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NCT03249909 · ClinicalTrials.gov registry record · NA
Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings
A NA study of Wounds and Injuries, sponsored by Molnlycke Health Care AB.
- Completed
- Registry status
- NA
- Development phase
- 109
- Enrollment target
- 8
- Study locations
NCT03249909: Completed NA study of Wounds and Injuries, sponsored by Molnlycke Health Care AB.
NCT03249909 is a NA study of Wounds and Injuries that has completed, run by Molnlycke Health Care AB. The registered enrollment target is 109 participants, below the 500-participant average among 27 other Wounds and Injuries trials with a reported enrollment target (78% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03249909, a NA study of Wounds and Injuries, has completed, sponsored by Molnlycke Health Care AB.
- COMPLETED
- Registry status
- NA
- Development phase
- 109 participants
- Enrollment target
- 8
- Study locations
Study Summary
Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds
Primary Outcome
The primary endpoint measures exudate status based on dressing condition in categorical variables: Dry, Moist, Wet, Saturated, Leaking. Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups was performed with a two-sided Sign test on the Intent To Treat (ITT) population at significance level 0.05. If a subject had missing values at 4 weeks (Visit 5), last observation carried forward (LOCF) was applied from Visit 2 (1 week
Conditions Studied
Interventions
- DEVICE Exufiber
- DEVICE Exufiber Ag+
- DEVICE Aquacel Ag Extra
Study Locations (8)
Florida
- University of Miami - Miami
- University of South Florida - Tampa
Arizona
- Midwestern University - Glendale
California
- Center for Clinical Research, Inc. - San Francisco
Idaho
- Boise VA Medical Center (Boise VAMC) M - Boise
New York
- Northwell Health - Lake Success
Ohio
- Jobst Vascular Institue (JVI) - Toledo
Pennsylvania
- Serena Group Research Institute - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2017-08-11 |
| Est. Completion | 2019-08-19 |
| Phase | NA |
What the finished NCT03249909 record still lists
NCT03249909 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 500-participant average among 27 other Wounds and Injuries trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Wounds and Injuries appearing as the primary indexed condition, and to 3 interventions - of which Exufiber is the first listed.
NCT03249909 lists 8 locations in 7 states (Florida, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT03249909 about?
NCT03249909 is a clinical study titled "Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings". Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds
What is the current status of trial NCT03249909?
This trial is currently completed. It is a NA study. The enrollment target is 109 participants. The study started on 2017-08-11. Estimated completion is 2019-08-19.
What conditions does trial NCT03249909 study?
This clinical trial studies the following conditions: Wounds and Injuries.
What interventions are being tested in trial NCT03249909?
The interventions under investigation include: Exufiber (DEVICE), Exufiber Ag+ (DEVICE), Aquacel Ag Extra (DEVICE).
Who is sponsoring clinical trial NCT03249909?
This trial is sponsored by Molnlycke Health Care AB, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03249909 being conducted?
This trial has 8 study locations across Arizona, California, Florida, Idaho, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03249909's enrollment target sits among peer trials
109 19th of 27 higher than 9 of 27 other Wounds and Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Wounds and Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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