Monitoring of Tissue Transfer Flaps by Modulated Imaging

Other Reconstructive Surgery Clinical Trial

Official title:

Non-contact, Intra-operative & Post-operative Device, Evaluation of Tissue Transfer Flaps After Reconstructive Surgery.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00792792
• Other study ID #: 20075891
• Status: Withdrawn
• Start date: January 2007
• Est. completion date: June 2018

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult 18 years and older planned to undergo reconstructive surgery

Exclusion Criteria:

• All emergency reconstructive surgery

Related Conditions & MeSH terms

• Other Reconstructive Surgery

Intervention

Device:
• Modulated Imaging
Modulated Imaging Spectroscopy

Locations

Country	Name	City	State
United States	University of California Medical Center	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfer Skin flap		up to 6 weeks