Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
NCT ID:
NCT02148302
Group ID:
EG000
Title:
Harvesting Device (CelluTome©)
Description:
open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers.
Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8.
A run-in period of two weeks followed by twelve weeks of active treatment
Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
57
Other Number Affected:
15
Other Number At Risk:
57
Study:
NCT02148302
Results Section:
NCT02148302
Adverse Events Module:
NCT02148302