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

NCT00633503 | Completed

• 1 other identifier: 2007-5891
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Reconstructive Surgical Procedures; Tissue Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• detection of flap complications by modulated imaging compared to clinical standards

  as long as hospital stay (baseline before surgery, 72 hours after surgery and before discharge from hospital)

Study Arms (1)

A-Observation

All patients undergoing pedicle and free tissue transfer.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (2)

Aesthetic and Plastic Surgery Institute

Orange, California, 92868, United States

Location

The University of California Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory RD Evans, MD, FACS

  Aesthetic and Plastic Surgery Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: January 1, 2011
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: April 5, 2021

Record last verified: 2021-04

Locations

US (2)