OCT in Open Fracture and Infected Fracture | NCT05785182

Studies
OCT in Open Fracture and Infected Fracture

NCT05785182

Sponsor

Dartmouth-Hitchcock Medical Center

Status

Recruiting

Last Update Posted

Jun 27, 2025Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Trauma Injury
Trauma
Open Fracture
Fracture Infection

Interventions

Open Fracture
Infected Fracture

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2023Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Mar 14, 2023

First Submission Date that Met QC Criteria

Mar 14, 2023

First Posted Date

Mar 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2025

Last Update Posted Date

Jun 27, 2025Actual

Name	Class
Dartmouth College	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open Fracture		High energy open fracture.	Procedure: Open Fracture
Infected Fracture		Infected open or closed fracture.	Procedure: Infected Fracture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Open Fracture	Procedure	Patients 18 years of age or older with open fracture. Provision of informed consent.	Open Fracture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
Open fracture
Fracture Related Infection

Exclusion Criteria:

Metatarsal fractures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients 18 years of age or older who present to DHMC (Lebanon) with open and infected fracture

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Holly B Symonds	Contact	603-653-9440		Holly.B.Symonds@hitchcock.org
Devin S Mullin	Contact	603-650-6032		Devin.S.Mullin@hitchcock.org

Overall Officials

Name	Affiliation	Role
Ida L Gitajn	Dartmouth-Hitchcock Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dartmouth-Hitchcock Medical Center	Recruiting	Lebanon	New Hampshire	03766	United States

Condition Browse Module

MeSH Terms

ID	Term
D000081084	Accidental Injuries
D014947	Wounds and Injuries
D005597	Fractures, Open

Ancestor Terms

ID	Term
D050723	Fractures, Bone

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000070799	Open Fracture Reduction

Ancestor Terms

ID	Term
D005592	Fracture Fixation
D019637	Orthopedic Procedures
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided