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Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures

NCT03826784 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-01-23

No results posted yet for this study

Summary

This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open tibia fractures). It is hypothesized that by 6 months, the number of subjects with successful bone healing will be greater in the BHA-treated group compared to subjects treated with standard of care alone. Open tibia fractures were chosen for this study because healing rates are typically longer than for other bone fractures due to the limited vascular supply, limited soft tissue coverage, and higher risk of infection.

Conditions

  • Tibial Fractures

Interventions

COMBINATION_PRODUCT

BHA

BHA active ingredients include a blood-derived component and beta-tricalcium phosphate. It is applied directly to the bone fracture and nearby viable bone at the time of wound closure.

Sponsors & Collaborators

  • Carmell Therapeutics Corporation

    lead INDUSTRY

Principal Investigators

  • Janet M Vargo, PhD · Carmell Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2022-01-31
Completion
2022-02-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03826784 on ClinicalTrials.gov