NCT01235299

Brief Summary

In case of free flap failure, time is of utmost importance as salvage rates have been reported to be inversely related to the time interval between the onset of ischemia and its clinical recognition. Consecutively, monitoring of free flaps remains of major importance. Currently, combined Laser-Doppler and Spectrophotometry is available to determine microcirculation of free flaps in reconstructive surgery as a scientific method of reliable assessment of flap perfusion. The investigators thought to analyze the correlation of free flap skin temperature and free frap microcirculation as an accurate tool of postoperative flap monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
Last Updated

February 27, 2017

Status Verified

November 1, 2010

Enrollment Period

2 months

First QC Date

November 4, 2010

Last Update Submit

February 23, 2017

Conditions

Flap Monitoring

Outcome Measures

Primary Outcomes (1)

  • Correlation of cutaneous microcirculation to free flap temperature

    4 months

Study Arms (3)

Healthy subjects

Subjects suffering from Diabetes mellitus

Subjects suffering from peripheral arterial occlusive disease

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients suffering from a soft tissue defect at any location of the body receiving free flap soft-tissue defect coverage at the Department of Plastic, Hand and Reconstructive Surgery, Medical School Hannover, Germany.

You may qualify if:

  • Age between 16 and 65 years

You may not qualify if:

  • soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis, chronic kidney or liver disease, cardiac dysfunction, arterial hypotension and any type of vasoactive medication, i.e. ß-blockers, calcium channel blockers, nitroglycerin or equal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School Hannover

Hanover, 30625, Germany

Location

Related Publications (1)

  • Kraemer R, Lorenzen J, Knobloch K, Papst S, Kabbani M, Koennecker S, Vogt PM. Free flap microcirculatory monitoring correlates to free flap temperature assessment. J Plast Reconstr Aesthet Surg. 2011 Oct;64(10):1353-8. doi: 10.1016/j.bjps.2011.04.030. Epub 2011 Jun 12.

    PMID: 21664205DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 5, 2010

Study Start

September 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

February 27, 2017

Record last verified: 2010-11

Locations

DE(1)