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NCT02492854 · ClinicalTrials.gov registry record · NA
Standard Versus PICO Dressings in Lower-Extremity Bypass Patients
A NA study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT02492854: Clinical Trial NA study, sponsored by Boston Medical Center.
NCT02492854 is a NA study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02492854, a NA study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
The objective of this study is to compare the effectiveness of standard moist dressings and PICO single-use negative pressure dressings in post-operative lower extremity bypass patients. This study will compare the dressings' ability to decrease swelling, decrease post-operative infection, and improve mobility and quality of life measures. Subjects will be asked to participate in this study because they will undergo a lower extremity bypass using the ipsilateral great saphenous vein. Subjects will then be randomized to two post-operative treatment groups. One group will receive standard sterile gauze and the other will receive PICO single-use negative pressure dressings. Both groups will be assessed for study measures in follow-up visits as clinically indicated up to 1 year with the 30 day timepoint as the primary outcome for study measures.
Primary Outcome
The primary endpoint is lower-extremity bypass post-operative recovery that is free of major complications at 30 days post operation. This will be measured by a composite score based on three outcomes- leg swelling, ambulation, and infection (defined as antibiotics being prescribed). Each will be assigned a 0 if not present or a 1 if present and then summed for the composite score. The range can be from 0 to 3 with higher scores associated with more complications associated with surgical site in
Interventions
- DEVICE PICO Single-Use Negative Pressure Dressings
- OTHER Sterile Gauze Dressings
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-07-20 |
| Est. Completion | 2021-01-20 |
| Phase | NA |
Why NCT02492854 stopped before completion
NCT02492854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which PICO Single-Use Negative Pressure Dressings is the first listed.
NCT02492854 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02492854 about?
NCT02492854 is a clinical study titled "Standard Versus PICO Dressings in Lower-Extremity Bypass Patients". The objective of this study is to compare the effectiveness of standard moist dressings and PICO single-use negative pressure dressings in post-operative lower extremity bypass patients. This study will compare the dressings' ability to decrease swelling, decrease post-operative infection, and impro...
What is the current status of trial NCT02492854?
This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2015-07-20. Estimated completion is 2021-01-20.
What interventions are being tested in trial NCT02492854?
The interventions under investigation include: PICO Single-Use Negative Pressure Dressings (DEVICE), Sterile Gauze Dressings (OTHER).
Who is sponsoring clinical trial NCT02492854?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02492854's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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