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Use of 5-Aminolevulinic Acid to Assess Bone and Tissue Profusion in Orthopaedic Infection Patients

NCT04976049 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-11-28

No results posted yet for this study

Summary

The focus of this study is to explore the variability distribution of 5-Aminolevulinic Acid (ALA)associated with bone and soft tissue perfusion in infection patients, using 5-ALA fluorescence imaging. In additional this study plans to evaluate the change in 5-ALA distribution from pre to post debridement and to preliminarily determine whether an orally administered dose of 20mg/kg 5-ALA can predict recurrent infection/treatment failure.

Conditions

Interventions

PROCEDURE

Imaging using 5-Aminolevulinic Acid (5-ALA) during surgery

Patients will be administered FDA approved oral 5-ALA and imaged by a FDA approved surgical fluorescence imaging device (Spy Elite) which is 0.5 meter away from the subject.

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Ida L Gitajn · Dartmouth-Hitchcock Medical Center

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-13
Primary Completion
2022-08-30
Completion
2022-11-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04976049 on ClinicalTrials.gov