Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures
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.
Timeline
- Start
- 2019-11
- Primary completion
- 2022-01
- Completion
- 2022-02
Outcome
Outcome not reported
Stopped: “Combined into an international study (CAR-BHA-I21)”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BHA | Unknown | — | Other |
Indications
No indication recorded.