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NCT01229358 · ClinicalTrials.gov registry record · Phase 4
Clinical Trial of a Silver Eluting Dressing System
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 500
- Enrollment target
NCT01229358: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT01229358 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 500 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01229358, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 500 participants
- Enrollment target
Study Summary
This prospective, multi-institutional randomized clinical trial of a silver ion eluting dressing material compared to standard dry gauze for closed skin incisions after open surgical revascularizations for peripheral vascular occlusive disease. Based on the ability of the silver to lower the bacterial contamination of these vulnerable surgical skin incisions, the investigators hypothesize that immediate application of Acticoat Absorbent® as a post-operative dressing will reduce closed incisional wound complications in patients undergoing lower extremity revascularizations involving infrainguinal skin incisions compared to standard non-silver eluting dressing material.
Primary Outcome
* No Wound Complication * Superficial Incisional SSI: Infection that occurs within 30 days after the operation and infection involves only skin/ SQ tissue of the incision * Deep Incisional SSI: Infection that occurs within 30 days after operation and infection appears to be related to the operation and infection involved deep tissues (fascial/muscle layers) of the incision * Other (seroma, lymphocele, hematoma, etc)
Interventions
- OTHER Surgical dressing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT01229358 record still lists
NCT01229358 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Surgical dressing is the first listed.
NCT01229358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01229358 about?
NCT01229358 is a clinical study titled "Clinical Trial of a Silver Eluting Dressing System". This prospective, multi-institutional randomized clinical trial of a silver ion eluting dressing material compared to standard dry gauze for closed skin incisions after open surgical revascularizations for peripheral vascular occlusive disease. Based on the ability of the silver to lower the bacteri...
What is the current status of trial NCT01229358?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 500 participants. The study started on 2010-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01229358?
The interventions under investigation include: Surgical dressing (OTHER).
Who is sponsoring clinical trial NCT01229358?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01229358's enrollment target sits among peer trials
500 165th of 2000 higher than 1,824 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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