Monitoring of Tissue Transfer Flaps by Modulated Imaging

Withdrawn

• Conditions: Other Reconstructive Surgery
• Interventions: Device: Modulated Imaging

• Registration Number: NCT00792792
• Lead Sponsor: University of California, Irvine

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 and veins at the recipient site. 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.

Detailed Description

The researchers developed a safe, non-contact, intra-operative and post-operative device called Modulated Imaging, can detect changes in a flap's optical properties and can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-14
• Study First Posted: 2008-11-18
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult 18 years and older planned to undergo reconstructive surgery

Exclusion Criteria

• All emergency reconstructive surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tissue transfer skin flap	Modulated Imaging	Modulated Imaging Spectroscopy

Primary Outcome Measures

Name	Time	Method
Transfer Skin flap	up to 6 weeks

Trial Locations

Locations (1)

University of California Medical Center; 🇺🇸 Orange, California, United States