OCT in Open Fracture and Infected Fracture

Recruiting

• Conditions: Trauma; Trauma Injury; Open Fracture; Fracture Infection
• Interventions: Procedure: Open Fracture; Procedure: Infected Fracture

• Registration Number: NCT05785182
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-14
• Study Start: 2023-03-27
• Study First Posted: 2023-03-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 18 years or older
• Open fracture
• Fracture Related Infection

Exclusion Criteria

• Metatarsal fractures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open Fracture	Open Fracture	High energy open fracture.
Infected Fracture	Infected Fracture	Infected open or closed fracture.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States