ClinicalTrials.gov
public full text
Public Domain
Regenn® Therapy System Safety Study
The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure Wound Therapy (NPWT), in the post-operative surgical wounds of patients undergoing lumbar spinal fusion surgeries. The main questions the study aims to answer are: * The device-related serious adverse event rate. * Patient post-operative pain as assessed using a validated pain measurement scoring system. * The number and type of adverse events. * The rate of delayed seroma formation. Participants will * Be screened for their suitability to participate in the investigational study using questions about their health, medical history, and current medications. * Undergo a physical exam, an assessment of patient vital signs and routine blood analyses. * Complete an Informed Consent Form if selected to participate in the investigational study. * Be randomly assigned to the different study arms. * Not change the operation of their respective device or to disturb components of their device. * Notify their surgeon or designated healthcare provider should they have any questions or encounter any issues with their device. * Attend two post-operative visits at approximately one month and three months.
Conceptio Open Archive
Analyze & explore related research in Conceptio
Connect this record directly into your research workflow or AI agent. Explore citations across open repositories, query full text, and export structured proof bundles.
This document is indexed with metadata only: full text is not available in the archive for this record. Open the official source ↗
Related documents
- Pilot Study to Assess Safety/Preliminary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery#830298
- Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India#906273
- Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control#877459
- Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy#993043
- VASC-AF Study: Vascular Closure vs Manual Compression#1140218
Record · ID 896514
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Bring this data into your agent: Connect via MCP or API · 20 free credits to start · no card required
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive