NCT00792792

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

11.4 years

First QC Date

November 14, 2008

Last Update Submit

October 28, 2022

Conditions

Other Reconstructive Surgery

Keywords

tissue transfer

Outcome Measures

Primary Outcomes (1)

  • Transfer Skin flap

    up to 6 weeks

Study Arms (1)

Tissue transfer skin flap

Modulated Imaging Spectroscopy

Device: Modulated Imaging

Interventions

Modulated ImagingDEVICE

Modulated Imaging Spectroscopy

Tissue transfer skin flap

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population will be selected from Surgical Department as outpatients and in-patient bases that require reconstructive surgery using a pedicle or free tissue transfer flap.

You may qualify if:

  • Adult 18 years and older planned to undergo reconstructive surgery

You may not qualify if:

  • All emergency reconstructive surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Medical Center

Orange, California, 92868, United States

Location

Study Officials

  • Evans R Gregory, PhD

    Aesthetic & Plastic Surgery Institute, UCIMC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gregory Evans, M.D., Chair, Department of Plastic Surgery

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 18, 2008

Study Start

January 1, 2007

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)