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NCT05785182 Clinical Trial

OCT in Open Fracture and Infected Fracture

Trauma Clinical Trial

Official title:
Optical Coherence Tomography Imaging to Visualize Bacteria or Biofilm on Hardware, Bone and Soft Tissue in Open Fracture and Infected Fracture

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05785182
Other study ID # STUDY02001786
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 27, 2023
Est. completion date June 2026

Study information
Verified date June 2024
Source Dartmouth-Hitchcock Medical Center
Contact Holly B Symonds
Phone 603-653-9440
Email Holly.B.Symonds@hitchcock.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a pilot prospective, observational study of patients with open or infected fracture evaluating the feasibility and acceptability of OCT, a light-based imaging modality that requires no drug or contrast agent.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date June 2026
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years or older - Open fracture - Fracture Related Infection Exclusion Criteria: - Metatarsal fractures

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Open Fracture
Patients 18 years of age or older with open fracture. Provision of informed consent.
• Infected Fracture
Patients 18 years of age or older with infected fracture. Provision of informed consent.

Locations
Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (2)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility and acceptability of OCT imaging The primary objective of this work is to demonstrate feasibility, acceptability, and preliminary effectiveness of Optical Coherence Tomography (OCT) to image bacteria and biofilm.
Data will be analyzed accordingly: The association between optical imaging parameters (particularly around biofilm and bacterial contamination) and (1) surgical wound severity and (2) development of infection or treatment failure for infection.		 36 months
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