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Assessment of Reconstructive Surgical Flaps Using Spatially Resolved Tissue Oxima

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42GM077713-02A2
Agency Tracking Number: R42GM077713
Amount: $1,305,690.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIGMS
Solicitation Number: PA10-051
Timeline
Solicitation Year: 2011
Award Year: 2011
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
1002 Health Sciences Rd.
IRVINE, CA -
United States
DUNS: 603130928
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 DAVID CUCCIA
 (949) 716-9570
 david.cuccia@modulatedimaging.com
Business Contact
 DAVID CUCCIA
Phone: (949) 824-8367
Email: david.cuccia@modulatedimaging.com
Research Institution
 UNIVERSITY OF CALIFORNIA IRVINE
 
5171 California, Ste #150
IRVINE, CA 92697-7600
United States

 () -
 Nonprofit College or University
Abstract

DESCRIPTION (provided by applicant): The use of tissue transfer flaps is a method of moving tissue from a donor location to recipient location and re-attaching the arteries and veins to the blood vessels at the recipient site. These procedures enable reconstructive surgery after trauma, as well as after surgical resection of cancer. Flap transfer surgery is subject to failure via a number of modes including vascular insufficiency caused by mechanical obstruction of the artery or vein, injury caused to the transferred tissues due to the lack of blood flow during the flap transfer, or due to ischemia-reperfusion injury. The first postoperative days after free tissue transfer are characterized by the risk of microvascular complications and loss of transferred tissue by necrosis. Loss of a free flap is a devastating experience to both the surgeon and the patient. Tissue oxygenation and maintenance of microvascular blood flow in grafted tissues are crucial for flap viability. Several studies have demonstrated that frequent monitoring and early detection of compromise results in earlier intervention which reduces the number of devastating complications that lead to tissue loss. Early in the era of microsurgery, flap monitoring was performed with only clinical observation of skin color, capillary refill, and dermal bleeding. However, issues related to staffing and subjective variations in clinical assessment of a flap's perfusion have led to the search for objective methods of flap monitoring. One promising technology for measuring local tissue oxygenation in-vivo is diffuse optical spectroscopy (DOS). DOS is a quantitative near-infrared (NIR) spectroscopy technique that can determine absolute concentrations of chromophores such as oxy and deoxy hemoglobin, fat and water. Modulated Imaging (MI) is a NIR imaging method invented at BLI that is based on the principles of DOS and employs patterned illumination to interrogate biological tissues. This non-contact approach enables rapid quantitative determination of the optical properties and in-vivo concentrations of chromophores over a wide field-of-view. The central aim of the proposed research is to further the development of Modulated Imaging and to assess the viability of this as a means to determine status of tissue reconstruction flaps. In Phase I, we carried out an in-vivo MI study using a dorsal pedicle flap rodent model. The dorsal pedicle flap is easily implemented to establish controlled ischemia and re-perfusion of the wounds. This allowed us to employ MI to deduce spatially resolved maps of tissue hemoglobin, oxygenation and hydration over the course of several days. In Phase II we propose to develop and validate an MI instrument for clinical use. Investigations will first evaluate the performance of MI in a controlled model of partial vascular congestion using adult Yorkshire pigs. This will be followed by a study in which MI and a potentially competing FDA cleared device will be employed in a clinical situation in order to assess local flap status. In parallelwith the Phase II research outlined herein, we will aggressively pursue commercialization of a medical device based on MI. PUBLIC HEALTH RELEVANCE: The use of tissue transfer flaps is a method of moving tissue from a donor location to recipient location and re-attaching the arteries and veins to the blood vessels at the recipient site. The medical utility of this process is to allow for reconstructive surgery after trauma, as well as after surgical resection of cancer. This type of reconstructive surgery is subject to failure caused by to mechanical obstruction of the artery or vein; injury caused to the transferred tissues due to the lack of blood flow when a free tissue flap is performed, (the tissue is disconnected prior to re-attaching the blood vessels); or due to a type of injury call ischemia- reperfusion injury, which is a type of injury that results after blood flow has been returned to the transferred tissue. Tissue oxygenation and maintenance of microvascular blood flow in grafted tissues are crucial for flap to survive. The first postoperative days after free tissue transfer are characterized by the risk of microvascular complications and loss of transferred tissue by necrosis. Loss of a free flap is a devastating experience to both the surgeon and the patient. In this proposal we will develop and validate an instrument that has the potential to identify flap failure earlier than is currently achievable. A successful effort has the potential to enable development of a new medical device thatwill have the capability to guide reconstructive surgery and post-surgical recovery, both reducing post-surgery complication rate and reducing uncertainty in flap healing. This may shorten the duration of hospital stay and associated heath care costs in addition to improving surgical outcomes.

* Information listed above is at the time of submission. *

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