OCT in Open Fracture and Infected Fracture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Open fracture
Fracture Related Infection
Disqualifiers
Metatarsal fractures
Trial population
Patients 18 years of age or older who present to DHMC (Lebanon) with open and infected fracture
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Open Fracture
Procedure/SurgeryPatients 18 years of age or older with open fracture. Provision of informed consent.
Infected Fracture
Procedure/SurgeryPatients 18 years of age or older with infected fracture. Provision of informed consent.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Open Fracture1 intervention
Group B: Infected Fracture1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
36 monthsSponsors and contacts
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Dartmouth-Hitchcock Medical Center
Lead sponsor
Dartmouth College
Collaborator
Source ClinicalTrials.gov