Local Antibiotic Delivery From an Intramedullary Nail After Surgical Treatment of Tibial Fractures at High Risk of Infection

ClinicalTrials.gov ID: NCT07927166

Open the official record

This page only displays public information reproduced from the official ClinicalTrials.gov record NCT07927166. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Nov 15, 2026, 12:23 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Local Antibiotic Delivery From an Intramedullary Nail After Surgical Treatment of Tibial Fractures at High Risk of Infection: A Multicenter, Prospective, Open-Label Clinical Trial (RESELUTE Study)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this clinical trial is to learn whether an antibiotic-releasing nail placed inside the shinbone (tibia) helps prevent infection and supports bone healing in adults with an open shinbone fracture. The study will test two versions of the Reselution Tibial Intramedullary Fixation System: one that releases vancomycin (Reselution V) and one that releases vancomycin and tobramycin (Reselution VT). The main question it aims to answer is: within 12 months of surgery, how many participants heal without unplanned repeat surgery on the injured leg, have a healed bone on X-ray, and have no serious device-related side effects? Participants will: * Have surgery to fix their shinbone with the Reselution nail * Have blood tests in the first 2 weeks after surgery (this testing may be stopped for later participants after an independent safety review) * Attend follow-up visits for up to 24 months, including X-rays and questionnaires

Study identification

NCT ID: NCT07927166
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: Reselute, Inc.; Industry
Enrollment: 317 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range: 22 Years to 80 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 2027 (Estimated)
Primary completion: Feb 2029 (Estimated)
Completion: Feb 2030 (Estimated)
Last update posted: Nov 10, 2026

2027 – 2030

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
University of Maryland, Baltimore	Baltimore	Maryland	21201	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07927166, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 10, 2026 · Synced Nov 15, 2026