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NCT02137447 · ClinicalTrials.gov registry record · Phase 4
Use of Negative Pressure Wound Therapy in High Risk Surgical Closed Incisions
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT02137447: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT02137447 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02137447, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in high risk surgical wounds to evaluate the rate of surgical site infections (SSIs). Hypothesis: Historically, the average rates of infective complications in surgical wounds types are 7.7% in clean wounds, 15% for contaminated and 35-40% for dirty wounds. The application of Prevena ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX) is expected to reduce these rates by 50%.
Primary Outcome
Incidence of SSIs within 1 month (4 weeks) from the index operation. SSI is defined by the Centers for Disease Control and Prevention's National Healthcare Surveillance Network
Interventions
- DEVICE Negative Pressure treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-09 |
| Phase | Phase 4 |
What the finished NCT02137447 record still lists
NCT02137447 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Negative Pressure treatment is the first listed.
NCT02137447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02137447 about?
NCT02137447 is a clinical study titled "Use of Negative Pressure Wound Therapy in High Risk Surgical Closed Incisions". The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in high risk surgical wounds to evaluate the rate of surgical site infections (SSIs). Hypothesis: Historically, the average rates of infective complications in surgical wounds types are 7.7% in clean wounds, 15%...
What is the current status of trial NCT02137447?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2014-05. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02137447?
The interventions under investigation include: Negative Pressure treatment (DEVICE).
Who is sponsoring clinical trial NCT02137447?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02137447's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 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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