Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment

NCT ID: NCT01235299

Last Updated: 2017-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Flap Monitoring

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy subjects

No interventions assigned to this group

Subjects suffering from Diabetes mellitus

No interventions assigned to this group

Subjects suffering from peripheral arterial occlusive disease

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age between 16 and 65 years

Exclusion Criteria

* 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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical School Hannover

Hanover, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21664205 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Kraemer002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Monitoring Free Tissue Transfer Hemodynamics Using NIRS
NCT06661525 ENROLLING_BY_INVITATION NA