 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
free tissue transfer
pedicle tissue transfer
complications
modulated imaging spectroscopy
observation
clinical observation/diagnosis
tissue defects requiring free tissue transfer
tissue defects requiring pedicle tissue transfer

ClinicalTrials.gov processed this record on October 01, 2014