Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT03709693
Brief Summary:
The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation. This study will also provide evidence of the clinical performance of SternaLock Blu for up to 90 days using real world evidence methodology. Sternal complications will be reported through 90 days follow up.
Detailed Description:
The primary endpoint for this study is the rate of deep sternal wound infection (DSWI) at 30 days post-operative, following a midline sternotomy closed with SternaLock Blu. DSWI is defined as deep infection involving muscle, bone, and/ or mediastinum requiring operative intervention and has all of the following conditions:
1. Wound opened with excision of tissue or re-exploration of mediastinum
2. Positive culture unless patient on antibiotics at the time of culture or no culture obtained
3. Treatment with antibiotics beyond perioperative prophylaxis
Post-operative sternal wound complications occurring within 90 days post-operative.
Outcomes will be reported up to 90 days after surgery, including data on adverse events associated with the use of SternaLock Blu Sternal Closure System from the moment of implantation to the end-of-study.
Study:
NCT03709693
Study Brief:
Protocol Section:
NCT03709693