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

NCT04976049 | Withdrawn

• 1 other identifier: STUDY02000990
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Trauma; Infection; Bone Fracture

Keywords

5-Aminolevulinic Acid, infection, orthopedics, imaging

Outcome Measures

Primary Outcomes (1)

• 5-Aminolevulinic Acid distribution variability

  Distribution of 5-Aminolevulinic Acid in the bone and soft tissue of infection patients, measured using fluorescent imaging.

  One Day

Secondary Outcomes (1)

• 5-Aminolevulinic Acid distribution pre and post debridement.

  One Day

Other Outcomes (1)

• 5-Aminolevulinic Acid Dose Effectiveness

  6 months

Study Arms (1)

Orthopedic infection

Subjects who have undergone previous trauma surgeries and have developed an infection will be assessed for protocol inclusion criteria. Patients will be administered a single, oral, 20mg/kg dose of 5-Aminolevulinic Acid (ALA) by a qualified member of their care team. This dose will be administered ideally 3 hours prior to surgery. Fluorescent imaging will be obtained pre and post irrigation and debridement.

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

Interventions

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

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.

Orthopedic infection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age or older who present to Dartmouth-Hitchcock Medical Center with an orthopaedic infection

You may qualify if:

• Patients 18 years of age or older.
• History of an extremity fracture.
• Prior definitive fracture management with external fixation, internal fixation, or joint fusion.
• Superficial, deep, or organ space surgical site infection (SSI) (as per Center for Disease Control criteria) at the fracture site that requires operative management.
• Will have all planned SSI care surgeries performed by a participating surgeon or delegate.
• Provision of informed consent.

You may not qualify if:

• Fractures of the hand cannot be imaged.
• Iodine allergy.
• Burns at the SSI site.
• Incarceration.
• Expected survival of less than 90 days.
• Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
• Adults unable to consent or whom do not have a legal authorized representative
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant or breastfeeding women
• History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis.
• History of liver disease within the last 12 months.
• Elevated liver function tests (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or bilirubin levels greater than 2.5 times the normal limit) from laboratory tests conducted within 30 days prior to surgery.
• Serum creatinine in excess of 180 µmol/L within 30 days prior to surgery.
• Inability to comply with the photosensitivity precautions associated with the study

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Infections; Fractures, Bone

Study Officials

• Ida L Gitajn

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedics

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: July 26, 2021
• Study Start: August 13, 2021
• Primary Completion: August 30, 2022
• Study Completion: November 21, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)