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NCT01341444 · ClinicalTrials.gov registry record · NA
The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant Subjects
A NA study, sponsored by KCI USA.
- Terminated
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT01341444: Clinical Trial NA study, sponsored by KCI USA.
NCT01341444 is a NA study that was terminated before completion, run by KCI USA. The registered enrollment target is 63 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01341444, a NA study, was terminated before completion, sponsored by KCI USA.
- TERMINATED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study Summary
This study is being conducted to see how safe and effective the Prevena Incision Management System "Prevena" is when placed over a renal transplantation incision. Prevena provides negative pressure (suction) wound therapy. Prevena will be tested while applied during the time each subject is hospitalized and up to 5 days after the surgery. Prevena is a small portable negative pressure device which consists of a therapy unit that delivers negative pressure. It also includes a dressing system that is intended for use over closed incisions after surgery. The intent of this study is to evaluate Prevena versus the standard care that a doctor would use normally after a kidney transplant.
Primary Outcome
The primary objective to compare short-term surgical incision-related clinical outcomes in Subjects undergoing open renal transplant surgery when treated with Prevena vs. the standard-of-care wound dressing. Clinical outcomes of interest are defined as Surgical Site Complications (SSCs) that include incisional fluid accumulation (i.e. seroma, hematoma, abscess), dehiscence, surgical site infection (SSI). These outcomes will be compared to a control group consisting of subjects screened for the s
Interventions
- DEVICE Prevena Incision Management System
- OTHER Standard of Care for Surgical Incisions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-05 |
| Phase | NA |
Why NCT01341444 stopped before completion
NCT01341444 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Prevena Incision Management System is the first listed.
NCT01341444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01341444 about?
NCT01341444 is a clinical study titled "The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant Subjects". This study is being conducted to see how safe and effective the Prevena Incision Management System "Prevena" is when placed over a renal transplantation incision. Prevena provides negative pressure (suction) wound therapy. Prevena will be tested while applied during the time each subject is hospital...
What is the current status of trial NCT01341444?
This trial is currently terminated. It is a NA study. The enrollment target is 63 participants. The study started on 2013-08. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01341444?
The interventions under investigation include: Prevena Incision Management System (DEVICE), Standard of Care for Surgical Incisions (OTHER).
Who is sponsoring clinical trial NCT01341444?
This trial is sponsored by KCI USA, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01341444's enrollment target sits among peer trials
63 1157th of 2000 higher than 844 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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