OCT in Open Fracture and Infected Fracture

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05785182

Collaborator

Dartmouth College (Other)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Injury Trauma Open Fracture Fracture Infection	Procedure: Open Fracture Procedure: Infected Fracture

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Open Fracture High energy open fracture.	Procedure: Open Fracture Patients 18 years of age or older with open fracture. Provision of informed consent.
Infected Fracture Infected open or closed fracture.	Procedure: Infected Fracture Patients 18 years of age or older with infected fracture. Provision of informed consent.

Arm

Intervention/Treatment

Open Fracture

High energy open fracture.

Procedure: Open Fracture

Patients 18 years of age or older with open fracture. Provision of informed consent.

Infected Fracture

Infected open or closed fracture.

Procedure: Infected Fracture

Patients 18 years of age or older with infected fracture. Provision of informed consent.

Outcome Measures

Primary Outcome Measures

Feasibility and acceptability of OCT imaging [36 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 years or older
Open fracture
Fracture Related Infection

Exclusion Criteria:

Metatarsal fractures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03766

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center
Dartmouth College

Investigators

Principal Investigator: Ida L Gitajn, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ida Leah Gitajn, Section Chief, Orthopaedics, Dartmouth-Hitchcock Medical Center

ClinicalTrials.gov Identifier:

NCT05785182

Other Study ID Numbers:

STUDY02001786

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Bone

Wounds and Injuries

Fractures, Open

Study Results

No Results Posted as of Mar 27, 2023